Medical Diagnostic Equipment Accessibility Standards, 6916-6939 [2012-2795]

Download as PDF 6916 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD 36 CFR Part 1195 [Docket No. ATBCB–2012–0003] RIN 3014–AA40 Medical Diagnostic Equipment Accessibility Standards Architectural and Transportation Barriers Compliance Board. ACTION: Notice of proposed rulemaking. AGENCY: The Architectural and Transportation Barriers Compliance Board (Access Board) is proposing accessibility standards for medical diagnostic equipment. The proposed standards contain minimum technical criteria to ensure that medical diagnostic equipment, including examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment used by health care providers for diagnostic purposes are accessible to and usable by individuals with disabilities. The standards will allow independent entry to, use of, and exit from the equipment by individuals with disabilities to the maximum extent possible. The standards do not impose any mandatory requirements on health care providers or medical device manufacturers. However, other agencies, referred to as an enforcing authority in the standards, may issue regulations or adopt policies that require health care providers subject to their jurisdiction to acquire accessible medical diagnostic equipment that conforms to the standards. SUMMARY: Submit comments by June 8, 2012. Hearings will be held on the proposed standards on the following dates: 1. March 14, 2012, 9:30 a.m. to 12 p.m., Washington, DC. 2. May 8, 2012, 9:30 a.m. to 12 p.m., Atlanta, GA. ADDRESSES: Submit comments by any of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Regulations.gov ID for this docket is ATBCB–2012–0003. • Email: docket@access-board.gov. Include docket number ATBCB–2012– 0003 in the subject line of the message. • Fax: 202–272–0081. • Mail or Hand Delivery/Courier: Office of Technical and Informational Services, Access Board, 1331 F Street mstockstill on DSK4VPTVN1PROD with PROPOSALS3 DATES: VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 NW., Suite 1000, Washington, DC 20004–1111. All comments, including any personal information provided, will be posted without change to https:// www.regulations.gov and are available for public viewing. The hearing locations are: 1. Washington, DC: Access Board Conference Room, 1331 F Street NW., Suite 800, Washington, DC 2004. 2. Atlanta, GA: Hilton Atlanta (Meeting Rooms 309–311), 255 Courtland Street NE., Atlanta, GA 30303. FOR FURTHER INFORMATION CONTACT: Earlene Sesker, Office of Technical and Information Services, Architectural and Transportation Barriers Compliance Board, 1331 F Street NW., Suite 1000, Washington, DC 20004–1111. Telephone: (202) 272–0022 (voice) or (202) 272–0091 (TTY). Email address sesker@access-board.gov. SUPPLEMENTARY INFORMATION: Table of Contents for Preamble 1. Public Participation and Request for Comments 2. Establishment of Advisory Committee 3. Background A. Access Board B. Patient Protection and Affordable Care Act and Section 510 of the Rehabilitation Act C. Americans With Disabilities Act and Section 504 of the Rehabilitation Act D. Department of Justice Activities Related to Health Care Providers and Medical Equipment E. Private Enforcement Efforts F. Consultation With Food and Drug Administration G. ANSI/AAMI HE 75 H. Barriers Affecting Accessibility and Usability of Medical Diagnostic Equipment 4. Organization of Technical Criteria 5. Discussion of Proposed Standards 6. Regulatory Analyses 1. Public Participation and Request for Comments The preamble includes questions that request comments on issues that the Access Board is particularly interested in receiving information from the public. The Access Board encourages all persons interested in the rulemaking to submit comments on the proposed standards and the questions in the preamble. Instructions for submitting and viewing comments are provided above under Addresses. The Access Board will consider all the comments and may change the proposed standards based on the comments. 2. Establishment of Advisory Committee The Access Board has used advisory committees consisting of representatives PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 of interest groups that are affected by its guidelines and standards to assist in developing the guidelines and standards. Advisory committees provide significant expertise on issues and an opportunity for interest groups to reach consensus on issues. The Access Board plans to convene an advisory committee when the comment period on the rulemaking closes to assist the Board in reviewing the comments and make recommendations on issues addressed in the rulemaking. The Access Board will issue a separate notice in the Federal Register announcing the establishment of the advisory committee and seeking nominations for membership on the advisory committee to represent the interests of individuals with disabilities, medical device manufacturers, health care providers, standards setting organizations, and other interested parties. Advisory committee meetings will be announced in advance in the Federal Register and will be open to the public. 3. Background A. Access Board The Access Board is an independent Federal agency established by Section 502 of the Rehabilitation Act (29 U.S.C. 792).1 The Access Board is responsible for developing accessibility guidelines and standards under various laws to ensure that individuals with disabilities have access to and use of buildings and facilities, transportation vehicles, and information and communication technology.2 Pursuant to these laws, other Federal agencies have adopted the Access Board’s guidelines and standards as mandatory requirements for entities subject to their jurisdiction.3 1 The Access Board consists of 13 members appointed by the President from the public, a majority of which are individuals with disabilities, and the heads of 12 Federal agencies or their designees whose positions are Executive Level IV or above. The Federal agencies are: The Departments of Commerce, Defense, Education, Health and Human Services, Housing and Urban Development, Interior, Justice, Labor, Transportation, and Veterans Affairs; General Services Administration; and United States Postal Service. 2 The Access Board has issued accessibility guidelines and standards under the following laws: Section 504 of the Americans with Disabilities Act (42 U.S.C. 12204) for buildings and facilities, and transportation vehicles; Section 502 of the Rehabilitation Act (29 U.S.C. 792) for buildings and facilities; Section 508 of the Rehabilitation Act (29 U.S.C. 794d) for electronic and information technology; and Section 255 of the Telecommunications Act (47 U.S.C. 255) for telecommunications equipment and customer premises equipment. Additional information on the guidelines and standards is available at: https:// www.access-board.gov. 3 The following Federal agencies have adopted the Access Board’s guidelines and standards as mandatory requirements for entities subject to their E:\FR\FM\09FEP3.SGM 09FEP3 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS3 B. Patient Protection and Affordable Care Act and Section 510 of the Rehabilitation Act Section 4203 of the Patient Protection and Affordable Care Act (Pub. L. 111– 148, 124 Stat. 570) amended Title V of the Rehabilitation Act, which establishes rights and protections for individuals with disabilities, by adding Section 510. Section 510 of the Rehabilitation Act (29 U.S.C. 794f) requires the Access Board, in consultation with the Commissioner of the Food and Drug Administration, to issue standards that contain minimum technical criteria to ensure that medical diagnostic equipment used in or in conjunction with medical settings such as physicians’ offices, clinics, emergency rooms, and hospitals is accessible to and usable by individuals with disabilities. The statute provides that the standards must allow for independent access to and use of the equipment by individuals with disabilities to the maximum extent possible. The statute lists examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment as examples of equipment to which the standards will apply. However, this list is not exclusive and the statute covers any equipment used by health care providers for diagnostic purposes. The statute does not cover medical devices used for monitoring or treating medical conditions such as glucometers and infusion pumps. Section 510 of the Rehabilitation Act requires the standards to be issued not later than 24 months after the enactment of the Patient Protection and Affordable Care Act. The Patient Protection and Affordable Care Act was enacted on March 23, 2010. Accordingly, the statutory deadline for issuing the standards is March 23, 2012. The statute also requires the Access Board, in consultation with the Commissioner of the Food and Drug Administration, to periodically review and amend the standards, as appropriate. Section 510 of the Rehabilitation Act does not require any entity to comply jurisdiction: Department of Justice (see 28 CFR 35.104 and 35.151; and 28 CFR 36.104 and 36.401 to 36.406); Department of Transportation (see 49 CFR 37.9 and Appendix A to 49 CFR part 37; and 49 CFR part 38); Federal Acquisition Regulatory Council (see 48 CFR 39.203); Federal Communications Commission (see 47 CFR part 6); General Services Administration (see 41 CFR 102– 77.65); and United States Postal Service (see 39 CFR 254.1). See also Deputy Secretary of Defense Memorandum on Access for People with Disabilities, October 31, 2008 at: https://www.accessboard.gov/ada-aba/dod-memorandum.htm. Some agencies have adopted the guidelines and standards with additions and modifications. VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 with the standards that the Access Board issues under this law. Compliance with the standards becomes mandatory only when an enforcing authority adopts the standards as mandatory requirements for entities subject to its jurisdiction. As discussed below, the Department of Justice (DOJ) may adopt the standards as mandatory requirements for health care providers pursuant to its authority under Titles II and III of the Americans with Disabilities Act. Other Federal agencies may adopt the standards as mandatory requirements for health care providers pursuant to their authority under Section 504 of the Rehabilitation Act. C. Americans With Disabilities Act and Section 504 of the Rehabilitation Act The Americans with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act are civil rights laws that prohibit discrimination on the basis of disability. Title II of the ADA (42 U.S.C. 12131 to 12165) applies to state and local governments, and Title III of the ADA (42 U.S.C. 12189 to 12189) applies to private entities that are public accommodations such as health care providers. Section 504 of the Rehabilitation Act (29 U.S.C. 792) applies to recipients of Federal financial assistance such as Medicaid and federally conducted programs. DOJ is responsible for issuing regulations to implement Titles II and III of the ADA.4 Federal agencies that provide Federal financial assistance are responsible for issuing regulations to implement Section 504 of the Rehabilitation Act for recipients of such assistance. Federal agencies also are responsible for issuing regulations to implement Section 504 of the Rehabilitation Act for their federally conducted programs. DOJ is responsible for overall enforcement of Titles II and III of the ADA, and Section 504 of the Rehabilitation Act as it applies to recipients of Federal financial assistance from DOJ and Federal financial assistance from other Federal agencies when those agencies refer complaints to DOJ for enforcement purposes.5 4 The Department of Transportation is responsible for issuing regulations to implement certain sections of Titles II and III of the ADA relating to transportation. 5 In its regulations implementing Title II of the ADA, DOJ has delegated responsibility for investigating complaints and conducting compliance reviews in specific subject matter areas to other Federal agencies, but at its discretion DOJ may retain complaints for investigation and appropriate disposition. See 28 CFR 35.190. DOJ has delegated responsibility for investigating complaints and conducting compliance reviews relating to the provision of health care services by state and local governments to the Department of Health and Human Services. Federal agencies that provide Federal financial assistance also investigate PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 6917 D. Department of Justice Activities Related to Health Care Providers and Medical Equipment Pursuant to the ADA and Section 504 of the Rehabilitation Act, health care providers must provide individuals with disabilities full and equal access to their health care services and facilities. DOJ has entered into settlement agreements with health care providers to enforce the ADA and Section 504 of the Rehabilitation Act.6 In July 2010, DOJ and the Department of Health and Human Services issued a guidance document for health care providers regarding their responsibilities to make their services and facilities accessible to individuals with mobility disabilities under the ADA and Section 504 of the Rehabilitation Act. See Access to Medical Care for Individuals with Mobility Disabilities available at: https://www.ada.gov/medcare_ta.htm. The guidance document includes information on accessible examination rooms and the clear floor space needed adjacent to medical equipment for individuals who use mobility devices to approach the equipment for transfer; accessible medical equipment (e.g., examination tables and chairs, mammography equipment, weight scales); patient lifts and other methods for transferring individuals from their mobility devices to medical equipment; and training health care personnel. In July 2010, DOJ also issued an advance notice of proposed rulemaking (ANPRM) announcing that, pursuant to the obligation that has always existed complaints and conduct compliance reviews regarding compliance with Section 504 of the Rehabilitation Act by recipients of such assistance. See Appendix A to 28 CFR part 41. The Federal agencies can refer matters that are not resolved successfully to DOJ for enforcement. 6 The settlement agreements by DOJ with health care providers and matters addressed in the agreements include: United States of America v. Inova Health System (March 30, 2011) auxiliary aids and services, including sign language interpreters; HCA Health Services of New Hampshire (Portsmouth Regional Hospital) (November 23, 2010) auxiliary aids and services, including sign language interpreters; Beth Israel Deaconess Medical Center (October 22, 2009) accessible facilities and accessible medical equipment; Gillespie v. Dimensions Health Corporation (July 12, 2006) auxiliary aids and services, including sign language interpreters; Washington Hospital Center (November 2, 2005) accessible facilities and accessible medical equipment; Valley Radiologists Medical Group, Inc. (November 2, 2005) accessible imaging equipment; Exodus Women’s Center (March 26, 2005) accessible examination tables; Dr. Robila Ashfaq (January 12, 2005) accessible examination table; and Georgetown University Hospital (October 31, 2001) providing assistance for transferring from a wheelchair to an examination table The settlement agreements are available at: https://www.ada.gov/ settlemt.htm. E:\FR\FM\09FEP3.SGM 09FEP3 6918 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules under the ADA for covered entities to provide accessible equipment and furniture, it was considering amending its regulations implementing Titles II and III of the ADA to include specific standards for the design and use of accessible equipment and furniture that is not fixed or built into a facility in order to ensure that programs and services provided by state and local governments and by public accommodations are accessible to individuals with disabilities.7 See 75 FR 43452 (July 26, 2010). Among other things, the ANPRM stated that DOJ was considering amending its ADA regulations to specifically require health care providers to acquire accessible medical equipment and that it would consider adopting the standards issued by the Access Board. DOJ also indicated its intention to include in its ADA regulations scoping requirements that specify the minimum number of types of accessible medical equipment required in different types of health care facilities. If DOJ proposes to amend its ADA regulations as announced in the ANPRM, it will publish a notice of proposed rulemaking (NPRM) requesting public comment. E. Private Enforcement Efforts mstockstill on DSK4VPTVN1PROD with PROPOSALS3 Private parties, including individuals with disabilities, have also entered into settlement agreements with health care providers to enforce the ADA and Section 504 of the Rehabilitation Act.8 7 The ANPRM requested public comment on several categories of equipment and furniture, including medical equipment (e.g., medical examination and treatment tables and chairs, scales, radiological diagnostic equipment, lifts, infusion pumps, rehabilitation equipment, hospital beds and gurneys, ancillary equipment such as positioning straps or cushions, protective padding, leg supports for gynecological examinations, rails and bars for patient safety and comfort, and call buttons); exercise equipment and furniture; accessible golf cars; beds in accessible guest rooms and sleeping rooms; beds in nursing homes and other care facilities; and electronic and information technology such as kiosks (i.e., interactive computer terminals that provide services), interactive transaction machines, point of sale devices, and automated teller machines. 8 The settlement agreements by private parties and matters addressed in the agreements include: Massachusetts General Hospital and Brigham and Women’s Hospital (June 26, 2009) accessible facilities, accessible medical equipment, and auxiliary aids and services; Thompson v. Sutter Health (July 11, 2008) accessible facilities, accessible medical equipment, and auxiliary aids and services; University of Southern California Medical Center (May 15, 2008) accessible facilities, accessible medical equipment, and auxiliary aids and services; and Metzler v. Kaiser Permanente (March 2001) accessible facilities and accessible medical equipment. The settlement agreements are available at: https:// thebarrierfreehealthcareinitiative.org/?page_id=16. VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 F. Consultation With Food and Drug Administration The Commissioner of the Food and Drug Administration has designated the Director of the Center for Devices and Radiological Health (FDA–CDRH) to consult with the Access Board on the development of standards for accessible medical diagnostic equipment. The Access Board has worked closely with the FDA–CDRH in developing the proposed standards. The FDA–CDRH may develop a guidance document to inform manufacturers how it intends to apply its regulatory authority to clearance or approval of medical devices addressed in the Access Board’s standards. If the FDA–CDRH develops such a guidance document, it will provide the public notice and opportunity to comment on a draft of the guidance document in accordance with its procedures for issuing guidance documents. See 21 CFR 10.115. G. ANSI/AAMI HE 75 In 2009, the Association for the Advancement of Medical Instrumentation issued ANSI/AAMI HE 75, a recommended practice on human factors design principles for medical devices. Chapter 16 of ANSI/AAMI HE 75 contains recommended practices regarding accessibility for patients and health care personnel with disabilities. Chapter 16 of ANSI/AAMI HE 75 is available at: https://www.aami.org/ he75/. The Access Board is committed to using voluntary consensus standards where practical and consistent with the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note). The Access Board has considered the recommended practices in Chapter 16 of ANSI/AAMI HE 75 in developing the technical criteria for the proposed standards. The technical criteria are generally consistent with and supplement the recommended practices in Chapter 16 of ANSI/AAMI HE 75. The Access Board seeks to promote harmonization of its guidelines and standards with voluntary consensus standards and plans to participate in future revisions to ANSI/AAMI HE 75. Question 1. Are there other voluntary consensus standards for medical diagnostic equipment that address accessibility for patients with disabilities, or are considering addressing accessibility for patients with disabilities in future revisions to the standards? PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 H. Barriers Affecting Accessibility and Usability of Medical Diagnostic Equipment The Rehabilitation Engineering Research Center on Accessible Medical Instrumentation conducted a national survey in 2004 to collect information on the types of medical equipment that is most difficult for individuals with disabilities to access and use.9 The survey was completed by a diverse sample of individuals with a wide range of disabilities, including mobility disabilities and sensory disabilities. Survey respondents who had experience with specific medical equipment rated their degree of difficulty when attempting to access or use the equipment as follows: • 75 percent rated examination tables as moderately difficult to impossible to use; • 68 percent rated radiology equipment as moderately difficult to impossible to use; • 53 percent rated weight scales as moderately difficult to impossible to use; and • 50 percent rated examination chairs as moderately difficult to impossible to use. Survey respondents reported difficulties with getting on and off the equipment, positioning their bodies on the equipment, physical comfort and safety, and communication issues. A subsequent study that involved focus group sessions of individuals with diverse disabilities provided additional information on barriers that affect the accessibility and usability of examination tables, examination chairs, imaging equipment, and weight scales.10 The equipment characteristics that the focus group participants identified as affecting their ability to access and use the equipment included the dimensions of the equipment (e.g., height, width, length), contact surfaces (e.g., stiffness, comfort, color contrast), supports for transferring onto and off of equipment and positioning their bodies on the equipment (e.g., handholds, 9 The results of the survey are reported in Jill M. Winters, Molly Follette Story, Kris Barnekow, June Isaacson Kailes, Brenda Premo, Erin Schier, Sarma Danturthi, and Jack M. Winters, ‘‘Results of a National Survey on Accessibility of Medical Instrumentation for Consumers,’’ in ‘‘Medical Instrumentation Accessibility and Usability Considerations,’’ edited by Jack M. Winters and Molly Follette Story (Boca Raton, CRC Press, 2007), 13–27. 10 The results of the focus group sessions are reported in Molly Follette Story, Erin Schwier, and June Isaacson Kailes, ‘‘Perspectives of Patients with Disabilities on the Accessibility of Medical Equipment: Examination Tables, Imaging Equipment, Medical Chairs, and Weight Scales,’’ Disability and Health Journal 2 (2009), 169–179. E:\FR\FM\09FEP3.SGM 09FEP3 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules 6919 armrests, side rails), controls (e.g., ease of operation), and displays and devices (e.g., legibility, understandability). The Access Board held a public meeting in July 2010 that featured panel discussions and presentations by experts and researchers on medical equipment accessibility, health care providers, medical device manufacturers, and other interested parties to provide information for developing the proposed standards. The transcript of the meeting is available at: https://www.access-board.gov/medicalequipment.htm. The technical criteria in the proposed standards address most of the barriers that have been identified as affecting the accessibility and usability of medical diagnostic equipment. However, it is not possible to address every barrier in the proposed standards, especially given the statutory deadline for issuing the standards. Research may be needed on some equipment characteristics that affect the accessibility and usability of equipment such as stiffness, comfort, and color contrast of contact surfaces. Section 510 of the Rehabilitation Act requires the Access Board to periodically review and amend the standards, as appropriate. The Access Board will address other barriers in future updates to the standards. Question 2. What other barriers that affect the accessibility and usability of medical diagnostic equipment should be addressed in future updates to the standards? Comments should include information on sources to support the development of technical criteria to address the barriers, where possible. Medical diagnostic equipment is typically designed to support patients in certain positions. For example, imaging equipment can be designed for use by patients lying on a platform bed, in a standing or seated position, or seated in a wheelchair. Examination chairs can be designed to recline and be used as examination tables. The technical criteria for providing patients with disabilities access to and use of each of these equipment types would differ based on the patient positions that the equipment is designed to support. Therefore, the technical criteria in the proposed standards are organized functionally by the patient positions that the equipment is designed to support instead of by types of equipment. Where equipment is designed to support more than one patient position, the equipment would have to meet the technical criteria for each position supported. The table below shows the four basic patient positions that medical diagnostic equipment can be designed to support; the equipment features that are addressed in the technical criteria for each of the patient positions; and the types of equipment to which the technical criteria apply for each of the patient positions. For example, X-ray equipment that is designed for use in a standing position for certain procedures would have to meet the technical criteria for slip resistant standing surface and standing supports for patients who use mobility aids such as canes or crutches, or who have limited stamina or other conditions that affect their ability to maintain balance. Mammography equipment that is designed for use by patients seated in a wheelchair would have to meet the technical criteria for wheelchair spaces, changes in level at entry to the wheelchair space, and height of the breast platform. The types of equipment listed in the last column of the table are meant to be illustrative. The technical criteria apply to any type of medical diagnostic equipment that is designed to support the patient positions indicated. Patient positions equipment designed to support Equipment features addressed in technical criteria Types of equipment to which technical criteria applies Supine, prone, or side-lying position (M301) .... Transfer surface, including height, size, and transfer sides. Transfer supports, stirrups, and head and back support. Lift compatibility ................................................ Seated position (M302) ..................................... Seated in a wheelchair (M303) ......................... Standing position (M304) ................................... 4. Organization of Technical Criteria Transfer surface, including height, size, and transfer sides. Transfer supports, armrests, and head and back support. Lift compatibility ................................................ Wheelchair space, including orientation, width, depth, knee and toe clearance, and surface slope. Changes in level at entry to wheelchair space, including ramps. Components capable of examining body parts of patients seated in a wheelchair, including height of breast platforms. Slip resistant standing surface ......................... mstockstill on DSK4VPTVN1PROD with PROPOSALS3 Standing supports ............................................ The proposed standards also include technical criteria for supports (see M305), for instructions or other information communicated to patients through the equipment (see M306), and for operable parts used by patients (see M307). VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 Question 3. In organizing the technical criteria functionally by the patient positions that medical diagnostic equipment is designed to support, is it clear which technical criteria apply to different types of equipment? If not, how should the technical criteria be organized so it is PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 Examination tables. Imaging equipment designed for use with platform beds. Examination chairs designed to recline and be used as examination tables. Examination chairs. Imaging equipment designed for use with a seat. Weight scales designed for use with a seat. Imaging equipment designed for wheelchair use. Weight scales designed for wheelchair use. Imaging equipment designed for use in standing position. Weight scales designed for use in standing position. clear which technical criteria apply to different types of equipment? 5. Discussion of Proposed Standards The proposed standards consist of three chapters. Chapter M1 addresses the application and administration of the proposed standards. Chapter M2 E:\FR\FM\09FEP3.SGM 09FEP3 6920 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules addresses scoping. Chapter M3 contains the technical criteria. The sections in each chapter are discussed below. Although the standards do not impose any mandatory requirements on health care providers or medical device manufacturers, the standards use mandatory language (i.e., shall) because other agencies, referred to as an enforcing authority in the standards, may issue regulations or adopt policies that require health care providers subject to their jurisdiction to acquire accessible medical diagnostic equipment that conforms to the standards. Sections marked as advisory provide guidance on the standards and are not mandatory. The Access Board is committed to writing standards that are clear, concise, and easy to understand so that persons who use the standards know what is required. Question 4. Is there language in the proposed standards that is ambiguous or not clear? Comments should identify specific language in the proposed standards that is ambiguous or not clear and, where possible, recommend alternate language that is clear. Chapter M1 Application and Administration M101.1 Purpose The proposed standards contain technical criteria for medical diagnostic equipment that is accessible to and usable by patients with disabilities. The standards provide for independent access to and use of diagnostic equipment by patients with disabilities to the maximum extent possible. mstockstill on DSK4VPTVN1PROD with PROPOSALS3 M101.2 Application As discussed above under Organization of Technical Criteria, the technical criteria are to be applied to medical diagnostic equipment based on the following patient positions that the equipment is designed to support: • Equipment used by patients in a supine, prone, or side-lying position (see M301); • Equipment used by patients in a seated position (see M302); • Equipment used by patients seated in a wheelchair (see M303); and • Equipment used by patients in a standing position (see M304). The diagnostic equipment’s labeling, instructions, and promotional material usually identify the patient positions that the equipment is designed to support. Where diagnostic equipment is designed to support more than one patient position, the technical criteria for each patient position supported are to be applied to the equipment. VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 Advisory M101.2 includes examples of diagnostic equipment designed to support more than one patient position and the technical criteria that apply to the equipment. M101.3 Equivalent Facilitation The use of alternative designs and technologies that result in substantially equivalent or greater accessibility than specified in the proposed standards is permitted. Generally, alternative designs or technologies that rely on assisted transfer only (e.g., use of a patient lift) are not permitted because they do not provide for independent access to and use of diagnostic equipment by patients with disabilities to the maximum extent possible. However, the standards include technical criteria for clearance in or around the base of the equipment for lift compatibility to allow the use of a patient lift by patients with disabilities for whom independent transfer may not be possible, and the use of alternative designs or technologies for lift compatibility is permitted. M101.4 Dimensions The standards are based on adult dimensions and anthropometrics. Dimensions that are not stated as ‘‘maximum’’ or ‘‘minimum’’ are absolute. M101.5 Dimensional Tolerances Dimensions are subject to conventional industry tolerances for manufacturing processes, material properties, and field conditions. Question 5. What information or resources are available concerning conventional industry tolerances for manufactured equipment such as medical diagnostic equipment? M102.1 Defined Terms The following terms are defined in the proposed standards: Enforcing authority, medical diagnostic equipment, operable parts, and transfer surface. The definition of medical diagnostic equipment is based on Section 510 of the Rehabilitation Act and means equipment used in or in conjunction with medical settings by health care providers for diagnostic purposes. For convenience purposes, the shorter term diagnostic equipment is used in place of medical diagnostic equipment after that term is first used in the standards. Examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment are examples of diagnostic equipment to which the standards apply. PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 The definitions of enforcing authority, transfer surface, and operable parts are discussed respectively under M201.1; M301.2 and M302.2; and M307. Question 6. Should other terms in the proposed standards be defined? Comments should identify specific terms in the proposed standards that should be defined and, where possible, recommend definitions. M102.2 Undefined Terms Collegiate dictionaries are used to define terms that are not defined in the proposed standards or in regulations or policies issued by the enforcing authority. M102.3 Interchangeability Singular and plural words, terms, and phrases are used interchangeably. Chapter M2 Scoping M201.1 Enforcing Authority The proposed standards do not include scoping requirements that specify the minimum number of types of accessible diagnostic equipment required in different types of health care facilities because Section 510 of the Rehabilitation Act authorizes the Access Board to issue only technical criteria. Other agencies, referred to as an enforcing authority in the standards (see defined terms in M102.1), may adopt the standards as mandatory requirements for entities subject to their jurisdiction. An enforcing authority can be a Federal, State, or local government agency that enforces laws prohibiting discrimination on the basis of disability, or regulates health care facilities. As discussed above under Department of Justice Activities Related to Health Care Providers and Medical Equipment, DOJ issued an ANPRM in July 2010 announcing that it was considering amending its regulations implementing Titles II and III of the ADA to specifically require health care providers to acquire accessible medical equipment and that it would consider adopting the standards issued by the Access Board. DOJ also indicated its intention to include in its ADA regulations scoping requirements that specify the minimum number of types of accessible medical equipment required in different types of health care facilities. Chapter M3 Technical Criteria Chapter M3 provides technical criteria for accessible diagnostic equipment based on the patient positions that the equipment is designed to support, including equipment used by patients in a supine, prone, or sidelying position (see M301); equipment E:\FR\FM\09FEP3.SGM 09FEP3 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules used by patients in a seated position (see M302); equipment used by patients seated in a wheelchair (see M303); and equipment used by patients in a standing position (see M304). Chapter M3 also provides technical criteria for supports (see M301.3, M302.3, M304.3, and M305); instructions and information communicated to patients through diagnostic equipment (see M306); and operable parts used by patients (see M307). The technical criteria specify measurements in inches and millimeters. The values stated in each system may not be exact equivalents, and each system should be used independently of the other. When discussing the technical criteria below, the measurements are stated in inches only. Figures showing example applications of the technical criteria to diagnostic equipment are available on the Access Board’s Web site at: https://www.accessboard.gov/medical-equipment.htm. The figures are provided to help readers understand how the technical criteria apply to diagnostic equipment. Question 7. Comments are requested on whether the figures can be improved to help readers better understand how the technical criteria apply to diagnostic equipment. mstockstill on DSK4VPTVN1PROD with PROPOSALS3 Sources for Technical Criteria The sources discussed below were used to develop the technical criteria. 2004 ADA and ABA Accessibility Guidelines The Access Board has developed and updated accessibility guidelines for buildings and facilities for over 30 years. The Access Board’s current guidelines for buildings and facilities were issued in 2004 and are known as the Americans with Disabilities Act and Architectural Barriers Act Accessibility Guidelines (hereinafter referred to as the ‘‘2004 ADA and ABA Accessibility Guidelines’’). The 2004 ADA and ABA Accessibility Guidelines are codified at 36 CFR part 1191 and are available at: https://www.access-board.gov/ada-aba/ final.cfm. The following technical criteria in the proposed standards are based on the 2004 ADA and ABA Accessibility Guidelines: • Height of transfer surfaces on diagnostic equipment used by patients in a supine, prone, or side-lying position and diagnostic equipment used by patients in a seated position (see M301.2.1 and M302.2.1); • Wheelchair spaces, including knee and toe clearance, and change in level at entry to the wheelchair spaces at diagnostic equipment used by patients VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 seated in a wheelchair (see M303.2 and M303.3); • Structural strength of transfer supports (see M305.2.2); and • Operable parts (see M307). The Access Board is also considering additional technical criteria based on the 2004 ADA and ABA Accessibility Guidelines for cross section dimensions and clearances around gripping surfaces on transfer and standing supports, and for reach ranges for operable parts on diagnostic equipment that are used by patients. Questions are included under the applicable sections requesting comments on whether the additional technical criteria under consideration would be appropriate for the equipment features or whether alternative technical criteria would be appropriate. Wheeled Mobility Anthropometry Project There have been dramatic changes in mobility devices and the characteristics of people who use these devices. The Access Board and the National Institute on Disability and Rehabilitation Research sponsored a Wheeled Mobility Anthropometry Project to collect measurements of approximately 500 people using a variety of mobility devices, including manual wheelchairs, power wheelchairs, and scooters. The Wheeled Mobility Anthropometry Project was conducted by the Center for Inclusive Design and Environmental Access. The final report on the Wheeled Mobility Anthropometry Project was issued in 2010 and is available at: https://www.udeworld.com/ anthropometrics.html. Data from the Wheeled Mobility Anthropometry Project showed that the seat heights of many mobility devices are above the range specified in the 2004 ADA and ABA Accessibility Guidelines for certain architectural features that involve transfers and that the dimensions for wheelchair spaces, including knee and toe clearance, do not accommodate many people in the sample. Data from the Wheeled Mobility Anthropometry Project also showed that many people in the sample needed a lower operating force to activate certain operable parts. The Wheeled Mobility Anthropometry Project included recommendations for specifications that would accommodate a broader range of people who use mobility devices. The data and recommendations from the Wheeled Mobility Anthropometry Project are discussed in connection with the following technical criteria: • Height of transfer surfaces on diagnostic equipment used by patients in a supine, prone, or side-lying position and diagnostic equipment used PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 6921 by patients in a seated position (see M301.2.1 and M302.2.1); • Wheelchair spaces, including knee and toe clearance, at diagnostic equipment used by patients while seated in a wheelchair (see M303.2); and • Operating force required to activate operable parts used by patients (see M307.4). The Access Board is considering specifying alternative technical criteria in the final standards based on the Wheeled Mobility Anthropometry Project. Questions are included under the applicable sections requesting comments on the alternative technical criteria. ANSI/AAMI HE 75 As discussed in the relevant sections below, the Access Board considered the recommended practices regarding accessibility in Chapter 16 of ANSI/ AAMI HE 75 in developing the technical criteria. The technical criteria are generally consistent with and supplement the recommended practices in ANSI/AAMI HE 75. Other Sources The Access Board used anthropometric data and other standards for the width of transfer surfaces on diagnostic equipment used by patients in a seated position (see M302.2.2), height of breast platforms on mammography equipment used by patients seated in a wheelchair (see M303.4.1), and standing supports in a vertical position for diagnostic equipment used by patients in a standing position (see M305.3.2). The sources are referenced in the relevant sections below. The Access Board also considered information provided at the July 2010 public meeting that featured panel discussions and presentations by experts and researchers on medical equipment accessibility, health care providers, medical device manufacturers, and other interested parties. The transcript of the meeting is available at: https://www.accessboard.gov/medical-equipment.htm. In addition, the Access Board considered public comments relating to medical equipment that were submitted in response to DOJ’s ANPRM on equipment and furniture. The public comments on DOJ’s ANPRM on equipment and furniture are available at https://www.regulations.gov (Docket ID: DOJ–CRT–2010–0008). Economic and Technical Impacts The technical criteria in Chapter 3 address the features that make diagnostic equipment accessible to and E:\FR\FM\09FEP3.SGM 09FEP3 mstockstill on DSK4VPTVN1PROD with PROPOSALS3 6922 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules usable by patients with disabilities. Comments are requested on the economic and technical impacts of the technical criteria in questions that follow the discussion of the technical criteria. Comments are welcomed from all sources. Manufacturers that currently incorporate accessible features in some of their products or plan to do so in the future are encouraged to comment particularly on Questions 8, 9, and 10. The Access Board will use the information provided in response to the questions to evaluate the economic and technical impacts of the technical criteria. Question 8. To what extent does diagnostic equipment currently incorporate features that conform to the technical criteria proposed in Chapter M3? If equipment conforms to some but not all of the technical criteria proposed in Chapter M3, the comments should identify which features conform to the technical criteria proposed in Chapter M3. Question 9. If diagnostic equipment does not currently incorporate features that conform to all the technical criteria proposed in Chapter M3, which technical criteria can be easily incorporated into the design or redesign and manufacture of equipment with little difficulty or expense? Which technical criteria would have the greatest incremental costs on the design or redesign and manufacture of equipment? Comments should include estimates of the incremental costs, where possible. Question 10. How often is diagnostic equipment redesigned? Would incorporating features that conform to the technical criteria proposed in Chapter M3 in the planned redesign of equipment lessen the economic and technical impacts? Question 11. Are there types of diagnostic equipment that cannot conform to certain technical criteria proposed in Chapter M3 because of the structural or operational characteristics of the equipment? Comments should identify the specific technical criteria which the equipment cannot conform to and discuss alternative methods for making the equipment accessible to patients with disabilities. Question 12. Do the technical criteria proposed in Chapter M3 have any positive or negative unintended consequences? VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 M301 Diagnostic Equipment Used by Patients in Supine, Prone, or Side-Lying Position M302 Diagnostic Equipment Used by Patients in Seated Position M301 provides technical criteria for diagnostic equipment used by patients in a supine, prone, or side-lying position, and M302 provides technical criteria for diagnostic equipment used by patients in a seated position. The purpose of these sections is to facilitate independent transfer onto and off of diagnostic equipment by patients with disabilities, including those who use mobility devices or aids, and to provide supports for patients with disabilities when positioning their bodies on the equipment. The sections also include provisions for clearance in and around the base of the equipment for lift compatibility to allow the use of a patient lift by patients with disabilities for whom independent transfer may not be possible. Except for the size of the transfer surface (see M301.2.2 and M302.2.2) and certain supports (see M301.3.2 for stirrups, and M302.3.2 for armrests), the technical criteria in these sections are the same and are discussed together below. The technical criteria for transfer surface size and for stirrups and armrests are discussed separately for diagnostic equipment used by patients in a supine, prone, or side-lying position and for diagnostic equipment used by patients in a seated position. Transfer Surface (M301.2 and M302.2) The technical criteria in M301.2 and M302.2 address the height and size of the transfer surface, and the transfer sides. The transfer surface is the part of the diagnostic equipment onto which patients who use mobility devices or aids transfer when moving onto and off of the equipment (see defined terms in M102.1). Depending on the configuration of the equipment, the transfer surface may coincide with the seat area of an examination chair, or occupy only a portion of an examination table or imaging bed platform. The technical criteria do not address the overall width and depth of patient support surfaces because of the diverse shape and size of these surfaces. Transfer Surface Height (M301.2.1 and M302.2.1) For many patients who use mobility devices, independent transfer is possible only if the height of the transfer surface is at or near the seat height of their mobility device. The transfer surface height is also critical for patients who use mobility aids such as walkers and canes and may find it difficult to get PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 up onto or down from an examination chair or table or imaging bed platform, and for facilitating assisted transfers. M301.2.1 and M302.2.1 would require the height of the transfer surface during patient transfer to be 17 inches minimum and 19 inches maximum measured from the floor to the top of the transfer surface. This height range is based on provisions in the 2004 ADA and ABA Accessibility Guidelines for architectural features that involve transfers (e.g., toilet seats, shower seats, dressing benches). Patient support surfaces can be adjusted to heights outside the specified dimensions when not needed for patient transfer such as when performing diagnostic procedures. Where patient support surfaces are contoured or upholstered for patient comfort or to support patient positioning during diagnostic procedures, the height of the transfer surface measured from the floor may vary across the transfer surface. The highest and lowest points of the transfer surface on such equipment would have to be within the specified dimensions. Where patient support surfaces are cushioned (e.g., polyurethane on top of cell foam), the upholstery may compress or deflect during use. If the height of the transfer surface is measured from the floor to the rigid platform under the cushion, the top of the upholstery may be outside the specified dimensions. Measuring the height of the transfer surface from the floor to the top of the upholstery under static conditions, without compression or deflection in the transfer surface, would provide a consistent method of measurement given the variety of materials used to cushion patient support surfaces and the differences in how the materials compress or deflect during use. Question 13. Should the technical criteria specify that the height of the transfer surface from the floor be measured to the top of the upholstery under static conditions, without compression or deflection in the transfer surface? Or should the technical criteria allow for more dynamic conditions and limit the amount of deflection permitted when a specific load is applied to the transfer surface? Adjustable Height Range Considered The technical criteria allow the height of transfer surfaces to be either fixed or adjustable within the 17 inches minimum and 19 inches maximum range. Based on the information discussed below, the Access Board is considering requiring in the final standards that the height of transfer surfaces be adjustable from 17 inches minimum to 25 inches maximum during E:\FR\FM\09FEP3.SGM 09FEP3 mstockstill on DSK4VPTVN1PROD with PROPOSALS3 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules patient transfer. Patient support surfaces can be adjusted outside this range when not needed for patient transfer such as when performing diagnostic procedures. Many types of diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position currently provide adjustable height patient support surfaces. ANSI/ AAMI HE75 recommends that the height of patient support surfaces ‘‘should be easy to adjust (ideally, powered) to suit the needs of health care professionals and patients.’’ ANSI/ AAMI HE75 further recommends that the height of patient support surfaces ‘‘should be adjustable to a position high enough to accommodate tall health care providers and the range of medical procedures that could occur * * * [and] to a position low enough [19 inches maximum] to allow for the comfort of providers who choose to work in a seated position, to enable patients to keep their feet on the floor while seated, and to accommodate patients who need to transfer laterally between the platform and a chair or wheelchair alongside.’’ See ANSI/AAMI HE 75, section 16.4.4. Transfer surfaces that are adjustable to the same heights as the seat heights of mobility devices reduce the effort needed to transfer since patients do not have to lift their body weight to make up the difference between the two surfaces, in one direction or the other. The Wheeled Mobility Anthropometry Project shows the occupied seat heights for people who use mobility devices vary considerably. See Analysis of Seat Heights for Wheeled Mobility Devices at: https://udeworld.com/analysis-ofseat-height-for-wheeled-mobilitydevices. The seat heights ranged from 16.3 inches to 23.9 inches for manual wheelchair users; 16.2 inches to 28.9 inches for power wheelchair users; and 18.8 inches to 25.3 inches for scooter users. Seat heights for males were typically higher than for females. Thirty (30) percent of male manual wheelchair users and 6 percent of male power wheelchair users had seat heights equal to or less than 19 inches. All the male manual wheelchair users and 92 percent of the male power wheelchair users had seat heights equal to or less than 25 inches. Thus, transfer surfaces that are adjustable from 17 inches minimum to 25 inches maximum during patient transfer accommodate significantly more patients who use mobility devices. Ideally, transfer surfaces should be adjustable to any height within the 17 inches minimum and 25 inches maximum range. However, intermediate heights may need to be established VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 within the range because of different methods for providing adjustability (e.g., power, mechanical) or other equipment limitations. The distance between the intermediate heights should be small. Question 14. Comments are requested on the following questions regarding the adjustable height range (17 inches minimum to 25 inches maximum during patient transfer) that the Access Board is considering requiring in the final standards for transfer surfaces on diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position: (a) What types of equipment currently provide patient support surfaces that are height adjustable? If there are several models of the same type of equipment, does at least one model provide patient support surfaces that are height adjustable? What is the range of adjustable heights? If the range of adjustable heights does not include 17 inches to 25 inches, what would be the incremental costs to achieve this range? (b) What types of equipment do not currently provide patient support surfaces that are height adjustable? What would be the incremental costs for the design or redesign and manufacture of the equipment to provide patient support surfaces that are height adjustable within the above range? (c) Are there types of equipment that cannot provide patient support surfaces that are height adjustable within the above range because of the structural or operational characteristics of the equipment? Comments should discuss alternative methods for making the equipment accessible to patients with disabilities. (d) Should intermediate heights be established within the above range? What intermediate heights within the above range would be appropriate to facilitate independent transfer by patients who use mobility devices and aids? Transfer Surface Size: Equipment Used by Patients in Supine, Prone, or SideLying Position (M301.2.2) As noted earlier, the technical criteria do not address the overall width and depth of patient support surfaces because of the diverse shape and size of these surfaces. ANSI/AAMI HE75 recommends that patient support surfaces ‘‘should allow patients to transfer themselves on and off safely and easily and to assume and maintain positions safely and comfortably.’’ For surfaces on which patients lie down, ANSI/AAMI HE75 recommends that ‘‘patients should be able to roll to a side PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 6923 or prone position with minimal need to lift or shift their center of gravity.’’ ANSI/AAMI HE75 notes that a standard examination table is 27 inches wide and a bariatric table is approximately 30 to 32 inches wide and recommends wider surfaces to make repositioning easier. See ANSI/AAMI HE 75, section 16.4.7. On diagnostic equipment used by patients in a supine, prone, or side-lying position, M301.2.2 would require the size of the transfer surface (i.e., part of the diagnostic equipment onto which patients who use mobility devices or aids transfer when moving onto and off of the equipment) to be 30 inches wide minimum and 15 inches deep minimum. The 30 inches minimum width is based on comments submitted by the Disability Rights Education and Defense Fund (DREDF) regarding medical equipment dimensions in response to DOJ’s ANPRM on equipment and furniture. The 30 inches minimum width and 15 inches minimum depth also are generally consistent with the dimensions specified in the 2004 ADA and ABA Accessibility Guidelines for rectangular seats in roll-in showers. The transfer surface dimensions do not include headrests, footrests, or similar supports for body extremities that do not support the patient’s overall body position. A transfer surface is permitted to be contoured; however, the minimum dimensions would have to fit within the contoured surface and cannot be reduced to accommodate an asymmetrical shape. As discussed under the technical criteria for transfer sides (see M301.2.3 and M302.2.3), the transfer surface would be located at a corner of the diagnostic equipment (e.g., foot of an examination table) to allow different approaches to the surface and a variety of transfers. The Access Board is considering requiring in the final standards that transfer surfaces be provided at more than one location on diagnostic equipment used by patients in a supine, prone, or side-lying position to accommodate the different ways patients with disabilities may transfer and reposition their bodies from a sitting to a lying position on such equipment. Question 15. Comments are requested on the following questions regarding the minimum dimensions (30 inches wide and 15 inches deep) proposed for the transfer surface on diagnostic equipment used by patients in a supine, prone, or side-lying position and whether transfer surfaces should be provided at more than one location on such equipment: E:\FR\FM\09FEP3.SGM 09FEP3 6924 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules (a) Do the above dimensions provide sufficient space for patients with disabilities to safely and easily transfer to the equipment? (b) Should the width of the patient support surface be at least as wide as the width of the transfer surface (30 inches minimum) to allow patients with disabilities to reposition their bodies to a lying down position and maintain positions safely and comfortably? What would be the incremental costs for the design or redesign and manufacture of the equipment to make the patient support surface at least as wide as the width of the transfer surface? (c) Would alternative dimensions be appropriate for transfer surfaces? Comments should include information on sources to support alternative dimensions, where possible. (d) Should an adjustable feature (e.g., extendable platform) be permitted to meet the transfer surface dimensions? (e) If transfer surfaces are required to be provided at more than one location on the equipment, where should the transfer surfaces be located? mstockstill on DSK4VPTVN1PROD with PROPOSALS3 Transfer Surface Size: Equipment Used by Patients in a Seated Position (M302.2.2) Seats on diagnostic equipment used by patients in a seated position typically provide back and arm support for patient comfort and stability. The space available for transfer on diagnostic equipment used by patients in a seated position is smaller than the space available on diagnostic equipment used by patients in a supine, prone, or sidelying position. On diagnostic equipment used by patients in a seated position, M302.2.2 would require the size of the transfer surface to be 21 inches wide minimum and 15 inches deep minimum. The 21 inches minimum width is based on the ideal chair width recommended in Architectural Graphic Standards for auditorium seating. See The American Institute of Architects, Architectural Graphic Standards (10th edition, 2000), page 919. The 15 inches minimum depth is generally consistent with the dimension specified in the 2004 ADA and ABA Accessibility Guidelines for rectangular seats in roll-in showers. The transfer surface dimensions do not include headrests, footrests, or similar supports for body extremities that do not support the patient’s overall body position. A transfer surface is permitted to be contoured; however, the minimum dimensions would have to fit within the contoured surface and cannot be reduced to accommodate an asymmetrical shape. VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 Question 16. Comments are requested on the following questions regarding the minimum dimensions (21 inches wide and 15 inches deep) proposed for the transfer surface on diagnostic equipment used by patients in a seated position: (a) Do the above dimensions provide sufficient space for patients with disabilities to safely and easily transfer to the equipment? (b) Would alternative dimensions be appropriate for transfer surfaces? Comments should include information on sources to support alternative dimensions, where possible. Transfer Sides (M301.2.3 and M302.2.3) M301.2.3 and M302.2.3 would require the transfer surface to be located so as to provide patients who use mobility devices the option to transfer onto the short side and the long side of the surface, and that each transfer side provide unobstructed access to the transfer surface. These sections would result in the transfer surface being located at a corner of the equipment and the two transfer sides adjoining at the edges of the equipment (e.g., foot of an examination table). Patients who use mobility devices would have the choice to approach parallel to the deep dimension of the transfer surface, parallel to the wide dimension of the transfer surface, or at an angle to the corner of the transfer surface and be able to perform a variety of transfers. Locating the transfer surface at a corner of the equipment and providing unobstructed access to the two transfer sides also would facilitate assisted transfers. Enforcing authorities may specify the clear floor space to be provided adjacent to the transfer sides of equipment in health care facilities. The transfer sides are permitted to be obstructed temporarily by features such as armrests, side rails, footrests, and stirrups provided they can be repositioned (e.g., folding armrests, removable side rails, retractable footrests and stirrups) to permit transfer. This is consistent with ANSI/AAMI HE 75 which recommends that ‘‘side rails, arm rests, leg supports * * * should be positioned, or able to be moved out of the way, so as not to interfere with the ability of users to transfer.’’ See ANSI/ AAMI HE 75, section 16.4.5. Otherwise, no part of the equipment can project beyond the edge of the transfer sides and obstruct access to the transfer surface. This is consistent with ANSI/ AAMI HE 75 which recommends that the ‘‘base of any patient-support platform should not extend horizontally beyond the edge of the support surface * * * [and] should not impede a PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 patient’s ability to orient a wheelchair next to the support surface.’’ See ANSI/ AAMI HE 75, section 16.4.2. The Access Board is considering whether the final standards should permit equipment parts to extend horizontally 3 inches maximum beyond the edge of the transfer sides provided they do not extend above the top of the transfer surface. This would allow handholds and other features which may facilitate transfer to be located on the transfer sides. The 2004 ADA and ABA Accessibility Guidelines provide a gap of 3 inches between the edge of a shower seat and the shower compartment entry, and the gap does not appear to interfere with transferring onto and off of the shower seat. Question 17. Comments are requested on the following questions regarding obstructions on the transfer sides: (a) Should equipment parts be permitted to extend horizontally 3 inches maximum beyond the edge of the transfer sides provided they do not extend above the top of the transfer surface? (b) If equipment parts are not permitted to extend horizontally 3 inches maximum beyond the edge of the transfer sides, would any diagnostic equipment need to be redesigned? Supports (M301.3, M302.3, and M305.2) ANSI/AAMI HE 75 recommends that handholds be ‘‘integrated into the device * * * [to] increase safety and assist patients in transferring on and off, positioning or repositioning their bodies, and maintaining static position.’’ See ANSI/AAMI HE 75, section 16.4.6. M301.3, M302.3, and M305.2 provide technical criteria for transfer and positioning supports on diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position. Some supports such as armrests and side rails can be used for transferring and positioning. As discussed under M301.2.3 and M302.2.3, transfer and positioning supports on the transfer sides of transfer surfaces would have to be capable of being repositioned (e.g., folding armrests, removable side rails, retractable footrests and stirrups) to permit transfer. Transfer Supports (M301.3.1, M302.3.1, and M305.2) M301.3.1 and M302.3.1 would require transfer supports to be provided for use with the transfer sides. M305.2.1 would require the transfer supports to be located within reach of the transfer surface and not obstruct transfer onto the surface when in position. M305.2.2 E:\FR\FM\09FEP3.SGM 09FEP3 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules would require the transfer supports and their connections to be capable of resisting vertical and horizontal forces of 250 pounds applied to all points of the transfer support. M305.2.3 would require the transfer supports to not rotate within their fittings. These technical criteria are based on provisions in the 2004 ADA and ABA Accessibility Guidelines for grab bars. Question 18. Comments are requested on the following questions regarding the structural strength of transfer supports: (a) Are transfer supports that can be repositioned (e.g., folding armrests, removable side rails) currently capable of resisting vertical and horizontal forces of 250 pounds applied to all points of the transfer support? If the transfer supports are not currently capable of resisting these forces, what would be the incremental costs for the design or redesign and manufacture of the equipment to provide transfer supports that are capable of resisting these forces? (b) Would alternative technical criteria be appropriate for the structural strength of transfer supports? Comments should include information on sources to support the alternative technical criteria, where possible. mstockstill on DSK4VPTVN1PROD with PROPOSALS3 Additional Technical Criteria Considered for Transfer Supports As discussed below, the Access Board is considering whether additional technical criteria would be appropriate for transfer supports. Location and Size Midmark Corporation provided information based on input from accessibility experts regarding side rails on examination tables in comments submitted in response to the DOJ’s ANPRM on equipment and furniture. The side rails are similar in shape to grab bars and are located on each of the long sides of the table. Each side rail can be removed to permit patients to transfer onto and off of the table, and to permit health care personnel to perform diagnostic procedures. The side rails can also be relocated along the table surface (from foot-end to head-end) for patients to position or reposition their bodies, and to maintain static positions. The side rails are 20 inches minimum in length, 6 inches minimum in height above the table surface, and 1 inch measured horizontally from the adjacent edge of the table surface. The Access Board is considering whether the following technical criteria would be appropriate for the location and size of transfer supports on diagnostic equipment used by patients in a supine, prone, or side-lying VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 position, and diagnostic equipment used by patients in a seated position: • At least one transfer support would be provided on the side of the transfer surface that is 15 inches deep minimum. The transfer support would be located on the side of the transfer surface that is opposite the transfer side (see M301.2.3 and M302.2.3) similar to the provisions in the 2004 ADA and ABA Accessibility Guidelines for grab bars provided at bathtubs and shower compartments with seats. This would be a minimum requirement. Where possible, it is recommended that supports be provided on each side of the transfer surface that is 15 inches deep minimum for patients to maintain position after they have transferred onto the equipment, and that the supports be repositionable to permit transfer. • The transfer support would extend horizontally the entire depth of the transfer surface and would be 15 inches minimum in length. • The gripping surface of the transfer support would be located 11⁄2 inches maximum measured horizontally from the adjacent edge of the transfer surface. This would ensure that the transfer support is within reach and can be effectively used during transfers. The above technical criteria would likely result in the transfer surface being located at the foot end of examination tables and allow the use of transfer supports similar to the side rails described in the information provided by Midmark Corporation. Question 19. Comments are requested on the following questions regarding the above technical criteria for the location and size of transfer supports on diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position: (a) Are the above technical criteria for the location and size of transfer supports sufficient to facilitate transfer and maintain position on the equipment? (b) Can transfer supports on different types of equipment meet the above technical criteria for the location and size of the supports? (c) What would be the incremental costs for the design or redesign and manufacture of transfer supports that meet the above criteria? (d) Would alternative technical criteria be appropriate for the location and size of transfer supports? Comments should include information on sources to support the alternative technical criteria, where possible. (e) Should angled or vertical transfer supports be permitted? PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 6925 Height The Access Board is considering whether 6 inches minimum and 19 inches maximum above the transfer surface would be an appropriate height for transfer supports on diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position. The minimum height is consistent with the information provided by Midmark Corporation on examination table side rails, and the maximum height is generally consistent with the height of grab bars above shower seats in the 2004 ADA and ABA Accessibility Guidelines. Question 20. Comments are requested on the following questions regarding the above height range (6 inches minimum and 19 inches maximum above the transfer surface) for transfer supports on diagnostic equipment used by patients in a supine, prone or side-lying position, and diagnostic equipment used by patients in a seated position: (a) Are transfer supports within the above height range usable by patients with disabilities? (b) Can transfer supports on different types of equipment meet the above height range? (c) Would alternative technical criteria be appropriate for the height of transfer supports? Comments should include information on sources to support the alternative technical criteria, where possible. Cross Section of Gripping Surfaces The 2004 ADA and ABA Accessibility Guidelines specify the following dimensions for grab bars to enable individuals with disabilities to firmly grasp the grab bars and support themselves during transfers: • Grab bars with circular cross sections must have an outside diameter of 11⁄4 inches minimum and 2 inches maximum. • Grab bars with non-circular cross sections must have a cross section dimension of 2 inches maximum and a perimeter dimension of 4 inches minimum and 4.8 inches maximum. The Access Board is considering whether the above cross section dimensions would be appropriate for the gripping surfaces of transfer supports on diagnostic equipment used by patients in a supine, prone, or sidelying position, and diagnostic equipment used by patients in a seated position. Question 21. Comments are requested on the following questions regarding the above cross section dimensions for the gripping surfaces of transfer supports on E:\FR\FM\09FEP3.SGM 09FEP3 6926 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position: (a) Can the gripping surfaces of transfer supports on different types of equipment meet the above cross section dimensions? (b) Can handholds that meet the above cross section dimensions be integrated into the design of armrests that are cushioned to support arms and elbows? (c) Are there alternative designs for the gripping surfaces of transfer supports that enable patients with disabilities to firmly grasp the supports and support themselves during transfer? Clearances Around Gripping Surfaces The 2004 ADA and ABA Accessibility Guidelines specify the following clearances around grab bars to ensure sufficient space for a person to grasp the grab bar: 11⁄2 inches absolute clearance between grab bars and the adjacent wall surfaces; 11⁄2 inches minimum clearance between grab bars and projecting objects below and at the ends of grab bars; and 12 inches minimum clearance between grab bars and projecting objects above grab bars. The Access Board is considering whether 11⁄2 inches minimum clearance around the gripping surface would be appropriate for transfer supports on diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position. Question 22. Can transfer supports on different types of equipment provide 11⁄2 inches minimum clearance around the gripping surface? mstockstill on DSK4VPTVN1PROD with PROPOSALS3 Stirrups (M301.3.2) Where stirrups are provided on diagnostic equipment used by patients in a supine, prone, or side-lying position, M301.3.2 would require the stirrups to provide a method of supporting, positioning, and securing the patient’s legs. This is consistent with ANSI/AAMI HE75 which recommends that ‘‘[f]or patients with limited leg strength and control, instead of stirrups that support only the foot and require active user leg strength, leg supports that support both the foot and the leg should be used to assist patients in keeping their legs in an appropriate position.’’ See ANSI/AAMI HE 75, section 16.4.7(g). Question 23. Comments are requested on the following questions regarding stirrups: (a) What would be the incremental costs for the design or redesign and manufacture of stirrups that provide a VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 method of supporting, positioning, and securing the patient’s legs? (b) Should diagnostic equipment used by patients in a seated position that provide stirrups such as urodynamics study chairs be required to provide a method of supporting, positioning, and securing the patient’s legs? Armrests (M302.3.2) M302.3.2 would require armrests to be provided on diagnostic equipment used by patients in a seated position. This is consistent with ANSI/AAMI HE75 which recommends that ‘‘[f]or support surfaces that require the patient to assume a seated position, armrests should be provided to enhance patient comfort, stability, and ease of transfer.’’ See ANSI/AAMI HE 75, section 16.4.7(e). Where armrests serve as transfer supports, the armrests would be required to meet the technical criteria in M305.2 for the location and structural strength of transfer supports. Otherwise, there are no technical criteria for armrests. Head and Back Support (M301.3.3 and M302.3.3) Where diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position can be adjusted to reclined positions, M301.3.3 and M302.3.3 would require head and back support to be provided throughout the entire range of the incline. This is consistent with ANSI/ AAMI HE75 which recommends that the ‘‘support surface needs to be adjustable or have adjustable support features (e.g., for the head, neck, back, lumbar region, leg, knee, and foot, as appropriate) to support patients in various postures and body positions in a manner that optimizes their comfort.’’ See ANSI/AAMI HE 75, section 16.4.7(h). Although not required by the proposed standards, examination tables that can be adjusted to a sitting position and then reclined to a horizontal position may be easier for patients with disabilities to transfer onto and off of than examination tables that are horizontal only. Positioning Supports Considered The Board is considering requiring in the final standards positioning supports such as rails, bars, or panels with handholds to be provided along the sides of diagnostic equipment used by patients in a supine, prone or side-lying position, and diagnostic equipment used by patients in a seated position that can be adjusted to a reclined position. As noted above, ANSI/AAMI recommends that handholds be PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 ‘‘integrated into the device * * * [to] increase safety and assist patients in transferring on and off, positioning or repositioning their bodies, and maintaining static position.’’ See ANSI/ AAMI HE 75, section 16.4.6. Pillows, wedges, and other padding can be used to stabilize and position patients on diagnostic equipment, but are not addressed in the proposed standards because they are not part of the diagnostic equipment. Question 24. Comments are requested on the following questions regarding positioning supports along the sides of diagnostic equipment used by patients in a supine, prone or side-lying position, and diagnostic equipment used by patients in a seated position that can be adjusted to a reclined position: (a) Should the technical criteria address the configuration of positioning supports (e.g., length, height above the patient support surface, location) to ensure their effectiveness? Or should the technical criteria require that positioning supports be provided within reach and provide flexibility for designing the supports based on the intended use of the equipment? (b) What would be the incremental costs for the design or redesign and manufacture of positioning supports? (c) Are there types of equipment that cannot provide positioning supports along the sides of the equipment because of the structural or operational characteristics of the equipment? Comments should discuss alternative methods to assist patients with disabilities safely position or reposition their bodies, and maintain a static position. Lift Compatibility (M301.4 and M302.4) M301.4 and M302.4 would require diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position to be usable with a patient lift for patients with disabilities for whom independent transfer may not be possible. A patient lift may be the only means of providing access to certain equipment that cannot meet the technical criteria for transfer surface height (see M301.2.1 and M302.2.1) because of the structural or operational characteristics of the equipment. For example, full body bone densitometers usually have components that move beneath the length of the patient support surface and may prevent the equipment from meeting the technical criteria for transfer surface height. Requiring the equipment to be usable with a patient lift is critical for ensuring the safety of both patients with E:\FR\FM\09FEP3.SGM 09FEP3 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS3 disabilities and health care personnel assisting with transfers. ANSI/AAMI HE 75 recommends that the ‘‘base of the device needs to have space underneath or along both sides (if the equipment is narrow) to accommodate the legs of portable mechanical lift equipment so that the patient can be suspended over the support surface before being lowered onto it.’’ See ANSI/AAMI HE 75, section 16.4.3. Portable floor lifts have legs with wheels that need to fit under or around the base of the diagnostic equipment. Lifts can vary in width along their length, and are usually the widest at the front casters and narrower at the patient sling location. Manufacturers of portable floor lifts usually recommend that the lifts be used with the legs extended in the widest position to maintain stability when lifting and lowering patients. As discussed below, the technical criteria provide two options for accommodating portable floor lifts consistent with ANSI/AAMI HE75: clearance in the base or clearance around the base. The clearances would be required at the side of the equipment where the portable floor lift is deployed so that the boom of the lift can maneuver far enough over the equipment and safely lower and raise the patient onto and off of the examination surface. The clearances do not restrict the overall size of the equipment base. Clearance in Base (M301.4.1 and M302.4.1) Clearance in the base of the equipment allows the legs of a portable floor lift to fit under the base of the equipment. The clearance can be an open area between the supporting posts beneath the equipment, or the equipment can be configured with a wide slot that is recessed into the base enclosure. M301.4.1 and M302.4.1 would require the clearance in the base to be 44 inches wide minimum, 6 inches high minimum measured from the floor, and 36 inches deep minimum measured from the edge of the examination surface. Where the width of the examination surface is less than 36 inches, the clearance depth would be required to extend the full width of the equipment. Equipment components are permitted to be located within 8 inches maximum of the centerline of the clearance width. Question 25. Comments are requested on the following questions regarding the proposed dimensions for clearance in the base of the equipment to allow the use of portable floor lifts: (a) Are the proposed dimensions for clearance in the base sufficient to VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 accommodate the various portable floor lifts used in health care facilities? (b) Do the proposed dimensions exclude certain types of lifts? (c) Should the clearance in the base be configured differently to allow additional flexibility for the use of portable floor lifts and, if so, how should it be configured? Clearance Around Base (M301.4.2 and M302.4.2) Clearance around the base of the equipment allows the legs of a portable floor lift to straddle the base. This option accommodates equipment with solid base enclosures that sit on or close to a floor. M301.4.2 and M302.4.2 would require the base of the equipment to provide a clearance 6 inches high minimum measured from the floor and 36 inches deep minimum measured from the edge of the examination surface. The width of the base permitted within this clearance would be 26 inches wide maximum at the edge of the examination surface and is permitted to increase at a rate of 1 inch in width for each 3 inches in depth. The permitted rate of increase in width can be distributed to each side of the base. Question 26. Comments are requested on the following questions regarding the proposed dimensions for clearance around the base of the equipment to allow the use of portable floor lifts: (a) Are the proposed dimensions sufficient to accommodate the various portable floor lifts used in health care facilities? (b) Do the proposed dimensions exclude certain types of lifts? (c) Should the clearance around the base be configured differently to allow additional flexibility for the use of portable floor lifts and, if so, how should it be configured? Overhead Lifts The technical criteria do not address overhead lifts that are usually mounted on the ceiling and operate on tracks suspended over the diagnostic equipment because the configuration of the equipment does not affect the operation of overhead lifts. Overhead lifts and portable floor lifts are used in health care facilities, and the technical criteria should not be viewed as preferring portable floor lifts. Overhead lifts may be the only option for certain diagnostic equipment because the structural or operational characteristics of the equipment prevent sufficient clearance in or around the base of the equipment for a portable floor lift. Question 27. If diagnostic equipment is designed for use with overhead lifts, should the equipment be exempted from PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 6927 providing clearance in or around the base for portable floor lifts? Folding Seats on Equipment Used by Patients Seated in a Wheelchair (M302.4 Exception) M302.4 includes an exception for diagnostic equipment that is designed for use by patients seated in a wheelchair and provides a folding seat. The exception does not require the equipment to comply with the technical criteria for lift compatibility because patients can use the equipment seated in a wheelchair. However, the folding seat would be required to meet the other technical criteria in M302 for transfer surfaces and supports. Question 28. Where diagnostic equipment is designed for use by patients seated in a wheelchair and provides a folding seat, should the folding seat be required to comply with the technical criteria in M302 for transfer surfaces and supports? M303 Diagnostic Equipment Used by Patients Seated in Wheelchair M303 provides technical criteria for diagnostic equipment used by patients seated in a wheelchair. M303 allows patients who use wheelchairs to position their wheelchairs at equipment typically used in a standing position such as mammography equipment, and also applies to equipment specifically designed for patients seated in a wheelchair such as weight scales and examination chairs. Wheelchair Spaces (M303.2) M303.2 would require a wheelchair space to be provided at diagnostic equipment used by patients seated in a wheelchair. M303.2 includes technical criteria for orientation, width, depth, and knee and toe clearance at wheelchair spaces. M303.2.1 would require wheelchair spaces to be designed so that patients seated in a wheelchair orient in the same direction that patients not seated in a wheelchair orient when using the equipment. For example, if an equipment component used to make images of body parts can be placed at different angles when used by patients who stand and by patients seated in a wheelchair, and patients who stand orient facing the component when it is in place for them, then the wheelchair space would be designed so that patients seated in a wheelchair orient facing the component when it is place for them. If the equipment is designed so that patients not seated in a wheelchair can orient their bodies in various directions when using the equipment, the wheelchair space would E:\FR\FM\09FEP3.SGM 09FEP3 mstockstill on DSK4VPTVN1PROD with PROPOSALS3 6928 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules be designed so that patients seated in a wheelchair can orient their bodies in the same directions. For example, if patients who stand can orient their bodies facing forwards or sideways in relation to the equipment when in use, the wheelchair space would be designed so that patients seated in a wheelchair can orient their bodies facing forwards or sideways in relation to the equipment when in use (i.e., wheelchair space can be entered from both the front or rear and from the side). M303.2.2 would require wheelchair spaces to be 36 inches (915 mm) wide minimum. This dimension is based on provisions in the 2004 ADA and ABA Accessibility Guidelines for maneuvering clearance where a clear floor or ground space is confined on all or part of three sides. M303.2.3 would require wheelchair spaces that can be entered from the front or rear to be 48 inches deep minimum, and wheelchair spaces that can be entered only from the side to be 60 inches deep minimum. These dimensions are based on provisions in the 2004 ADA and ABA Accessibility Guidelines. The Wheeled Mobility Anthropometry Project showed that the 48 inches deep dimension for wheelchair spaces entered from the front or rear does not accommodate many people in the sample, and that increasing the depth of wheelchair spaces entered from the front or rear to 58 inches minimum would accommodate 95 percent of the people in the sample. See Final Report of the Wheeled Mobility Anthropometry Project, pages 86–88. The Access Board is considering requiring in the final standards wheelchair spaces that can be entered from the front or rear to be 58 inches deep minimum. Question 29. Comments are requested on the following questions regarding the depth dimension (58 inches minimum) that the Access Board is considering requiring in the final standards for wheelchair spaces that can be entered from the front or rear: (a) What would be the incremental costs for the design or redesign and manufacture of the equipment to provide a wheelchair space that is 58 inches deep minimum? (b) Are there types of equipment that cannot provide a wheelchair space that is 58 inches deep minimum because of the structural or operational characteristics of the equipment? Diagnostic equipment with wheelchair spaces on raised platforms such as weight scales typically provide low barriers or curbs on the sides of the platform that are not used for entering and exiting the equipment to prevent VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 wheelchairs from slipping off the platform (i.e., edge protection). The Access Board is considering requiring edge protection at wheelchair spaces on raised platforms in the final standards. Question 30. Is there diagnostic equipment with wheelchair spaces on raised platforms that does not currently provide edge protection? If so, what would be the incremental costs to provide edge protection on such equipment? Exceptions Considered for Wheelchair Spaces on Raised Platforms The Access Board is considering adding exceptions in the final standards to the minimum width in M303.2.2 and the minimum depth in M303.2.3 for diagnostic equipment with wheelchair spaces on raised platforms. The exception to the minimum width in M303.2.2 would apply where ramped surfaces are provided on the opposite sides of the raised platform so that patients using wheelchairs can enter and exit the platform facing the same direction. The exception would permit the width of the wheelchair space between the edge protection to be reduced to 32 inches wide minimum at the platform level. This dimension is based on provisions in the 2004 ADA and ABA Accessibility Guidelines that allow accessible routes, which normally must be 36 inches wide minimum, to be 32 inches wide minimum for short distances such as at door openings. The exception would require a space 36 inches wide minimum to be provided outside the perimeter of the raised platform and above any edge protection so that patients using a manual wheelchair can extend their arms and elbows when they push on the wheel rims to maneuver onto and off of the platforms. The exception to the minimum depth in M303.2.3 for wheelchair spaces entered from the front or rear would permit a portion of the 48 inch minimum depth of the wheelchair space that accommodates the wheelchair footrests to extend beyond the raised platform and over any edge protection. For example, the wheelchair footrests would be allowed to extend beyond the depth of the raised platform and over any edge protection on wheelchair weight scales used by patients seated in a wheelchair. If exceptions are permitted to the minimum width and depth of wheelchair spaces on raised platforms, the technical criteria would specify the minimum and maximum height for any edge protection to prevent wheelchairs from slipping off the platform, but also allow the wheelchair footrests to extend PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 over the edge protection where the wheelchair space extends beyond the depth of the platform. Question 31. Comments are requested on the following questions regarding adding exceptions in the final standards to the minimum width in M303.2.2 and the minimum depth in M303.2.3 for diagnostic equipment with wheelchair spaces on raised platforms: (a) What is the typical distance between the front caster wheels of manual and power wheelchairs and the tips of the toes of the wheelchair user? How much of the 48 inch minimum depth of a wheelchair space that can be entered from the front or rear should be permitted to extend beyond the raised platform and over any edge protection? Comments should include information on sources to support the dimensions, where possible. (b) What should be the maximum height for any edge protection to allow the wheelchair footrests to extend over the edge protection where the wheelchair space extends beyond the depth of the platform? Comments should include information on sources to support the dimensions, where possible. (c) Where the equipment provides supports for patients who stand (e.g., handrails), should the exceptions prohibit the supports from obstructing the 36 inch wide minimum and 48 inch deep minimum space outside the perimeter of the raised platform and above any edge protection? Scooters have different wheelbases than manual and power wheelchairs. Diagnostic equipment with wheelchair spaces on raised platforms should also be usable by patients who use scooters. Patients who use scooters may have other options for using equipment with wheelchair spaces on raised platforms. For example, a weight scale with a raised platform for wheelchair use may provide a folding seat and supports for patients who can transfer independently from their mobility device to the scale. Question 32. Comments are requested on the following questions regarding diagnostic equipment with wheelchair spaces on raised platforms and the use of such equipment by patients who use scooters: (a) Is equipment with wheelchair spaces on raised platforms such as wheelchair scales currently usable by patients who use scooters? (b) If the equipment is not currently usable by patients who use scooters, should the width and depth of the raised platform be changed so that the equipment is usable by patients who use scooters? Comments should include E:\FR\FM\09FEP3.SGM 09FEP3 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules information on sources to support the dimensions, where possible. (c) Should folding seats and supports be required on equipment with wheelchair spaces on raised platforms for patients who can transfer independently from their mobility device to the raised platform? (d) If folding seats and supports are provided on equipment with wheelchair spaces on raised platforms, should the raised platform also accommodate scooters? Question 33. If exceptions are not permitted in the final standards to the minimum width and depth of wheelchair spaces on diagnostic equipment with raised platforms, comments are requested on the following questions: (a) What would be the incremental costs for the design or redesign and manufacture of equipment with raised platforms to provide a wheelchair space that that can be entered from the front or rear and conforms to the dimensions proposed in M303.2.2 and M303.2.3 (i.e., 36 inches wide minimum and 48 inches deep minimum)? (b) What would be the incremental costs for the design or redesign and manufacture of equipment with raised platforms to provide a wheelchair space that can be entered from the front or rear and conforms to the dimensions recommended by the Wheeled Mobility Anthropometry Project (i.e., 36 inches wide minimum and 58 inches deep minimum)? Knee and Toe Clearance (M303.2.4) M303.2.4 would require the depth of wheelchair spaces to include knee and toe clearance of 17 inches minimum and 25 inches maximum. Knee and toe clearance under breast platforms would be 25 inches deep. Knee and toe clearance are critical where patients seated in a wheelchair need to position their knees and toes next to or underneath a component of the diagnostic equipment. The component can be deeper than the 25 inches maximum depth required for knee and toe clearance, but a portion of the 6929 wheelchair space would be required to include knee and toe clearance of 17 inches minimum and 25 inches maximum under the component. The dimensions for toe clearance in M303.2.4.1 and knee clearance in M303.2.4.2 are based on the 2004 ADA and ABA Accessibility Guidelines and are shown in the second column of the table below. The Wheeled Mobility Anthropometry Project showed that these dimensions do not accommodate many people in the sample and recommended alternative dimensions that would accommodate 95 percent of the people in the sample. The alternative dimensions recommended by Wheeled Mobility Anthropometry Project are shown in the last column of the table below. See Final Report of the Wheeled Mobility Anthropometry Project, pages 89–92. The Access Board is considering requiring in the final standards the dimensions for toe clearance and knee clearance recommended by the Wheeled Mobility Anthropometry Project. Dimensions recommended by wheeled mobility anthropometry project Toe Clearance ............................. 6 inches deep maximum at 9 inches above the floor Knee Clearance .......................... mstockstill on DSK4VPTVN1PROD with PROPOSALS3 Proposed dimensions based on 2004 ADA and ABA accessibility guidelines 11 inches deep minimum at 9 inches above the floor, and 8 inches deep minimum at 27 inches above the floor. Between 9 inches and 27 inches above the floor, knee clearance is permitted to reduce at rate of 1 inch in depth for every 6 inches in height. 5 inches deep maximum at 14 inches above the floor. 12 inches deep minimum at 28 inches above the floor. Question 34. Comments are requested on the following questions regarding the dimensions for toe clearance and knee clearance recommended by the Wheeled Mobility Anthropometry Project that the Access Board is considering requiring in the final standards: (a) What would be the incremental costs for the design or redesign and manufacture of the equipment to include toe clearance and knee clearance that meets the dimensions recommended by the Wheeled Mobility Anthropometry Project? (b) Are there types of equipment that cannot include toe clearance and knee clearance that meets the dimensions recommended by the Wheeled Mobility Anthropometry Project because of the structural or operational characteristics of the equipment? M303.2.5 would require wheelchair space surfaces to not slope more than 1:48 in any direction. This is consistent with the 2004 ADA and ABA Accessibility Guidelines. VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 Knee clearance is same depth throughout and not sloped. Changes in Level at Entry to Wheelchair Spaces (M303.3) Additional Technical Criteria Considered for Handrails on Ramps M303.3 includes technical criteria for changes in level at the entry to a wheelchair space as may occur at wheelchair weight scales with raised platforms. The technical criteria are consistent with the 2004 ADA and ABA Accessibility Guidelines. Level changes up to 1⁄4 inch high are permitted to be vertical. Level changes between 1⁄4 inch high and 1⁄2 inch high would be required to be beveled with a slope not steeper than 1:2. Level changes greater than 1⁄2 inch high would be required to be ramped. Ramp runs would be required to have a running slope not steeper than 1:12 and a cross slope not steeper than 1:48. The clear width of ramp runs would be required to be 36 inches minimum. Ramps with drop offs 1⁄2 inch or greater would be required to provide edge protection 2 inches high minimum on each side to prevent users from inadvertently travelling off the sides of the ramped surface. M303.3.3.5 would require handrails to be provided on each side of the ramp when the vertical rise of the ramp exceeds 6 inches. This is consistent with the 2004 ADA and ABA Accessibility Guidelines. The Access Board is considering whether the technical criteria for handrails on ramps in section 505 of the 2004 ADA and ABA Accessibility Guidelines would be appropriate for handrails on diagnostic equipment ramps. These technical criteria are available at https:// www.access-board.gov/ada-aba/ final.cfm#a505 and address continuity, height, clearance, gripping surface, cross section, surfaces, fittings, and handrail extensions. Question 35. Comments are requested on the following questions regarding the technical criteria for handrails in section 505 of the 2004 ADA and ABA Accessibility Guidelines: PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 E:\FR\FM\09FEP3.SGM 09FEP3 6930 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS3 (a) Can handrails on diagnostic equipment ramps meet these technical criteria? (b) What would be the incremental costs for the design or redesign and manufacture of the equipment to provide handrails on diagnostic equipment ramps that conform to these technical criteria? Components (M303.4) M303.4 would require the components of diagnostic equipment used to examine specific body parts to be capable of examining the body parts of a patient seated in a wheelchair. The height of the component and any adjustable feature would have to accommodate patients seated in a wheelchair. For example, an X-ray platform on which a patient places their arm or hand would have to be capable of examining the arm or hand of a patient seated in a wheelchair. Mammography equipment was the subject of considerable discussion at the public meeting held by the Access Board in July 2010. The discussion highlighted the need for mammography equipment that is accessible to patients seated in a wheelchair. In addition to providing knee and toe clearance at the breast platform (see M303.2.4), the height of the breast platform was identified as critical to ensuring that mammography equipment is accessible to patients seated in a wheelchair. Mammography equipment with adjustable breast platforms is available. M303.4.1 would require the height of the breast platform to be 30 inches (760 mm) high minimum and 42 inches (1065 mm) high maximum above the floor when mammography equipment is used by patients seated in a wheelchair. The Wheeled Mobility Anthropometry Project showed that the seat heights of 96 percent of women using manual wheelchairs and 98 percent of women using power wheelchairs in the sample was between 17 inches and 24 inches above the floor. See Analysis of Seat Heights for Wheeled Mobility Devices at: https://udeworld.com/analysis-ofseat-height-for-wheeled-mobilitydevices. Other anthropometric data show the heights of the midpoint of the breast to be 13 inches for the 5th percentile woman and 18 inches for the 95th percentile woman when measured from seat height. See Laura Peebles and Beverley Norris, Adultdata: The Handbook of Adult Anthropometric and Strength Measurements: Data for Design Safety (London, Department of Trade and Industry, 1998), page 71. The proposed height range for the breast platform is based on the above anthropometric data. Breast platforms VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 can be located outside the proposed height range when not used by patients seated in a wheelchair. Question 36. Comments are requested on the following questions regarding breast platforms: (a) Is the proposed height range for the breast platform (30 inches high minimum and 42 inches high maximum above the floor) sufficient to accommodate patients seated in a wheelchair? (b) Are there other features of the breast platform that the technical criteria should address to ensure accessibility and, if so, how should they be addressed? Comments should include information on sources to support the technical criteria for the features, where possible. M304 Diagnostic Equipment Used by Patients in Standing Position M304 provides technical criteria for diagnostic equipment used by patients in a standing position such as a weight scale and X-ray equipment that is used in a standing position for certain diagnostic procedures. M304.2 and M304.3 would require a slip resistant standing surface and standing supports to accommodate patients with mobility disabilities who ambulate, patients who have limited stamina, and patients who have other conditions that affect their ability to maintain the balance needed to position themselves on the equipment or to maintain a standing posture at an equipment component. The proposed standards do not require diagnostic equipment to support more than one position. Where possible, it is recommended that diagnostic equipment be usable by patients with disabilities in as many positions as possible (i.e., standing position, seated position, and seated in a wheelchair). For example, mammography equipment with adjustable breast plates can be used by patients with disabilities in a standing position where standing supports are provided, in a seated position where a folding or removable seat is provided, and seated in a wheelchair where a wheelchair space is provided. A weight scale with a wheelchair space and ramped entry also can be used by patients with disabilities in a standing position where standing supports are provided and in a seated position where a folding or removable seat is provided. Question 37. Comments are requested on the following questions regarding whether a folding or removable seat should be required on diagnostic equipment used by patients in a standing position: PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 (a) Should a folding or removable seat be required on weight scale platforms? (b) Should a folding or removable seat be required on other types of diagnostic equipment used by patients in a standing position? (c) What would be the incremental costs for the design or redesign and manufacture of the equipment to provide a folding or removable seat on weight scale platforms or other types of diagnostic equipment used by patients in a standing position? (d) If folding or removable seats are provided on diagnostic equipment used by patients in a standing position, should the equipment be required to meet the technical criteria in M302 regarding transfer surfaces, supports, and lift compatibility for diagnostic equipment used by patients in a seated position? Standing Supports (M304.3 and M305.3) M304.3 would require standing supports to be provided on each side of the standing surface on diagnostic equipment used by patients in a standing position. M305.3 would require the standing supports to provide continuous support throughout the use of the diagnostic equipment and to not rotate within their fittings. M305.3 also provides technical criteria for standing supports in horizontal and vertical positions. Standing supports can be provided in a horizontal position, vertical position, or a combination of horizontal and vertical positions, as long as the minimum length of gripping surface is provided for the support position used on each side of the standing surface. Standing supports that adjust from horizontal to vertical positions and at angles in between, such as a bar that folds up and locks into multiple positions, can be used. These kinds of adjustable supports are not required but would accommodate a broad range of patients with disabilities, particularly where a patient needs to assume multiple body positions for a diagnostic procedure or needs to step up onto a surface and then maintain balance afterwards. For standing supports in a horizontal position, M305.3.1 would require the gripping surface to be 4 inches long minimum. The top of the gripping surface would be required to be 34 inches minimum and 38 inches maximum above the standing surface. The minimum length of the gripping surface is based on anthropometric data that provides specifications for men and women grasping cylinder grips which are stated as a range from 3.6 inches to 4.5 inches. See Henry Dreyfuss Associates and Alvin R. Tilley, The E:\FR\FM\09FEP3.SGM 09FEP3 mstockstill on DSK4VPTVN1PROD with PROPOSALS3 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules Measure of Man & Woman: Human Factors in Design, (New York, John Wiley and Sons, 2002), page 43. Where possible, it is recommended that a longer gripping surface or multiple horizontal supports be provided. The minimum and maximum height of the gripping surface above the standing surface is based on the provisions for handrails in the 2004 ADA and ABA Accessibility Guidelines. For standing supports in a vertical position, M305.3.2 would require the gripping surface to be 18 inches long minimum. The bottom of the support would be required to be 34 inches minimum and 37 inches maximum above the standing surface. The minimum length of the gripping surface is based on provisions for vertical grab bars at accessible bathing fixtures and toilets in ICC A117.1–2009 Accessible and Usable Buildings and Facilities. The minimum and maximum height of the bottom of the support above the standing surface is based on anthropometric data for the 1th percentile woman (minimum) and the 99th percentile man (maximum). See Henry Dreyfuss Associates and Alvin R. Tilley, The Measure of Man & Woman: Human Factors in Design, (New York, John Wiley and Sons, 2002), pages 13, 14, and 28. Question 38. Comments are requested on the following questions regarding standing supports for diagnostic equipment used by patients in a standing position: (a) What standing support configurations are currently provided and are they effective for patients with disabilities? (b) Would alternative technical criteria for standing supports be appropriate? Comments should include information on sources to support the alternative technical criteria, where possible. (c) Are angled standing supports effective for patients with disabilities and should technical criteria be provided for angled standing supports? Comments should include information on sources to support the technical criteria for angled standing supports, where possible. (d) Are there industry standards for the structural strength of standing supports? The 2004 ADA and ABA Accessibility Guidelines specify the following dimensions for grab bars to enable individuals with disabilities to firmly grasp the grab bars and support themselves during transfers: • Grab bars with circular cross sections must have an outside diameter VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 of 11⁄4 inches minimum and 2 inches maximum. • Grab bars with non-circular cross sections must have a cross section dimension of 2 inches maximum and a perimeter dimension of 4 inches minimum and 4.8 inches maximum. The Access Board is considering whether the above cross section dimensions would be appropriate for the gripping surfaces of standing supports on diagnostic equipment used by patients in a standing position. Question 39. Comments are requested on the following questions regarding the above cross section dimensions for the gripping surfaces of standing supports on diagnostic equipment used by patients in a standing position: (a) Can the gripping surfaces of standing supports on different types of equipment meet the above cross section dimensions? (b) Are there alternative designs for the gripping surfaces of standing supports that enable patients with disabilities to firmly grasp the supports? The Access Board is also considering whether a 11⁄2 inches minimum clearance around the gripping surface of standing supports would be appropriate to ensure that the surface can be grasped. Question 40. Can standing supports on different types of equipment provide 11⁄2 inches minimum clearance around the gripping surface without encountering obstructions? M305 Supports M305 provides the technical criteria for transfer supports and standing supports. The technical criteria for transfer supports are discussed under M301 Diagnostic Equipment Used by Patients in Supine, Prone, or Side-Lying Position and M302 Diagnostic Equipment Used by Patients in Seated Position. The technical criteria for standing supports are discussed under M304 Diagnostic Equipment Used by Patients in Standing Position. M306 Communication Where diagnostic equipment communicates instructions or other information to the patient, M306 would require the instructions or other information to be provided in at least two of the following methods: audible, visible, or tactile. For example, magnetic resonance imaging (MRI) and X-ray computed tomography (CT) equipment may instruct the patient to hold their breath for a short period during a scan by means of a flashing light or icon. A flashing light or icon would be sufficient to notify a patient who is deaf to hold their breath, but a voice prompt, PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 6931 sound alert, or tactile vibration would be needed to notify a patient who is blind to hold their breath. For MRI equipment, auditory methods may not be effective due to the noise generated by the equipment and a tactile vibration may be the only effective method to notify a patient who is blind to hold their breath. ANSI/AAMI HE 75 recommends that vibration ‘‘be used as a redundant mode for transmitting information such as an attention getting signal.’’ See ANSI/AAMI HE 75, section 16.3.5.6. Question 41. Comments are requested on the following questions regarding methods of communication provided by diagnostic equipment: (a) Should diagnostic equipment that communicates instructions or other information to the patient be required to provide the instructions or other information in all three methods of communication (i.e., audible, visible, and tactile)? (b) What would be the incremental costs for the design or redesign and manufacture of the equipment to provide all three methods of communication (i.e., audible, visible, and tactile)? M307 Operable Parts M307 provides technical criteria for operable parts used by patients to activate, deactivate, or adjust the diagnostic equipment (see defined terms in M102.1). For example, equipment used for an auditory examination may require the patient to press a button when sounds are heard. M307 does not apply to controls used only by health care personnel or others who are not patients. M307.2 would require operable parts to be tactilely discernible without activation. Patients who are blind or have low vision have difficulty distinguishing a flat membrane button or similar control unless it is tactilely discernible from the surrounding surface and any adjacent controls. The most common method to ensure that buttons and similar controls are tactilely discernible is to raise part or all of the control surface above the surrounding surface and at a distance from any adjacent controls such that a relief of each individual control can be determined by touch. This also prevents unintended or accidental activation of the operable parts. M307.2 is consistent with recommendations in ANSI/AAMI HE 75 that ‘‘features should be operable from controls that are tactilely discernible and that can be explored without being activated.’’ See ANSI/ AAMI HE 75, section 16.3.5.5. E:\FR\FM\09FEP3.SGM 09FEP3 mstockstill on DSK4VPTVN1PROD with PROPOSALS3 6932 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules M307.3 would require operable parts such as dials, switches, and levers to be operable with one hand without tight grasping, pinching, or twisting of the wrist. M307.4 would require the force to activate operable parts to not exceed 5 pounds. M307.3 and M307.4 are based on provisions for operable parts in the 2004 ADA and ABA Accessibility Guidelines. M307.3 and M307.4 are also consistent with recommendations in ANSI/AAMI HE 75 that ‘‘devices should have at least one mode of use that does not require fine motor control or the performance of simultaneous actions.’’ ANSI/AAMI HE 75 includes additional recommended practices for accessible controls. See ANSI/AAMI HE 75, section 16.3.3. The Wheeled Mobility Anthropometry Project recommended that ‘‘operable parts that require fine grips preferably should not require exertion of lateral pinch grip forces in excess of 2 pounds force to accommodate the vast majority of * * * users having at least some grasping capability.’’ The Wheeled Mobility Anthropometry Project recommended that the 5 pounds maximum force be retained for other types of operable parts. See Final Report of the Wheeled Mobility Anthropometry Project, page 105. The Access Board is considering requiring in the final standards that operable parts used by patients that require fine grips to not exceed 2 pounds maximum operating force. Question 42. Comments are requested on the following questions regarding the operating force (2 pounds maximum) that the Access Board is considering requiring in the final standards for operable parts used by patients that require fine grips: (a) What would be the incremental costs for the design or redesign and manufacture of the equipment to provide operable parts that meet the above operating force? (b) Are there types of equipment that cannot provide operable parts that meet the above operating force because of the structural or operational characteristics of the equipment? The 2004 ADA and ABA Accessibility Guidelines require that operable parts be placed within certain reach ranges. For an unobstructed forward reach or side reach, the reach ranges are 48 inches maximum for a high reach and 15 inches minimum for a low reach. ANSI/AAMI HE 75 provides guidance on reach ranges based on provisions in an earlier version of accessibility guidelines for buildings and facilities issued by the Access Board, the 1991 Americans with Disabilities Act Accessibility Guidelines (ADAAG). VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 ANSI/AAMI HE 75 also recommends a remote control as an alternative to a direct reach. See ANSI/AAMI HE 75, section 16.3.2.2. The reach ranges in the 2004 ADA and ABA Accessibility Guidelines provide greater accessibility than the reach ranges in the 1991 ADAAG. Question 43. Comments are requested on the following questions regarding reach ranges for operable parts on diagnostic equipment that are used by patients: (a) Would the reach ranges in the 2004 ADA and ABA Accessibility Guidelines for an unobstructed forward reach or side reach (48 inches maximum for a high reach and 15 inches minimum for a low reach) be appropriate for operable parts on diagnostic equipment that are used by patients? (b) Would alternative technical criteria be appropriate for reach ranges for operable parts on diagnostic equipment that are used by patients? Comments should include information on sources to support the alternative technical criteria, where possible. 6. Regulatory Analyses Executive Order 13563 (Improving Regulation and Regulatory Review) and Executive Order 12866 (Regulatory Planning and Review): Preliminary Regulatory Assessment The Office of Management and Budget has reviewed this proposed rule in accordance with Executive Orders 13563 and 12866. Among other things, Executive Order 13563 directs agencies to propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs; tailor the regulation to impose the least burden on society, consistent with obtaining the regulatory objectives; and, in choosing among alternative regulatory approaches, select those approaches that maximize net benefits. Executive Order 13563 recognizes that some benefits and costs are difficult to quantify and provides that, where appropriate and permitted by law, agencies may consider and discuss qualitatively values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts. The Access Board has prepared a preliminary regulatory assessment for the proposed standards. The preliminary regulatory assessment is available on the Access Board’s Web site at: https://www.access-board.gov/ medical-equipment.htm. The preliminary regulatory assessment is summarized below. PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 Need for and Benefits of the Proposed Standards The U.S. Census Bureau reports that 54.4 million Americans, about one in five U.S. residents, reported some level of disability in 2005.11 The number of individuals with disabilities is almost equal to the combined total population of California and Florida. The U.S. Census Bureau provides this breakdown of the population of people aged 15 and older: • 27.4 million (11.9 percent) had difficulty with ambulatory activities of the lower body; • 22.6 million (9.8 percent) had difficulty walking a quarter of a mile; • 21.8 million (9.4 percent) had difficulty climbing a flight of stairs; • 10.2 million (4.4 percent) used a cane, crutches, or walker to assist with mobility; • 3.3 million (1.4 percent) used a wheelchair or other wheeled mobility device; • 7.8 million (3 percent) had difficulty seeing words or letters in ordinary newspaper print, including 1.8 million who are completely unable to see; and • 7.8 million (3 percent) had difficulty hearing conversations, including 1 million who are unable to hear conversations at all. The prevalence of disability increases with age. The Administration on Aging reports that there were 39.6 million persons age 65 or older in the United States in 2009, and that this population is expected to increase to 55 million in 2020.12 Among this population, 37 percent reported some type of disability in 2005.13 A national survey collected information on the types of medical equipment that is most difficult for individuals with disabilities to access and use.14 The survey was completed by a diverse sample of individuals with a wide range of disabilities, including mobility disabilities and sensory disabilities. Survey respondents who had experience with specific medical 11 ‘‘Americans with Disabilities: 2005’’ (2008) available at: https://www.census.gov/prod/ 2008pubs/p70-117.pdf. 12 ‘‘A Profile of Older Americans: 2010’’ available at: https://www.aoa.gov/AoARoot/Aging_Statistics/ Profile/index.aspx. 13 See footnote 11. 14 The results of the survey are reported in Jill M. Winters, Molly Follette Story, Kris Barnekow, June Isaacson Kailes, Brenda Premo, Erin Schier, Sarma Danturthi, and Jack M. Winters, ‘‘Results of a National Survey on Accessibility of Medical Instrumentation for Consumers,’’ in ‘‘Medical Instrumentation Accessibility and Usability Considerations,’’ edited by Jack M. Winters and Molly Follette Story (Boca Raton, CRC Press, 2007), 13–27. E:\FR\FM\09FEP3.SGM 09FEP3 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS3 equipment rated their degree of difficulty when attempting to access or use the equipment as follows: • 75 percent rated examination tables as moderately difficult to impossible to use; • 68 percent rated radiology equipment as moderately difficult to impossible to use; • 53 percent rated weight scales as moderately difficult to impossible to use; and • 50 percent rated examination chairs as moderately difficult to impossible to use. Survey respondents reported difficulties with getting on and off the equipment, positioning their bodies on the equipment, physical comfort and safety, and communication issues. Focus group sessions of individuals with disabilities reported that participants find examination tables, imaging equipment, and other diagnostic equipment not only difficult but unsafe to use, and that these negative health care experiences can result in their not scheduling regular medical examinations and diagnostic procedures.15 A report on the ‘‘The Current State of Health Care for People with Disabilities’’ issued by the National Council on Disability found that individuals with disabilities experienced significant health disparities and barriers to health care, as compared to individuals without disabilities.16 Among the key barriers cited in the report is the lack of accessible examination equipment. A report on the ‘‘Importance of Accessible Examination Tables, Chairs and Weight Scales’’ issued by the Center for Disability Issues and the Health Professions discusses how the lack of accessible equipment reduces the likelihood that individuals with disabilities will receive timely and appropriate health care.17 Health care providers may not perform some diagnostic procedures for patients with disabilities because they lack accessible equipment. This can result in suboptimal examinations, missed or delayed diagnoses, and worsening conditions that require more expensive and extensive treatments. 15 The results of the focus group sessions are reported in Molly Follette Story, Erin Schwier, and June Isaacson Kailes, ‘‘Perspectives of Patients with Disabilities on the Accessibility of Medical Equipment: Examination Tables, Imaging Equipment, Medical Chairs, and Weight Scales,’’ Disability and Health Journal 2 (2009), 169–179. 16 The report is available at: https://www.ncd.gov/ publications/2009/Sept302009. 17 The report is available at: https:// www.cdihp.org/products.html#tables. VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 The proposed standards address many of the barriers that have been identified as affecting the accessibility and usability of diagnostic equipment by individuals with disabilities. The standards will improve the quality of health care for individuals with disabilities and ensure that they receive examinations, diagnostic procedures, and other health care services equal to those received by individuals without disabilities. The standards will facilitate independent transfers by individuals with disabilities onto and off of diagnostic equipment, and enable them to maintain their independence, confidence, and dignity. The standards will lessen the need for health care personnel to assist individuals with disabilities when transferring on and off of diagnostic equipment. Where assisted transfers are necessary, the proposed standards will also facilitate such transfers. The proposed standards will reduce the risk of injury during transfers to both health care personnel and patients.18 The proposed standards will result in more positive health care experiences for individuals with disabilities and health care providers. Entities Potentially Affected by Proposed Standards The proposed standards do not impose any mandatory requirements on health care providers or medical device manufacturers. Thus, there are no compliance costs that can be attributed to the proposed standards. As discussed below, if an enforcing authority such as DOJ adopts the standards as mandatory requirements for entities subject to its jurisdiction, health care providers may experience some compliance costs. Medical device manufacturers may have an economic incentive to produce accessible products that conform to the standards for health care providers who need to acquire accessible medical diagnostic equipment. Health Care Providers As discussed under Department of Justice Activities Related to Health Care Providers and Medical Equipment, health care providers must provide individuals with disabilities full and equal access to their health care services and facilities to comply with the ADA and Section 504 of the Rehabilitation Act. Both the Federal government through DOJ and private parties, including individuals with disabilities, have entered into settlement agreements 18 Lifting and transferring patients is a major risk factor for back injury among nurses and health aides. See Alan Hedge, ‘‘Back Care for Nurses’’ available at: https://www.spineuniverse.com/ wellness/ergonomics/back-care-nurses. PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 6933 with health care providers to enforce the ADA and Section 504 of the Rehabilitation Act. In July 2010, DOJ and the Department of Health and Human Services issued a guidance document for health care providers regarding their responsibilities to make their services and facilities accessible to individuals with mobility disabilities under the ADA and Section 504 of the Rehabilitation Act. See Access to Medical Care for Individuals with Mobility Disabilities available at: https://www.ada.gov/medcare_ta.htm. The guidance document includes information on accessible examination rooms and the clear floor space needed adjacent to medical equipment for individuals who use mobility devices to approach the equipment for transfer; accessible medical equipment (e.g., examination tables and chairs, mammography equipment, weight scales); patient lifts and other methods for transferring individuals from their mobility devices to medical equipment; and training health care personnel. In July 2010, DOJ also issued an ANPRM announcing that, pursuant to the obligation that has always existed under the ADA for covered entities to provide accessible equipment and furniture, it was considering amending its regulations implementing Titles II and III of the ADA to include specific standards for the design and use of accessible equipment and furniture that is not fixed or built into a facility in order to ensure that programs and services provided by state and local governments and by public accommodations are accessible to individuals with disabilities. See 75 FR 43452 (July 26, 2010). Among other things, the ANPRM stated that DOJ was considering amending its ADA regulations to specifically require health care providers to acquire accessible medical equipment and that it would consider adopting the standards issued by the Access Board. DOJ also indicated its intention to include in its ADA regulations scoping requirements that specify the minimum number of types of accessible medical equipment required in different types of health care facilities. If DOJ proposes to amend its ADA regulations as announced in the ANPRM, it will publish a notice of proposed rulemaking (NPRM) requesting public comment and will prepare a regulatory assessment in accordance with Executive Orders 13563 and 12866. Medical Device Manufacturers If DOJ amends its ADA regulations as announced in the ANPRM, medical device manufacturers may have an E:\FR\FM\09FEP3.SGM 09FEP3 6934 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules economic incentive to produce accessible products that conform to the standards for health care providers who need to acquire accessible medical diagnostic equipment. The size of the economic incentive will depend on the amount of accessible medical diagnostic equipment health care providers need to acquire and the manufacturers’ incremental costs to design or redesign and manufacture accessible products that conform to the standards. Many medical device manufacturers currently incorporate accessible features in some of their products such as patient support surfaces that are height adjustable, transfer and positioning supports, and scales designed for use by patients seated in a wheelchair. The incremental costs for manufacturers to conform these products to the standards are expected to be small because the features may already meet or closely meet the standards. The incremental costs may be greater for manufacturers that do not currently incorporate accessible features in their products but plan to do so in future designs or redesigns of their products. The incremental costs to design or redesign and manufacture accessible products that conform to the standards will be incurred voluntarily by manufacturers that choose to produce them for health care providers who need to acquire accessible medical diagnostic equipment. Some manufacturers may choose not to design or redesign and manufacture accessible products that conform to the standards, or may produce accessible products with less market appeal than that of their competitors, thereby losing market share and incurring losses. These economic impacts are not regulatory costs and are not generally social costs because for the most part, one manufacturer’s loss is another manufacturer’s gain. The following questions in the preamble request comments on the incremental costs to design or redesign and manufacture accessible products that conform to the technical criteria in the proposed standards, as well as alternative and additional technical criteria that the Access Board is considering: • Questions 9 and 10 on the technical criteria in Chapter M3; • Questions 14 (a) and (b) on height adjustable patient support surfaces; • Question 15 (b) on width of patient support surfaces on equipment used by patients in a supine, prone, or side-lying position; • Question 18 (a) on structural strength of repositionable transfer supports; • Question 19 (c) on location and size of transfer supports; • Question 23 (a) on stirrups; • Question 24 (b) on positioning supports; • Question 29 (a) on alternative dimension for minimum depth of wheelchair spaces; • Question 30 on edge protection for wheelchair spaces on raised platforms: • Question 33 on dimensions for wheelchair spaces on raised platforms; • Question 34 (a) on alternative dimensions for toe clearance and knee clearance at wheelchair spaces; • Question 35 (b) on handrails on diagnostic equipment ramps; • Question 37 (c) on a folding or removable seat on weight scale platforms or other types of diagnostic equipment used by patients in a standing position; • Question 41 (b) on audible, visible, and tactile communications; and • Question 42 (a) on operating force for operable parts. The Access Board will consider the information provided in the comments when preparing the final standards, and will provide an analysis of the incremental costs with the final standards. Table type mstockstill on DSK4VPTVN1PROD with PROPOSALS3 Question 44. Does the above sample fairly reflect the range of costs for examination tables? Treatment tables typically have a flat top. Some models have adjustable backrests, but the backrests typically cannot support patients in a sitting position. Treatment tables typically VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 74 15 30 have a fixed height of 31 inches measured from the floor to the top of the table. The lower cost products have an open base with an H-brace or shelf. The higher cost products have cabinets, drawers, or shelves. Adjustable height treatment tables are available, but are not included in the sample. The MSRP PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 The Access Board and its contractor, Eastern Research Group, collected product data and unit costs for a broad sample of examination tables and weight scales, including products with accessible features. The Access Board and Eastern Research Group did not evaluate the products for conformance with the proposed standards and do not endorse any of the products included in the sample. The Access Board and Eastern Research Group used the Internet to collect the product data and unit costs. Medical equipment suppliers typically list the manufacturer suggested retail price (MSRP) for the products on their Web sites and sell the products at discounted prices. The discounted prices for the same product can vary widely among medical equipment suppliers. Health care providers typically purchase the products for less than the MSRP (i.e., actual price paid is less than MRSP). The unit costs in the tables below are the MSRP, and are shown as a range of lower cost and higher cost products rounded to the nearest $50. The data shows that there are a wide variety of examination tables and weight scales available to meet almost every budget. Product data and unit costs for examination chairs and imaging equipment will be provided when the final standards are issued. Examination Tables Product data and unit costs were collected for examination tables produced by five manufacturers. The manufacturer’s Web sites typically grouped the tables by the following types: Treatment tables, manual tables, and power tables. The number of each type of table made by the manufacturers, the number of tables included in the sample, and range of lower cost and higher cost products are summarized below. Lower cost products MSRP Products in sample Products Treatment ......................................................................................... Manual ............................................................................................. Power ............................................................................................... Product Data and Unit Costs 20 9 25 $400–$850 1,250 1,650–2,900 Higher cost products MSRP $850–$1,450 2,250 3,650–16,800 for adjustable height treatment tables ranged from $1,500 to $2,400. Manual tables typically have a fully articulated, pneumatic backrest. The backrests typically can support patients in a seated position and recline to a lying position. Manual tables typically have a fixed height of 32 inches E:\FR\FM\09FEP3.SGM 09FEP3 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules measured from the floor to the top of the table. Manual tables typically have cabinets, drawers, or shelves. Power tables have an electric motor that can adjust the table height to as low as 18 inches and as high as 40 inches above the floor on some products. The higher cost products have a fully articulated, pneumatic or powered, backrest that can support patients in a seated position and recline to a lying position. Some power tables have armrests, grab rails, side rails, and cabinets or drawers. Weight Scales Product data and unit costs were collected for weight scales produced by eight manufacturers. The scales are grouped by the following types: Standon scales and wheelchair scales. Within each group, there are mechanical and Stand-on scales Mechanical without Handrails .......................................................... Mechanical with Handrails ............................................................... Digital without Handrails .................................................................. Digital with Handrails ....................................................................... Question 45. Does the above sample fairly reflect the range of costs for standon scales? Stand-on mechanical scales typically have a weight capacity ranging from 400 22 1 50 21 mstockstill on DSK4VPTVN1PROD with PROPOSALS3 2 32 8 Question 46. Does the above sample fairly reflect the range of costs for wheelchair scales? Wheelchair mechanical scales with a ramped platform typically have a weight capacity ranging from 350 to 500 pounds. Wheelchair digital scales with a ramped platform typically have a weight capacity ranging from 800 to 1,000 pounds. Wheelchair digital scales with a flush platform in the floor typically have a weight capacity of 1,000 pounds. Some wheelchair digital scales have standard or optional handrails for use as a stand-on bariatric scale. The Access Board has made a preliminary determination based on the preliminary regulatory assessment that the benefits of the proposed standards will justify the costs; that the proposed standards will impose the least burden on society, consistent with obtaining the regulatory objectives; and that the regulatory approach selected will maximize net benefits. minimize the impacts on small entities, and make the analysis available for public comment. The proposed standards do not impose any mandatory requirements on any entity, including small entities. Nonetheless, in keeping with the Regulatory Flexibility Act, the Access Board has prepared this initial regulatory flexibility analysis. Regulatory Flexibility Act: Initial Regulatory Flexibility Analysis The objective of the proposed standards is to ensure that medical diagnostic equipment is accessible to and usable by individuals with disabilities. The proposed standards address barriers that affect the The Regulatory Flexibility Act requires agencies to consider the impacts of their regulatory proposals on small entities, analyze alternatives that VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 Reason the Access Board Is Issuing the Proposed Standards Section 510 of the Rehabilitation Act (29 U.S.C. 794f) requires the Access Board, in consultation with the Commissioner of the Food and Drug Administration, to issue standards that contain minimum technical criteria to ensure that medical diagnostic equipment used in or in conjunction with medical settings such as physicians’ offices, clinics, emergency rooms, and hospitals is accessible to and usable by individuals with disabilities. Objective of, and Legal Basis for, the Proposed Standards PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 $250 700 300–600 600–1,050 Higher cost products MSRP $550 700 700–1,200 1,750–2,600 on digital scales with handrails typically have a weight capacity ranging from 500 to 1,000 pounds, and the higher cost products typically are bariatric scales. Lower cost products MSRP Products in sample Products Mechanical with Ramped Platform .................................................. Digital with Ramped Platform .......................................................... Digital with Flush Platform in Floor .................................................. Lower cost products MSRP 3 1 15 9 to 500 pounds. Stand-on digital scales without handrails typically have a weight capacity ranging from 400 to 750 pounds, and the higher cost products typically have larger platforms. Stand- Wheelchair scales digital scales. Unit costs are presented for stand-on scales with and without handrails. Unit costs are presented for wheelchair scales with raised platforms and with flush platforms in the floor. The number of each type of scale made by the manufacturers, the number of scales included in the sample, and range of lower cost and higher cost products are summarized below. Products in sample Products 6935 2 15 5 $1,200 800–1,700 3,300 Higher cost products MSRP $2,900 2,100–4,950 6,500 accessibility and usability of medical diagnostic equipment by individuals with disabilities. The legal basis for the proposed standards is Section 510 of the Rehabilitation Act. Small Entities Potentially Affected by Proposed Standards The proposed standards do not impose any mandatory requirements on health care providers or medical device manufacturers. As discussed below, if an enforcing authority such as DOJ adopts the standards as mandatory requirements for entities subject to its jurisdiction, small health care providers may experience some compliance costs. Small medical device manufacturers may have an economic incentive to produce accessible products that conform to the standards for health care providers who need to acquire accessible medical diagnostic equipment. Health Care Providers As discussed under Department of Justice Activities Related to Health Care Providers and Medical Equipment, health care providers must provide individuals with disabilities full and equal access to their health care services and facilities to comply with the ADA E:\FR\FM\09FEP3.SGM 09FEP3 mstockstill on DSK4VPTVN1PROD with PROPOSALS3 6936 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules and Section 504 of the Rehabilitation Act. Both the Federal government through DOJ and private parties, including individuals with disabilities, have entered into settlement agreements with health care providers to enforce the ADA and Section 504 of the Rehabilitation Act. In July 2010, DOJ and the Department of Health and Human Services issued a guidance document for health care providers regarding their responsibilities to make their services and facilities accessible to individuals with mobility disabilities under the ADA and Section 504 of the Rehabilitation Act. See Access to Medical Care for Individuals with Mobility Disabilities available at: https://www.ada.gov/medcare_ta.htm. The guidance document includes information on accessible examination rooms and the clear floor space needed adjacent to medical equipment for individuals who use mobility devices to approach the equipment for transfer; accessible medical equipment (e.g., examination tables and chairs, mammography equipment, weight scales); patient lifts and other methods for transferring individuals from their mobility devices to medical equipment; and training health care personnel. In July 2010, DOJ also issued an ANPRM announcing that, pursuant to the obligation that has always existed under the ADA for covered entities to provide accessible equipment and furniture, it was considering amending its regulations implementing Titles II and III of the ADA to include specific standards for the design and use of accessible equipment and furniture that is not fixed or built into a facility in order to ensure that programs and services provided by state and local governments and by public accommodations are accessible to individuals with disabilities. See 75 FR 43452 (July 26, 2010). Among other things, the ANPRM stated that DOJ was considering amending its ADA regulations to specifically require health care providers to acquire accessible medical equipment and that it would consider adopting the standards issued by the Access Board. DOJ also indicated its intention to include in its ADA regulations scoping requirements that specify the minimum number of types of accessible medical equipment required in different types of health care facilities. If DOJ proposes to amend its ADA regulations as announced in the ANPRM, it will publish a notice of proposed rulemaking (NPRM) requesting public comment and will prepare an initial and final regulatory VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 flexibility analyses in accordance with the Regulatory Flexibility Act. Compliance Requirements in Proposed Standards Medical Device Manufacturers The proposed standards contain technical criteria for accessible medical diagnostic equipment. The proposed standards do not impose any mandatory requirements on medical device manufacturers or health care providers. If DOJ amends its ADA regulations as announced in the ANPRM, small medical device manufacturers may have an economic incentive to produce accessible products that conform to the standards for health care providers who need to acquire accessible medical diagnostic equipment. The size of the economic incentive will depend on the amount of accessible medical diagnostic equipment health care providers need to acquire and the manufacturers’ incremental costs to design or redesign and manufacture accessible products that conform to the standards. Many medical device manufacturers currently incorporate accessible features in some of their products such as patient support surfaces that are height adjustable, transfer and positioning supports, and scales designed for use by patients seated in a wheelchair. The incremental costs for manufacturers to conform these products to the standards are expected to be small because the features may already meet or closely meet the standards. The incremental costs may be greater for manufacturers that do not currently incorporate accessible features in their products but plan to do so in future designs or redesigns of their products. The incremental costs to design or redesign and manufacture accessible products that conform to the standards will be incurred voluntarily by manufacturers that choose to produce them for health care providers who need to acquire accessible medical diagnostic equipment. Some manufacturers may choose not to design or redesign and manufacture accessible products that conform to the standards, or may produce accessible products with less market appeal than that of their competitors, thereby losing market share and incurring losses. These economic impacts are not regulatory costs and are not generally social costs because for the most part, one manufacturer’s loss is another manufacturer’s gain. The preamble requests comments on the incremental costs to design or redesign and manufacture products that conform to the technical criteria in the proposed standards, as well as alternative and additional technical criteria that the Access Board is considering. The Access Board will consider the information provided in the comments when preparing the final standards, and will provide an analysis of the incremental costs with the final standards. PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 Other Relevant Federal Rules and Guidance Documents As discussed above, DOJ and the Department of Health and Human Services issued a guidance document for health care providers regarding their responsibilities to make their services and facilities accessible to individuals with mobility disabilities under the ADA and Section 504 of the Rehabilitation Act. DOJ also issued an ANPRM announcing that it was considering amending its regulations implementing Titles II and III of the ADA to ensure that equipment and furniture used in programs and services provided by state and local governments and by public accommodations are accessible to individuals with disabilities. See 75 FR 43452 (July 26, 2010). Among other things, the ANPRM stated that DOJ was considering amending its ADA regulations to specifically require health care providers to acquire accessible medical equipment and that it would consider adopting the standards issued by the Access Board. DOJ also indicated its intention to include in its ADA regulations scoping requirements that specify the minimum number of types of accessible medical equipment required in different types of health care facilities. The Access Board worked closely with the FDA–CDRH in developing the proposed standards. The FDA–CDRH may develop a guidance document to inform manufacturers how it intends to apply its regulatory authority to clearance or approval of medical devices addressed in the Access Board’s standards. If the FDA–CDRH develops such a guidance document, it will provide the public notice and opportunity to comment on a draft of the guidance document in accordance with its procedures for issuing guidance documents. See 21 CFR 10.115. Significant Alternatives Questions are included in the preamble requesting comments on the economic and technical impacts of the technical criteria in the proposed standards, and whether alternative technical criteria would be appropriate. The Access Board plans to convene an advisory committee when the comment E:\FR\FM\09FEP3.SGM 09FEP3 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules period on the rulemaking closes to assist the Board in reviewing the comments and make recommendations on issues addressed in the rulemaking. The Access Board will analyze the comments submitted in response to the questions and the advisory committee’s recommendations, including alternatives that achieve the statutory objectives of ensuring that medical diagnostic equipment is accessible to and usable by individuals with disabilities and minimize any significant impacts of the standards on small entities. The Access Board will prepare a final regulatory flexibility analysis when the final standards are issued that discusses any significant alternatives considered. Executive Order 13132 (Federalism) The proposed standards do not impose any mandatory requirements on State and local governments. The proposed standards do not have any direct effects on the state governments, the relationship between the national government and state governments, or the distribution of power and responsibilities among the various levels of government. The proposed standards do not preempt state law. Therefore, the consultation and other requirements of Executive Order 13132 (Federalism) do not apply. Unfunded Mandates Reform Act The proposed standards do not impose any mandatory requirements on state, local, or tribal governments or the private sector. Therefore, the Unfunded Mandates Reform Act does not apply. List of Subjects in 36 CFR Part 1195 Health care, Individuals with disabilities, Medical devices. Nancy Starnes, Chair. For the reasons stated in the preamble, the Access Board proposes to add part 1195 to title 36 of the Code of Federal Regulations to read as follows: mstockstill on DSK4VPTVN1PROD with PROPOSALS3 PART 1195—STANDARDS FOR ACCESSIBILE MEDICAL DIAGNOSTIC EQUIPMENT Sec. 1195.1 Standards. Appendix to Part 1195—Standards for Accessible Medical Diagnostic Equipment Standards. The standards for accessible medical diagnostic equipment are set forth in the appendix to this part. Other agencies, referred to as an enforcing authority in VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 Appendix to Part 1195—Standards for Accessible Medical Diagnostic Equipment Chapter M1: Application and Administration M101 General M101.1 Purpose. The standards contain technical criteria for medical diagnostic equipment that is accessible to and usable by patients with disabilities. The standards provide for independent access to and use of diagnostic equipment by patients with disabilities to the maximum extent possible. M101.2 Application. The standards shall be applied to diagnostic equipment based on the patient positions that the equipment is designed to support. Where diagnostic equipment is designed to support more than one patient position, the standards for each patient position supported shall be applied to the equipment. Advisory M101.2 Application. The following examples illustrate how the standards apply to diagnostic equipment designed to support more than one patient position: • An examination chair converts to an examination table. The technical criteria in M302 for diagnostic equipment used by patients in a seated position; and in M301 for diagnostic equipment used by patients in a supine, prone, or side-lying position apply. • A weight scale can be used by patients seated in a wheelchair, or seated on a builtin folding seat, or standing and holding onto supports. The technical criteria in M303 for diagnostic equipment used by patients seated in a wheelchair; in M302 for diagnostic equipment used by patients in a seated position; and in M304 for diagnostic equipment used by patients in a standing position apply. M101.3 Equivalent Facilitation. The use of alternative designs or technologies that result in substantially equivalent or greater accessibility and usability than specified in the standards is permitted. M101.4 Dimensions. The standards are based on adult dimensions and anthropometrics. Dimensions that are not stated as ‘‘maximum’’ or ‘‘minimum’’ are absolute. M101.5 Dimensional Tolerances. Dimensions are subject to conventional industry tolerances for manufacturing processes, material properties, and field conditions. M102 Authority: 29 U.S.C. 794f. § 1195.1 the standards, may adopt the standards as mandatory requirements for entities subject to their jurisdiction. Definitions M102.1 Defined Terms. For the purpose of the standards, the following terms have the indicated meaning: Enforcing Authority. An agency that adopts the standards as mandatory requirements for entities subject to its jurisdiction. Medical Diagnostic Equipment (Diagnostic Equipment). Equipment used in or in conjunction with medical settings by health care providers for diagnostic purposes. PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 6937 Operable Parts. A component of diagnostic equipment that is used by the patient to activate, deactivate, or adjust the equipment. Transfer Surface. Part of diagnostic equipment onto which patients who use mobility devices or aids transfer when moving onto and off of the equipment. M102.2 Undefined Terms. The meaning of terms not defined in M102.1 or in regulations or policies issued by an enforcing authority shall be defined by collegiate dictionaries in the sense that the context implies. M102.3 Interchangeability. Words, terms, and phrases used in the singular include the plural and those used in the plural include the singular. Chapter M2: Scoping M201 General M201.1 Enforcing Authority. The enforcing authority specifies the minimum number of types of accessible diagnostic equipment that are required to comply with the standards in different types of health care facilities. Chapter M3: Technical Criteria M301 Diagnostic Equipment Used by Patients in Supine, Prone, or Side-Lying Position M301.1 General. Where diagnostic equipment is used by patients in a supine, prone, or side-lying position, it shall comply with M301. M301.2 Transfer Surface. A transfer surface shall be provided and shall comply with M301.2. M301.2.1 Height. The height of the transfer surface during patient transfer shall be 17 inches (430 mm) minimum and 19 inches (485 mm) maximum measured from the floor to the top of the transfer surface. Advisory M301.2.1 Height. The transfer surface is permitted to be positioned outside of the specified height range when not needed to facilitate transfer. M301.2.2 Size. The transfer surface shall be 30 inches (760 mm) wide minimum and 15 inches (381 mm) deep minimum. Advisory M301.2.2 Size. The size requirements in this section apply only to the portion of the diagnostic equipment used for transfer. M301.2.3 Transfer Sides. The transfer surface shall be located to provide options to transfer from a mobility device onto one short side (depth) and one long side (width) of the surface. Each transfer side shall provide unobstructed access to the transfer surface. Exception: Temporary obstructions shall be permitted provided that they can be repositioned to permit transfer. Advisory M301.2.3 Transfer Sides: Exception. Arm rests, footrests, side rails, and stirrups are examples of obstructions. M301.3 Supports. Transfer supports, stirrups, and reclining surfaces shall comply with M301.3. M301.3.1 Transfer Supports. Transfer supports shall be provided for use with the transfer sides required by M301.2.3 and shall comply with M305.2. M301.3.2 Stirrups. Where stirrups are provided, they shall provide a method of E:\FR\FM\09FEP3.SGM 09FEP3 6938 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS3 supporting, positioning, and securing the patient’s legs. M301.3.3 Head and Back Support. Where the diagnostic equipment is used in a reclined position, head and back support shall be provided. Where the incline of the back support can be modified while in use, head and back support shall be provided throughout the entire range of the incline. M301.4 Lift Compatibility. Diagnostic equipment shall be usable with a patient lift and shall comply with M301.4.1 or M301.4.2. M301.4.1 Clearance in Base. The base of the equipment shall provide a clearance 44 inches (1120 mm) wide minimum, 6 inches (150 mm) high minimum measured from the floor, and 36 inches (915 mm) deep minimum measured from the edge of the examination surface. Where the width of the examination surface is less than 36 inches (915 mm), the clearance depth shall extend the full width of the equipment. Equipment components are permitted to be located within 8 inches (205 mm) maximum of the centerline of the clearance width. M301.4.2 Clearance Around Base. The base of the equipment shall provide a clearance 6 inches (150 mm) high minimum measured from the floor and 36 inches (915 mm) deep minimum measured from the edge of the examination surface. The width of the base permitted within this clearance shall be 26 inches (660 mm) wide maximum at the edge of the examination surface and shall be permitted to increase at a rate of 1 inch (25 mm) in width for each 3 inches (75 mm) in depth. M302 Diagnostic Equipment Used by Patients in Seated Position M302.1 General. Where diagnostic equipment is used by patients in a seated position, it shall comply with M302. M302.2 Transfer Surface. A transfer surface shall be provided and shall comply with M302.2. M302.2.1 Height. The height of the transfer surface during patient transfer shall be 17 inches (430 mm) minimum and 19 inches (485 mm) maximum measured from the floor to the top of the transfer surface. Advisory M302.2.1 Height. The transfer surface is permitted to be positioned outside of the specified height range when not needed to facilitate transfer. M302.2.2 Size. The transfer surface shall be 21 inches (610 mm) wide minimum and 15 inches (381 mm) deep minimum. Advisory M302.2.2 Size. The size requirements in this section apply only to the portion of the seat used for transfer. M302.2.3 Transfer Sides. The transfer surface shall be located to provide options to transfer from a mobility device onto one short side (depth) and one long side (width) of the surface. Each transfer side shall provide unobstructed access to the transfer surface. Exception: Temporary obstructions shall be permitted provided that they can be repositioned to permit transfer. Advisory M302.2.3 Transfer Sides: Exception. Armrests, footrests, and side rails are examples of obstructions. M302.3 Supports. Transfer supports, armrests, and reclining surfaces shall comply with M302.3. VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 M302.3.1 Transfer Supports. Transfer supports shall be provided for use with the transfer sides required by M302.2.3 and shall comply with M305.2. M302.3.2 Armrests. Where diagnostic equipment is used by patients in a seated position, armrests shall be provided. Advisory M302.3.2 Armrests. Armrests on transfer sides are not permitted to obstruct access to the transfer surface. See M302.2.3 Exception. M302.3.3 Head and Back Support. Where the diagnostic equipment is used in a reclined position, head and back support shall be provided. Where the incline of the back support can be modified while in use, head and back support shall be provided throughout the entire range of the incline. M302.4 Lift Compatibility. Diagnostic equipment shall be usable with a patient lift and shall comply with M302.4.1 or M302.4.2. Exception: Where diagnostic equipment meets the requirements of M303 and provides a folding seat, the equipment shall not be required to comply with M302.4. M302.4.1 Clearance in Base. The base of the equipment shall provide a clearance 44 inches (1120 mm) wide minimum, 6 inches (150 mm) high minimum measured from the floor, and 36 inches (915 mm) deep minimum measured from the edge of the examination surface. Where the width of the examination surface is less than 36 inches (915 mm), the clearance depth shall extend the full width of the equipment. Equipment components are permitted to be located within 8 inches (205 mm) maximum of the centerline of the clearance width. M302.4.2 Clearance Around Base. The base of the equipment shall provide a clearance 6 inches (150 mm) high minimum measured from the floor and 36 inches (915 mm) deep minimum measured from the edge of the examination surface. The width of the base permitted within this clearance shall be 26 inches (660 mm) wide maximum at the edge of the examination surface and shall be permitted to increase at a rate of 1 inch (25 mm) in width for each 3 inches (75 mm) in depth. M303 Diagnostic Equipment Used by Patients Seated in a Wheelchair M303.1 General. Diagnostic equipment used by patients seated in a wheelchair shall comply with M303. M303.2 Wheelchair Spaces. A wheelchair space complying with M303.2 shall be provided at diagnostic equipment. Advisory M303.2 Wheelchair Spaces. A wheelchair space can be used to accommodate patients who use wheelchairs as well as other mobility devices and seating. M303.2.1 Orientation. Wheelchair spaces shall be designed so that a patient seated in a wheelchair orients in the same direction that a patient not seated in a wheelchair orients when the diagnostic equipment is in use. M303.2.2 Width. Wheelchair spaces shall be 36 inches (915 mm) wide minimum. M303.2.3 Depth. Where wheelchair spaces can be entered from the front or rear, the wheelchair space shall be 48 inches (1220 mm) deep minimum. Where wheelchair spaces can be entered only from the side, the PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 wheelchair space shall be 60 inches (1525 mm) deep minimum. M303.2.4 Knee and Toe Clearance. Wheelchair spaces shall include knee and toe clearance complying with M303.2.4. The depth of the wheelchair space shall include knee and toe clearance of 17 inches (430 mm) minimum and 25 inches (635 mm) maximum. Knee and toe clearance under breast platforms shall be 25 inches (635 mm) deep. M303.2.4.1 Toe Clearance. Toe clearance shall be provided at a height of 9 inches (230 mm) above the floor to a depth of 6 inches (150 mm) maximum. M303.2.4.2 Knee Clearance. Knee clearance shall be provided at a depth of 11 inches (280 mm) minimum and 25 inches (635 mm) maximum at 9 inches (230 mm) above the floor and at a depth of 8 inches (205 mm) minimum at 27 inches (685 mm) above the floor. Between 9 inches (230 mm) and 27 inches (685 mm) above the floor, the knee clearance shall be permitted to reduce at a rate of 1 inch (25 mm) in depth for every 6 inches (150 mm) in height. M303.2.5 Surfaces. Wheelchair space surfaces shall not slope more than 1:48 in any direction. M303.3 Entry. Where there is a change in level at the entry to a wheelchair space, the change in level shall comply with M303.3. M303.3.1 Vertical. Changes in level of 1⁄4 inch (6.4 mm) high maximum shall be permitted to be vertical. M303.3.2 Beveled. Changes in level between 1⁄4 inch (6.4 mm) high and 1⁄2 inch (13 mm) high maximum shall be beveled with a slope not steeper than 1:2. M303.3.3 Ramped. Changes in level greater than 1⁄2 inch (13 mm) high shall be ramped and shall comply with M303.3.3. M303.3.3.1 Running Slope. Ramp runs shall have a running slope not steeper than 1:12. M303.3.3.2 Cross Slope. The cross slope of ramp runs shall not be steeper than 1:48. M303.3.3.3 Clear Width. The clear width of ramp runs shall be 36 inches (915 mm) minimum. M303.3.3.4 Edge Protection. Ramps with drop offs 1⁄2 inch (13 mm) or greater shall provide edge protection 2 inches (50 mm) high minimum on each side. M303.3.3.5 Handrails. Ramps with a rise greater than 6 inches (150 mm) shall provide handrails on each side. M303.4 Components. Where components of diagnostic equipment are used to examine specific body parts, the components shall be capable of examining the body parts of a patient seated in a wheelchair. Breast platforms shall comply with M303.4.1. M303.4.1 Breast Platforms. The height of the breast platform shall be 30 inches (760 mm) high minimum and 42 inches (1065 mm) high maximum above the floor when in use by a patient seated in a wheelchair. M304 Diagnostic Equipment Used by Patients in Standing Position M304.1 General. Diagnostic equipment used by patients in a standing position shall comply with M304. M304.2 Standing Surface. The surface on which the patient stands shall be slip resistant. E:\FR\FM\09FEP3.SGM 09FEP3 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules M304.3 Standing Supports. Standing supports shall be provided on each side of the standing surface and shall comply with M305.3. mstockstill on DSK4VPTVN1PROD with PROPOSALS3 M305 Supports M305.1 General. Supports shall comply with M305, as applicable. M305.2 Transfer Supports. Transfer supports shall comply with M305.2. M305.2.1 Location. Transfer supports shall be located within reach of the transfer surface and shall not obstruct transfer onto or off of the surface when in position. M305.2.2 Structural Strength. Transfer supports and their connections shall be capable of resisting vertical and horizontal forces of 250 pounds (1,112 N) applied at all points on the transfer support. M305.2.3 Fittings. Transfer supports shall not rotate within their fittings. M305.3 Standing Supports. Standing supports shall provide continuous support throughout use of the diagnostic equipment and shall comply with M305.3. M305.3.1 Horizontal Position. Where the support is horizontal, the top of the gripping VerDate Mar<15>2010 18:37 Feb 08, 2012 Jkt 226001 surface shall be 34 inches (865 mm) minimum and 38 inches (965 mm) maximum above the standing surface. The gripping surface shall be 4 inches (100 mm) long minimum. M305.3.2 Vertical Position. Where the support is vertical, it shall be 18 inches (455 mm) minimum in length and the bottom end of the support shall be 34 inches (865 mm) high minimum and 37 inches (940 mm) high maximum above the standing surface. M305.3.3 Fittings. Standing supports shall not rotate within their fittings. M306 Communication M306.1 General. Where instructions or other information is communicated to the patient through the diagnostic equipment, the instructions and other information shall be provided in at least two of the following methods: audible, visible, or tactile. Advisory M306.1 General. Patients should not be required to adjust position to receive audible, visible, or tactile communications. A volume control can be helpful, particularly in diagnostic equipment where hearing aids cannot be worn. In PO 00000 Frm 00025 Fmt 4701 Sfmt 9990 6939 selecting the methods of communication it is important to consider the diagnostic equipment characteristics. For example, audible communication may not be effective for magnetic resonance imaging (MRI) equipment due to the noise level when the equipment is in use. M307 Operable Parts M307.1 General. Operable parts for patient use shall comply with M307. M307.2 Tactilely Discernible. Operable parts shall be tactilely discernible without activation. M307.3 Operation. Operable parts shall be operable with one hand and shall not require tight grasping, pinching, or twisting of the wrist. M307.4 Operating Force. The force required to activate operable parts shall be 5 pounds (22.2 N) maximum. [FR Doc. 2012–2795 Filed 2–8–12; 8:45 am] BILLING CODE 8150–01–P E:\FR\FM\09FEP3.SGM 09FEP3

Agencies

Architectural and Transportation Barriers Compliance Board

[Federal Register Volume 77, Number 27 (Thursday, February 9, 2012)]
[Proposed Rules]
[Pages 6916-6939]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2795]

[[Page 6915]]

Vol. 77

Thursday,

No. 27

February 9, 2012

Part III

Architectural and Transportation Barriers Compliance Board

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36 CFR Part 1195

Medical Diagnostic Equipment Accessibility Standards; Proposed Rule

Federal Register / Vol. 77 , No. 27 / Thursday, February 9, 2012 /
Proposed Rules

[[Page 6916]]

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ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD

36 CFR Part 1195

[Docket No. ATBCB-2012-0003]
RIN 3014-AA40

Medical Diagnostic Equipment Accessibility Standards

AGENCY: Architectural and Transportation Barriers Compliance Board.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Architectural and Transportation Barriers Compliance Board
(Access Board) is proposing accessibility standards for medical
diagnostic equipment. The proposed standards contain minimum technical
criteria to ensure that medical diagnostic equipment, including
examination tables, examination chairs, weight scales, mammography
equipment, and other imaging equipment used by health care providers
for diagnostic purposes are accessible to and usable by individuals
with disabilities. The standards will allow independent entry to, use
of, and exit from the equipment by individuals with disabilities to the
maximum extent possible. The standards do not impose any mandatory
requirements on health care providers or medical device manufacturers.
However, other agencies, referred to as an enforcing authority in the
standards, may issue regulations or adopt policies that require health
care providers subject to their jurisdiction to acquire accessible
medical diagnostic equipment that conforms to the standards.

DATES: Submit comments by June 8, 2012. Hearings will be held on the
proposed standards on the following dates:
1. March 14, 2012, 9:30 a.m. to 12 p.m., Washington, DC.
2. May 8, 2012, 9:30 a.m. to 12 p.m., Atlanta, GA.

ADDRESSES: Submit comments by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Regulations.gov ID for
this docket is ATBCB-2012-0003.
Email: board.gov">docket@access-board.gov. Include docket number
ATBCB-2012-0003 in the subject line of the message.
Fax: 202-272-0081.
Mail or Hand Delivery/Courier: Office of Technical and
Informational Services, Access Board, 1331 F Street NW., Suite 1000,
Washington, DC 20004-1111.
All comments, including any personal information provided, will be
posted without change to https://www.regulations.gov and are available
for public viewing.
The hearing locations are:
1. Washington, DC: Access Board Conference Room, 1331 F Street NW.,
Suite 800, Washington, DC 2004.
2. Atlanta, GA: Hilton Atlanta (Meeting Rooms 309-311), 255
Courtland Street NE., Atlanta, GA 30303.

FOR FURTHER INFORMATION CONTACT: Earlene Sesker, Office of Technical
and Information Services, Architectural and Transportation Barriers
Compliance Board, 1331 F Street NW., Suite 1000, Washington, DC 20004-
1111. Telephone: (202) 272-0022 (voice) or (202) 272-0091 (TTY). Email
address board.gov">sesker@access-board.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

1. Public Participation and Request for Comments
2. Establishment of Advisory Committee
3. Background
A. Access Board
B. Patient Protection and Affordable Care Act and Section 510 of
the Rehabilitation Act
C. Americans With Disabilities Act and Section 504 of the
Rehabilitation Act
D. Department of Justice Activities Related to Health Care
Providers and Medical Equipment
E. Private Enforcement Efforts
F. Consultation With Food and Drug Administration
G. ANSI/AAMI HE 75
H. Barriers Affecting Accessibility and Usability of Medical
Diagnostic Equipment
4. Organization of Technical Criteria
5. Discussion of Proposed Standards
6. Regulatory Analyses

1. Public Participation and Request for Comments

The preamble includes questions that request comments on issues
that the Access Board is particularly interested in receiving
information from the public. The Access Board encourages all persons
interested in the rulemaking to submit comments on the proposed
standards and the questions in the preamble. Instructions for
submitting and viewing comments are provided above under Addresses. The
Access Board will consider all the comments and may change the proposed
standards based on the comments.

2. Establishment of Advisory Committee

The Access Board has used advisory committees consisting of
representatives of interest groups that are affected by its guidelines
and standards to assist in developing the guidelines and standards.
Advisory committees provide significant expertise on issues and an
opportunity for interest groups to reach consensus on issues. The
Access Board plans to convene an advisory committee when the comment
period on the rulemaking closes to assist the Board in reviewing the
comments and make recommendations on issues addressed in the
rulemaking. The Access Board will issue a separate notice in the
Federal Register announcing the establishment of the advisory committee
and seeking nominations for membership on the advisory committee to
represent the interests of individuals with disabilities, medical
device manufacturers, health care providers, standards setting
organizations, and other interested parties. Advisory committee
meetings will be announced in advance in the Federal Register and will
be open to the public.

3. Background

A. Access Board

The Access Board is an independent Federal agency established by
Section 502 of the Rehabilitation Act (29 U.S.C. 792).\1\ The Access
Board is responsible for developing accessibility guidelines and
standards under various laws to ensure that individuals with
disabilities have access to and use of buildings and facilities,
transportation vehicles, and information and communication
technology.\2\ Pursuant to these laws, other Federal agencies have
adopted the Access Board's guidelines and standards as mandatory
requirements for entities subject to their jurisdiction.\3\
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\1\ The Access Board consists of 13 members appointed by the
President from the public, a majority of which are individuals with
disabilities, and the heads of 12 Federal agencies or their
designees whose positions are Executive Level IV or above. The
Federal agencies are: The Departments of Commerce, Defense,
Education, Health and Human Services, Housing and Urban Development,
Interior, Justice, Labor, Transportation, and Veterans Affairs;
General Services Administration; and United States Postal Service.
\2\ The Access Board has issued accessibility guidelines and
standards under the following laws: Section 504 of the Americans
with Disabilities Act (42 U.S.C. 12204) for buildings and
facilities, and transportation vehicles; Section 502 of the
Rehabilitation Act (29 U.S.C. 792) for buildings and facilities;
Section 508 of the Rehabilitation Act (29 U.S.C. 794d) for
electronic and information technology; and Section 255 of the
Telecommunications Act (47 U.S.C. 255) for telecommunications
equipment and customer premises equipment. Additional information on
the guidelines and standards is available at: https://www.access-
board.gov.
\3\ The following Federal agencies have adopted the Access
Board's guidelines and standards as mandatory requirements for
entities subject to their jurisdiction: Department of Justice (see
28 CFR 35.104 and 35.151; and 28 CFR 36.104 and 36.401 to 36.406);
Department of Transportation (see 49 CFR 37.9 and Appendix A to 49
CFR part 37; and 49 CFR part 38); Federal Acquisition Regulatory
Council (see 48 CFR 39.203); Federal Communications Commission (see
47 CFR part 6); General Services Administration (see 41 CFR 102-
77.65); and United States Postal Service (see 39 CFR 254.1). See
also Deputy Secretary of Defense Memorandum on Access for People
with Disabilities, October 31, 2008 at: https://www.access-board.gov/ada-aba/dod-memorandum.htm. Some agencies have adopted the
guidelines and standards with additions and modifications.

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[[Page 6917]]

B. Patient Protection and Affordable Care Act and Section 510 of the
Rehabilitation Act

Section 4203 of the Patient Protection and Affordable Care Act
(Pub. L. 111-148, 124 Stat. 570) amended Title V of the Rehabilitation
Act, which establishes rights and protections for individuals with
disabilities, by adding Section 510. Section 510 of the Rehabilitation
Act (29 U.S.C. 794f) requires the Access Board, in consultation with
the Commissioner of the Food and Drug Administration, to issue
standards that contain minimum technical criteria to ensure that
medical diagnostic equipment used in or in conjunction with medical
settings such as physicians' offices, clinics, emergency rooms, and
hospitals is accessible to and usable by individuals with disabilities.
The statute provides that the standards must allow for independent
access to and use of the equipment by individuals with disabilities to
the maximum extent possible. The statute lists examination tables,
examination chairs, weight scales, mammography equipment, and other
imaging equipment as examples of equipment to which the standards will
apply. However, this list is not exclusive and the statute covers any
equipment used by health care providers for diagnostic purposes. The
statute does not cover medical devices used for monitoring or treating
medical conditions such as glucometers and infusion pumps.
Section 510 of the Rehabilitation Act requires the standards to be
issued not later than 24 months after the enactment of the Patient
Protection and Affordable Care Act. The Patient Protection and
Affordable Care Act was enacted on March 23, 2010. Accordingly, the
statutory deadline for issuing the standards is March 23, 2012. The
statute also requires the Access Board, in consultation with the
Commissioner of the Food and Drug Administration, to periodically
review and amend the standards, as appropriate.
Section 510 of the Rehabilitation Act does not require any entity
to comply with the standards that the Access Board issues under this
law. Compliance with the standards becomes mandatory only when an
enforcing authority adopts the standards as mandatory requirements for
entities subject to its jurisdiction. As discussed below, the
Department of Justice (DOJ) may adopt the standards as mandatory
requirements for health care providers pursuant to its authority under
Titles II and III of the Americans with Disabilities Act. Other Federal
agencies may adopt the standards as mandatory requirements for health
care providers pursuant to their authority under Section 504 of the
Rehabilitation Act.

C. Americans With Disabilities Act and Section 504 of the
Rehabilitation Act

The Americans with Disabilities Act (ADA) and Section 504 of the
Rehabilitation Act are civil rights laws that prohibit discrimination
on the basis of disability. Title II of the ADA (42 U.S.C. 12131 to
12165) applies to state and local governments, and Title III of the ADA
(42 U.S.C. 12189 to 12189) applies to private entities that are public
accommodations such as health care providers. Section 504 of the
Rehabilitation Act (29 U.S.C. 792) applies to recipients of Federal
financial assistance such as Medicaid and federally conducted programs.
DOJ is responsible for issuing regulations to implement Titles II and
III of the ADA.\4\ Federal agencies that provide Federal financial
assistance are responsible for issuing regulations to implement Section
504 of the Rehabilitation Act for recipients of such assistance.
Federal agencies also are responsible for issuing regulations to
implement Section 504 of the Rehabilitation Act for their federally
conducted programs. DOJ is responsible for overall enforcement of
Titles II and III of the ADA, and Section 504 of the Rehabilitation Act
as it applies to recipients of Federal financial assistance from DOJ
and Federal financial assistance from other Federal agencies when those
agencies refer complaints to DOJ for enforcement purposes.\5\
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\4\ The Department of Transportation is responsible for issuing
regulations to implement certain sections of Titles II and III of
the ADA relating to transportation.
\5\ In its regulations implementing Title II of the ADA, DOJ has
delegated responsibility for investigating complaints and conducting
compliance reviews in specific subject matter areas to other Federal
agencies, but at its discretion DOJ may retain complaints for
investigation and appropriate disposition. See 28 CFR 35.190. DOJ
has delegated responsibility for investigating complaints and
conducting compliance reviews relating to the provision of health
care services by state and local governments to the Department of
Health and Human Services. Federal agencies that provide Federal
financial assistance also investigate complaints and conduct
compliance reviews regarding compliance with Section 504 of the
Rehabilitation Act by recipients of such assistance. See Appendix A
to 28 CFR part 41. The Federal agencies can refer matters that are
not resolved successfully to DOJ for enforcement.
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D. Department of Justice Activities Related to Health Care Providers
and Medical Equipment

Pursuant to the ADA and Section 504 of the Rehabilitation Act,
health care providers must provide individuals with disabilities full
and equal access to their health care services and facilities. DOJ has
entered into settlement agreements with health care providers to
enforce the ADA and Section 504 of the Rehabilitation Act.\6\
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\6\ The settlement agreements by DOJ with health care providers
and matters addressed in the agreements include: United States of
America v. Inova Health System (March 30, 2011) auxiliary aids and
services, including sign language interpreters; HCA Health Services
of New Hampshire (Portsmouth Regional Hospital) (November 23, 2010)
auxiliary aids and services, including sign language interpreters;
Beth Israel Deaconess Medical Center (October 22, 2009) accessible
facilities and accessible medical equipment; Gillespie v. Dimensions
Health Corporation (July 12, 2006) auxiliary aids and services,
including sign language interpreters; Washington Hospital Center
(November 2, 2005) accessible facilities and accessible medical
equipment; Valley Radiologists Medical Group, Inc. (November 2,
2005) accessible imaging equipment; Exodus Women's Center (March 26,
2005) accessible examination tables; Dr. Robila Ashfaq (January 12,
2005) accessible examination table; and Georgetown University
Hospital (October 31, 2001) providing assistance for transferring
from a wheelchair to an examination table The settlement agreements
are available at: https://www.ada.gov/settlemt.htm.
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In July 2010, DOJ and the Department of Health and Human Services
issued a guidance document for health care providers regarding their
responsibilities to make their services and facilities accessible to
individuals with mobility disabilities under the ADA and Section 504 of
the Rehabilitation Act. See Access to Medical Care for Individuals with
Mobility Disabilities available at: https://www.ada.gov/medcare_ta.htm.
The guidance document includes information on accessible examination
rooms and the clear floor space needed adjacent to medical equipment
for individuals who use mobility devices to approach the equipment for
transfer; accessible medical equipment (e.g., examination tables and
chairs, mammography equipment, weight scales); patient lifts and other
methods for transferring individuals from their mobility devices to
medical equipment; and training health care personnel.
In July 2010, DOJ also issued an advance notice of proposed
rulemaking (ANPRM) announcing that, pursuant to the obligation that has
always existed

[[Page 6918]]

under the ADA for covered entities to provide accessible equipment and
furniture, it was considering amending its regulations implementing
Titles II and III of the ADA to include specific standards for the
design and use of accessible equipment and furniture that is not fixed
or built into a facility in order to ensure that programs and services
provided by state and local governments and by public accommodations
are accessible to individuals with disabilities.\7\ See 75 FR 43452
(July 26, 2010). Among other things, the ANPRM stated that DOJ was
considering amending its ADA regulations to specifically require health
care providers to acquire accessible medical equipment and that it
would consider adopting the standards issued by the Access Board. DOJ
also indicated its intention to include in its ADA regulations scoping
requirements that specify the minimum number of types of accessible
medical equipment required in different types of health care
facilities. If DOJ proposes to amend its ADA regulations as announced
in the ANPRM, it will publish a notice of proposed rulemaking (NPRM)
requesting public comment.
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\7\ The ANPRM requested public comment on several categories of
equipment and furniture, including medical equipment (e.g., medical
examination and treatment tables and chairs, scales, radiological
diagnostic equipment, lifts, infusion pumps, rehabilitation
equipment, hospital beds and gurneys, ancillary equipment such as
positioning straps or cushions, protective padding, leg supports for
gynecological examinations, rails and bars for patient safety and
comfort, and call buttons); exercise equipment and furniture;
accessible golf cars; beds in accessible guest rooms and sleeping
rooms; beds in nursing homes and other care facilities; and
electronic and information technology such as kiosks (i.e.,
interactive computer terminals that provide services), interactive
transaction machines, point of sale devices, and automated teller
machines.
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E. Private Enforcement Efforts

Private parties, including individuals with disabilities, have also
entered into settlement agreements with health care providers to
enforce the ADA and Section 504 of the Rehabilitation Act.\8\
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\8\ The settlement agreements by private parties and matters
addressed in the agreements include: Massachusetts General Hospital
and Brigham and Women's Hospital (June 26, 2009) accessible
facilities, accessible medical equipment, and auxiliary aids and
services; Thompson v. Sutter Health (July 11, 2008) accessible
facilities, accessible medical equipment, and auxiliary aids and
services; University of Southern California Medical Center (May 15,
2008) accessible facilities, accessible medical equipment, and
auxiliary aids and services; and Metzler v. Kaiser Permanente (March
2001) accessible facilities and accessible medical equipment. The
settlement agreements are available at: https://thebarrierfreehealthcareinitiative.org/?page_id=16.
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F. Consultation With Food and Drug Administration

The Commissioner of the Food and Drug Administration has designated
the Director of the Center for Devices and Radiological Health (FDA-
CDRH) to consult with the Access Board on the development of standards
for accessible medical diagnostic equipment. The Access Board has
worked closely with the FDA-CDRH in developing the proposed standards.
The FDA-CDRH may develop a guidance document to inform manufacturers
how it intends to apply its regulatory authority to clearance or
approval of medical devices addressed in the Access Board's standards.
If the FDA-CDRH develops such a guidance document, it will provide the
public notice and opportunity to comment on a draft of the guidance
document in accordance with its procedures for issuing guidance
documents. See 21 CFR 10.115.

G. ANSI/AAMI HE 75

In 2009, the Association for the Advancement of Medical
Instrumentation issued ANSI/AAMI HE 75, a recommended practice on human
factors design principles for medical devices. Chapter 16 of ANSI/AAMI
HE 75 contains recommended practices regarding accessibility for
patients and health care personnel with disabilities. Chapter 16 of
ANSI/AAMI HE 75 is available at: https://www.aami.org/he75/ he75/.
The Access Board is committed to using voluntary consensus
standards where practical and consistent with the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note). The Access
Board has considered the recommended practices in Chapter 16 of ANSI/
AAMI HE 75 in developing the technical criteria for the proposed
standards. The technical criteria are generally consistent with and
supplement the recommended practices in Chapter 16 of ANSI/AAMI HE 75.
The Access Board seeks to promote harmonization of its guidelines and
standards with voluntary consensus standards and plans to participate
in future revisions to ANSI/AAMI HE 75.
Question 1. Are there other voluntary consensus standards for
medical diagnostic equipment that address accessibility for patients
with disabilities, or are considering addressing accessibility for
patients with disabilities in future revisions to the standards?

H. Barriers Affecting Accessibility and Usability of Medical Diagnostic
Equipment

The Rehabilitation Engineering Research Center on Accessible
Medical Instrumentation conducted a national survey in 2004 to collect
information on the types of medical equipment that is most difficult
for individuals with disabilities to access and use.\9\ The survey was
completed by a diverse sample of individuals with a wide range of
disabilities, including mobility disabilities and sensory disabilities.
Survey respondents who had experience with specific medical equipment
rated their degree of difficulty when attempting to access or use the
equipment as follows:
---------------------------------------------------------------------------

\9\ The results of the survey are reported in Jill M. Winters,
Molly Follette Story, Kris Barnekow, June Isaacson Kailes, Brenda
Premo, Erin Schier, Sarma Danturthi, and Jack M. Winters, ``Results
of a National Survey on Accessibility of Medical Instrumentation for
Consumers,'' in ``Medical Instrumentation Accessibility and
Usability Considerations,'' edited by Jack M. Winters and Molly
Follette Story (Boca Raton, CRC Press, 2007), 13-27.
---------------------------------------------------------------------------

Survey respondents reported difficulties with getting on and off the
equipment, positioning their bodies on the equipment, physical comfort
and safety, and communication issues.
A subsequent study that involved focus group sessions of
individuals with diverse disabilities provided additional information
on barriers that affect the accessibility and usability of examination
tables, examination chairs, imaging equipment, and weight scales.\10\
The equipment characteristics that the focus group participants
identified as affecting their ability to access and use the equipment
included the dimensions of the equipment (e.g., height, width, length),
contact surfaces (e.g., stiffness, comfort, color contrast), supports
for transferring onto and off of equipment and positioning their bodies
on the equipment (e.g., handholds,

[[Page 6919]]

armrests, side rails), controls (e.g., ease of operation), and displays
and devices (e.g., legibility, understandability).
---------------------------------------------------------------------------

\10\ The results of the focus group sessions are reported in
Molly Follette Story, Erin Schwier, and June Isaacson Kailes,
``Perspectives of Patients with Disabilities on the Accessibility of
Medical Equipment: Examination Tables, Imaging Equipment, Medical
Chairs, and Weight Scales,'' Disability and Health Journal 2 (2009),
169-179.
---------------------------------------------------------------------------

The Access Board held a public meeting in July 2010 that featured
panel discussions and presentations by experts and researchers on
medical equipment accessibility, health care providers, medical device
manufacturers, and other interested parties to provide information for
developing the proposed standards. The transcript of the meeting is
available at: https://www.access-board.gov/medical-equipment.htm.
The technical criteria in the proposed standards address most of
the barriers that have been identified as affecting the accessibility
and usability of medical diagnostic equipment. However, it is not
possible to address every barrier in the proposed standards, especially
given the statutory deadline for issuing the standards. Research may be
needed on some equipment characteristics that affect the accessibility
and usability of equipment such as stiffness, comfort, and color
contrast of contact surfaces. Section 510 of the Rehabilitation Act
requires the Access Board to periodically review and amend the
standards, as appropriate. The Access Board will address other barriers
in future updates to the standards.
Question 2. What other barriers that affect the accessibility and
usability of medical diagnostic equipment should be addressed in future
updates to the standards? Comments should include information on
sources to support the development of technical criteria to address the
barriers, where possible.

4. Organization of Technical Criteria

Medical diagnostic equipment is typically designed to support
patients in certain positions. For example, imaging equipment can be
designed for use by patients lying on a platform bed, in a standing or
seated position, or seated in a wheelchair. Examination chairs can be
designed to recline and be used as examination tables. The technical
criteria for providing patients with disabilities access to and use of
each of these equipment types would differ based on the patient
positions that the equipment is designed to support. Therefore, the
technical criteria in the proposed standards are organized functionally
by the patient positions that the equipment is designed to support
instead of by types of equipment. Where equipment is designed to
support more than one patient position, the equipment would have to
meet the technical criteria for each position supported.
The table below shows the four basic patient positions that medical
diagnostic equipment can be designed to support; the equipment features
that are addressed in the technical criteria for each of the patient
positions; and the types of equipment to which the technical criteria
apply for each of the patient positions. For example, X-ray equipment
that is designed for use in a standing position for certain procedures
would have to meet the technical criteria for slip resistant standing
surface and standing supports for patients who use mobility aids such
as canes or crutches, or who have limited stamina or other conditions
that affect their ability to maintain balance. Mammography equipment
that is designed for use by patients seated in a wheelchair would have
to meet the technical criteria for wheelchair spaces, changes in level
at entry to the wheelchair space, and height of the breast platform.
The types of equipment listed in the last column of the table are meant
to be illustrative. The technical criteria apply to any type of medical
diagnostic equipment that is designed to support the patient positions
indicated.

------------------------------------------------------------------------
Equipment features Types of equipment
Patient positions equipment addressed in to which technical
designed to support technical criteria criteria applies
------------------------------------------------------------------------
Supine, prone, or side-lying Transfer surface, Examination
position (M301). including height, tables.
size, and
transfer sides.
Transfer supports, Imaging equipment
stirrups, and designed for use
head and back with platform
support. beds.
Lift compatibility Examination chairs
designed to
recline and be
used as
examination
tables.
Seated position (M302).......... Transfer surface, Examination
including height, chairs.
size, and
transfer sides.
Transfer supports, Imaging equipment
armrests, and designed for use
head and back with a seat.
support.
Lift compatibility Weight scales
designed for use
with a seat.
Seated in a wheelchair (M303)... Wheelchair space, Imaging equipment
including designed for
orientation, wheelchair use.
width, depth,
knee and toe
clearance, and
surface slope.
Changes in level Weight scales
at entry to designed for
wheelchair space, wheelchair use.
including ramps.
Components capable
of examining body
parts of patients
seated in a
wheelchair,
including height
of breast
platforms.
Standing position (M304)........ Slip resistant Imaging equipment
standing surface. designed for use
in standing
position.
Standing supports. Weight scales
designed for use
in standing
position.
------------------------------------------------------------------------

The proposed standards also include technical criteria for supports
(see M305), for instructions or other information communicated to
patients through the equipment (see M306), and for operable parts used
by patients (see M307).
Question 3. In organizing the technical criteria functionally by
the patient positions that medical diagnostic equipment is designed to
support, is it clear which technical criteria apply to different types
of equipment? If not, how should the technical criteria be organized so
it is clear which technical criteria apply to different types of
equipment?

5. Discussion of Proposed Standards

The proposed standards consist of three chapters. Chapter M1
addresses the application and administration of the proposed standards.
Chapter M2

[[Page 6920]]

addresses scoping. Chapter M3 contains the technical criteria. The
sections in each chapter are discussed below. Although the standards do
not impose any mandatory requirements on health care providers or
medical device manufacturers, the standards use mandatory language
(i.e., shall) because other agencies, referred to as an enforcing
authority in the standards, may issue regulations or adopt policies
that require health care providers subject to their jurisdiction to
acquire accessible medical diagnostic equipment that conforms to the
standards. Sections marked as advisory provide guidance on the
standards and are not mandatory.
The Access Board is committed to writing standards that are clear,
concise, and easy to understand so that persons who use the standards
know what is required.
Question 4. Is there language in the proposed standards that is
ambiguous or not clear? Comments should identify specific language in
the proposed standards that is ambiguous or not clear and, where
possible, recommend alternate language that is clear.

Chapter M1 Application and Administration

M101.1 Purpose

The proposed standards contain technical criteria for medical
diagnostic equipment that is accessible to and usable by patients with
disabilities. The standards provide for independent access to and use
of diagnostic equipment by patients with disabilities to the maximum
extent possible.

M101.2 Application

As discussed above under Organization of Technical Criteria, the
technical criteria are to be applied to medical diagnostic equipment
based on the following patient positions that the equipment is designed
to support:
Equipment used by patients in a supine, prone, or side-
lying position (see M301);
Equipment used by patients in a seated position (see
M302);
Equipment used by patients seated in a wheelchair (see
M303); and
Equipment used by patients in a standing position (see
M304).
The diagnostic equipment's labeling, instructions, and promotional
material usually identify the patient positions that the equipment is
designed to support. Where diagnostic equipment is designed to support
more than one patient position, the technical criteria for each patient
position supported are to be applied to the equipment. Advisory M101.2
includes examples of diagnostic equipment designed to support more than
one patient position and the technical criteria that apply to the
equipment.

M101.3 Equivalent Facilitation

The use of alternative designs and technologies that result in
substantially equivalent or greater accessibility than specified in the
proposed standards is permitted. Generally, alternative designs or
technologies that rely on assisted transfer only (e.g., use of a
patient lift) are not permitted because they do not provide for
independent access to and use of diagnostic equipment by patients with
disabilities to the maximum extent possible. However, the standards
include technical criteria for clearance in or around the base of the
equipment for lift compatibility to allow the use of a patient lift by
patients with disabilities for whom independent transfer may not be
possible, and the use of alternative designs or technologies for lift
compatibility is permitted.

M101.4 Dimensions

The standards are based on adult dimensions and anthropometrics.
Dimensions that are not stated as ``maximum'' or ``minimum'' are
absolute.

M101.5 Dimensional Tolerances

Dimensions are subject to conventional industry tolerances for
manufacturing processes, material properties, and field conditions.
Question 5. What information or resources are available concerning
conventional industry tolerances for manufactured equipment such as
medical diagnostic equipment?

M102.1 Defined Terms

The following terms are defined in the proposed standards:
Enforcing authority, medical diagnostic equipment, operable parts, and
transfer surface.
The definition of medical diagnostic equipment is based on Section
510 of the Rehabilitation Act and means equipment used in or in
conjunction with medical settings by health care providers for
diagnostic purposes. For convenience purposes, the shorter term
diagnostic equipment is used in place of medical diagnostic equipment
after that term is first used in the standards. Examination tables,
examination chairs, weight scales, mammography equipment, and other
imaging equipment are examples of diagnostic equipment to which the
standards apply.
The definitions of enforcing authority, transfer surface, and
operable parts are discussed respectively under M201.1; M301.2 and
M302.2; and M307.
Question 6. Should other terms in the proposed standards be
defined? Comments should identify specific terms in the proposed
standards that should be defined and, where possible, recommend
definitions.

M102.2 Undefined Terms

Collegiate dictionaries are used to define terms that are not
defined in the proposed standards or in regulations or policies issued
by the enforcing authority.

M102.3 Interchangeability

Singular and plural words, terms, and phrases are used
interchangeably.

Chapter M2 Scoping

M201.1 Enforcing Authority

The proposed standards do not include scoping requirements that
specify the minimum number of types of accessible diagnostic equipment
required in different types of health care facilities because Section
510 of the Rehabilitation Act authorizes the Access Board to issue only
technical criteria. Other agencies, referred to as an enforcing
authority in the standards (see defined terms in M102.1), may adopt the
standards as mandatory requirements for entities subject to their
jurisdiction. An enforcing authority can be a Federal, State, or local
government agency that enforces laws prohibiting discrimination on the
basis of disability, or regulates health care facilities. As discussed
above under Department of Justice Activities Related to Health Care
Providers and Medical Equipment, DOJ issued an ANPRM in July 2010
announcing that it was considering amending its regulations
implementing Titles II and III of the ADA to specifically require
health care providers to acquire accessible medical equipment and that
it would consider adopting the standards issued by the Access Board.
DOJ also indicated its intention to include in its ADA regulations
scoping requirements that specify the minimum number of types of
accessible medical equipment required in different types of health care
facilities.

Chapter M3 Technical Criteria

Chapter M3 provides technical criteria for accessible diagnostic
equipment based on the patient positions that the equipment is designed
to support, including equipment used by patients in a supine, prone, or
side-lying position (see M301); equipment

[[Page 6921]]

used by patients in a seated position (see M302); equipment used by
patients seated in a wheelchair (see M303); and equipment used by
patients in a standing position (see M304). Chapter M3 also provides
technical criteria for supports (see M301.3, M302.3, M304.3, and M305);
instructions and information communicated to patients through
diagnostic equipment (see M306); and operable parts used by patients
(see M307). The technical criteria specify measurements in inches and
millimeters. The values stated in each system may not be exact
equivalents, and each system should be used independently of the other.
When discussing the technical criteria below, the measurements are
stated in inches only.
Figures showing example applications of the technical criteria to
diagnostic equipment are available on the Access Board's Web site at:
https://www.access-board.gov/medical-equipment.htm. The figures are
provided to help readers understand how the technical criteria apply to
diagnostic equipment.
Question 7. Comments are requested on whether the figures can be
improved to help readers better understand how the technical criteria
apply to diagnostic equipment.

Sources for Technical Criteria

The sources discussed below were used to develop the technical
criteria.

2004 ADA and ABA Accessibility Guidelines

The Access Board has developed and updated accessibility guidelines
for buildings and facilities for over 30 years. The Access Board's
current guidelines for buildings and facilities were issued in 2004 and
are known as the Americans with Disabilities Act and Architectural
Barriers Act Accessibility Guidelines (hereinafter referred to as the
``2004 ADA and ABA Accessibility Guidelines''). The 2004 ADA and ABA
Accessibility Guidelines are codified at 36 CFR part 1191 and are
available at: https://www.access-board.gov/ada-aba/final.cfm.
The following technical criteria in the proposed standards are
based on the 2004 ADA and ABA Accessibility Guidelines:
Height of transfer surfaces on diagnostic equipment used
by patients in a supine, prone, or side-lying position and diagnostic
equipment used by patients in a seated position (see M301.2.1 and
M302.2.1);
Wheelchair spaces, including knee and toe clearance, and
change in level at entry to the wheelchair spaces at diagnostic
equipment used by patients seated in a wheelchair (see M303.2 and
M303.3);
Structural strength of transfer supports (see M305.2.2);
and
Operable parts (see M307).
The Access Board is also considering additional technical criteria
based on the 2004 ADA and ABA Accessibility Guidelines for cross
section dimensions and clearances around gripping surfaces on transfer
and standing supports, and for reach ranges for operable parts on
diagnostic equipment that are used by patients. Questions are included
under the applicable sections requesting comments on whether the
additional technical criteria under consideration would be appropriate
for the equipment features or whether alternative technical criteria
would be appropriate.

Wheeled Mobility Anthropometry Project

There have been dramatic changes in mobility devices and the
characteristics of people who use these devices. The Access Board and
the National Institute on Disability and Rehabilitation Research
sponsored a Wheeled Mobility Anthropometry Project to collect
measurements of approximately 500 people using a variety of mobility
devices, including manual wheelchairs, power wheelchairs, and scooters.
The Wheeled Mobility Anthropometry Project was conducted by the Center
for Inclusive Design and Environmental Access. The final report on the
Wheeled Mobility Anthropometry Project was issued in 2010 and is
available at: https://www.udeworld.com/anthropometrics.html.
Data from the Wheeled Mobility Anthropometry Project showed that
the seat heights of many mobility devices are above the range specified
in the 2004 ADA and ABA Accessibility Guidelines for certain
architectural features that involve transfers and that the dimensions
for wheelchair spaces, including knee and toe clearance, do not
accommodate many people in the sample. Data from the Wheeled Mobility
Anthropometry Project also showed that many people in the sample needed
a lower operating force to activate certain operable parts. The Wheeled
Mobility Anthropometry Project included recommendations for
specifications that would accommodate a broader range of people who use
mobility devices. The data and recommendations from the Wheeled
Mobility Anthropometry Project are discussed in connection with the
following technical criteria:
Height of transfer surfaces on diagnostic equipment used
by patients in a supine, prone, or side-lying position and diagnostic
equipment used by patients in a seated position (see M301.2.1 and
M302.2.1);
Wheelchair spaces, including knee and toe clearance, at
diagnostic equipment used by patients while seated in a wheelchair (see
M303.2); and
Operating force required to activate operable parts used
by patients (see M307.4).
The Access Board is considering specifying alternative technical
criteria in the final standards based on the Wheeled Mobility
Anthropometry Project. Questions are included under the applicable
sections requesting comments on the alternative technical criteria.

ANSI/AAMI HE 75

As discussed in the relevant sections below, the Access Board
considered the recommended practices regarding accessibility in Chapter
16 of ANSI/AAMI HE 75 in developing the technical criteria. The
technical criteria are generally consistent with and supplement the
recommended practices in ANSI/AAMI HE 75.

Other Sources

The Access Board used anthropometric data and other standards for
the width of transfer surfaces on diagnostic equipment used by patients
in a seated position (see M302.2.2), height of breast platforms on
mammography equipment used by patients seated in a wheelchair (see
M303.4.1), and standing supports in a vertical position for diagnostic
equipment used by patients in a standing position (see M305.3.2). The
sources are referenced in the relevant sections below.
The Access Board also considered information provided at the July
2010 public meeting that featured panel discussions and presentations
by experts and researchers on medical equipment accessibility, health
care providers, medical device manufacturers, and other interested
parties. The transcript of the meeting is available at: https://www.access-board.gov/medical-equipment.htm. In addition, the Access
Board considered public comments relating to medical equipment that
were submitted in response to DOJ's ANPRM on equipment and furniture.
The public comments on DOJ's ANPRM on equipment and furniture are
available at https://www.regulations.gov (Docket ID: DOJ-CRT-2010-0008).

Economic and Technical Impacts

The technical criteria in Chapter 3 address the features that make
diagnostic equipment accessible to and

[[Page 6922]]

usable by patients with disabilities. Comments are requested on the
economic and technical impacts of the technical criteria in questions
that follow the discussion of the technical criteria. Comments are
welcomed from all sources. Manufacturers that currently incorporate
accessible features in some of their products or plan to do so in the
future are encouraged to comment particularly on Questions 8, 9, and
10. The Access Board will use the information provided in response to
the questions to evaluate the economic and technical impacts of the
technical criteria.
Question 8. To what extent does diagnostic equipment currently
incorporate features that conform to the technical criteria proposed in
Chapter M3? If equipment conforms to some but not all of the technical
criteria proposed in Chapter M3, the comments should identify which
features conform to the technical criteria proposed in Chapter M3.
Question 9. If diagnostic equipment does not currently incorporate
features that conform to all the technical criteria proposed in Chapter
M3, which technical criteria can be easily incorporated into the design
or redesign and manufacture of equipment with little difficulty or
expense? Which technical criteria would have the greatest incremental
costs on the design or redesign and manufacture of equipment? Comments
should include estimates of the incremental costs, where possible.
Question 10. How often is diagnostic equipment redesigned? Would
incorporating features that conform to the technical criteria proposed
in Chapter M3 in the planned redesign of equipment lessen the economic
and technical impacts?
Question 11. Are there types of diagnostic equipment that cannot
conform to certain technical criteria proposed in Chapter M3 because of
the structural or operational characteristics of the equipment?
Comments should identify the specific technical criteria which the
equipment cannot conform to and discuss alternative methods for making
the equipment accessible to patients with disabilities.
Question 12. Do the technical criteria proposed in Chapter M3 have
any positive or negative unintended consequences?

M301 Diagnostic Equipment Used by Patients in Supine, Prone, or Side-
Lying Position

M302 Diagnostic Equipment Used by Patients in Seated Position

M301 provides technical criteria for diagnostic equipment used by
patients in a supine, prone, or side-lying position, and M302 provides
technical criteria for diagnostic equipment used by patients in a
seated position. The purpose of these sections is to facilitate
independent transfer onto and off of diagnostic equipment by patients
with disabilities, including those who use mobility devices or aids,
and to provide supports for patients with disabilities when positioning
their bodies on the equipment. The sections also include provisions for
clearance in and around the base of the equipment for lift
compatibility to allow the use of a patient lift by patients with
disabilities for whom independent transfer may not be possible. Except
for the size of the transfer surface (see M301.2.2 and M302.2.2) and
certain supports (see M301.3.2 for stirrups, and M302.3.2 for
armrests), the technical criteria in these sections are the same and
are discussed together below. The technical criteria for transfer
surface size and for stirrups and armrests are discussed separately for
diagnostic equipment used by patients in a supine, prone, or side-lying
position and for diagnostic equipment used by patients in a seated
position.

Transfer Surface (M301.2 and M302.2)

The technical criteria in M301.2 and M302.2 address the height and
size of the transfer surface, and the transfer sides. The transfer
surface is the part of the diagnostic equipment onto which patients who
use mobility devices or aids transfer when moving onto and off of the
equipment (see defined terms in M102.1). Depending on the configuration
of the equipment, the transfer surface may coincide with the seat area
of an examination chair, or occupy only a portion of an examination
table or imaging bed platform. The technical criteria do not address
the overall width and depth of patient support surfaces because of the
diverse shape and size of these surfaces.

Transfer Surface Height (M301.2.1 and M302.2.1)

For many patients who use mobility devices, independent transfer is
possible only if the height of the transfer surface is at or near the
seat height of their mobility device. The transfer surface height is
also critical for patients who use mobility aids such as walkers and
canes and may find it difficult to get up onto or down from an
examination chair or table or imaging bed platform, and for
facilitating assisted transfers.
M301.2.1 and M302.2.1 would require the height of the transfer
surface during patient transfer to be 17 inches minimum and 19 inches
maximum measured from the floor to the top of the transfer surface.
This height range is based on provisions in the 2004 ADA and ABA
Accessibility Guidelines for architectural features that involve
transfers (e.g., toilet seats, shower seats, dressing benches). Patient
support surfaces can be adjusted to heights outside the specified
dimensions when not needed for patient transfer such as when performing
diagnostic procedures.
Where patient support surfaces are contoured or upholstered for
patient comfort or to support patient positioning during diagnostic
procedures, the height of the transfer surface measured from the floor
may vary across the transfer surface. The highest and lowest points of
the transfer surface on such equipment would have to be within the
specified dimensions.
Where patient support surfaces are cushioned (e.g., polyurethane on
top of cell foam), the upholstery may compress or deflect during use.
If the height of the transfer surface is measured from the floor to the
rigid platform under the cushion, the top of the upholstery may be
outside the specified dimensions. Measuring the height of the transfer
surface from the floor to the top of the upholstery under static
conditions, without compression or deflection in the transfer surface,
would provide a consistent method of measurement given the variety of
materials used to cushion patient support surfaces and the differences
in how the materials compress or deflect during use.
Question 13. Should the technical criteria specify that the height
of the transfer surface from the floor be measured to the top of the
upholstery under static conditions, without compression or deflection
in the transfer surface? Or should the technical criteria allow for
more dynamic conditions and limit the amount of deflection permitted
when a specific load is applied to the transfer surface?

Adjustable Height Range Considered

The technical criteria allow the height of transfer surfaces to be
either fixed or adjustable within the 17 inches minimum and 19 inches
maximum range. Based on the information discussed below, the Access
Board is considering requiring in the final standards that the height
of transfer surfaces be adjustable from 17 inches minimum to 25 inches
maximum during

[[Page 6923]]

patient transfer. Patient support surfaces can be adjusted outside this
range when not needed for patient transfer such as when performing
diagnostic procedures.
Many types of diagnostic equipment used by patients in a supine,
prone, or side-lying position, and diagnostic equipment used by
patients in a seated position currently provide adjustable height
patient support surfaces. ANSI/AAMI HE75 recommends that the height of
patient support surfaces ``should be easy to adjust (ideally, powered)
to suit the needs of health care professionals and patients.'' ANSI/
AAMI HE75 further recommends that the height of patient support
surfaces ``should be adjustable to a position high enough to
accommodate tall health care providers and the range of medical
procedures that could occur * * * [and] to a position low enough [19
inches maximum] to allow for the comfort of providers who choose to
work in a seated position, to enable patients to keep their feet on the
floor while seated, and to accommodate patients who need to transfer
laterally between the platform and a chair or wheelchair alongside.''
See ANSI/AAMI HE 75, section 16.4.4.
Transfer surfaces that are adjustable to the same heights as the
seat heights of mobility devices reduce the effort needed to transfer
since patients do not have to lift their body weight to make up the
difference between the two surfaces, in one direction or the other. The
Wheeled Mobility Anthropometry Project shows the occupied seat heights
for people who use mobility devices vary considerably. See Analysis of
Seat Heights for Wheeled Mobility Devices at: https://udeworld.com/analysis-of-seat-height-for-wheeled-mobility-devices. The seat heights
ranged from 16.3 inches to 23.9 inches for manual wheelchair users;
16.2 inches to 28.9 inches for power wheelchair users; and 18.8 inches
to 25.3 inches for scooter users. Seat heights for males were typically
higher than for females. Thirty (30) percent of male manual wheelchair
users and 6 percent of male power wheelchair users had seat heights
equal to or less than 19 inches. All the male manual wheelchair users
and 92 percent of the male power wheelchair users had seat heights
equal to or less than 25 inches. Thus, transfer surfaces that are
adjustable from 17 inches minimum to 25 inches maximum during patient
transfer accommodate significantly more patients who use mobility
devices.
Ideally, transfer surfaces should be adjustable to any height
within the 17 inches minimum and 25 inches maximum range. However,
intermediate heights may need to be established within the range
because of different methods for providing adjustability (e.g., power,
mechanical) or other equipment limitations. The distance between the
intermediate heights should be small.
Question 14. Comments are requested on the following questions
regarding the adjustable height range (17 inches minimum to 25 inches
maximum during patient transfer) that the Access Board is considering
requiring in the final standards for transfer surfaces on diagnostic
equipment used by patients in a supine, prone, or side-lying position,
and diagnostic equipment used by patients in a seated position:
(a) What types of equipment currently provide patient support
surfaces that are height adjustable? If there are several models of the
same type of equipment, does at least one model provide patient support
surfaces that are height adjustable? What is the range of adjustable
heights? If the range of adjustable heights does not include 17 inches
to 25 inches, what would be the incremental costs to achieve this
range?
(b) What types of equipment do not currently provide patient
support surfaces that are height adjustable? What would be the
incremental costs for the design or redesign and manufacture of the
equipment to provide patient support surfaces that are height
adjustable within the above range?
(c) Are there types of equipment that cannot provide patient
support surfaces that are height adjustable within the above range
because of the structural or operational characteristics of the
equipment? Comments should discuss alternative methods for making the
equipment accessible to patients with disabilities.
(d) Should intermediate heights be established within the above
range? What intermediate heights within the above range would be
appropriate to facilitate independent transfer by patients who use
mobility devices and aids?

Transfer Surface Size: Equipment Used by Patients in Supine, Prone, or
Side-Lying Position (M301.2.2)

As noted earlier, the technical criteria do not address the overall
width and depth of patient support surfaces because of the diverse
shape and size of these surfaces. ANSI/AAMI HE75 recommends that
patient support surfaces ``should allow patients to transfer themselves
on and off safely and easily and to assume and maintain positions
safely and comfortably.'' For surfaces on which patients lie down,
ANSI/AAMI HE75 recommends that ``patients should be able to roll to a
side or prone position with minimal need to lift or shift their center
of gravity.'' ANSI/AAMI HE75 notes that a standard examination table is
27 inches wide and a bariatric table is approximately 30 to 32 inches
wide and recommends wider surfaces to make repositioning easier. See
ANSI/AAMI HE 75, section 16.4.7.
On diagnostic equipment used by patients in a supine, prone, or
side-lying position, M301.2.2 would require the size of the transfer
surface (i.e., part of the diagnostic equipment onto which patients who
use mobility devices or aids transfer when moving onto and off of the
equipment) to be 30 inches wide minimum and 15 inches deep minimum. The
30 inches minimum width is based on comments submitted by the
Disability Rights Education and Defense Fund (DREDF) regarding medical
equipment dimensions in response to DOJ's ANPRM on equipment and
furniture. The 30 inches minimum width and 15 inches minimum depth also
are generally consistent with the dimensions specified in the 2004 ADA
and ABA Accessibility Guidelines for rectangular seats in roll-in
showers.
The transfer surface dimensions do not include headrests,
footrests, or similar supports for body extremities that do not support
the patient's overall body position. A transfer surface is permitted to
be contoured; however, the minimum dimensions would have to fit within
the contoured surface and cannot be reduced to accommodate an
asymmetrical shape.
As discussed under the technical criteria for transfer sides (see
M301.2.3 and M302.2.3), the transfer surface would be located at a
corner of the diagnostic equipment (e.g., foot of an examination table)
to allow different approaches to the surface and a variety of
transfers. The Access Board is considering requiring in the final
standards that transfer surfaces be provided at more than one location
on diagnostic equipment used by patients in a supine, prone, or side-
lying position to accommodate the different ways patients with
disabilities may transfer and reposition their bodies from a sitting to
a lying position on such equipment.
Question 15. Comments are requested on the following questions
regarding the minimum dimensions (30 inches wide and 15 inches deep)
proposed for the transfer surface on diagnostic equipment used by
patients in a supine, prone, or side-lying position and whether
transfer surfaces should be provided at more than one location on such
equipment:

[[Page 6924]]

(a) Do the above dimensions provide sufficient space for patients
with disabilities to safely and easily transfer to the equipment?
(b) Should the width of the patient support surface be at least as
wide as the width of the transfer surface (30 inches minimum) to allow
patients with disabilities to reposition their bodies to a lying down
position and maintain positions safely and comfortably? What would be
the incremental costs for the design or redesign and manufacture of the
equipment to make the patient support surface at least as wide as the
width of the transfer surface?
(c) Would alternative dimensions be appropriate for transfer
surfaces? Comments should include information on sources to support
alternative dimensions, where possible.
(d) Should an adjustable feature (e.g., extendable platform) be
permitted to meet the transfer surface dimensions?
(e) If transfer surfaces are required to be provided at more than
one location on the equipment, where should the transfer surfaces be
located?

Transfer Surface Size: Equipment Used by Patients in a Seated Position
(M302.2.2)

Seats on diagnostic equipment used by patients in a seated position
typically provide back and arm support for patient comfort and
stability. The space available for transfer on diagnostic equipment
used by patients in a seated position is smaller than the space
available on diagnostic equipment used by patients in a supine, prone,
or side-lying position.
On diagnostic equipment used by patients in a seated position,
M302.2.2 would require the size of the transfer surface to be 21 inches
wide minimum and 15 inches deep minimum. The 21 inches minimum width is
based on the ideal chair width recommended in Architectural Graphic
Standards for auditorium seating. See The American Institute of
Architects, Architectural Graphic Standards (10th edition, 2000), page
919. The 15 inches minimum depth is generally consistent with the
dimension specified in the 2004 ADA and ABA Accessibility Guidelines
for rectangular seats in roll-in showers.
The transfer surface dimensions do not include headrests,
footrests, or similar supports for body extremities that do not support
the patient's overall body position. A transfer surface is permitted to
be contoured; however, the minimum dimensions would have to fit within
the contoured surface and cannot be reduced to accommodate an
asymmetrical shape.
Question 16. Comments are requested on the following questions
regarding the minimum dimensions (21 inches wide and 15 inches deep)
proposed for the transfer surface on diagnostic equipment used by
patients in a seated position:
(a) Do the above dimensions provide sufficient space for patients
with disabilities to safely and easily transfer to the equipment?
(b) Would alternative dimensions be appropriate for transfer
surfaces? Comments should include information on sources to support
alternative dimensions, where possible.

Transfer Sides (M301.2.3 and M302.2.3)

M301.2.3 and M302.2.3 would require the transfer surface to be
located so as to provide patients who use mobility devices the option
to transfer onto the short side and the long side of the surface, and
that each transfer side provide unobstructed access to the transfer
surface. These sections would result in the transfer surface being
located at a corner of the equipment and the two transfer sides
adjoining at the edges of the equipment (e.g., foot of an examination
table). Patients who use mobility devices would have the choice to
approach parallel to the deep dimension of the transfer surface,
parallel to the wide dimension of the transfer surface, or at an angle
to the corner of the transfer surface and be able to perform a variety
of transfers. Locating the transfer surface at a corner of the
equipment and providing unobstructed access to the two transfer sides
also would facilitate assisted transfers. Enforcing authorities may
specify the clear floor space to be provided adjacent to the transfer
sides of equipment in health care facilities.
The transfer sides are permitted to be obstructed temporarily by
features such as armrests, side rails, footrests, and stirrups provided
they can be repositioned (e.g., folding armrests, removable side rails,
retractable footrests and stirrups) to permit transfer. This is
consistent with ANSI/AAMI HE 75 which recommends that ``side rails, arm
rests, leg supports * * * should be positioned, or able to be moved out
of the way, so as not to interfere with the ability of users to
transfer.'' See ANSI/AAMI HE 75, section 16.4.5. Otherwise, no part of
the equipment can project beyond the edge of the transfer sides and
obstruct access to the transfer surface. This is consistent with ANSI/
AAMI HE 75 which recommends that the ``base of any patient-support
platform should not extend horizontally beyond the edge of the support
surface * * * [and] should not impede a patient's ability to orient a
wheelchair next to the support surface.'' See ANSI/AAMI HE 75, section
16.4.2.
The Access Board is considering whether the final standards should
permit equipment parts to extend horizontally 3 inches maximum beyond
the edge of the transfer sides provided they do not extend above the
top of the transfer surface. This would allow handholds and other
features which may facilitate transfer to be located on the transfer
sides. The 2004 ADA and ABA Accessibility Guidelines provide a gap of 3
inches between the edge of a shower seat and the shower compartment
entry, and the gap does not appear to interfere with transferring onto
and off of the shower seat.
Question 17. Comments are requested on the following questions
regarding obstructions on the transfer sides:
(a) Should equipment parts be permitted to extend horizontally 3
inches maximum beyond the edge of the transfer sides provided they do
not extend above the top of the transfer surface?
(b) If equipment parts are not permitted to extend horizontally 3
inches maximum beyond the edge of the transfer sides, would any
diagnostic equipment need to be redesigned?

Supports (M301.3, M302.3, and M305.2)

ANSI/AAMI HE 75 recommends that handholds be ``integrated into the
device * * * [to] increase safety and assist patients in transferring
on and off, positioning or repositioning their bodies, and maintaining
static position.'' See ANSI/AAMI HE 75, section 16.4.6. M301.3, M302.3,
and M305.2 provide technical criteria for transfer and positioning
supports on diagnostic equipment used by patients in a supine, prone,
or side-lying position, and diagnostic equipment used by patients in a
seated position. Some supports such as armrests and side rails can be
used for transferring and positioning. As discussed under M301.2.3 and
M302.2.3, transfer and positioning supports on the transfer sides of
transfer surfaces would have to be capable of being repositioned (e.g.,
folding armrests, removable side rails, retractable footrests and
stirrups) to permit transfer.

Transfer Supports (M301.3.1, M302.3.1, and M305.2)

M301.3.1 and M302.3.1 would require transfer supports to be
provided for use with the transfer sides. M305.2.1 would require the
transfer supports to be located within reach of the transfer surface
and not obstruct transfer onto the surface when in position. M305.2.2

[[Page 6925]]

would require the transfer supports and their connections to be capable
of resisting vertical and horizontal forces of 250 pounds applied to
all points of the transfer support. M305.2.3 would require the transfer
supports to not rotate within their fittings. These technical criteria
are based on provisions in the 2004 ADA and ABA Accessibility
Guidelines for grab bars.
Question 18. Comments are requested on the following questions
regarding the structural strength of transfer supports:
(a) Are transfer supports that can be repositioned (e.g., folding
armrests, removable side rails) currently capable of resisting vertical
and horizontal forces of 250 pounds applied to all points of the
transfer support? If the transfer supports are not currently capable of
resisting these forces, what would be the incremental costs for the
design or redesign and manufacture of the equipment to provide transfer
supports that are capable of resisting these forces?
(b) Would alternative technical criteria be appropriate for the
structural strength of transfer supports? Comments should include
information on sources to support the alternative technical criteria,
where possible.

Additional Technical Criteria Considered for Transfer Supports

As discussed below, the Access Board is considering whether
additional technical criteria would be appropriate for transfer
supports.

Location and Size

Midmark Corporation provided information based on input from
accessibility experts regarding side rails on examination tables in
comments submitted in response to the DOJ's ANPRM on equipment and
furniture. The side rails are similar in shape to grab bars and are
located on each of the long sides of the table. Each side rail can be
removed to permit patients to transfer onto and off of the table, and
to permit health care personnel to perform diagnostic procedures. The
side rails can also be relocated along the table surface (from foot-end
to head-end) for patients to position or reposition their bodies, and
to maintain static positions. The side rails are 20 inches minimum in
length, 6 inches minimum in height above the table surface, and 1 inch
measured horizontally from the adjacent edge of the table surface.
The Access Board is considering whether the following technical
criteria would be appropriate for the location and size of transfer
supports on diagnostic equipment used by patients in a supine, prone,
or side-lying position, and diagnostic equipment used by patients in a
seated position:
At least one transfer support would be provided on the
side of the transfer surface that is 15 inches deep minimum. The
transfer support would be located on the side of the transfer surface
that is opposite the transfer side (see M301.2.3 and M302.2.3) similar
to the provisions in the 2004 ADA and ABA Accessibility Guidelines for
grab bars provided at bathtubs and shower compartments with seats. This
would be a minimum requirement. Where possible, it is recommended that
supports be provided on each side of the transfer surface that is 15
inches deep minimum for patients to maintain position after they have
transferred onto the equipment, and that the supports be repositionable
to permit transfer.
The transfer support would extend horizontally the entire
depth of the transfer surface and would be 15 inches minimum in length.
The gripping surface of the transfer support would be
located 1\1/2\ inches maximum measured horizontally from the adjacent
edge of the transfer surface. This would ensure that the transfer
support is within reach and can be effectively used during transfers.
The above technical criteria would likely result in the transfer
surface being located at the foot end of examination tables and allow
the use of transfer supports similar to the side rails described in the
information provided by Midmark Corporation.
Question 19. Comments are requested on the following questions
regarding the above technical criteria for the location and size of
transfer supports on diagnostic equipment used by patients in a supine,
prone, or side-lying position, and diagnostic equipment used by
patients in a seated position:
(a) Are the above technical criteria for the location and size of
transfer supports sufficient to facilitate transfer and maintain
position on the equipment?
(b) Can transfer supports on different types of equipment meet the
above technical criteria for the location and size of the supports?
(c) What would be the incremental costs for the design or redesign
and manufacture of transfer supports that meet the above criteria?
(d) Would alternative technical criteria be appropriate for the
location and size of transfer supports? Comments should include
information on sources to support the alternative technical criteria,
where possible.
(e) Should angled or vertical transfer supports be permitted?

Height

The Access Board is considering whether 6 inches minimum and 19
inches maximum above the transfer surface would be an appropriate
height for transfer supports on diagnostic equipment used by patients
in a supine, prone, or side-lying position, and diagnostic equipment
used by patients in a seated position. The minimum height is consistent
with the information provided by Midmark Corporation on examination
table side rails, and the maximum height is generally consistent with
the height of grab bars above shower seats in the 2004 ADA and ABA
Accessibility Guidelines.
Question 20. Comments are requested on the following questions
regarding the above height range (6 inches minimum and 19 inches
maximum above the transfer surface) for transfer supports on diagnostic
equipment used by patients in a supine, prone or side-lying position,
and diagnostic equipment used by patients in a seated position:
(a) Are transfer supports within the above height range usable by
patients with disabilities?
(b) Can transfer supports on different types of equipment meet the
above height range?
(c) Would alternative technical criteria be appropriate for the
height of transfer supports? Comments should include information on
sources to support the alternative technical criteria, where possible.

Cross Section of Gripping Surfaces

The 2004 ADA and ABA Accessibility Guidelines specify the following
dimensions for grab bars to enable individuals with disabilities to
firmly grasp the grab bars and support themselves during transfers:
Grab bars with circular cross sections must have an
outside diameter of 1\1/4\ inches minimum and 2 inches maximum.
Grab bars with non-circular cross sections must have a
cross section dimension of 2 inches maximum and a perimeter dimension
of 4 inches minimum and 4.8 inches maximum.
The Access Board is considering whether the above cross section
dimensions would be appropriate for the gripping surfaces of transfer
supports on diagnostic equipment used by patients in a supine, prone,
or side-lying position, and diagnostic equipment used by patients in a
seated position.
Question 21. Comments are requested on the following questions
regarding the above cross section dimensions for the gripping surfaces
of transfer supports on

[[Page 6926]]

diagnostic equipment used by patients in a supine, prone, or side-lying
position, and diagnostic equipment used by patients in a seated
position:
(a) Can the gripping surfaces of transfer supports on different
types of equipment meet the above cross section dimensions?
(b) Can handholds that meet the above cross section dimensions be
integrated into the design of armrests that are cushioned to support
arms and elbows?
(c) Are there alternative designs for the gripping surfaces of
transfer supports that enable patients with disabilities to firmly
grasp the supports and support themselves during transfer?

Clearances Around Gripping Surfaces

The 2004 ADA and ABA Accessibility Guidelines specify the following
clearances around grab bars to ensure sufficient space for a person to
grasp the grab bar: 1\1/2\ inches absolute clearance between grab bars
and the adjacent wall surfaces; 1\1/2\ inches minimum clearance between
grab bars and projecting objects below and at the ends of grab bars;
and 12 inches minimum clearance between grab bars and projecting
objects above grab bars.
The Access Board is considering whether 1\1/2\ inches minimum
clearance around the gripping surface would be appropriate for transfer
supports on diagnostic equipment used by patients in a supine, prone,
or side-lying position, and diagnostic equipment used by patients in a
seated position.
Question 22. Can transfer supports on different types of equipment
provide 1\1/2\ inches minimum clearance around the gripping surface?

Stirrups (M301.3.2)

Where stirrups are provided on diagnostic equipment used by
patients in a supine, prone, or side-lying position, M301.3.2 would
require the stirrups to provide a method of supporting, positioning,
and securing the patient's legs. This is consistent with ANSI/AAMI HE75
which recommends that ``[f]or patients with limited leg strength and
control, instead of stirrups that support only the foot and require
active user leg strength, leg supports that support both the foot and
the leg should be used to assist patients in keeping their legs in an
appropriate position.'' See ANSI/AAMI HE 75, section 16.4.7(g).
Question 23. Comments are requested on the following questions
regarding stirrups:
(a) What would be the incremental costs for the design or redesign
and manufacture of stirrups that provide a method of supporting,
positioning, and securing the patient's legs?
(b) Should diagnostic equipment used by patients in a seated
position that provide stirrups such as urodynamics study chairs be
required to provide a method of supporting, positioning, and securing
the patient's legs?

Armrests (M302.3.2)

M302.3.2 would require armrests to be provided on diagnostic
equipment used by patients in a seated position. This is consistent
with ANSI/AAMI HE75 which recommends that ``[f]or support surfaces that
require the patient to assume a seated position, armrests should be
provided to enhance patient comfort, stability, and ease of transfer.''
See ANSI/AAMI HE 75, section 16.4.7(e). Where armrests serve as
transfer supports, the armrests would be required to meet the technical
criteria in M305.2 for the location and structural strength of transfer
supports. Otherwise, there are no technical criteria for armrests.

Head and Back Support (M301.3.3 and M302.3.3)

Where diagnostic equipment used by patients in a supine, prone, or
side-lying position, and diagnostic equipment used by patients in a
seated position can be adjusted to reclined positions, M301.3.3 and
M302.3.3 would require head and back support to be provided throughout
the entire range of the incline. This is consistent with ANSI/AAMI HE75
which recommends that the ``support surface needs to be adjustable or
have adjustable support features (e.g., for the head, neck, back,
lumbar region, leg, knee, and foot, as appropriate) to support patients
in various postures and body positions in a manner that optimizes their
comfort.'' See ANSI/AAMI HE 75, section 16.4.7(h). Although not
required by the proposed standards, examination tables that can be
adjusted to a sitting position and then reclined to a horizontal
position may be easier for patients with disabilities to transfer onto
and off of than examination tables that are horizontal only.

Positioning Supports Considered

The Board is considering requiring in the final standards
positioning supports such as rails, bars, or panels with handholds to
be provided along the sides of diagnostic equipment used by patients in
a supine, prone or side-lying position, and diagnostic equipment used
by patients in a seated position that can be adjusted to a reclined
position. As noted above, ANSI/AAMI recommends that handholds be
``integrated into the device * * * [to] increase safety and assist
patients in transferring on and off, positioning or repositioning their
bodies, and maintaining static position.'' See ANSI/AAMI HE 75, section
16.4.6. Pillows, wedges, and other padding can be used to stabilize and
position patients on diagnostic equipment, but are not addressed in the
proposed standards because they are not part of the diagnostic
equipment.
Question 24. Comments are requested on the following questions
regarding positioning supports along the sides of diagnostic equipment
used by patients in a supine, prone or side-lying position, and
diagnostic equipment used by patients in a seated position that can be
adjusted to a reclined position:
(a) Should the technical criteria address the configuration of
positioning supports (e.g., length, height above the patient support
surface, location) to ensure their effectiveness? Or should the
technical criteria require that positioning supports be provided within
reach and provide flexibility for designing the supports based on the
intended use of the equipment?
(b) What would be the incremental costs for the design or redesign
and manufacture of positioning supports?
(c) Are there types of equipment that cannot provide positioning
supports along the sides of the equipment because of the structural or
operational characteristics of the equipment? Comments should discuss
alternative methods to assist patients with disabilities safely
position or reposition their bodies, and maintain a static position.

Lift Compatibility (M301.4 and M302.4)

M301.4 and M302.4 would require diagnostic equipment used by
patients in a supine, prone, or side-lying position, and diagnostic
equipment used by patients in a seated position to be usable with a
patient lift for patients with disabilities for whom independent
transfer may not be possible. A patient lift may be the only means of
providing access to certain equipment that cannot meet the technical
criteria for transfer surface height (see M301.2.1 and M302.2.1)
because of the structural or operational characteristics of the
equipment. For example, full body bone densitometers usually have
components that move beneath the length of the patient support surface
and may prevent the equipment from meeting the technical criteria for
transfer surface height. Requiring the equipment to be usable with a
patient lift is critical for ensuring the safety of both patients with

[[Page 6927]]

disabilities and health care personnel assisting with transfers.
ANSI/AAMI HE 75 recommends that the ``base of the device needs to
have space underneath or along both sides (if the equipment is narrow)
to accommodate the legs of portable mechanical lift equipment so that
the patient can be suspended over the support surface before being
lowered onto it.'' See ANSI/AAMI HE 75, section 16.4.3. Portable floor
lifts have legs with wheels that need to fit under or around the base
of the diagnostic equipment. Lifts can vary in width along their
length, and are usually the widest at the front casters and narrower at
the patient sling location. Manufacturers of portable floor lifts
usually recommend that the lifts be used with the legs extended in the
widest position to maintain stability when lifting and lowering
patients.
As discussed below, the technical criteria provide two options for
accommodating portable floor lifts consistent with ANSI/AAMI HE75:
clearance in the base or clearance around the base. The clearances
would be required at the side of the equipment where the portable floor
lift is deployed so that the boom of the lift can maneuver far enough
over the equipment and safely lower and raise the patient onto and off
of the examination surface. The clearances do not restrict the overall
size of the equipment base.

Clearance in Base (M301.4.1 and M302.4.1)

Clearance in the base of the equipment allows the legs of a
portable floor lift to fit under the base of the equipment. The
clearance can be an open area between the supporting posts beneath the
equipment, or the equipment can be configured with a wide slot that is
recessed into the base enclosure. M301.4.1 and M302.4.1 would require
the clearance in the base to be 44 inches wide minimum, 6 inches high
minimum measured from the floor, and 36 inches deep minimum measured
from the edge of the examination surface. Where the width of the
examination surface is less than 36 inches, the clearance depth would
be required to extend the full width of the equipment. Equipment
components are permitted to be located within 8 inches maximum of the
centerline of the clearance width.
Question 25. Comments are requested on the following questions
regarding the proposed dimensions for clearance in the base of the
equipment to allow the use of portable floor lifts:
(a) Are the proposed dimensions for clearance in the base
sufficient to accommodate the various portable floor lifts used in
health care facilities?
(b) Do the proposed dimensions exclude certain types of lifts?
(c) Should the clearance in the base be configured differently to
allow additional flexibility for the use of portable floor lifts and,
if so, how should it be configured?

Clearance Around Base (M301.4.2 and M302.4.2)

Clearance around the base of the equipment allows the legs of a
portable floor lift to straddle the base. This option accommodates
equipment with solid base enclosures that sit on or close to a floor.
M301.4.2 and M302.4.2 would require the base of the equipment to
provide a clearance 6 inches high minimum measured from the floor and
36 inches deep minimum measured from the edge of the examination
surface. The width of the base permitted within this clearance would be
26 inches wide maximum at the edge of the examination surface and is
permitted to increase at a rate of 1 inch in width for each 3 inches in
depth. The permitted rate of increase in width can be distributed to
each side of the base.
Question 26. Comments are requested on the following questions
regarding the proposed dimensions for clearance around the base of the
equipment to allow the use of portable floor lifts:
(a) Are the proposed dimensions sufficient to accommodate the
various portable floor lifts used in health care facilities?
(b) Do the proposed dimensions exclude certain types of lifts?
(c) Should the clearance around the base be configured differently
to allow additional flexibility for the use of portable floor lifts
and, if so, how should it be configured?

Overhead Lifts

The technical criteria do not address overhead lifts that are
usually mounted on the ceiling and operate on tracks suspended over the
diagnostic equipment because the configuration of the equipment does
not affect the operation of overhead lifts. Overhead lifts and portable
floor lifts are used in health care facilities, and the technical
criteria should not be viewed as preferring portable floor lifts.
Overhead lifts may be the only option for certain diagnostic equipment
because the structural or operational characteristics of the equipment
prevent sufficient clearance in or around the base of the equipment for
a portable floor lift.
Question 27. If diagnostic equipment is designed for use with
overhead lifts, should the equipment be exempted from providing
clearance in or around the base for portable floor lifts?

Folding Seats on Equipment Used by Patients Seated in a Wheelchair
(M302.4 Exception)

M302.4 includes an exception for diagnostic equipment that is
designed for use by patients seated in a wheelchair and provides a
folding seat. The exception does not require the equipment to comply
with the technical criteria for lift compatibility because patients can
use the equipment seated in a wheelchair. However, the folding seat
would be required to meet the other technical criteria in M302 for
transfer surfaces and supports.
Question 28. Where diagnostic equipment is designed for use by
patients seated in a wheelchair and provides a folding seat, should the
folding seat be required to comply with the technical criteria in M302
for transfer surfaces and supports?

M303 Diagnostic Equipment Used by Patients Seated in Wheelchair

M303 provides technical criteria for diagnostic equipment used by
patients seated in a wheelchair. M303 allows patients who use
wheelchairs to position their wheelchairs at equipment typically used
in a standing position such as mammography equipment, and also applies
to equipment specifically designed for patients seated in a wheelchair
such as weight scales and examination chairs.

Wheelchair Spaces (M303.2)

M303.2 would require a wheelchair space to be provided at
diagnostic equipment used by patients seated in a wheelchair. M303.2
includes technical criteria for orientation, width, depth, and knee and
toe clearance at wheelchair spaces.
M303.2.1 would require wheelchair spaces to be designed so that
patients seated in a wheelchair orient in the same direction that
patients not seated in a wheelchair orient when using the equipment.
For example, if an equipment component used to make images of body
parts can be placed at different angles when used by patients who stand
and by patients seated in a wheelchair, and patients who stand orient
facing the component when it is in place for them, then the wheelchair
space would be designed so that patients seated in a wheelchair orient
facing the component when it is place for them. If the equipment is
designed so that patients not seated in a wheelchair can orient their
bodies in various directions when using the equipment, the wheelchair
space would

[[Page 6928]]

be designed so that patients seated in a wheelchair can orient their
bodies in the same directions. For example, if patients who stand can
orient their bodies facing forwards or sideways in relation to the
equipment when in use, the wheelchair space would be designed so that
patients seated in a wheelchair can orient their bodies facing forwards
or sideways in relation to the equipment when in use (i.e., wheelchair
space can be entered from both the front or rear and from the side).
M303.2.2 would require wheelchair spaces to be 36 inches (915 mm)
wide minimum. This dimension is based on provisions in the 2004 ADA and
ABA Accessibility Guidelines for maneuvering clearance where a clear
floor or ground space is confined on all or part of three sides.
M303.2.3 would require wheelchair spaces that can be entered from
the front or rear to be 48 inches deep minimum, and wheelchair spaces
that can be entered only from the side to be 60 inches deep minimum.
These dimensions are based on provisions in the 2004 ADA and ABA
Accessibility Guidelines. The Wheeled Mobility Anthropometry Project
showed that the 48 inches deep dimension for wheelchair spaces entered
from the front or rear does not accommodate many people in the sample,
and that increasing the depth of wheelchair spaces entered from the
front or rear to 58 inches minimum would accommodate 95 percent of the
people in the sample. See Final Report of the Wheeled Mobility
Anthropometry Project, pages 86-88. The Access Board is considering
requiring in the final standards wheelchair spaces that can be entered
from the front or rear to be 58 inches deep minimum.
Question 29. Comments are requested on the following questions
regarding the depth dimension (58 inches minimum) that the Access Board
is considering requiring in the final standards for wheelchair spaces
that can be entered from the front or rear:
(a) What would be the incremental costs for the design or redesign
and manufacture of the equipment to provide a wheelchair space that is
58 inches deep minimum?
(b) Are there types of equipment that cannot provide a wheelchair
space that is 58 inches deep minimum because of the structural or
operational characteristics of the equipment?
Diagnostic equipment with wheelchair spaces on raised platforms
such as weight scales typically provide low barriers or curbs on the
sides of the platform that are not used for entering and exiting the
equipment to prevent wheelchairs from slipping off the platform (i.e.,
edge protection). The Access Board is considering requiring edge
protection at wheelchair spaces on raised platforms in the final
standards.
Question 30. Is there diagnostic equipment with wheelchair spaces
on raised platforms that does not currently provide edge protection? If
so, what would be the incremental costs to provide edge protection on
such equipment?

Exceptions Considered for Wheelchair Spaces on Raised Platforms

The Access Board is considering adding exceptions in the final
standards to the minimum width in M303.2.2 and the minimum depth in
M303.2.3 for diagnostic equipment with wheelchair spaces on raised
platforms.
The exception to the minimum width in M303.2.2 would apply where
ramped surfaces are provided on the opposite sides of the raised
platform so that patients using wheelchairs can enter and exit the
platform facing the same direction. The exception would permit the
width of the wheelchair space between the edge protection to be reduced
to 32 inches wide minimum at the platform level. This dimension is
based on provisions in the 2004 ADA and ABA Accessibility Guidelines
that allow accessible routes, which normally must be 36 inches wide
minimum, to be 32 inches wide minimum for short distances such as at
door openings. The exception would require a space 36 inches wide
minimum to be provided outside the perimeter of the raised platform and
above any edge protection so that patients using a manual wheelchair
can extend their arms and elbows when they push on the wheel rims to
maneuver onto and off of the platforms.
The exception to the minimum depth in M303.2.3 for wheelchair
spaces entered from the front or rear would permit a portion of the 48
inch minimum depth of the wheelchair space that accommodates the
wheelchair footrests to extend beyond the raised platform and over any
edge protection. For example, the wheelchair footrests would be allowed
to extend beyond the depth of the raised platform and over any edge
protection on wheelchair weight scales used by patients seated in a
wheelchair.
If exceptions are permitted to the minimum width and depth of
wheelchair spaces on raised platforms, the technical criteria would
specify the minimum and maximum height for any edge protection to
prevent wheelchairs from slipping off the platform, but also allow the
wheelchair footrests to extend over the edge protection where the
wheelchair space extends beyond the depth of the platform.
Question 31. Comments are requested on the following questions
regarding adding exceptions in the final standards to the minimum width
in M303.2.2 and the minimum depth in M303.2.3 for diagnostic equipment
with wheelchair spaces on raised platforms:
(a) What is the typical distance between the front caster wheels of
manual and power wheelchairs and the tips of the toes of the wheelchair
user? How much of the 48 inch minimum depth of a wheelchair space that
can be entered from the front or rear should be permitted to extend
beyond the raised platform and over any edge protection? Comments
should include information on sources to support the dimensions, where
possible.
(b) What should be the maximum height for any edge protection to
allow the wheelchair footrests to extend over the edge protection where
the wheelchair space extends beyond the depth of the platform? Comments
should include information on sources to support the dimensions, where
possible.
(c) Where the equipment provides supports for patients who stand
(e.g., handrails), should the exceptions prohibit the supports from
obstructing the 36 inch wide minimum and 48 inch deep minimum space
outside the perimeter of the raised platform and above any edge
protection?
Scooters have different wheelbases than manual and power
wheelchairs. Diagnostic equipment with wheelchair spaces on raised
platforms should also be usable by patients who use scooters. Patients
who use scooters may have other options for using equipment with
wheelchair spaces on raised platforms. For example, a weight scale with
a raised platform for wheelchair use may provide a folding seat and
supports for patients who can transfer independently from their
mobility device to the scale.
Question 32. Comments are requested on the following questions
regarding diagnostic equipment with wheelchair spaces on raised
platforms and the use of such equipment by patients who use scooters:
(a) Is equipment with wheelchair spaces on raised platforms such as
wheelchair scales currently usable by patients who use scooters?
(b) If the equipment is not currently usable by patients who use
scooters, should the width and depth of the raised platform be changed
so that the equipment is usable by patients who use scooters? Comments
should include

[[Page 6929]]

information on sources to support the dimensions, where possible.
(c) Should folding seats and supports be required on equipment with
wheelchair spaces on raised platforms for patients who can transfer
independently from their mobility device to the raised platform?
(d) If folding seats and supports are provided on equipment with
wheelchair spaces on raised platforms, should the raised platform also
accommodate scooters?
Question 33. If exceptions are not permitted in the final standards
to the minimum width and depth of wheelchair spaces on diagnostic
equipment with raised platforms, comments are requested on the
following questions:
(a) What would be the incremental costs for the design or redesign
and manufacture of equipment with raised platforms to provide a
wheelchair space that that can be entered from the front or rear and
conforms to the dimensions proposed in M303.2.2 and M303.2.3 (i.e., 36
inches wide minimum and 48 inches deep minimum)?
(b) What would be the incremental costs for the design or redesign
and manufacture of equipment with raised platforms to provide a
wheelchair space that can be entered from the front or rear and
conforms to the dimensions recommended by the Wheeled Mobility
Anthropometry Project (i.e., 36 inches wide minimum and 58 inches deep
minimum)?

Knee and Toe Clearance (M303.2.4)

M303.2.4 would require the depth of wheelchair spaces to include
knee and toe clearance of 17 inches minimum and 25 inches maximum. Knee
and toe clearance under breast platforms would be 25 inches deep. Knee
and toe clearance are critical where patients seated in a wheelchair
need to position their knees and toes next to or underneath a component
of the diagnostic equipment. The component can be deeper than the 25
inches maximum depth required for knee and toe clearance, but a portion
of the wheelchair space would be required to include knee and toe
clearance of 17 inches minimum and 25 inches maximum under the
component.
The dimensions for toe clearance in M303.2.4.1 and knee clearance
in M303.2.4.2 are based on the 2004 ADA and ABA Accessibility
Guidelines and are shown in the second column of the table below. The
Wheeled Mobility Anthropometry Project showed that these dimensions do
not accommodate many people in the sample and recommended alternative
dimensions that would accommodate 95 percent of the people in the
sample. The alternative dimensions recommended by Wheeled Mobility
Anthropometry Project are shown in the last column of the table below.
See Final Report of the Wheeled Mobility Anthropometry Project, pages
89-92. The Access Board is considering requiring in the final standards
the dimensions for toe clearance and knee clearance recommended by the
Wheeled Mobility Anthropometry Project.

------------------------------------------------------------------------
Proposed dimensions Dimensions
based on 2004 ADA recommended by
and ABA wheeled mobility
accessibility anthropometry
guidelines project
------------------------------------------------------------------------
Toe Clearance............... 6 inches deep 5 inches deep
maximum at 9 inches maximum at 14
above the floor. inches above the
floor.
Knee Clearance.............. 11 inches deep 12 inches deep
minimum at 9 inches minimum at 28
above the floor, inches above the
and 8 inches deep floor.
minimum at 27
inches above the
floor.
Between 9 inches and Knee clearance is
27 inches above the same depth
floor, knee throughout and not
clearance is sloped.
permitted to reduce
at rate of 1 inch
in depth for every
6 inches in height.
------------------------------------------------------------------------

Question 34. Comments are requested on the following questions
regarding the dimensions for toe clearance and knee clearance
recommended by the Wheeled Mobility Anthropometry Project that the
Access Board is considering requiring in the final standards:
(a) What would be the incremental costs for the design or redesign
and manufacture of the equipment to include toe clearance and knee
clearance that meets the dimensions recommended by the Wheeled Mobility
Anthropometry Project?
(b) Are there types of equipment that cannot include toe clearance
and knee clearance that meets the dimensions recommended by the Wheeled
Mobility Anthropometry Project because of the structural or operational
characteristics of the equipment?
M303.2.5 would require wheelchair space surfaces to not slope more
than 1:48 in any direction. This is consistent with the 2004 ADA and
ABA Accessibility Guidelines.

Changes in Level at Entry to Wheelchair Spaces (M303.3)

M303.3 includes technical criteria for changes in level at the
entry to a wheelchair space as may occur at wheelchair weight scales
with raised platforms. The technical criteria are consistent with the
2004 ADA and ABA Accessibility Guidelines. Level changes up to \1/4\
inch high are permitted to be vertical. Level changes between \1/4\
inch high and \1/2\ inch high would be required to be beveled with a
slope not steeper than 1:2. Level changes greater than \1/2\ inch high
would be required to be ramped. Ramp runs would be required to have a
running slope not steeper than 1:12 and a cross slope not steeper than
1:48. The clear width of ramp runs would be required to be 36 inches
minimum. Ramps with drop offs \1/2\ inch or greater would be required
to provide edge protection 2 inches high minimum on each side to
prevent users from inadvertently travelling off the sides of the ramped
surface.

Additional Technical Criteria Considered for Handrails on Ramps

M303.3.3.5 would require handrails to be provided on each side of
the ramp when the vertical rise of the ramp exceeds 6 inches. This is
consistent with the 2004 ADA and ABA Accessibility Guidelines. The
Access Board is considering whether the technical criteria for
handrails on ramps in section 505 of the 2004 ADA and ABA Accessibility
Guidelines would be appropriate for handrails on diagnostic equipment
ramps. These technical criteria are available at https://www.access-board.gov/ada-aba/final.cfm#a505 and address continuity, height,
clearance, gripping surface, cross section, surfaces, fittings, and
handrail extensions.
Question 35. Comments are requested on the following questions
regarding the technical criteria for handrails in section 505 of the
2004 ADA and ABA Accessibility Guidelines:

[[Page 6930]]

(a) Can handrails on diagnostic equipment ramps meet these
technical criteria?
(b) What would be the incremental costs for the design or redesign
and manufacture of the equipment to provide handrails on diagnostic
equipment ramps that conform to these technical criteria?

Components (M303.4)

M303.4 would require the components of diagnostic equipment used to
examine specific body parts to be capable of examining the body parts
of a patient seated in a wheelchair. The height of the component and
any adjustable feature would have to accommodate patients seated in a
wheelchair. For example, an X-ray platform on which a patient places
their arm or hand would have to be capable of examining the arm or hand
of a patient seated in a wheelchair.
Mammography equipment was the subject of considerable discussion at
the public meeting held by the Access Board in July 2010. The
discussion highlighted the need for mammography equipment that is
accessible to patients seated in a wheelchair. In addition to providing
knee and toe clearance at the breast platform (see M303.2.4), the
height of the breast platform was identified as critical to ensuring
that mammography equipment is accessible to patients seated in a
wheelchair. Mammography equipment with adjustable breast platforms is
available. M303.4.1 would require the height of the breast platform to
be 30 inches (760 mm) high minimum and 42 inches (1065 mm) high maximum
above the floor when mammography equipment is used by patients seated
in a wheelchair. The Wheeled Mobility Anthropometry Project showed that
the seat heights of 96 percent of women using manual wheelchairs and 98
percent of women using power wheelchairs in the sample was between 17
inches and 24 inches above the floor. See Analysis of Seat Heights for
Wheeled Mobility Devices at: https://udeworld.com/analysis-of-seat-height-for-wheeled-mobility-devices. Other anthropometric data show the
heights of the midpoint of the breast to be 13 inches for the 5th
percentile woman and 18 inches for the 95th percentile woman when
measured from seat height. See Laura Peebles and Beverley Norris,
Adultdata: The Handbook of Adult Anthropometric and Strength
Measurements: Data for Design Safety (London, Department of Trade and
Industry, 1998), page 71. The proposed height range for the breast
platform is based on the above anthropometric data. Breast platforms
can be located outside the proposed height range when not used by
patients seated in a wheelchair.
Question 36. Comments are requested on the following questions
regarding breast platforms:
(a) Is the proposed height range for the breast platform (30 inches
high minimum and 42 inches high maximum above the floor) sufficient to
accommodate patients seated in a wheelchair?
(b) Are there other features of the breast platform that the
technical criteria should address to ensure accessibility and, if so,
how should they be addressed? Comments should include information on
sources to support the technical criteria for the features, where
possible.

M304 Diagnostic Equipment Used by Patients in Standing Position

M304 provides technical criteria for diagnostic equipment used by
patients in a standing position such as a weight scale and X-ray
equipment that is used in a standing position for certain diagnostic
procedures. M304.2 and M304.3 would require a slip resistant standing
surface and standing supports to accommodate patients with mobility
disabilities who ambulate, patients who have limited stamina, and
patients who have other conditions that affect their ability to
maintain the balance needed to position themselves on the equipment or
to maintain a standing posture at an equipment component.
The proposed standards do not require diagnostic equipment to
support more than one position. Where possible, it is recommended that
diagnostic equipment be usable by patients with disabilities in as many
positions as possible (i.e., standing position, seated position, and
seated in a wheelchair). For example, mammography equipment with
adjustable breast plates can be used by patients with disabilities in a
standing position where standing supports are provided, in a seated
position where a folding or removable seat is provided, and seated in a
wheelchair where a wheelchair space is provided. A weight scale with a
wheelchair space and ramped entry also can be used by patients with
disabilities in a standing position where standing supports are
provided and in a seated position where a folding or removable seat is
provided.
Question 37. Comments are requested on the following questions
regarding whether a folding or removable seat should be required on
diagnostic equipment used by patients in a standing position:
(a) Should a folding or removable seat be required on weight scale
platforms?
(b) Should a folding or removable seat be required on other types
of diagnostic equipment used by patients in a standing position?
(c) What would be the incremental costs for the design or redesign
and manufacture of the equipment to provide a folding or removable seat
on weight scale platforms or other types of diagnostic equipment used
by patients in a standing position?
(d) If folding or removable seats are provided on diagnostic
equipment used by patients in a standing position, should the equipment
be required to meet the technical criteria in M302 regarding transfer
surfaces, supports, and lift compatibility for diagnostic equipment
used by patients in a seated position?

Standing Supports (M304.3 and M305.3)

M304.3 would require standing supports to be provided on each side
of the standing surface on diagnostic equipment used by patients in a
standing position. M305.3 would require the standing supports to
provide continuous support throughout the use of the diagnostic
equipment and to not rotate within their fittings.
M305.3 also provides technical criteria for standing supports in
horizontal and vertical positions. Standing supports can be provided in
a horizontal position, vertical position, or a combination of
horizontal and vertical positions, as long as the minimum length of
gripping surface is provided for the support position used on each side
of the standing surface. Standing supports that adjust from horizontal
to vertical positions and at angles in between, such as a bar that
folds up and locks into multiple positions, can be used. These kinds of
adjustable supports are not required but would accommodate a broad
range of patients with disabilities, particularly where a patient needs
to assume multiple body positions for a diagnostic procedure or needs
to step up onto a surface and then maintain balance afterwards.
For standing supports in a horizontal position, M305.3.1 would
require the gripping surface to be 4 inches long minimum. The top of
the gripping surface would be required to be 34 inches minimum and 38
inches maximum above the standing surface. The minimum length of the
gripping surface is based on anthropometric data that provides
specifications for men and women grasping cylinder grips which are
stated as a range from 3.6 inches to 4.5 inches. See Henry Dreyfuss
Associates and Alvin R. Tilley, The

[[Page 6931]]

Measure of Man & Woman: Human Factors in Design, (New York, John Wiley
and Sons, 2002), page 43. Where possible, it is recommended that a
longer gripping surface or multiple horizontal supports be provided.
The minimum and maximum height of the gripping surface above the
standing surface is based on the provisions for handrails in the 2004
ADA and ABA Accessibility Guidelines.
For standing supports in a vertical position, M305.3.2 would
require the gripping surface to be 18 inches long minimum. The bottom
of the support would be required to be 34 inches minimum and 37 inches
maximum above the standing surface. The minimum length of the gripping
surface is based on provisions for vertical grab bars at accessible
bathing fixtures and toilets in ICC A117.1-2009 Accessible and Usable
Buildings and Facilities. The minimum and maximum height of the bottom
of the support above the standing surface is based on anthropometric
data for the 1th percentile woman (minimum) and the 99th percentile man
(maximum). See Henry Dreyfuss Associates and Alvin R. Tilley, The
Measure of Man & Woman: Human Factors in Design, (New York, John Wiley
and Sons, 2002), pages 13, 14, and 28.
Question 38. Comments are requested on the following questions
regarding standing supports for diagnostic equipment used by patients
in a standing position:
(a) What standing support configurations are currently provided and
are they effective for patients with disabilities?
(b) Would alternative technical criteria for standing supports be
appropriate? Comments should include information on sources to support
the alternative technical criteria, where possible.
(c) Are angled standing supports effective for patients with
disabilities and should technical criteria be provided for angled
standing supports? Comments should include information on sources to
support the technical criteria for angled standing supports, where
possible.
(d) Are there industry standards for the structural strength of
standing supports?
The 2004 ADA and ABA Accessibility Guidelines specify the following
dimensions for grab bars to enable individuals with disabilities to
firmly grasp the grab bars and support themselves during transfers:
Grab bars with circular cross sections must have an
outside diameter of 1\1/4\ inches minimum and 2 inches maximum.
Grab bars with non-circular cross sections must have a
cross section dimension of 2 inches maximum and a perimeter dimension
of 4 inches minimum and 4.8 inches maximum.
The Access Board is considering whether the above cross section
dimensions would be appropriate for the gripping surfaces of standing
supports on diagnostic equipment used by patients in a standing
position.
Question 39. Comments are requested on the following questions
regarding the above cross section dimensions for the gripping surfaces
of standing supports on diagnostic equipment used by patients in a
standing position:
(a) Can the gripping surfaces of standing supports on different
types of equipment meet the above cross section dimensions?
(b) Are there alternative designs for the gripping surfaces of
standing supports that enable patients with disabilities to firmly
grasp the supports?
The Access Board is also considering whether a 1\1/2\ inches
minimum clearance around the gripping surface of standing supports
would be appropriate to ensure that the surface can be grasped.
Question 40. Can standing supports on different types of equipment
provide 1\1/2\ inches minimum clearance around the gripping surface
without encountering obstructions?

M305 Supports

M305 provides the technical criteria for transfer supports and
standing supports. The technical criteria for transfer supports are
discussed under M301 Diagnostic Equipment Used by Patients in Supine,
Prone, or Side-Lying Position and M302 Diagnostic Equipment Used by
Patients in Seated Position. The technical criteria for standing
supports are discussed under M304 Diagnostic Equipment Used by Patients
in Standing Position.

M306 Communication

Where diagnostic equipment communicates instructions or other
information to the patient, M306 would require the instructions or
other information to be provided in at least two of the following
methods: audible, visible, or tactile. For example, magnetic resonance
imaging (MRI) and X-ray computed tomography (CT) equipment may instruct
the patient to hold their breath for a short period during a scan by
means of a flashing light or icon. A flashing light or icon would be
sufficient to notify a patient who is deaf to hold their breath, but a
voice prompt, sound alert, or tactile vibration would be needed to
notify a patient who is blind to hold their breath. For MRI equipment,
auditory methods may not be effective due to the noise generated by the
equipment and a tactile vibration may be the only effective method to
notify a patient who is blind to hold their breath. ANSI/AAMI HE 75
recommends that vibration ``be used as a redundant mode for
transmitting information such as an attention getting signal.'' See
ANSI/AAMI HE 75, section 16.3.5.6.
Question 41. Comments are requested on the following questions
regarding methods of communication provided by diagnostic equipment:
(a) Should diagnostic equipment that communicates instructions or
other information to the patient be required to provide the
instructions or other information in all three methods of communication
(i.e., audible, visible, and tactile)?
(b) What would be the incremental costs for the design or redesign
and manufacture of the equipment to provide all three methods of
communication (i.e., audible, visible, and tactile)?

M307 Operable Parts

M307 provides technical criteria for operable parts used by
patients to activate, deactivate, or adjust the diagnostic equipment
(see defined terms in M102.1). For example, equipment used for an
auditory examination may require the patient to press a button when
sounds are heard. M307 does not apply to controls used only by health
care personnel or others who are not patients.
M307.2 would require operable parts to be tactilely discernible
without activation. Patients who are blind or have low vision have
difficulty distinguishing a flat membrane button or similar control
unless it is tactilely discernible from the surrounding surface and any
adjacent controls. The most common method to ensure that buttons and
similar controls are tactilely discernible is to raise part or all of
the control surface above the surrounding surface and at a distance
from any adjacent controls such that a relief of each individual
control can be determined by touch. This also prevents unintended or
accidental activation of the operable parts. M307.2 is consistent with
recommendations in ANSI/AAMI HE 75 that ``features should be operable
from controls that are tactilely discernible and that can be explored
without being activated.'' See ANSI/AAMI HE 75, section 16.3.5.5.

[[Page 6932]]

M307.3 would require operable parts such as dials, switches, and
levers to be operable with one hand without tight grasping, pinching,
or twisting of the wrist. M307.4 would require the force to activate
operable parts to not exceed 5 pounds. M307.3 and M307.4 are based on
provisions for operable parts in the 2004 ADA and ABA Accessibility
Guidelines. M307.3 and M307.4 are also consistent with recommendations
in ANSI/AAMI HE 75 that ``devices should have at least one mode of use
that does not require fine motor control or the performance of
simultaneous actions.'' ANSI/AAMI HE 75 includes additional recommended
practices for accessible controls. See ANSI/AAMI HE 75, section 16.3.3.
The Wheeled Mobility Anthro-
pometry Project recommended that ``operable parts that require fine
grips preferably should not require exertion of lateral pinch grip
forces in excess of 2 pounds force to accommodate the vast majority of
* * * users having at least some grasping capability.'' The Wheeled
Mobility Anthropometry Project recommended that the 5 pounds maximum
force be retained for other types of operable parts. See Final Report
of the Wheeled Mobility Anthropometry Project, page 105. The Access
Board is considering requiring in the final standards that operable
parts used by patients that require fine grips to not exceed 2 pounds
maximum operating force.
Question 42. Comments are requested on the following questions
regarding the operating force (2 pounds maximum) that the Access Board
is considering requiring in the final standards for operable parts used
by patients that require fine grips:
(a) What would be the incremental costs for the design or redesign
and manufacture of the equipment to provide operable parts that meet
the above operating force?
(b) Are there types of equipment that cannot provide operable parts
that meet the above operating force because of the structural or
operational characteristics of the equipment?
The 2004 ADA and ABA Accessibility Guidelines require that operable
parts be placed within certain reach ranges. For an unobstructed
forward reach or side reach, the reach ranges are 48 inches maximum for
a high reach and 15 inches minimum for a low reach. ANSI/AAMI HE 75
provides guidance on reach ranges based on provisions in an earlier
version of accessibility guidelines for buildings and facilities issued
by the Access Board, the 1991 Americans with Disabilities Act
Accessibility Guidelines (ADAAG). ANSI/AAMI HE 75 also recommends a
remote control as an alternative to a direct reach. See ANSI/AAMI HE
75, section 16.3.2.2. The reach ranges in the 2004 ADA and ABA
Accessibility Guidelines provide greater accessibility than the reach
ranges in the 1991 ADAAG.
Question 43. Comments are requested on the following questions
regarding reach ranges for operable parts on diagnostic equipment that
are used by patients:
(a) Would the reach ranges in the 2004 ADA and ABA Accessibility
Guidelines for an unobstructed forward reach or side reach (48 inches
maximum for a high reach and 15 inches minimum for a low reach) be
appropriate for operable parts on diagnostic equipment that are used by
patients?
(b) Would alternative technical criteria be appropriate for reach
ranges for operable parts on diagnostic equipment that are used by
patients? Comments should include information on sources to support the
alternative technical criteria, where possible.

6. Regulatory Analyses

Executive Order 13563 (Improving Regulation and Regulatory Review) and
Executive Order 12866 (Regulatory Planning and Review): Preliminary
Regulatory Assessment

The Office of Management and Budget has reviewed this proposed rule
in accordance with Executive Orders 13563 and 12866. Among other
things, Executive Order 13563 directs agencies to propose or adopt a
regulation only upon a reasoned determination that its benefits justify
its costs; tailor the regulation to impose the least burden on society,
consistent with obtaining the regulatory objectives; and, in choosing
among alternative regulatory approaches, select those approaches that
maximize net benefits. Executive Order 13563 recognizes that some
benefits and costs are difficult to quantify and provides that, where
appropriate and permitted by law, agencies may consider and discuss
qualitatively values that are difficult or impossible to quantify,
including equity, human dignity, fairness, and distributive impacts.
The Access Board has prepared a preliminary regulatory assessment
for the proposed standards. The preliminary regulatory assessment is
available on the Access Board's Web site at: https://www.access-board.gov/medical-equipment.htm. The preliminary regulatory assessment
is summarized below.

Need for and Benefits of the Proposed Standards

The U.S. Census Bureau reports that 54.4 million Americans, about
one in five U.S. residents, reported some level of disability in
2005.\11\ The number of individuals with disabilities is almost equal
to the combined total population of California and Florida. The U.S.
Census Bureau provides this breakdown of the population of people aged
15 and older:
---------------------------------------------------------------------------

\11\ ``Americans with Disabilities: 2005'' (2008) available at:
https://www.census.gov/prod/2008pubs/p70-117.pdf.
---------------------------------------------------------------------------

27.4 million (11.9 percent) had difficulty with ambulatory
activities of the lower body;
22.6 million (9.8 percent) had difficulty walking a
quarter of a mile;
21.8 million (9.4 percent) had difficulty climbing a
flight of stairs;
10.2 million (4.4 percent) used a cane, crutches, or
walker to assist with mobility;
3.3 million (1.4 percent) used a wheelchair or other
wheeled mobility device;
7.8 million (3 percent) had difficulty seeing words or
letters in ordinary newspaper print, including 1.8 million who are
completely unable to see; and
7.8 million (3 percent) had difficulty hearing
conversations, including 1 million who are unable to hear conversations
at all.
The prevalence of disability increases with age. The Administration
on Aging reports that there were 39.6 million persons age 65 or older
in the United States in 2009, and that this population is expected to
increase to 55 million in 2020.\12\ Among this population, 37 percent
reported some type of disability in 2005.\13\
---------------------------------------------------------------------------

\12\ ``A Profile of Older Americans: 2010'' available at: https://www.aoa.gov/AoARoot/Aging_Statistics/Profile/index.aspx.
\13\ See footnote 11.
---------------------------------------------------------------------------

A national survey collected information on the types of medical
equipment that is most difficult for individuals with disabilities to
access and use.\14\ The survey was completed by a diverse sample of
individuals with a wide range of disabilities, including mobility
disabilities and sensory disabilities. Survey respondents who had
experience with specific medical

[[Page 6933]]

equipment rated their degree of difficulty when attempting to access or
use the equipment as follows:
---------------------------------------------------------------------------

\14\ The results of the survey are reported in Jill M. Winters,
Molly Follette Story, Kris Barnekow, June Isaacson Kailes, Brenda
Premo, Erin Schier, Sarma Danturthi, and Jack M. Winters, ``Results
of a National Survey on Accessibility of Medical Instrumentation for
Consumers,'' in ``Medical Instrumentation Accessibility and
Usability Considerations,'' edited by Jack M. Winters and Molly
Follette Story (Boca Raton, CRC Press, 2007), 13-27.
---------------------------------------------------------------------------

75 percent rated examination tables as moderately
difficult to impossible to use;
68 percent rated radiology equipment as moderately
difficult to impossible to use;
53 percent rated weight scales as moderately difficult to
impossible to use; and
50 percent rated examination chairs as moderately
difficult to impossible to use.
Survey respondents reported difficulties with getting on and off
the equipment, positioning their bodies on the equipment, physical
comfort and safety, and communication issues. Focus group sessions of
individuals with disabilities reported that participants find
examination tables, imaging equipment, and other diagnostic equipment
not only difficult but unsafe to use, and that these negative health
care experiences can result in their not scheduling regular medical
examinations and diagnostic procedures.\15\
---------------------------------------------------------------------------

\15\ The results of the focus group sessions are reported in
Molly Follette Story, Erin Schwier, and June Isaacson Kailes,
``Perspectives of Patients with Disabilities on the Accessibility of
Medical Equipment: Examination Tables, Imaging Equipment, Medical
Chairs, and Weight Scales,'' Disability and Health Journal 2 (2009),
169-179.
---------------------------------------------------------------------------

A report on the ``The Current State of Health Care for People with
Disabilities'' issued by the National Council on Disability found that
individuals with disabilities experienced significant health
disparities and barriers to health care, as compared to individuals
without disabilities.\16\ Among the key barriers cited in the report is
the lack of accessible examination equipment. A report on the
``Importance of Accessible Examination Tables, Chairs and Weight
Scales'' issued by the Center for Disability Issues and the Health
Professions discusses how the lack of accessible equipment reduces the
likelihood that individuals with disabilities will receive timely and
appropriate health care.\17\ Health care providers may not perform some
diagnostic procedures for patients with disabilities because they lack
accessible equipment. This can result in suboptimal examinations,
missed or delayed diagnoses, and worsening conditions that require more
expensive and extensive treatments.
---------------------------------------------------------------------------

\16\ The report is available at: https://www.ncd.gov/publications/2009/Sept302009.
\17\ The report is available at: https://www.cdihp.org/products.html#tables.
---------------------------------------------------------------------------

The proposed standards address many of the barriers that have been
identified as affecting the accessibility and usability of diagnostic
equipment by individuals with disabilities. The standards will improve
the quality of health care for individuals with disabilities and ensure
that they receive examinations, diagnostic procedures, and other health
care services equal to those received by individuals without
disabilities. The standards will facilitate independent transfers by
individuals with disabilities onto and off of diagnostic equipment, and
enable them to maintain their independence, confidence, and dignity.
The standards will lessen the need for health care personnel to assist
individuals with disabilities when transferring on and off of
diagnostic equipment. Where assisted transfers are necessary, the
proposed standards will also facilitate such transfers. The proposed
standards will reduce the risk of injury during transfers to both
health care personnel and patients.\18\ The proposed standards will
result in more positive health care experiences for individuals with
disabilities and health care providers.
---------------------------------------------------------------------------

\18\ Lifting and transferring patients is a major risk factor
for back injury among nurses and health aides. See Alan Hedge,
``Back Care for Nurses'' available at: https://www.spineuniverse.com/wellness/ergonomics/back-care-nurses.
---------------------------------------------------------------------------

Entities Potentially Affected by Proposed Standards

The proposed standards do not impose any mandatory requirements on
health care providers or medical device manufacturers. Thus, there are
no compliance costs that can be attributed to the proposed standards.
As discussed below, if an enforcing authority such as DOJ adopts the
standards as mandatory requirements for entities subject to its
jurisdiction, health care providers may experience some compliance
costs. Medical device manufacturers may have an economic incentive to
produce accessible products that conform to the standards for health
care providers who need to acquire accessible medical diagnostic
equipment.

Health Care Providers

As discussed under Department of Justice Activities Related to
Health Care Providers and Medical Equipment, health care providers must
provide individuals with disabilities full and equal access to their
health care services and facilities to comply with the ADA and Section
504 of the Rehabilitation Act. Both the Federal government through DOJ
and private parties, including individuals with disabilities, have
entered into settlement agreements with health care providers to
enforce the ADA and Section 504 of the Rehabilitation Act. In July
2010, DOJ and the Department of Health and Human Services issued a
guidance document for health care providers regarding their
responsibilities to make their services and facilities accessible to
individuals with mobility disabilities under the ADA and Section 504 of
the Rehabilitation Act. See Access to Medical Care for Individuals with
Mobility Disabilities available at: https://www.ada.gov/medcare_ta.htm.
The guidance document includes information on accessible examination
rooms and the clear floor space needed adjacent to medical equipment
for individuals who use mobility devices to approach the equipment for
transfer; accessible medical equipment (e.g., examination tables and
chairs, mammography equipment, weight scales); patient lifts and other
methods for transferring individuals from their mobility devices to
medical equipment; and training health care personnel. In July 2010,
DOJ also issued an ANPRM announcing that, pursuant to the obligation
that has always existed under the ADA for covered entities to provide
accessible equipment and furniture, it was considering amending its
regulations implementing Titles II and III of the ADA to include
specific standards for the design and use of accessible equipment and
furniture that is not fixed or built into a facility in order to ensure
that programs and services provided by state and local governments and
by public accommodations are accessible to individuals with
disabilities. See 75 FR 43452 (July 26, 2010). Among other things, the
ANPRM stated that DOJ was considering amending its ADA regulations to
specifically require health care providers to acquire accessible
medical equipment and that it would consider adopting the standards
issued by the Access Board. DOJ also indicated its intention to include
in its ADA regulations scoping requirements that specify the minimum
number of types of accessible medical equipment required in different
types of health care facilities. If DOJ proposes to amend its ADA
regulations as announced in the ANPRM, it will publish a notice of
proposed rulemaking (NPRM) requesting public comment and will prepare a
regulatory assessment in accordance with Executive Orders 13563 and
12866.

Medical Device Manufacturers

If DOJ amends its ADA regulations as announced in the ANPRM,
medical device manufacturers may have an

[[Page 6934]]

economic incentive to produce accessible products that conform to the
standards for health care providers who need to acquire accessible
medical diagnostic equipment. The size of the economic incentive will
depend on the amount of accessible medical diagnostic equipment health
care providers need to acquire and the manufacturers' incremental costs
to design or redesign and manufacture accessible products that conform
to the standards.
Many medical device manufacturers currently incorporate accessible
features in some of their products such as patient support surfaces
that are height adjustable, transfer and positioning supports, and
scales designed for use by patients seated in a wheelchair. The
incremental costs for manufacturers to conform these products to the
standards are expected to be small because the features may already
meet or closely meet the standards. The incremental costs may be
greater for manufacturers that do not currently incorporate accessible
features in their products but plan to do so in future designs or
redesigns of their products. The incremental costs to design or
redesign and manufacture accessible products that conform to the
standards will be incurred voluntarily by manufacturers that choose to
produce them for health care providers who need to acquire accessible
medical diagnostic equipment. Some manufacturers may choose not to
design or redesign and manufacture accessible products that conform to
the standards, or may produce accessible products with less market
appeal than that of their competitors, thereby losing market share and
incurring losses. These economic impacts are not regulatory costs and
are not generally social costs because for the most part, one
manufacturer's loss is another manufacturer's gain.
The following questions in the preamble request comments on the
incremental costs to design or redesign and manufacture accessible
products that conform to the technical criteria in the proposed
standards, as well as alternative and additional technical criteria
that the Access Board is considering:
Questions 9 and 10 on the technical criteria in Chapter
M3;
Questions 14 (a) and (b) on height adjustable patient
support surfaces;
Question 15 (b) on width of patient support surfaces on
equipment used by patients in a supine, prone, or side-lying position;
Question 18 (a) on structural strength of repositionable
transfer supports;
Question 19 (c) on location and size of transfer supports;
Question 23 (a) on stirrups;
Question 24 (b) on positioning supports;
Question 29 (a) on alternative dimension for minimum depth
of wheelchair spaces;
Question 30 on edge protection for wheelchair spaces on
raised platforms:
Question 33 on dimensions for wheelchair spaces on raised
platforms;
Question 34 (a) on alternative dimensions for toe
clearance and knee clearance at wheelchair spaces;
Question 35 (b) on handrails on diagnostic equipment
ramps;
Question 37 (c) on a folding or removable seat on weight
scale platforms or other types of diagnostic equipment used by patients
in a standing position;
Question 41 (b) on audible, visible, and tactile
communications; and
Question 42 (a) on operating force for operable parts.
The Access Board will consider the information provided in the
comments when preparing the final standards, and will provide an
analysis of the incremental costs with the final standards.

Product Data and Unit Costs

The Access Board and its contractor, Eastern Research Group,
collected product data and unit costs for a broad sample of examination
tables and weight scales, including products with accessible features.
The Access Board and Eastern Research Group did not evaluate the
products for conformance with the proposed standards and do not endorse
any of the products included in the sample. The Access Board and
Eastern Research Group used the Internet to collect the product data
and unit costs. Medical equipment suppliers typically list the
manufacturer suggested retail price (MSRP) for the products on their
Web sites and sell the products at discounted prices. The discounted
prices for the same product can vary widely among medical equipment
suppliers. Health care providers typically purchase the products for
less than the MSRP (i.e., actual price paid is less than MRSP). The
unit costs in the tables below are the MSRP, and are shown as a range
of lower cost and higher cost products rounded to the nearest $50. The
data shows that there are a wide variety of examination tables and
weight scales available to meet almost every budget.
Product data and unit costs for examination chairs and imaging
equipment will be provided when the final standards are issued.

Examination Tables

Product data and unit costs were collected for examination tables
produced by five manufacturers. The manufacturer's Web sites typically
grouped the tables by the following types: Treatment tables, manual
tables, and power tables. The number of each type of table made by the
manufacturers, the number of tables included in the sample, and range
of lower cost and higher cost products are summarized below.

----------------------------------------------------------------------------------------------------------------
Products in Lower cost Higher cost
Table type Products sample products MSRP products MSRP
----------------------------------------------------------------------------------------------------------------
Treatment............................... 74 20 $400-$850 $850-$1,450
Manual.................................. 15 9 1,250 2,250
Power................................... 30 25 1,650-2,900 3,650-16,800
----------------------------------------------------------------------------------------------------------------

Question 44. Does the above sample fairly reflect the range of
costs for examination tables?
Treatment tables typically have a flat top. Some models have
adjustable backrests, but the backrests typically cannot support
patients in a sitting position. Treatment tables typically have a fixed
height of 31 inches measured from the floor to the top of the table.
The lower cost products have an open base with an H-brace or shelf. The
higher cost products have cabinets, drawers, or shelves. Adjustable
height treatment tables are available, but are not included in the
sample. The MSRP for adjustable height treatment tables ranged from
$1,500 to $2,400.
Manual tables typically have a fully articulated, pneumatic
backrest. The backrests typically can support patients in a seated
position and recline to a lying position. Manual tables typically have
a fixed height of 32 inches

[[Page 6935]]

measured from the floor to the top of the table. Manual tables
typically have cabinets, drawers, or shelves.
Power tables have an electric motor that can adjust the table
height to as low as 18 inches and as high as 40 inches above the floor
on some products. The higher cost products have a fully articulated,
pneumatic or powered, backrest that can support patients in a seated
position and recline to a lying position. Some power tables have
armrests, grab rails, side rails, and cabinets or drawers.

Weight Scales

Product data and unit costs were collected for weight scales
produced by eight manufacturers. The scales are grouped by the
following types: Stand-on scales and wheelchair scales. Within each
group, there are mechanical and digital scales. Unit costs are
presented for stand-on scales with and without handrails. Unit costs
are presented for wheelchair scales with raised platforms and with
flush platforms in the floor. The number of each type of scale made by
the manufacturers, the number of scales included in the sample, and
range of lower cost and higher cost products are summarized below.

----------------------------------------------------------------------------------------------------------------
Products in Lower cost Higher cost
Stand-on scales Products sample products MSRP products MSRP
----------------------------------------------------------------------------------------------------------------
Mechanical without Handrails............ 22 3 $250 $550
Mechanical with Handrails............... 1 1 700 700
Digital without Handrails............... 50 15 300-600 700-1,200
Digital with Handrails.................. 21 9 600-1,050 1,750-2,600
----------------------------------------------------------------------------------------------------------------

Question 45. Does the above sample fairly reflect the range of
costs for stand-on scales?
Stand-on mechanical scales typically have a weight capacity ranging
from 400 to 500 pounds. Stand-on digital scales without handrails
typically have a weight capacity ranging from 400 to 750 pounds, and
the higher cost products typically have larger platforms. Stand-on
digital scales with handrails typically have a weight capacity ranging
from 500 to 1,000 pounds, and the higher cost products typically are
bariatric scales.

----------------------------------------------------------------------------------------------------------------
Products in Lower cost Higher cost
Wheelchair scales Products sample products MSRP products MSRP
----------------------------------------------------------------------------------------------------------------
Mechanical with Ramped Platform......... 2 2 $1,200 $2,900
Digital with Ramped Platform............ 32 15 800-1,700 2,100-4,950
Digital with Flush Platform in Floor.... 8 5 3,300 6,500
----------------------------------------------------------------------------------------------------------------

Question 46. Does the above sample fairly reflect the range of
costs for wheelchair scales?
Wheelchair mechanical scales with a ramped platform typically have
a weight capacity ranging from 350 to 500 pounds. Wheelchair digital
scales with a ramped platform typically have a weight capacity ranging
from 800 to 1,000 pounds. Wheelchair digital scales with a flush
platform in the floor typically have a weight capacity of 1,000 pounds.
Some wheelchair digital scales have standard or optional handrails for
use as a stand-on bariatric scale.
The Access Board has made a preliminary determination based on the
preliminary regulatory assessment that the benefits of the proposed
standards will justify the costs; that the proposed standards will
impose the least burden on society, consistent with obtaining the
regulatory objectives; and that the regulatory approach selected will
maximize net benefits.

Regulatory Flexibility Act: Initial Regulatory Flexibility Analysis

The Regulatory Flexibility Act requires agencies to consider the
impacts of their regulatory proposals on small entities, analyze
alternatives that minimize the impacts on small entities, and make the
analysis available for public comment. The proposed standards do not
impose any mandatory requirements on any entity, including small
entities. Nonetheless, in keeping with the Regulatory Flexibility Act,
the Access Board has prepared this initial regulatory flexibility
analysis.

Reason the Access Board Is Issuing the Proposed Standards

Section 510 of the Rehabilitation Act (29 U.S.C. 794f) requires the
Access Board, in consultation with the Commissioner of the Food and
Drug Administration, to issue standards that contain minimum technical
criteria to ensure that medical diagnostic equipment used in or in
conjunction with medical settings such as physicians' offices, clinics,
emergency rooms, and hospitals is accessible to and usable by
individuals with disabilities.

Objective of, and Legal Basis for, the Proposed Standards

The objective of the proposed standards is to ensure that medical
diagnostic equipment is accessible to and usable by individuals with
disabilities. The proposed standards address barriers that affect the
accessibility and usability of medical diagnostic equipment by
individuals with disabilities. The legal basis for the proposed
standards is Section 510 of the Rehabilitation Act.

Small Entities Potentially Affected by Proposed Standards

The proposed standards do not impose any mandatory requirements on
health care providers or medical device manufacturers. As discussed
below, if an enforcing authority such as DOJ adopts the standards as
mandatory requirements for entities subject to its jurisdiction, small
health care providers may experience some compliance costs. Small
medical device manufacturers may have an economic incentive to produce
accessible products that conform to the standards for health care
providers who need to acquire accessible medical diagnostic equipment.

Health Care Providers

[[Page 6936]]

and Section 504 of the Rehabilitation Act. Both the Federal government
through DOJ and private parties, including individuals with
disabilities, have entered into settlement agreements with health care
providers to enforce the ADA and Section 504 of the Rehabilitation Act.
In July 2010, DOJ and the Department of Health and Human Services
issued a guidance document for health care providers regarding their
responsibilities to make their services and facilities accessible to
individuals with mobility disabilities under the ADA and Section 504 of
the Rehabilitation Act. See Access to Medical Care for Individuals with
Mobility Disabilities available at: https://www.ada.gov/medcare_ta.htm.
The guidance document includes information on accessible examination
rooms and the clear floor space needed adjacent to medical equipment
for individuals who use mobility devices to approach the equipment for
transfer; accessible medical equipment (e.g., examination tables and
chairs, mammography equipment, weight scales); patient lifts and other
methods for transferring individuals from their mobility devices to
medical equipment; and training health care personnel. In July 2010,
DOJ also issued an ANPRM announcing that, pursuant to the obligation
that has always existed under the ADA for covered entities to provide
accessible equipment and furniture, it was considering amending its
regulations implementing Titles II and III of the ADA to include
specific standards for the design and use of accessible equipment and
furniture that is not fixed or built into a facility in order to ensure
that programs and services provided by state and local governments and
by public accommodations are accessible to individuals with
disabilities. See 75 FR 43452 (July 26, 2010). Among other things, the
ANPRM stated that DOJ was considering amending its ADA regulations to
specifically require health care providers to acquire accessible
medical equipment and that it would consider adopting the standards
issued by the Access Board. DOJ also indicated its intention to include
in its ADA regulations scoping requirements that specify the minimum
number of types of accessible medical equipment required in different
types of health care facilities. If DOJ proposes to amend its ADA
regulations as announced in the ANPRM, it will publish a notice of
proposed rulemaking (NPRM) requesting public comment and will prepare
an initial and final regulatory flexibility analyses in accordance with
the Regulatory Flexibility Act.

Medical Device Manufacturers

If DOJ amends its ADA regulations as announced in the ANPRM, small
medical device manufacturers may have an economic incentive to produce
accessible products that conform to the standards for health care
providers who need to acquire accessible medical diagnostic equipment.
The size of the economic incentive will depend on the amount of
accessible medical diagnostic equipment health care providers need to
acquire and the manufacturers' incremental costs to design or redesign
and manufacture accessible products that conform to the standards.
Many medical device manufacturers currently incorporate accessible
features in some of their products such as patient support surfaces
that are height adjustable, transfer and positioning supports, and
scales designed for use by patients seated in a wheelchair. The
incremental costs for manufacturers to conform these products to the
standards are expected to be small because the features may already
meet or closely meet the standards. The incremental costs may be
greater for manufacturers that do not currently incorporate accessible
features in their products but plan to do so in future designs or
redesigns of their products. The incremental costs to design or
redesign and manufacture accessible products that conform to the
standards will be incurred voluntarily by manufacturers that choose to
produce them for health care providers who need to acquire accessible
medical diagnostic equipment. Some manufacturers may choose not to
design or redesign and manufacture accessible products that conform to
the standards, or may produce accessible products with less market
appeal than that of their competitors, thereby losing market share and
incurring losses. These economic impacts are not regulatory costs and
are not generally social costs because for the most part, one
manufacturer's loss is another manufacturer's gain.
The preamble requests comments on the incremental costs to design
or redesign and manufacture products that conform to the technical
criteria in the proposed standards, as well as alternative and
additional technical criteria that the Access Board is considering. The
Access Board will consider the information provided in the comments
when preparing the final standards, and will provide an analysis of the
incremental costs with the final standards.

Compliance Requirements in Proposed Standards

The proposed standards contain technical criteria for accessible
medical diagnostic equipment. The proposed standards do not impose any
mandatory requirements on medical device manufacturers or health care
providers.

Other Relevant Federal Rules and Guidance Documents

As discussed above, DOJ and the Department of Health and Human
Services issued a guidance document for health care providers regarding
their responsibilities to make their services and facilities accessible
to individuals with mobility disabilities under the ADA and Section 504
of the Rehabilitation Act. DOJ also issued an ANPRM announcing that it
was considering amending its regulations implementing Titles II and III
of the ADA to ensure that equipment and furniture used in programs and
services provided by state and local governments and by public
accommodations are accessible to individuals with disabilities. See 75
FR 43452 (July 26, 2010). Among other things, the ANPRM stated that DOJ
was considering amending its ADA regulations to specifically require
health care providers to acquire accessible medical equipment and that
it would consider adopting the standards issued by the Access Board.
DOJ also indicated its intention to include in its ADA regulations
scoping requirements that specify the minimum number of types of
accessible medical equipment required in different types of health care
facilities.
The Access Board worked closely with the FDA-CDRH in developing the
proposed standards. The FDA-CDRH may develop a guidance document to
inform manufacturers how it intends to apply its regulatory authority
to clearance or approval of medical devices addressed in the Access
Board's standards. If the FDA-CDRH develops such a guidance document,
it will provide the public notice and opportunity to comment on a draft
of the guidance document in accordance with its procedures for issuing
guidance documents. See 21 CFR 10.115.

Significant Alternatives

Questions are included in the preamble requesting comments on the
economic and technical impacts of the technical criteria in the
proposed standards, and whether alternative technical criteria would be
appropriate. The Access Board plans to convene an advisory committee
when the comment

[[Page 6937]]

period on the rulemaking closes to assist the Board in reviewing the
comments and make recommendations on issues addressed in the
rulemaking. The Access Board will analyze the comments submitted in
response to the questions and the advisory committee's recommendations,
including alternatives that achieve the statutory objectives of
ensuring that medical diagnostic equipment is accessible to and usable
by individuals with disabilities and minimize any significant impacts
of the standards on small entities. The Access Board will prepare a
final regulatory flexibility analysis when the final standards are
issued that discusses any significant alternatives considered.

Executive Order 13132 (Federalism)

The proposed standards do not impose any mandatory requirements on
State and local governments. The proposed standards do not have any
direct effects on the state governments, the relationship between the
national government and state governments, or the distribution of power
and responsibilities among the various levels of government. The
proposed standards do not preempt state law. Therefore, the
consultation and other requirements of Executive Order 13132
(Federalism) do not apply.

Unfunded Mandates Reform Act

The proposed standards do not impose any mandatory requirements on
state, local, or tribal governments or the private sector. Therefore,
the Unfunded Mandates Reform Act does not apply.

List of Subjects in 36 CFR Part 1195

Health care, Individuals with disabilities, Medical devices.

Nancy Starnes,
Chair.

For the reasons stated in the preamble, the Access Board proposes
to add part 1195 to title 36 of the Code of Federal Regulations to read
as follows:

PART 1195--STANDARDS FOR ACCESSIBILE MEDICAL DIAGNOSTIC EQUIPMENT

Sec.
1195.1 Standards.
Appendix to Part 1195--Standards for Accessible Medical Diagnostic
Equipment

Authority: 29 U.S.C. 794f.

Sec. 1195.1 Standards.

The standards for accessible medical diagnostic equipment are set
forth in the appendix to this part. Other agencies, referred to as an
enforcing authority in the standards, may adopt the standards as
mandatory requirements for entities subject to their jurisdiction.

Appendix to Part 1195--Standards for Accessible Medical Diagnostic
Equipment

Chapter M1: Application and Administration

M101 General

M101.1 Purpose. The standards contain technical criteria for
medical diagnostic equipment that is accessible to and usable by
patients with disabilities. The standards provide for independent
access to and use of diagnostic equipment by patients with
disabilities to the maximum extent possible.
M101.2 Application. The standards shall be applied to diagnostic
equipment based on the patient positions that the equipment is
designed to support. Where diagnostic equipment is designed to
support more than one patient position, the standards for each
patient position supported shall be applied to the equipment.
Advisory M101.2 Application. The following examples illustrate
how the standards apply to diagnostic equipment designed to support
more than one patient position:
An examination chair converts to an examination table.
The technical criteria in M302 for diagnostic equipment used by
patients in a seated position; and in M301 for diagnostic equipment
used by patients in a supine, prone, or side-lying position apply.
A weight scale can be used by patients seated in a
wheelchair, or seated on a built-in folding seat, or standing and
holding onto supports. The technical criteria in M303 for diagnostic
equipment used by patients seated in a wheelchair; in M302 for
diagnostic equipment used by patients in a seated position; and in
M304 for diagnostic equipment used by patients in a standing
position apply.
M101.3 Equivalent Facilitation. The use of alternative designs
or technologies that result in substantially equivalent or greater
accessibility and usability than specified in the standards is
permitted.
M101.4 Dimensions. The standards are based on adult dimensions
and anthropometrics.
Dimensions that are not stated as ``maximum'' or ``minimum'' are
absolute.
M101.5 Dimensional Tolerances. Dimensions are subject to
conventional industry tolerances for manufacturing processes,
material properties, and field conditions.

M102 Definitions

M102.1 Defined Terms. For the purpose of the standards, the
following terms have the indicated meaning:
Enforcing Authority. An agency that adopts the standards as
mandatory requirements for entities subject to its jurisdiction.
Medical Diagnostic Equipment (Diagnostic Equipment). Equipment
used in or in conjunction with medical settings by health care
providers for diagnostic purposes.
Operable Parts. A component of diagnostic equipment that is used
by the patient to activate, deactivate, or adjust the equipment.
Transfer Surface. Part of diagnostic equipment onto which
patients who use mobility devices or aids transfer when moving onto
and off of the equipment.
M102.2 Undefined Terms. The meaning of terms not defined in
M102.1 or in regulations or policies issued by an enforcing
authority shall be defined by collegiate dictionaries in the sense
that the context implies.
M102.3 Interchangeability. Words, terms, and phrases used in the
singular include the plural and those used in the plural include the
singular.

Chapter M2: Scoping

M201 General

M201.1 Enforcing Authority. The enforcing authority specifies
the minimum number of types of accessible diagnostic equipment that
are required to comply with the standards in different types of
health care facilities.

Chapter M3: Technical Criteria

M301 Diagnostic Equipment Used by Patients in Supine, Prone, or Side-
Lying Position

M301.1 General. Where diagnostic equipment is used by patients
in a supine, prone, or side-lying position, it shall comply with
M301.
M301.2 Transfer Surface. A transfer surface shall be provided
and shall comply with M301.2.
M301.2.1 Height. The height of the transfer surface during
patient transfer shall be 17 inches (430 mm) minimum and 19 inches
(485 mm) maximum measured from the floor to the top of the transfer
surface.
Advisory M301.2.1 Height. The transfer surface is permitted to
be positioned outside of the specified height range when not needed
to facilitate transfer.
M301.2.2 Size. The transfer surface shall be 30 inches (760 mm)
wide minimum and 15 inches (381 mm) deep minimum.
Advisory M301.2.2 Size. The size requirements in this section
apply only to the portion of the diagnostic equipment used for
transfer.
M301.2.3 Transfer Sides. The transfer surface shall be located
to provide options to transfer from a mobility device onto one short
side (depth) and one long side (width) of the surface. Each transfer
side shall provide unobstructed access to the transfer surface.
Exception: Temporary obstructions shall be permitted provided
that they can be repositioned to permit transfer.
Advisory M301.2.3 Transfer Sides: Exception. Arm rests,
footrests, side rails, and stirrups are examples of obstructions.
M301.3 Supports. Transfer supports, stirrups, and reclining
surfaces shall comply with M301.3.
M301.3.1 Transfer Supports. Transfer supports shall be provided
for use with the transfer sides required by M301.2.3 and shall
comply with M305.2.
M301.3.2 Stirrups. Where stirrups are provided, they shall
provide a method of

[[Page 6938]]

supporting, positioning, and securing the patient's legs.
M301.3.3 Head and Back Support. Where the diagnostic equipment
is used in a reclined position, head and back support shall be
provided. Where the incline of the back support can be modified
while in use, head and back support shall be provided throughout the
entire range of the incline.
M301.4 Lift Compatibility. Diagnostic equipment shall be usable
with a patient lift and shall comply with M301.4.1 or M301.4.2.
M301.4.1 Clearance in Base. The base of the equipment shall
provide a clearance 44 inches (1120 mm) wide minimum, 6 inches (150
mm) high minimum measured from the floor, and 36 inches (915 mm)
deep minimum measured from the edge of the examination surface.
Where the width of the examination surface is less than 36 inches
(915 mm), the clearance depth shall extend the full width of the
equipment. Equipment components are permitted to be located within 8
inches (205 mm) maximum of the centerline of the clearance width.
M301.4.2 Clearance Around Base. The base of the equipment shall
provide a clearance 6 inches (150 mm) high minimum measured from the
floor and 36 inches (915 mm) deep minimum measured from the edge of
the examination surface. The width of the base permitted within this
clearance shall be 26 inches (660 mm) wide maximum at the edge of
the examination surface and shall be permitted to increase at a rate
of 1 inch (25 mm) in width for each 3 inches (75 mm) in depth.

M302 Diagnostic Equipment Used by Patients in Seated Position

M302.1 General. Where diagnostic equipment is used by patients
in a seated position, it shall comply with M302.
M302.2 Transfer Surface. A transfer surface shall be provided
and shall comply with M302.2.
M302.2.1 Height. The height of the transfer surface during
patient transfer shall be 17 inches (430 mm) minimum and 19 inches
(485 mm) maximum measured from the floor to the top of the transfer
surface.
Advisory M302.2.1 Height. The transfer surface is permitted to
be positioned outside of the specified height range when not needed
to facilitate transfer.
M302.2.2 Size. The transfer surface shall be 21 inches (610 mm)
wide minimum and 15 inches (381 mm) deep minimum.
Advisory M302.2.2 Size. The size requirements in this section
apply only to the portion of the seat used for transfer.
M302.2.3 Transfer Sides. The transfer surface shall be located
to provide options to transfer from a mobility device onto one short
side (depth) and one long side (width) of the surface. Each transfer
side shall provide unobstructed access to the transfer surface.
Exception: Temporary obstructions shall be permitted provided
that they can be repositioned to permit transfer.
Advisory M302.2.3 Transfer Sides: Exception. Armrests,
footrests, and side rails are examples of obstructions.
M302.3 Supports. Transfer supports, armrests, and reclining
surfaces shall comply with M302.3.
M302.3.1 Transfer Supports. Transfer supports shall be provided
for use with the transfer sides required by M302.2.3 and shall
comply with M305.2.
M302.3.2 Armrests. Where diagnostic equipment is used by
patients in a seated position, armrests shall be provided.
Advisory M302.3.2 Armrests. Armrests on transfer sides are not
permitted to obstruct access to the transfer surface. See M302.2.3
Exception.
M302.3.3 Head and Back Support. Where the diagnostic equipment
is used in a reclined position, head and back support shall be
provided. Where the incline of the back support can be modified
while in use, head and back support shall be provided throughout the
entire range of the incline.
M302.4 Lift Compatibility. Diagnostic equipment shall be usable
with a patient lift and shall comply with M302.4.1 or M302.4.2.
Exception: Where diagnostic equipment meets the requirements of
M303 and provides a folding seat, the equipment shall not be
required to comply with M302.4.
M302.4.1 Clearance in Base. The base of the equipment shall
provide a clearance 44 inches (1120 mm) wide minimum, 6 inches (150
mm) high minimum measured from the floor, and 36 inches (915 mm)
deep minimum measured from the edge of the examination surface.
Where the width of the examination surface is less than 36 inches
(915 mm), the clearance depth shall extend the full width of the
equipment. Equipment components are permitted to be located within 8
inches (205 mm) maximum of the centerline of the clearance width.
M302.4.2 Clearance Around Base. The base of the equipment shall
provide a clearance 6 inches (150 mm) high minimum measured from the
floor and 36 inches (915 mm) deep minimum measured from the edge of
the examination surface. The width of the base permitted within this
clearance shall be 26 inches (660 mm) wide maximum at the edge of
the examination surface and shall be permitted to increase at a rate
of 1 inch (25 mm) in width for each 3 inches (75 mm) in depth.

M303 Diagnostic Equipment Used by Patients Seated in a Wheelchair

M303.1 General. Diagnostic equipment used by patients seated in
a wheelchair shall comply with M303.
M303.2 Wheelchair Spaces. A wheelchair space complying with
M303.2 shall be provided at diagnostic equipment.
Advisory M303.2 Wheelchair Spaces. A wheelchair space can be
used to accommodate patients who use wheelchairs as well as other
mobility devices and seating.
M303.2.1 Orientation. Wheelchair spaces shall be designed so
that a patient seated in a wheelchair orients in the same direction
that a patient not seated in a wheelchair orients when the
diagnostic equipment is in use.
M303.2.2 Width. Wheelchair spaces shall be 36 inches (915 mm)
wide minimum.
M303.2.3 Depth. Where wheelchair spaces can be entered from the
front or rear, the wheelchair space shall be 48 inches (1220 mm)
deep minimum. Where wheelchair spaces can be entered only from the
side, the wheelchair space shall be 60 inches (1525 mm) deep
minimum.
M303.2.4 Knee and Toe Clearance. Wheelchair spaces shall include
knee and toe clearance complying with M303.2.4. The depth of the
wheelchair space shall include knee and toe clearance of 17 inches
(430 mm) minimum and 25 inches (635 mm) maximum. Knee and toe
clearance under breast platforms shall be 25 inches (635 mm) deep.
M303.2.4.1 Toe Clearance. Toe clearance shall be provided at a
height of 9 inches (230 mm) above the floor to a depth of 6 inches
(150 mm) maximum.
M303.2.4.2 Knee Clearance. Knee clearance shall be provided at a
depth of 11 inches (280 mm) minimum and 25 inches (635 mm) maximum
at 9 inches (230 mm) above the floor and at a depth of 8 inches (205
mm) minimum at 27 inches (685 mm) above the floor. Between 9 inches
(230 mm) and 27 inches (685 mm) above the floor, the knee clearance
shall be permitted to reduce at a rate of 1 inch (25 mm) in depth
for every 6 inches (150 mm) in height.
M303.2.5 Surfaces. Wheelchair space surfaces shall not slope
more than 1:48 in any direction.
M303.3 Entry. Where there is a change in level at the entry to a
wheelchair space, the change in level shall comply with M303.3.
M303.3.1 Vertical. Changes in level of \1/4\ inch (6.4 mm) high
maximum shall be permitted to be vertical.
M303.3.2 Beveled. Changes in level between \1/4\ inch (6.4 mm)
high and \1/2\ inch (13 mm) high maximum shall be beveled with a
slope not steeper than 1:2.
M303.3.3 Ramped. Changes in level greater than \1/2\ inch (13
mm) high shall be ramped and shall comply with M303.3.3.
M303.3.3.1 Running Slope. Ramp runs shall have a running slope
not steeper than 1:12.
M303.3.3.2 Cross Slope. The cross slope of ramp runs shall not
be steeper than 1:48.
M303.3.3.3 Clear Width. The clear width of ramp runs shall be 36
inches (915 mm) minimum.
M303.3.3.4 Edge Protection. Ramps with drop offs \1/2\ inch (13
mm) or greater shall provide edge protection 2 inches (50 mm) high
minimum on each side.
M303.3.3.5 Handrails. Ramps with a rise greater than 6 inches
(150 mm) shall provide handrails on each side.
M303.4 Components. Where components of diagnostic equipment are
used to examine specific body parts, the components shall be capable
of examining the body parts of a patient seated in a wheelchair.
Breast platforms shall comply with M303.4.1.
M303.4.1 Breast Platforms. The height of the breast platform
shall be 30 inches (760 mm) high minimum and 42 inches (1065 mm)
high maximum above the floor when in use by a patient seated in a
wheelchair.

M304 Diagnostic Equipment Used by Patients in Standing Position

M304.1 General. Diagnostic equipment used by patients in a
standing position shall comply with M304.
M304.2 Standing Surface. The surface on which the patient stands
shall be slip resistant.

[[Page 6939]]

M304.3 Standing Supports. Standing supports shall be provided on
each side of the standing surface and shall comply with M305.3.

M305 Supports

M305.1 General. Supports shall comply with M305, as applicable.
M305.2 Transfer Supports. Transfer supports shall comply with
M305.2.
M305.2.1 Location. Transfer supports shall be located within
reach of the transfer surface and shall not obstruct transfer onto
or off of the surface when in position.
M305.2.2 Structural Strength. Transfer supports and their
connections shall be capable of resisting vertical and horizontal
forces of 250 pounds (1,112 N) applied at all points on the transfer
support.
M305.2.3 Fittings. Transfer supports shall not rotate within
their fittings.
M305.3 Standing Supports. Standing supports shall provide
continuous support throughout use of the diagnostic equipment and
shall comply with M305.3.
M305.3.1 Horizontal Position. Where the support is horizontal,
the top of the gripping surface shall be 34 inches (865 mm) minimum
and 38 inches (965 mm) maximum above the standing surface. The
gripping surface shall be 4 inches (100 mm) long minimum.
M305.3.2 Vertical Position. Where the support is vertical, it
shall be 18 inches (455 mm) minimum in length and the bottom end of
the support shall be 34 inches (865 mm) high minimum and 37 inches
(940 mm) high maximum above the standing surface.
M305.3.3 Fittings. Standing supports shall not rotate within
their fittings.

M306 Communication

M306.1 General. Where instructions or other information is
communicated to the patient through the diagnostic equipment, the
instructions and other information shall be provided in at least two
of the following methods: audible, visible, or tactile.
Advisory M306.1 General. Patients should not be required to
adjust position to receive audible, visible, or tactile
communications. A volume control can be helpful, particularly in
diagnostic equipment where hearing aids cannot be worn. In selecting
the methods of communication it is important to consider the
diagnostic equipment characteristics. For example, audible
communication may not be effective for magnetic resonance imaging
(MRI) equipment due to the noise level when the equipment is in use.

M307 Operable Parts

M307.1 General. Operable parts for patient use shall comply with
M307.
M307.2 Tactilely Discernible. Operable parts shall be tactilely
discernible without activation.
M307.3 Operation. Operable parts shall be operable with one hand
and shall not require tight grasping, pinching, or twisting of the
wrist.
M307.4 Operating Force. The force required to activate operable
parts shall be 5 pounds (22.2 N) maximum.

[FR Doc. 2012-2795 Filed 2-8-12; 8:45 am]
BILLING CODE 8150-01-P

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