Standards for Accessible Medical Diagnostic Equipment, 2810-2848 [2016-31186]

Agencies

• Architectural and Transportation Barriers Compliance Board

[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Rules and Regulations]
[Pages 2810-2848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31186]



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Vol. 82

Monday,

No. 5

January 9, 2017

Part IV





Architectural and Transportation Barriers Compliance Board





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36 CFR Part 1195





Standards for Accessible Medical Diagnostic Equipment; Final Rule

Federal Register / Vol. 82 , No. 5 / Monday, January 9, 2017 / Rules 
and Regulations

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ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD

36 CFR Part 1195

RIN 3014-AA40


Standards for Accessible Medical Diagnostic Equipment

AGENCY: Architectural and Transportation Barriers Compliance Board.

ACTION: Final rule.

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SUMMARY: The Architectural and Transportation Barriers Compliance Board 
(Access Board or Board) is issuing accessibility standards for medical 
diagnostic equipment. The standards for medical diagnostic equipment 
(MDE Standards) contain minimum technical criteria to ensure that 
medical diagnostic equipment, including but not limited to, 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 MDE Standards will allow independent entry to, use 
of, and exit from the equipment by individuals with disabilities to the 
maximum extent possible. The MDE Standards do not impose any mandatory 
requirements on health care providers or medical device manufacturers. 
However, other agencies, referred to as enforcing authorities in the 
MDE Standards, may issue regulations or adopt policies that require 
health care providers subject to their jurisdiction to acquire 
accessible medical diagnostic equipment that complies with the MDE 
Standards.

DATES: The final rule is effective February 8, 2017.

FOR FURTHER INFORMATION CONTACT: Earlene Sesker, U.S. Access Board, 
1331 F Street NW., Suite 1000, Washington, DC 20004-1111. Telephone 
numbers: 202-272-0022 (voice) or 202-272-0091 (TTY). Email address: 
board.gov">sesker@access-board.gov. Or Rex Pace, U.S. Access Board, 1331 F Street 
NW., Suite 1000, Washington, DC 20004-1111. Telephone numbers: 202-272-
0023 (voice) or 202-272-0050 (TTY). Email address: board.gov">pace@access-board.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Purpose and Legal Authority

    The Access Board is an independent federal agency established by 
Section 502 of the Rehabilitation Act (29 U.S.C. 792). 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. 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.
    On March 23, 2010, Section 4203 of the Patient Protection and 
Affordable Care Act (ACA) amended Title V of the Rehabilitation Act, 
which established the rights and protections for individuals with 
disabilities, by adding Section 510. Public Law 111-148, 124 Stat. 
570). Section 510 of the Rehabilitation Act charges the Access Board, 
in consultation with the Commissioner of the Food and Drug 
Administration, with issuing standards that set forth the minimum 
technical criteria to ensure that medical diagnostic equipment 
(diagnostic equipment) used in (or in conjunction with) ``physician's 
offices, clinics, emergency rooms, hospitals, and other medical 
settings, is accessible to, and usable by, individuals with 
accessibility needs, and shall allow independent entry to, use of, and 
exit from the equipment by such individuals to the maximum extent 
possible.'' 29 U.S.C. 794f.
    The statute gives examples of diagnostic equipment, including 
``examination tables, examination chairs (including chairs used for eye 
examinations or procedures, and dental examinations or procedures), 
weight scales, mammography equipment, x-ray machines, and other 
radiological equipment commonly used for diagnostic purposes by health 
professionals.'' 29 U.S.C. 794f. This list is not considered 
exhaustive, but is illustrative of types of medical diagnostic 
equipment.
    Section 510 of the Rehabilitation Act instructs the Access Board to 
promulgate technical standards regarding accessibility of medical 
diagnostic equipment, but does not give the Access Board authority to 
enforce these standards. Compliance with the MDE Standards becomes 
mandatory only when an enforcing authority adopts the MDE Standards as 
mandatory for entities subject to its jurisdiction. Additionally, the 
enforcing agencies will determine the application and scope of these 
standards, such as who must comply and the extent to which medical 
diagnostic equipment used by covered entities must comply with these 
MDE Standards. As discussed below, the U.S. Department of Justice (DOJ) 
may adopt the MDE 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.
    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.
    The Commissioner of the Food and Drug Administration designated the 
Director of the Center for Devices and Radiological Health (FDA-CDRH) 
to consult with the Access Board on the development of the MDE 
Standards. The Access Board has worked throughout the process with the 
FDA-CDRH in developing these Standards.

B. Summary of Major Provisions and Organization of Technical Criteria

    The Access Board has divided the MDE Standards into separate 
technical criteria based on how the diagnostic equipment is used by the 
patient: (1) Supine, prone, or side lying position (M301); (2) seated 
position (M302); (3) while seated in a wheelchair (M303); and (4) 
standing position (M304). For each category the Access Board has 
provided technical criteria to allow independent access to and ensure 
the diagnostic equipment was usable by patients with disabilities to 
the maximum extent possible. The technical requirements for diagnostic 
equipment used by patients in the supine, prone, or side-lying position 
and diagnostic equipment used by patients in the seated position focus 
on ensuring the patient can transfer from a mobility device onto the 
diagnostic equipment. The other two categories, M303 and M304, focus on 
the necessary technical requirements to allow the patient to use the 
diagnostic equipment while seated in their wheeled mobility device, or 
while standing, respectively.
    The MDE Standards also include technical criteria for supports 
(M305), for instructions or other information communicated to patients 
through the equipment (M306), and for operable parts used by patients 
(M307).

C. Costs and Benefits

    The MDE Standards are advisory and are not binding until adopted by 
an enforcing authority. The Access Board's mandate was to establish 
only the minimum technical criteria, however enforcing authorities may 
establish scoping requirements in the future. As

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such, the final rule does not directly impose any obligations on health 
care providers or medical device manufacturers. Only when another 
federal agency, through separate rulemaking, adopts the MDE Standards 
(in whole or in part) as mandatory for entities under its jurisdiction, 
will compliance be required. At this point, the Access Board does not 
know whether enforcing authorities will adopt the MDE Standards, nor 
(if they do) to what extent health care practices or particular types 
of medical diagnostic equipment will be required to comply with the 
Standards' technical requirements. For this reason, the Board cannot 
estimate the incremental monetary or quantitative impacts of the final 
rule.
    Nevertheless, the Board is able to characterize qualitatively some 
of the potential impacts of these Standards. If enforcing agencies 
adopt the MDE Standards as mandatory for entities regulated under their 
jurisdiction, the Standards could affect health care providers, medical 
device manufacturers, and individuals with disabilities. Once health 
care providers and facilities are required to acquire accessible 
medical equipment, they could incur compliance costs, to the extent 
that their equipment is not already accessible. Medical device 
manufacturers would then decide whether to incur incremental costs to 
meet the demand for accessible equipment, and some or many 
manufacturers may have an economic incentive to produce accessible 
equipment. Finally, given the many barriers to health care that 
patients with mobility and communication disabilities encounter due to 
inaccessible medical diagnostic equipment, individuals with 
disabilities will benefit from access to and use of diagnostic 
equipment meeting the MDE Standards. Consequently, they may be able to 
receive health care comparable to that received by their non-disabled 
counterparts.
    In addition, the Standards could yield some immediate benefits, 
even before any adoption by implementing agencies in formal rulemaking. 
First, the technical specifications for accessible MDE incorporated in 
the Standards will benefit enforcing agencies that are considering 
similar accessibility requirements for entities under their 
jurisdiction. Although enforcing agencies have full authority over 
whether to adopt the Access Board's final rule (in whole or in part), 
the technical specifications in the MDE Standards reflect the input 
from a diverse set of stakeholders and provide solid groundwork for any 
future rulemaking pertaining to the accessibility of medical diagnostic 
equipment. Second, the Standards will serve as a best-practice document 
for the medical device industry and for health care providers and 
facilities. While the MDE Standards are non-binding, health care 
providers can use this final rule as guidance on how to provide 
equitable access to medical diagnostic equipment for people with 
mobility and communication disabilities. Manufacturers can also use the 
MDE Standards as they target their research and development efforts at 
producing diagnostic equipment that can be used by a larger segment of 
population--one that includes more people with disability and older 
adults.
    The Board thus concludes that the potential benefits of the MDE 
Standards justify its potential costs; that the MDE Standards will 
impose the least burden on society, consistent with achieving the 
regulatory objectives; and that the regulatory approach selected will 
maximize net benefits.

II. Rulemaking History

    Section 510 of the Rehabilitation Act requires the Access Board to 
issue standards for medical diagnostic equipment to ensure such 
equipment is accessible to, and usable by, individuals with 
disabilities no later than 24 months after the date of the enactment of 
the ACA. 29 U.S.C 794f.\1\ On July 29, 2010, after the Rehabilitation 
Act was amended, the Access Board held a 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 to provide information for 
developing the proposed standards. The transcript of the meeting is 
available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/background/public-information-meeting.
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    \1\ Patient Protection and Affordable Care Act, Public Law 111-
148, 124 Stat. 570 (2010).
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    On February 9, 2012, the Access Board formally commenced the 
rulemaking process and issued a notice of proposed rulemaking proposing 
accessibility standards for medical diagnostic equipment. Notice of 
Proposed Rulemaking--Medical Diagnostic Equipment Accessibility 
Standards, 77 FR 6916 (February 9, 2012) (hereinafter MDE NPRM). The 
proposed standards contained minimum technical criteria to ensure that 
medical diagnostic equipment, including, but not limited to, 
examination tables, examination chairs, weight scales, mammography 
equipment, and other imaging equipment used by health care providers 
for diagnostic purpose is accessible to, and usable by, individuals 
with disabilities. Id. The Access Board held two public hearings during 
the comment period, March 14, 2012 in Washington, DC and May 8, 2012 in 
Atlanta, GA. At the public hearings, 27 witnesses presented testimony 
regarding the need for accessibility standards for medical diagnostic 
equipment, the difficulty of obtaining health care for persons with 
disabilities, the current state of medical equipment and, the ability 
of medical diagnostic equipment to meet the proposed standards. The 
transcripts of the public meetings are available at https://www.regulations.gov/docket?D=ATBCB-2012-0003.
    The public comment period for the proposed rule ended on June 6, 
2012. Comments were submitted by persons with disabilities, 
governmental agencies, disability rights organizations, and 
representatives of the medical diagnostic equipment industry and the 
medical community. In all, 59 comments were received; twenty-four from 
individuals, thirteen from the medical diagnostic equipment industry 
and the medical community, nine from disability rights organizations, 
four from accessibility consultants, three from academics, two from 
state and federal organizations, and four duplicate submissions. The 
public comments are available at https://www.regulations.gov/docket?D=ATBCB-2012-0003.
    On March 13, 2012, the Access Board published a notice of intent to 
establish an advisory committee to advise the Board on matters 
addressed in the MDE NPRM and issues raised in the public comments. 
Notice of Intent to Establish Advisory Committee--Medical Diagnostic 
Equipment Accessibility Standards, 77 FR 14706 (March 13, 2012). On 
July 5, 2012, the Access Board established the Medical Diagnostic 
Equipment Accessibility Standards Advisory Committee (MDE Advisory 
Committee). Notice of Establishment; Appointment of Members--Medical 
Diagnostic Equipment Accessibility Standards Advisory Committee, 77 FR 
39656 (July 5, 2012). The MDE Advisory Committee was comprised of 
individuals from 24 organizations representing a range of stakeholders 
and ex officio members from the FDA, Department of Justice, and the

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Department of Veterans Affairs.\2\ The MDE Advisory Committee met from 
September 2012 through May 2013 and much of the work occurred within 
five subcommittees that addressed the major categories of MDE and the 
issues raised by commenters: Examination Tables and Chairs; Stretchers; 
Diagnostic Imaging Equipment; Mammography Equipment; and Weight Scales. 
In June 2013, the MDE Advisory Committee presented 54 recommendations 
to the Access Board. The committee members reached a consensus on all 
of their recommendations, except for the recommended lowest or minimum 
height for adjustable-height transfer surfaces. The MDE Advisory 
Committee made recommendations regarding transfer surface height, 
transfer surface size, transfer sides, transfer supports, armrests, 
stirrups, lift compatibility, wheelchair spaces, and standing supports. 
The final report of the Medical Diagnostic Equipment Accessibility 
Standards Advisory Committee (December 6, 2013), is available at 
https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report (hereinafter, MDE 
Advisory Committee Report).
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    \2\ The ADA National Network, Boston Center for Independent 
Living, Brewer Company, Conference of Radiation Control Program 
Directors, Inc., Duke University and Medical Center, Equal Rights 
Center, Evan Terry Associates, P.C., GE Healthcare, Harris Family 
Center for Disability and Health Policy at Western University of 
Health Sciences, Hausmann Industries, Inc., Hill-Rom Company, Inc., 
Hologic, Inc., Medical Positioning, Inc., Medical Technology 
Industries, Inc., Midmark Corporation, National Council on 
Independent Living, Paralyzed Veterans of America, Phillips 
Healthcare, Scale-Tronix, Inc., Siemens Medical Solutions USA, Inc., 
Stryker Medical, Sutter Health, United Spinal Association, and 
University of the Sciences in Philadelphia, Department of 
Occupational Therapy. 77 FR 39656.
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III. Summary of Comments

    In all 60 comments were received; the comments are available at: 
https://www.regulations.gov/docket?D=ATBCB-2012-0003. Overall the 
comments provided detailed responses to the questions posed in the 
preamble to the MDE NPRM. They provided many alternatives and 
recommended changes to the proposed requirements, which are discussed 
throughout this preamble. The disability rights organizations generally 
supported the proposed rule and recommended multiple ways to increase 
accessibility. The manufacturers provided a great deal of information 
on what types of accessible equipment is currently on the market, what 
the providers are requesting for accessible equipment, and the 
limitations of certain diagnostic equipment in meeting some of the 
requirements in the proposed standards. Most of these comments and 
recommendations are discussed below in the Significant Changes and the 
Section-by-Section Analysis. In addition, some commenters also raised 
concerns with the accessibility of diagnostic equipment to providers 
who have disabilities, weight and patient load, the need for training 
of staff on how to properly assist patients with disabilities, and 
requirements to ensure the room is accessible. While valid and 
important issues about accessibility, most of these concerns are 
outside the purview of the Access Board as they relate to issues 
unrelated to the equipment itself or the built environment, and 
therefore, have not been addressed by the MDE Standards.
    In the preamble to the MDE NPRM, the Access Board identified the 
following barriers to accessibility, as documented in the 
Rehabilitation Engineering Research Center on Accessible Medical 
Instrument National Survey,\3\ including equipment characteristics that 
affect patients ability to access and use medical equipment, such as: 
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, armrests, side rails), controls (e.g., 
ease of operation), and displays and devices (e.g., legibility and 
understandability). The Access Board sought public input on what other 
barriers affect the accessibility and usability of medical diagnostic 
equipment. NPRM, 77 FR at 6919, question 2. Nine commenters responded 
(two manufacturers, four accessibility consultants, three disability 
rights organizations, and an individual) and provided examples of 
additional barriers that they believe should be addressed in future 
updates of the MDE Standards. These recommendations included the 
accessibility of offices of healthcare providers, user positioning, 
communication, device operation, feature controls, compatibility of 
medical diagnostic equipment with assistive technology, weight 
capacity, and adding space to accommodate a patient's durable medical 
equipment. Additionally, the commenters noted that the proposed 
standards focused mostly on individuals with mobility disabilities and 
recommended providing standards to encompass individuals with autism, 
Alzheimer's, sensory disabilities, cognitive disabilities, and 
bariatric patients.
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    \3\ This survey was conducted in 2004 to collect information on 
the types of medical equipment that is most difficult for 
individuals with disabilities to access and use. The results of the 
focus group sessions are reported in Molly Follette Story, Erin 
Schwier, and June Issacson 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.
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    The technical criteria in the final rule addresses most of the 
barriers that were identified in the study as affecting the 
accessibility and usability of medical diagnostic equipment. However, 
at this time it is not possible for the MDE Standards to address every 
barrier. The Access Board is very interested in the additional barriers 
raised by public commenters and believes that further research is 
needed on some of the recommendations; such as equipment 
characteristics of stiffness, comfort, and color contrast of contact 
surfaces, and ensuring the accessibility of people with sensory and 
cognitive disabilities, and pediatric and bariatric patients. 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 MDE Standards.
    Additionally, commenters noted other areas of medical diagnostic 
equipment and issues of patient accessibility and recommended multiple 
changes or additions to the final rule. Specifically, commenters 
recommended adding weight capacity or patient load requirements, 
ensuring that the room is accessible, developing a manner to evaluate 
and measure the accessibility of equipment to give to patients, 
requiring staff training on how to use accessible equipment and how to 
provide assistance to people with disabilities, and requiring patient 
support surfaces. Based on the Access Board's review of these issues, 
many of the commenters concerns are outside the scope of this 
rulemaking but are issues that may be addressed by enforcing 
authorities when they provide scoping and application requirements in 
adopting the MDE Standards. Additionally, the Board may elect to 
address the accessibility of examination rooms and other spaces 
containing diagnostic equipment under its authority to develop 
guidelines for buildings and facilities subject to the ADA and ABA. The 
other issues of weight capacity and patient support surfaces will be 
added to the additional barriers list above, and considered for 
inclusion when the MDE Standards are updated.
    The Access Board received nine comments asserting that figures help 
the reader to better understand the technical

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criteria; these commenters recommended some minor changes to the 
advisory figures and strongly supported the usefulness of the figures. 
The Office of the Federal Register does not permit advisory materials 
to be published in the Code of Federal Regulations. Consequently, as 
the figures are advisory, only the version of the final rule posted on 
the Access Board's Web site will include advisory text and figures. The 
online version of the final rule, as well as other materials related to 
this rulemaking, can be found here https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking.

IV. Significant Changes to the MDE NPRM

    This section of the preamble addresses significant changes made 
from the MDE NPRM to the final rule in response to the comments 
received, recommendations from the MDE Advisory Committee, and other 
information that has come to the Access Board's attention during the 
rulemaking process. Individual provisions of the rule are discussed in 
detail under the Section-by-Section Analysis below.

A. Chapter 2: M201 Scoping

    In the final rule, Chapter 2 establishes that the enforcing 
authority will determine the number and types of diagnostic equipment 
to which the MDE Standards will apply. There was only one significant 
change to this section, which added a general exception for diagnostic 
equipment that is unable to meet one or more of the requirements in the 
final rule.
1. General Exception
    The MDE NPRM proposed several limited exceptions to certain 
provisions addressing the limitations of current technology and design. 
Through testimony at the public hearings, comments, and MDE Advisory 
Committee discussions, the manufacturers of imaging equipment 
consistently raised concerns about inherent barriers to compliance with 
the proposed MDE Standards due to the location of imaging and 
mechanical components necessary to achieve the diagnostic aims. Some 
specific examples include: Dual Energy X-Ray Absorptiometry (DXA) 
machines, with a mechanism that moves imaging components along a track 
beneath the patient surface precluding height adjustability for the 
transfer surface; prone biopsy tables that must be of a sufficient 
height to permit health care providers access beneath the patient 
surface to perform procedures, precluding the equipment from meeting 
the minimum transfer surface height; and mammography machines with low 
dose radiation detectors that are larger in size than conventional 
configurations and required to be in locations that partially obstruct 
clearances for knee and toe space beneath the breast platform. While 
the MDE NPRM proposed several specific technical exceptions in Chapter 
3, the exceptions did not address the manufacturers' overall concerns 
regarding imaging equipment. Section 510 of the Rehabilitation Act 
requires the MDE Standards to provide independent access ``to the 
maximum extent possible.'' The Access Board interprets this language as 
recognizing that, in some situations, current technology may preclude 
diagnostic equipment from meeting all of the technical requirements in 
the MDE Standards. Therefore, the Access Board has added a general 
exception to Chapter 2 allowing compliance to the maximum extent 
practicable for the rare circumstance where full compliance would alter 
diagnostically required structural or operational characteristics of 
the equipment, and would prevent the use of the equipment for its 
intended diagnostic purpose. Any equipment utilizing this exception is 
still required to meet all other applicable provisions of the MDE 
Standards. We anticipate that this exception will be employed on a very 
limited basis for a few specialized equipment types, primarily imaging 
equipment. This provision is not intended to exempt a piece of 
diagnostic equipment from the MDE Standards as a whole. Limitations 
resulting from existing equipment designs or manufacturing practices 
that could be altered to meet the requirements are not a basis for 
invoking this exception; only diagnostically required structural or 
operational characteristics that cannot be made to comply with the 
technical requirements without preventing the use of the equipment for 
its intended diagnostic purpose are covered by this provision.

B. M301 Diagnostic Equipment Used by Patients in a Supine, Prone, or 
Side-Lying Position and M302 Diagnostic Equipment Used by Patients in a 
Seated Position

    In the final rule M301 and M302 provide the technical requirements 
for diagnostic equipment used in the supine, prone, or side-lying 
position, and diagnostic equipment used by patients in the seated 
position. Sections M301 and M302, which ensure that patients can 
transfer from their mobility devices onto the diagnostic equipment, 
share many technical requirements. Therefore, the Significant Changes 
Section addresses the transfer surface and lift compatibility 
requirements for M301 and M302 together. New exceptions pertaining to 
weight scales and to the type of equipment that must comply with M301 
and the decision to remove the armrest requirements from M302, are also 
discussed below.
1. Transfer Surface
a. Transfer Surface Adjustability
    The MDE NPRM proposed that the same transfer surface height range 
of 17 inches minimum to 19 inches maximum be applied to both diagnostic 
equipment used in the supine, prone, or side-lying position and 
diagnostic equipment used in the seated position (proposed M301.2.1 and 
M302.2.1, respectively). The Board considered it likely that diagnostic 
equipment would be adjustable in height to serve practitioners' needs 
however, the transfer surface could be fixed within the proposed height 
range. The Access Board sought public comment in the MDE NPRM preamble 
on whether the final standards should require the height of the 
transfer surface to be adjustable from 17 inches minimum to 25 inches 
maximum. NPRM, 77 FR at 6922-6933, questions 13 and 14. The majority of 
commenters, including manufacturers and disability advocates, supported 
both an adjustability requirement and the proposed high transfer 
height, but disagreed on what should be the low transfer height.
    The MDE Advisory Committee recommended a high transfer height of at 
least 25 inches and recommended that the transfer surface be adjustable 
in small, virtually continuous increments. MDE Advisory Committee 
Report, 67-71, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. However, the MDE Advisory Committee did not achieve 
consensus on what should be the minimum low height. Id.
    After considering the public comments and the recommendations from 
the MDE Advisory Committee, the Access Board has decided to include in 
the final rule the following requirements for diagnostic equipment used 
in the supine, prone or side-lying position, and for diagnostic 
equipment used in the seated position: An adjustable transfer height 
range with a minimum high and low height; four intermediate transfer 
heights within the adjustable range; and a specific method to measure 
the transfer heights. These new

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requirements are incorporated into the transfer height provision for 
diagnostic equipment used in the supine, prone, or side-lying position, 
and for diagnostic equipment used in the seated position, in the final 
rule (M301.2.1 and M302.2.1, respectively). These provisions have been 
renamed ``Adjustability,'' and are discussed in detail below.
(1) Adjustability: Minimum High Transfer Height
    In the preamble to the MDE NPRM, the Access Board sought comment in 
question 14 on whether the final rule should require an adjustable 
height range of 17 inches to 25 inches; whether equipment currently met 
this proposed requirement and, if not, what would the cost be to 
achieve that range; and whether intermediate heights should also be 
required within the adjustable height range. NPRM, 77 FR at 6923. While 
20 commenters responded to question 14, only four commenters explicitly 
addressed the proposed minimum high height of 25 inches. Of these, two 
commenters (an accessibility consultant and a state agency concerned 
with accessibility) concurred with a minimum high height of 25 inches. 
One commenter, a manufacturer, recommended increasing the minimum high 
height to 28 inches for all diagnostic equipment except magnetic 
resonance imaging (MRI) equipment, which has limitations that may 
prevent it from reaching 28 inches. Another manufacturer gave examples 
of the height ranges of its beds and stretchers, each of which met the 
25-inch minimum high height.
    After reviewing the comments and other evidence before it, the MDE 
Advisory Committee recommended a high transfer height requirement of 25 
inches noting that:

[t]he anthropometric data referenced . . . in the Wheeled Mobility 
Anthropometry Project shows seat heights for people who use mobility 
devices are above 19 inches. For manual wheelchair user's seats 
measured up to 23.9 inches; for power wheelchair users up to 28.9 
inches; and for scooter users to 25.3 inches. Seat heights for males 
were typically higher than for females. 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. Therefore, 
transfer surfaces that are adjustable to a 25-inch maximum during 
patient transfer accommodate most patients who use mobility devices. 
Since one key factor in ease of transfer is locating the transfer 
surface near or at the same height as the seat of the wheeled 
mobility device, moving the minimum high point for adjustability of 
transfer surfaces, improves access for many. This particularly 
benefits persons using powered mobility devices and scooters with 
higher seat heights.

MDE Advisory Committee Report, 69, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.
    The Access Board was persuaded by the arguments of commenters and 
the MDE Advisory Committee in favor of requiring a minimum high 
transfer surface height of 25 inches. A 25-inch minimum high height 
will ensure that the transfer surface can be raised up to the height of 
the vast majority of wheelchair seat heights, which are 25 inches high 
or lower. The final rule requires a minimum high transfer surface 
height of 25 inches for both diagnostic equipment used in the supine, 
prone or side-lying position (M301.2.1), as well as diagnostic 
equipment used in the seated position (M302.2.1). Nothing in the rule 
prohibits a manufacturer from providing a high transfer height above 25 
inches as long as transfer is provided within the range specified up to 
25 inches.
(2) Adjustability: Minimum Low Transfer Height
    The Access Board received many comments from disability rights 
organizations, individuals, accessibility consultants, and a health 
care provider supporting the need for lower height adjustable tables. 
Specifically, these commenters explained the need for adjustable height 
tables to facilitate and promote independent or semi-independent 
transfer. These commenters explained the delay in diagnosis and 
treatment when patients are unable to transfer from their wheeled 
mobility device to the examination surface and are inadequately 
examined while remaining in their wheelchair. These commenters also 
explained that adjustable tables would enhance both the safety of 
patients, by reducing the risk of falls and injury incurred from 
assisted transfer, as well as reducing injury to medical staff and 
caregivers by lessening the likelihood of back and other lifting 
injuries. One individual commenter recalled being bruised when she was 
dragged onto medical equipment that was too high, while another 
commenter noted that the risk to healthcare workers increases when 
access to medical diagnostic equipment is not optimized.
    In addressing what the low transfer height should be, 12 commenters 
responded to question 14 specifically addressing the proposed minimum 
low transfer surface height. Six commenters (an individual, a state 
agency concerned with accessibility, two accessibility consultants and 
two disability rights advocates, one whose comment was supported by 50 
disability rights organizations) supported requiring a low transfer 
height of 17 inches. These commenters asserted that the lower height 
would provide more accessibility, safety for both patients and 
healthcare providers, and allow more patients to transfer independently 
or semi-independently. One commenter, a medical association, supported 
allowing a minimum low height range of 17 to 19 inches recommending as 
much latitude for manufacturers as possible. The remaining six 
commenters (manufacturers and a medical association) voiced strong 
concerns about the cost of complying with a minimum low height of 17 
inches, the potential consequences of being unable to raise the 
equipment up to a height comfortable for practitioners, and whether 
current technology and designs would allow diagnostic equipment to 
reach such a low height. Additionally, some of the manufacturers and 
medical associations voicing support for a minimum low height of 19 
inches, indicated that either their equipment currently meets or would 
be capable of meeting a 19-inch low height requirement.
    Like the public commenters, the MDE Advisory Committee was divided 
on this issue and was unable to reach consensus regarding a minimum low 
transfer surface height. MDE Advisory Committee Report, 70, available 
at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. Individual 
Committee members' recommendations for a low transfer surface height 
requirement were split across three options: 17 inches, 18 inches 
(viewed as compromise to some and a preferred minimum height by 
others), and 19 inches. Id. at 139-143. The Committee devoted 
considerable time to examining available evidence, consulting experts, 
and discussing the merits of the three height options. Id. 
Additionally, the Examination Tables and Chairs Subcommittee held six 
meetings, discussed this issue in-depth, and developed a Subcommittee 
recommendation for the MDE Advisory Committee of 19 inches as the 
minimum transfer surface height standard, with 17 inches as the ``best 
practice.'' Id. The MDE Advisory Committee members heard presentations 
from several clinicians and manufacturers on the topic of minimum 
transfer surface

[[Page 2815]]

height.\4\ Advisory Committee members also considered a presentation 
from Edward Steinfeld, ArchD on the findings from the Anthropometry of 
Wheeled Mobility Project, which was conducted at the Center for 
Inclusive Design and Environmental Access (IDeA) at the State 
University of New York at Buffalo.\5\ Id.
---------------------------------------------------------------------------

    \4\ Clinician presenters included Barbara Ridley, RN, FNP, Cathy 
Ellis, PT, Medical Diagnostic Equipment; Michael Yochelson, MD, 
Medical Diagnostic Equipment; Lauren Snowden, PT, DPT, Practitioner 
Perspective on Transfers to Examination Services; Nuket Curran, PT, 
Diagnostic Equipment & Patient Accessibility: Closing the ``Gap''; 
Douglas Coldwell, MD, Medical Imaging; Theresa Branham, RT, ARRT, 
Technologist Perspective to Patient Access. MDE Advisory Committee 
Report, 141-142, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. Manufacturer presenters included Willa 
Crolius, Institute of Human Centered Design, No Formal Presentation, 
presented videos showing transfer; Michelle Lustrino, Mechanical 
Engineer, Hologic, Inc., Mammography Industry: Accessibility 
Standards; Glen Nygard, Senior Principal Engineer, Hologic, Inc., 
Dual-Energy X-ray Absorptiometry (DXA) for Osteoporosis Assessment; 
Elisabeth George, Vice President of Global Regulations & Standards 
Chair of Technical and Regulatory Affairs Committee, Phillips 
Healthcare, Medical Imaging; John Jaeckle, Chief Regulatory Affairs 
Strategist Chair of CT-Xray Committee, GE Healthcare, MITA, & John 
Metellus, Product Marketing Manager, Siemens Healthcare, Equipment 
with Bores and X-ray Devices Accessibility; Bob Menke & John Wells, 
Midmark Corporation, Examination Table Accessibility Standards; Jeff 
Baker, Brad Baker, & Darren Walters, Medical Technology Industries, 
Inc., Performance and Efficacy Considerations for Examination 
Chairs. Id.
    \5\ The Access Board and the National Institute on Disability 
and Rehabilitation Research sponsored the 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.
---------------------------------------------------------------------------

    After careful consideration of the available information, the MDE 
Advisory Committee was unable to agree upon a recommendation for a 
transfer surface height, and Committee members were invited to submit 
minority reports supporting their view of the issue.\6\ The MDE 
Advisory Committee Report states that ``[a] full reading of these 
Minority Reports is critical to understanding the range of views 
guiding the various stakeholder organizations that served on the MDE 
Advisory Committee about the recommendation for the minimum transfer 
height.'' Id. at 143. (The minority reports are available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports).
---------------------------------------------------------------------------

    \6\ The Committee Members who submitted minority reports 
includes: Boston Center for Independent Living; The ADA National 
Network; Brewer Company; Duke University and Medical Center; Equal 
Rights Center; Harris Family Center for Disability and Health Policy 
at Western University of Health Sciences; Hausmann Industries, Inc.; 
Hologic, Inc.; Medical Technology Industries, Inc.; Midmark 
Corporation; National Council on Independent Living; Paralyzed 
Veterans of America; Phillips Healthcare; Siemens Medical Solutions 
USA, Inc.; United Spinal Association; University of the Sciences in 
Philadelphia. The Minority Reports are available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports.
---------------------------------------------------------------------------

    The minority reports submitted by the disability advocates and 
academics supported a minimum low height of 17 inches. See Minority 
Reports from Boston Center for Independent Living Inc., National 
Network for ADA Centers, and Medical Diagnostic Equipment Advisory 
Committee,\7\ available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports. These minority reports explained 
the importance of accessible care and of ensuring as many independent 
transfers as possible. Id. The reports noted that both patients and 
providers risk injuring themselves during assisted transfer. Id. In 
their reports, disability advocates and academics asserted that a 17-
inch low height provides the greatest number of individuals the 
opportunity to transfer independently. Id. Additionally, the reports 
pointed to current accessibility standards for toilet seats, shower 
seats, and tub seats, which require a height of 17 inches minimum and 
19 inches maximum. Id. These reports argued that if the MDE Standards 
moved away from this range, then the Access Board must adopt the lowest 
end of the range, 17 inches, to provide the most accessibility. Id. 
Additionally, the National Council on Independent Living asserted that:
---------------------------------------------------------------------------

    \7\ Endorsed by Harris Family Center for Disability and Health 
Policy at Western University of Health Sciences, The ADA National 
Network, Equal Rights Center, National Council on Independent 
Living, Paralyzed Veterans of America, United Spinal Association, 
Duke University and Health System, and University of the Sciences in 
Philadelphia, Department of Occupational Therapy.

    Most manufacturers on the Committee had a 19 to 21-inch surface 
available currently, with at least one having a product at 18. Their 
argument has always been that providing the lowest transfer heights 
would be an extraordinary expense and burden on the business 
community (their consumer), not based on how it benefitted a patient 
with a disability. This effort was never supposed to be about the 
manufacturers or the doctors. It is the charge of this committee to 
answer questions and come up with recommendations for accessibility, 
based by some members on engineering and others by experience. 
NCIL's 30-plus years of experience as advocates for people with 
disabilities dictates that we continue to strongly insist that the 
U.S. Access Board maintain the low accessible height at 17 inches 
above the floor in order for medical and diagnostic equipment to be 
---------------------------------------------------------------------------
accessed by the greatest number of people.

Minority Report from National Council on Independent Living (Sept. 27, 
2013), available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports.
    The minority reports submitted by manufacturers supported a minimum 
low height of 19 inches. See Minority Reports from Hologic, Inc., 
Midmark Corporation, MITA Advisory Committee Members,\8\ and 
Recommendation of 19-inch Lower Adjustable Height as the Minimum 
Accessibility Standard (Joint Report),\9\ available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports. 
Similar to the minority reports supporting a minimum low height of 17 
inches, these minority reports relied on the existing accessibility 
standards, such as those for shower seats, tub seats, amusement park 
rides, toilets, and benches. However, unlike the minority reports from 
members supporting a minimum 17-inch low height, these reports asserted 
that because 19 inches is a permissible transfer height under existing 
accessibility standards, it is similarly acceptable for medical 
diagnostic equipment. The manufacturers also noted that currently there 
are not any accessible diagnostic tables on the market that meet a 17-
inch low height requirement. The Brewer Company, LLC stated that:

    \8\ Joint Report prepared by medical diagnostic imaging 
equipment industry members of the MDE Advisory committee, including 
GE Healthcare, Phillips Healthcare, Siemens Healthcare, and Hologic, 
Inc.

    \9\ Submitted by The Brewer Company, Hausmann Industries, 
Medical Technology Industries, Inc., and Midmark Corporation.
---------------------------------------------------------------------------

    Brewer has been manufacturing adjustable height examination 
tables since 2002. These tables were designed specifically for 
wheelchair accessibility by meeting the 19-inch height referenced in 
the ADA/ABA Accessibility Guidelines. Brewer is ISO 13485 certified. 
ISO requires a robust method for recording customer, end user, and 
clinician feedback. In the 11 years we have been selling adjustable 
height examination tables we do not have a single complaint on 
record regarding the accessibility of our 19'' low height tables. 
There have been no

[[Page 2816]]

requests for a lower table. In addition, market growth of the 
adjustable height tables with 19 inch low heights provides further 
evidence that these tables are meeting the accessibility needs of 
---------------------------------------------------------------------------
patients requiring independent wheelchair transfer.

Minority Report from The Brewer Company, LLC (Oct. 1, 2013), available 
at https://www.access-board/guidelines-and-standardshealth-/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports. 
The exam table manufacturers asserted that they would incur costs to 
comply with a 17-inch low height, but would not incur costs to comply 
with a 19-inch low height requirement. See Recommendation of 19-inch 
Lower Adjustable Height as the Minimum Accessibility Standard (Joint 
Report) (Sept. 27, 2013), available at https://www.access-board/guidelines-and-standardshealth-/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports (characterizing a 
table with a 19-inch transfer height as a ``baseline 0%'' cost increase 
for ``accessible equipment as currently available on the market'').
    In their joint minority report, examination table manufacturers 
asserted, ``Based on our analysis, we determined that transfer surface 
height requirements lower than 19 inches would increase the cost of 
designing and manufacturing examination tables, reduce the rate of 
adoption of accessible equipment, and increase the health provider's 
cost of purchasing accessible equipment.'' Id.
    With respect to the cost of compliance for the tables on imaging 
equipment, some manufacturers noted the inherent difficulty of 
redesign, the potential cascading impacts of adopting a low height of 
17 inches, and the difficulty in that imaging equipment undergoes many 
years of work before they become commercially available. See Minority 
Report of GE Healthcare, Phillips Healthcare, Siemens Healthcare, and 
Hologic, Inc., available at https://www.access-board/guidelines-and-standardshealth-/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports. Specifically, the imaging equipment 
manufacturers asserted that:

given the integrated nature of the table to the system and its 
imaging performance, that a change of even a few inches in minimum 
transfer surface low height constitutes a significant engineering 
change to the device. Any such change must ensure there are no 
adverse effects to image quality, system performance, and patient 
safety. Complete scanner re-testing and re-certification under our 
formal FDA quality system and design controls are needed to verify 
overall system performance and safety.
    Moreover, the most significant of these design changes can 
result in cascading alterations to the scanner, potentially leading 
to unacceptable heating in the case of MR, impacts on image signal/
quality, and changes in dose levels to ensure the same, effective, 
high quality images and increased examination times, that is, 
additional workflow steps.

Id.

    After carefully considering the totality of comments received and 
the MDE Advisory Committee materials, the Access Board has concluded 
that there is insufficient information to designate a single minimum 
low height requirement at this time. Specifically, there is 
insufficient data on the extent to which and how many individuals would 
benefit from a transfer height lower than 19 inches. Due to this lack 
of sufficient information, coupled with the lack of consensus among the 
MDE Advisory Committee and the commenters, the Access Board has decided 
to establish, for five years only, a range for the minimum low height 
requirement of 17 inches to 19 inches. During the five-year period 
following issuance of the final rule, any low transfer height between 
17 and 19 inches will meet the MDE Standards. The Access Board 
acknowledges that this is a temporary solution, and has commissioned a 
study to quantify the portion of the population that would benefit from 
a low transfer height below 19 inches. A pilot study was completed 
prior to the publication of this final rule. A sunset provision has 
been included in the final rule that will repeal this low height range 
five years after the date of publication in the Federal Register, 
leaving only the requirements for the high transfer height and the 
additional transfer positions below the high transfer height. The 
Access Board intends to amend this portion of the final rule with a 
subsequent rulemaking to establish a minimum low transfer surface 
height once the study has been completed and before the sunset 
provision takes effect.
(3) Adjustability: Transfer Surface Intermediate Heights
    In the MDE NPRM there was no requirement for the transfer surface 
to have intermediate transfer heights. Under the proposed rule, 
diagnostic equipment would be in compliance if it provided a low 
transfer height anywhere within the range of 17 inches minimum and 19 
inches maximum. In addition to the matter of low transfer height, the 
Access Board sought public comment in question 14(c) on whether the 
final rule should require intermediate heights between a minimum low 
transfer height and a minimum high transfer height. NPRM, 77 FR at 
6923. Three commenters responded (two accessibility consultants and a 
disability rights advocate) and supported the idea of requiring 
intermediate heights within a minimum low height and minimum high 
height of the transfer surface. One commenter, an accessibility 
consultant, recommended intervals of \1/2\ to 1 inch, indicating that 
\1/2\ inch increments would be more practical to match the varying 
heights of wheelchairs and mobility devices, which is critical for many 
patients in performing independent transfers. The MDE Advisory 
Committee recommended adjustable height in small, virtually continuous 
increments. To support this recommendation, the MDE Advisory Committee 
explained:

that adjustability greatly increases the overall accessibility of 
equipment for all persons. Adjustable height MDE, such as exam 
tables, imaging tables and chairs, will make it possible to position 
the transfer surface near the height of the seat of the mobility 
device. For some, independent transfers are only possible when there 
is minimal or no change in vertical height between the seat of the 
mobility device and the transfer surface. People may prefer or, in 
some cases, require, transfer to a slightly lower surface moving the 
transfer surface lower than the seat of the mobility device; then 
adjusting the transfer surface to above the seat for the return 
transfer. MDE Advisory Committee Report, 68, available at https://www.access-board/guidelines-and-standardshealth-/about-this-rulemaking/advisory-committee-final-report.

    The Access Board has decided to require that the height of the 
transfer surface be adjustable within the range for the minimum low and 
high heights in at least four unspecified intermediate heights, but has 
determined that the intermediate heights should be set a minimum of one 
inch apart. While the Access Board agrees that continuous adjustment is 
preferable, requiring such adjustability could preclude the use of 
certain types of lifting devices such as hydraulic systems that work in 
increments. The intent is to permit manufacturers flexibility in 
setting intermediate heights and not prohibitively restrict designs to 
those of particular manufacturers or equipment.
(4) Adjustability: Method of Measurement
    The MDE NPRM proposed that the measurement of the height of the 
transfer surface for both diagnostic equipment used in the supine, 
prone, or side-lying position and diagnostic equipment used in the 
seated position, be taken from the floor to the top of the transfer 
surface (proposed M301.2.1 and M302.2.1, respectively). The Access

[[Page 2817]]

Board sought comment in question 13 in the MDE NPRM preamble, on 
whether the measurement should be taken with the upholstery in static 
(uncompressed) conditions, or with a certain amount of deflection. 
NPRM, 77 FR at 6922. The Access Board received eleven comments in 
response, most of which agreed with measuring the transfer surface in a 
static condition. A few commenters disagreed: One manufacturer 
recommended measuring in static conditions, but allowing a \3/4\ inch 
bolster in no more than 25 percent of the short side of the transfer 
surface to be permitted to be outside the height requirement; two 
commenters (medical association and manufacturer) asserted that the 
method of measurement should be dependent on the type of diagnostic 
equipment and left up to the manufacturers; and two commenters (state 
agency concerned with accessibility and accessibility consultant) 
recommended that the transfer surface meet the criteria in both dynamic 
and static conditions. The MDE Advisory Committee concurred with those 
comments recommending that the measurement be made with the upholstery 
in a static condition to ensure a consistent point of measurement. The 
MDE Advisory Committee explained that ``[s]ince many transfer surfaces 
are not perfectly flat, measuring to the highest point in an 
uncompressed state provides this consistent point of measurement.'' MDE 
Advisory Committee Report, 71, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Access Board agrees with the 
Advisory Committee's rationale and the final rule requires that the 
height be measured from the floor to the top of the uncompressed 
transfer surface. This method will ensure consistent measurement across 
all diagnostic equipment. Taking the measurement at the highest point 
on the transfer surface allows for small bolsters or contours and does 
not significantly increase the overall height of the transfer for 
people with disabilities.
b. Transfer Surface Location
    The MDE NPRM proposed the same location and transfer sides of the 
transfer surface for diagnostic equipment used by patients in the 
supine, prone, or side-lying position (M301) and diagnostic equipment 
used by patients in the seated position (M302). This transfer surface 
was located at the end of the diagnostic equipment and provided options 
to transfer from a mobility device onto one short side and one long 
side of the transfer surface. (proposed M301.2.3 and M302.2.3, 
respectively). Numerous commenters objected on the basis that this type 
of transfer is not always possible for certain types of medical 
diagnostic equipment; the MDE Advisory Committee agreed with commenter 
concerns. The Access Board is persuaded by many of the concerns raised 
by commenters and the MDE Advisory Committee. In the final rule the 
structure and content of the transfer surface provision has been 
revised for diagnostic equipment used by patients in the supine, prone, 
or side-lying positions to provide two types of transfer surfaces; end 
transfer surfaces and side transfer surfaces. For diagnostic equipment 
used by patients in the seated position, the Access Board has decided 
to retain the proposed rule requirements for transfer surface location 
and transfer sides, but has added an exception to the transfer sides 
provision in the final rule to address the concerns raised by 
commenters and the MDE Advisory Committee.
(1) Transfer Surface Location for Diagnostic Equipment Used in the 
Supine, Prone, or Side-Lying Position
    Multiple commenters expressed concerns that transfer cannot always 
occur at the end of the diagnostic equipment as contemplated by the 
requirements in the proposed rule. One commenter elaborated that 
stretchers and hospital beds are always entered from one or the other 
long side of the bed, not the foot end, due to obstructions at the head 
and foot ends that cannot be removed. Another commenter recommended 
allowing transfer space at both the center and the end of the transfer 
surface.
    Evidence presented to the MDE Advisory Committee during its 
deliberations revealed that it is not always possible to transfer from 
adjoining sides at the end of the diagnostic equipment in the prone, 
supine, or side-lying position on certain types of equipment such as 
stretchers and imaging equipment with scanning beds. MDE Advisory 
Committee Report, 75-82, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. This is because many models of this equipment 
can be obstructed on the head or foot ends by necessary components such 
as emergency extraction handles, the gantry design, or integral patient 
positioning features. Id. For equipment with long patient examination 
surfaces such as stretchers and the scanning beds of many types of 
imaging machines, the foot end is not intended as a transfer point; 
patients transfer onto the surface on either of the long sides, 
approaching the equipment more towards the center. Id. Additionally, a 
transfer approach at the foot location may not be practical for many 
people with disabilities who would have to move themselves or be moved 
across a significant length of the surface to place their bodies into a 
position for effective imaging. Id. The MDE Advisory Committee 
recommended permitting an alternative transfer surface which was 
rotated in its orientation such that the width paralleled the 
examination surface's length and its depth spanned the examination 
surface's width, and was located near the center point of the 
diagnostic equipment surface. Id.
    Based on the comments received and the MDE Advisory Committee 
recommendations, the Access Board has concluded that for diagnostic 
equipment used by patients in supine, prone, or side-lying positions 
two transfer surface orientations are possible depending on the 
intended location from which the transfer is to be made. These 
orientations are now identified as an end transfer surface and side 
transfer surface. This necessitated adding the definition of ``end 
transfer surface'' and ``side transfer surface'' to the defined terms 
(M102.1) in the final rule and resulted in the removal of the proposed 
M301.2.3 Transfer Sides, as that is now described within the two types 
of transfer surfaces provided. The end transfer surface accommodates 
the transfer method conceived of in the proposed rule; where the 
transfer occurs at one end of the examination surface and allows the 
patient the option to transfer at the end and on one adjoining side of 
the examination surface. The side transfer surface responds to the 
concerns raised by commenters and the MDE Advisory Committee to 
accommodate diagnostic equipment where transfer occurs within the 
length of the examination surface and allows patient transfer at the 
sides of the examination surface. Side transfer surfaces most typically 
will be imaging equipment, stretchers, hospital beds, and other 
equipment where the end is obstructed and cannot be used for transfer. 
Accordingly, the Access Board has reorganized the requirements 
regarding the transfer surface for M301 into two types based on where 
the transfer is to occur: ``End Transfer'' or ``Side Transfer.'' This 
revision to provide options for two types of transfer surfaces 
necessitated adding additional technical criteria addressing transfer 
surface size (M301.2.3) and transfer supports (M305.2), as well as 
adding the

[[Page 2818]]

definition of ``end transfer surface'' and ``side transfer surface'' to 
the defined terms (M102.1) in the final rule. These new requirements 
are addressed below in the applicable section in the Section-by-Section 
Analysis.
(2) Transfer Surface Location for Diagnostic Equipment Used in the 
Seated Position
    Commenters also raised concerns with the provisions in the MDE NPRM 
related to transferring to medical diagnostic equipment used by 
patients in the seated position. Commenters stated that there is 
certain diagnostic equipment used by patients in the seated position 
where transfer at the end of the seat by two adjoining sides is not 
feasible. Specifically, commenters raised concerns about diagnostic 
equipment with fixed footrests, such as podiatry and dentistry chairs. 
Transfer onto these types of diagnostic equipment must be made from 
either long side, similar to the side transfer surface described above. 
One commenter explained that fixed footrest chairs are meant to treat 
patients with their legs extended parallel to the ground. If entered as 
suggested in the proposed rule the patient would have to enter the 
chair by positioning themselves onto this fixed footrest section that 
is at a downward angle and would require the patient to slide up an 
inclined surface to be properly positioned on the diagnostic equipment.
    The MDE Advisory Committee agreed with a majority of the commenters 
that some examination chairs which have fixed footrests prevent 
transfer as conceived of in the proposed rule. The Committee noted 
that:

the footrests obstruct access to the foot end of the chair. Examples 
of chairs that fit this category are most dental chairs and podiatry 
chairs. The current design allows only one long side for transfer, 
which limits some patient transfers where a patient can use only one 
side of the body due to paralysis on one side or other such 
conditions. To address this issue, the recommendation requires 
chairs with footrest obstructions to allow patient transfers from 
both [long] sides of the chair. The solution creates the option for 
either a left or right transfer. MDE Advisory Committee Report, 83, 
available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

    The Access Board agrees that diagnostic equipment used by patients 
in the seated position with fixed footrests requires a different 
transfer approach than those without fixed footrests. Therefore, the 
Access Board has added an exception to the transfer sides provision 
(M302.2.4) in the final rule to permit diagnostic equipment with fixed 
footrests to provide options to transfer from opposing sides of the 
transfer surface.
    The American Dental Association proposed a complete exemption of 
dental chairs from the MDE Standards, asserting that the Access Board 
has not provided any evidence that dental offices are inaccessible, 
citing to the national survey in MDE NPRM ``that collected information 
on the types of medical equipment that are most difficult for 
individuals with disabilities to access and use. The American Dental 
Association urge[d] the Access Board to refrain from proposing costly 
new requirements based on examination chairs that are only `moderately 
difficult' for disabled patients to use.'' The American Dental 
Association explains that ``dental chairs already have many 
accessibility features built in and manufacturers as well as health 
care providers have an economic incentive to produce and procure 
accessible medical diagnostic equipment and therefore, the American 
Dental Association does not believe that additional regulations are 
necessary, particularly with respect to dental examination chairs.'' 
Comment of American Dental Association, Notice of Proposed Rulemaking 
for Medical Diagnostic Equipment, (Apr. 4, 2012), available at https://www.regulations.gov/document?D=ATBCB-2012-0003-0037.
    The Access Board does not concur with the comment urging that 
dental chairs should receive a blanket exemption. The record is replete 
with evidence that individuals with disabilities do encounter barriers 
to dental care as a result of inaccessible dental chairs. For example, 
one commenter, a disability rights organization representing 37,000 
members, explained that it asked its members ``and others with 
disabilities about the barriers they encounter when seeking medical 
care and treatment. The most frequent responses involved access to 
examination chairs, dentist chairs, scales and mammography and 
colonoscopy equipment.'' Comment of United Spinal Association, Notice 
of Proposed Rulemaking for Medical Diagnostic Equipment, (June 4, 
2012), available at https://www.regulations.gov/document?D=ATBCB-2012-0003-0029. Additionally, at the public hearing on May 8, 2012, a 
commenter raised concerns about the ability to obtain dental care when 
unable to transfer onto the dental chair. The public hearing transcript 
is available at https://www.regulations.gov/docket?D=ATBCB-2012-0003. 
Accordingly, the Access Board has concluded that dental chairs are 
appropriately covered by this rule.
c. Transfer Surface Size for Diagnostic Equipment Used by Patients in 
the Supine, Prone, or Side-Lying Position
    The MDE NPRM proposed a transfer surface size for diagnostic 
equipment used in the supine, prone, or side-lying position of 30 
inches wide and 15 inches deep minimum (proposed M301.2.2). These 
dimensions were based on the dimensions specified in the 2004 ADA and 
ABA Accessibility Guidelines for rectangular seats in roll-in showers 
(36 CFR part 1191, App. D 610.3.1) and the ANSI/AAMI HE 75 which 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. ANSI/AAMI HE 75, section 16.4.7, 
available at https://www.aami.org/he75. The Access Board sought input in 
question 15 in the MDE NPRM preamble on whether this size transfer 
surface was sufficient to effectuate transfer. NPRM, 77 FR at 6923-
6924. Of the 12 commenters who responded, only two supported the 
transfer surface size in the proposed rule. Four of the remaining 
commenters (manufacturers) felt that the transfer surface width should 
be decreased, while five (disability rights organizations, a medical 
association, and an individual) believed a larger surface was needed. 
The last commenter, recommended one size transfer surface for both 
seated and supine, prone, or side-lying diagnostic equipment. Commenter 
recommendations for transfer surface width ranged from 24 inches to 36 
inches, while no commenters addressed the proposed depth of 15 inches. 
Those advocating for a larger width were concerned about the ability of 
the patient to reposition after transfer and about accommodating obese 
patients. Those commenters supporting a smaller transfer surface raised 
concerns about the ability to transfer with a large surface preventing 
the patient from reaching transfer supports on the opposite side of the 
transfer surface, while still seated in the wheeled mobility device. 
The commenters were also concerned that making existing tables comply 
would require entire base redesigns as product stability would have to 
be re-evaluated with a wider table. Commenters also raised concerns 
that a larger transfer surface would conflict with bore size 
limitations on imaging equipment and that it could limit the health 
care provider's access to the patient for proper exam. Finally, two 
commenters, in response to question

[[Page 2819]]

15(e), agreed that an adjustable feature such as an extendable 
platform, should be permitted to meet the transfer surface dimensions 
so long as it does not move when a load is applied and it is a 
permanent part of the device.
    The MDE Advisory Committee discussions mirrored the comments to the 
MDE NPRM with recommendations ranging from 24 inches to 36 inches for 
the width of the transfer surface. The MDE Advisory Committee reviewed 
evidence about transfer surface size to include: Numerous video clips 
showing various transfers (both assisted and unassisted); industry 
exhibited tables to show current table and chair widths; and the 
findings of the Wheeled Mobility Anthropometry Project presented by Dr. 
Edward Steinfeld of the IDeA Center at the University of Buffalo. MDE 
Advisory Committee Report, 72-76, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Wheeled Mobility Anthropometry 
Project provided an analysis of transfer surface dimensions based on 
data collected from the study. The study is available at https://www.udeworld.com/anthropometrics.html. The data indicated that the 
minimum width of a table transfer surface could be as narrow as 28 
inches and still accommodate 95 percent of the users sampled. Id. Some 
members of the MDE Advisory Committee noted that there was little gain 
in usability by increasing the transfer surface width from 28 inches to 
30 inches, and that the significant gain in usability came from 
increasing the surface to 36 inches to accommodate very large or obese 
patients. MDE Advisory Committee Report, 72-76, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. While the committee members 
expressed concern about the need to provide accessibility criteria for 
obese patients, it decided that there is insufficient data to determine 
specific criteria at this time and recommended accessibility for 
bariatric patients be addressed in a subsequent rulemaking. Id. The 
Access Board concurs with the MDE Advisory Committee that while there 
is a need to address the accessibility needs of obese patients, more 
research is necessary before requirements can be developed. The MDE 
Advisory Committee also noted that if the surface is too wide it can 
become challenging for smaller sized persons to effectuate transfer, 
and thus by making all accessible equipment 36 inches wide, some 
patients would be unable to reach across the table to grasp the 
transfer support on the other side to utilize the support in the 
transfer process. Id. The MDE Advisory Committee recommended decreasing 
the required transfer surface width to 28 inches minimum for all 
diagnostic equipment used by patients in a supine, prone, or side-lying 
position. Id. at 73.
    The MDE Advisory Committee made multiple recommendations for the 
transfer surface depth of diagnostic equipment used by patients in the 
supine, prone, or side-lying position. Id. at 74-76. The MDE Advisory 
Committee differentiated between equipment whose transfer surface was 
located on the end of the equipment with transfer sides on one short 
side and one long side of adjoining sides and stretchers and imaging 
equipment, which the MDE Advisory Committee noted transfer takes place 
in the center on either of the long sides. Id. For all diagnostic 
equipment used by patients in a supine, prone, or side-lying position, 
except imaging equipment, the MDE Advisory Committee recommended 
increasing the transfer surface depth to 17 inches, explaining that 
existing equipment already encompasses this dimension. Id. The MDE 
Advisory Committee included stretchers in this requirement, even though 
they have a transfer orientation akin to imaging equipment. Id. For 
imaging equipment, the MDE Advisory Committee recommended a transfer 
surface size of 28 inches long minimum by 28 inches deep minimum. The 
MDE Advisory Committee also recommended the addition of an exception 
for imaging equipment transfer surface size; to allow a decrease in 
depth to no less than 21 inches where it is technically infeasible to 
reach the 28 inches minimum. Id. at 75-76. The Committee explained that 
``all x-ray tables meet the 28-inch table [depth] . . . because of 
physical design constraints such as bore size, not all tables used with 
equipment with bores meet the 28-inch-[deep] criteria, but all meet the 
21-inch minimum.'' Id.
    As discussed above in Section IV.B.1.b (Significant Changes--
Transfer Surface Location) the restructure of the transfer surface to 
include two types of transfer surfaces; end transfer surface and side 
transfer surface, necessitates new technical requirements for the new 
side transfer surface. Accordingly, based on the comments received and 
the recommendations from the MDE Advisory Committee, the final rule 
establishes different sizes for each of the end and side transfer 
surfaces. The final rule requires that diagnostic equipment with an end 
transfer surface be a minimum size of 28 inches wide and 17 inches 
long. The Access Board has decreased the minimum width of the transfer 
surface from 30 inches to 28 inches based on the evidence presented to 
the advisory committee that 28 inches is sufficient to accommodate 95 
percent of the users and will ensure that patients are able to utilize 
the transfer supports on the opposite side of the transfer surface. The 
Access Board has increased the length of the end transfer surface from 
15 inches to 17 inches based on the evidence that diagnostic equipment 
currently on the market is already built to this dimension. In the 
final rule, the Access Board does not see a reason to prohibit an 
adjustable feature, such as a table with extendable sides, from meeting 
the size requirements of the transfer surface but believes it is 
unlikely that any diagnostic equipment would contain such a feature.
    For diagnostic equipment with side transfer surfaces, the Access 
Board has decided to require a transfer surface size of 28 inches wide 
by 28 inches long, minimum. While the MDE Advisory Committee 
recommended only increasing the transfer surface size for imaging 
equipment to 28 inches deep by 28 inches wide minimum, the Access Board 
has concluded that diagnostic equipment used by patients in the supine, 
prone, or side-lying position with side transfer surfaces involve the 
same transfer dynamics whether they are imaging equipment, hospital 
beds, or stretchers and therefore should be subject to the same 
transfer surface size requirement.
    Additionally, the Access Board concurs with the MDE Advisory 
Committee recommendation to provide an exception for the transfer 
surface size of imaging equipment in the final rule given the physical 
limitations affecting surface depth for imaging equipment with bores 
and the fact that it is unclear when technological advances in bore 
size may permit larger patient examination surfaces. However, the 
Access Board has narrowed the application of this exception only to 
imaging equipment with bores. The Access Board has determined that this 
exception, as recommended, was intended to account for the space 
constraints of imaging equipment with bores and wants to ensure the 
exception stays as narrow as possible. Therefore, in the final rule, 
the Access Board has provided an exception which permits the imaging 
bed of imaging equipment with bores' to be a minimum of 21 inches wide 
but requires the transfer surface to be the full width of the 
examination surface. As this exception applies regardless of whether 
the

[[Page 2820]]

imaging equipment has an end transfer surface or a side transfer 
surface, an exception has been added to each requirement (M301.2.3.1 
and M301.2.3.2, respectively). Additionally, the Board has added two 
definitions to the final rule, ``imaging equipment with bores'' and 
``imaging bed'' to assist with the application of this exception. 
(M102.1 final rule).
d. Unobstructed Transfer
    The MDE NPRM proposed that each transfer side provide unobstructed 
access to the transfer surface, with an exception to permit temporary 
obstructions as long as they could be repositioned during transfer 
(proposed M301.2.3 and M302.2.3). As explained in the MDE NPRM 
preamble, the unobstructed access requirement was to ensure that 
armrests, side rails, stirrups, or other equipment parts attached to 
the diagnostic equipment did not impede the patient's ability to 
transfer. NPRM, 77 FR at 6923. The final rule retains the proposed 
requirements for unobstructed transfer for diagnostic equipment used in 
a supine, prone, or side-lying position, as well as diagnostic 
equipment used in the seated position, and has added a new exception 
described below.
    In the preamble to the MDE NPRM the Access Board noted that it was 
considering permitting equipment parts to extend a maximum of three 
inches horizontally beyond the edge of the transfer side. The Access 
Board explained that ``[t]he 2004 ADA and ABA Accessibility Guidelines 
provide a gap of 3 inches between the edge of the shower seat and the 
shower compartment entry, and the gap does not appear to interfere with 
transferring onto and off of the shower seat.'' NPRM, 77 FR at 6924. 
The Access Board sought input from the public in the MDE NPRM preamble 
question 17, on whether equipment parts should be permitted to extend a 
maximum of three inches horizontally beyond the edge of the transfer 
sides, provided that they did not extend above the top of the transfer 
surface. Id. Six of the eleven commenters who responded to this 
question supported permitting equipment parts to extend up to three 
inches horizontally beyond the edge of the transfer surface. However, 
these commenters were primarily manufacturers who also expressed 
concerns about the cost of equipment redesign if a provision permitting 
the three-inch gap was not included in the final standards. The other 
five commenters, disability rights advocates and an accessibility 
consultant, did not support allowing equipment parts to extend up to 
three inches horizontally, unless they were removable. These commenters 
raised concerns that the equipment parts would impede transfer. 
Additionally, a manufacturer, responding to question 9 in the MDE NPRM, 
explained that all beds, stretchers, and cots have side rails that can 
be moved to allow unobstructed access for transfer.
    The MDE Advisory Committee reviewed the comments. The Committee 
observed that transfer supports provide handholds that facilitate 
transfers onto and off of the equipment, and that some types of 
diagnostic equipment have components that create a gap between the 
transfer surface and the outer edge of the equipment on the side used 
for transfer. MDE Advisory Committee Report, 78-82, available at 
https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory 
Committee reviewed the 2010 ADA Standards for shower compartment seat 
requirements, which allows a three-inch gap between the edge of a seat 
and the shower compartment entry, to determine if these gaps presented 
a problem to individuals attempting to transfer. The MDE Advisory 
Committee also considered anthropometric data from the Impact of 
Transfer Setup on the Performance of Independent Transfers study by the 
VA Pittsburgh Healthcare System in collaboration with the Human 
Engineering Research Laboratories at the University of Pittsburgh. Id. 
This study examined the transfer experience with an adjustable height 
transfer surface. This study is available at https://herl.pitt.edu/ab/. 
The MDE Advisory Committee explained that ``[t]he results showed that 
95% of subjects could transfer when the seat and surface are at the 
same height with a 3.5-inch gap. This data helped inform the 
recommendation for the exception since the 3-inch criteria is less than 
that used in the research and should assure effective transfers for 
most.'' MDE Advisory Committee Report, 79, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee 
recommended allowing a maximum three-inch obstruction protruding from 
the transfer sides, ``placing a limit on the size of the gap between 
the transfer surface and the outer edge of the equipment on the side 
used for transfer,'' that applies to both the long length (width) and 
short length (depth) transfer sides. Id. The Committee also recommended 
special consideration for stretchers, to incorporate the provision of 
IEC 60601-2-52 to establish a maximum vertical obstruction at no less 
than one inch below the top of the transfer surface. Id.
    Based on the comments received and the MDE Advisory Committee 
recommendations, the Access Board is persuaded that a gap of up to 
three inches between the transfer side and the wheeled mobility device 
will not impede transfer given that accessible diagnostic equipment 
will be required to be adjustable. In addition, the Access Board is not 
persuaded that special consideration for stretchers is necessary in 
order to accommodate the IEC 60601-2-52 prohibition against vertical 
obstructions within one inch of the top of the patient surface. The 
final rule would not permit obstruction above the patient surface; 
consequently, by meeting the IEC requirements manufacturers will meet 
the MDE Standards.
    Accordingly, the final rule includes an exception permitting 
obstructions of no more than three inches deep beyond the transfer side 
of the transfer surface provided that such obstructions do not protrude 
above the top of the transfer surface. A common example of this type of 
obstruction is articulating side rails on stretchers that move out of 
the way during transfer, but create a gap between the transfer surface 
and the mobility device. The exception allowing obstructions of up to 
three inches is included in each of the new provisions for unobstructed 
transfer for diagnostic equipment used in the supine, prone, or side-
lying position (M301.2.4), and diagnostic equipment used in the seated 
position (M302.2.5), as Exception 1.
    As noted above, the Access Board has retained the original 
exception from the MDE NPRM, permitting temporary obstructions provided 
that they can be repositioned out of the way during transfer. In the 
final rule, the Board moved this provision to Exception 2 to 
accommodate the new exception discussed above, and added language to 
specify that this exception may also apply to obstructions that qualify 
for Exception 1. For example, side rails that create a gap of three 
inches from the transfer side of the diagnostic equipment to the 
mobility device when moved out of the way for transfer, but also 
protrude above the top of the transfer surface when in place as a side 
rail.
2. Armrests Requirement
    In the MDE NPRM, the Access Board required diagnostic equipment 
used by patients in the seated position to

[[Page 2821]]

provide armrests (proposed M302.3.2). The only commenter that addressed 
whether armrests should be required was a manufacturer who requested 
that beds, cots, and stretchers be excluded from the requirements as 
they are required to have side rails per IEC 60601-2-52. The MDE 
Advisory Committee addressed the armrest provision during their 
discussions of transfer supports and explained that ``armrests serve a 
similar function, and occupy the same physical space as the transfer 
supports as described in the MDE NPRM. The MDE NPRM requires transfer 
supports for all chairs, so the additional equipment for armrests for 
chairs was not only redundant, but could potentially create a physical 
conflict between the two devices.'' MDE Advisory Committee Report, 104, 
available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The 
MDE Advisory Committee recommended that armrests not be required, but 
if provided they cannot obstruct transfer supports. Additionally, the 
Committee noted that transfer supports meeting the final requirements, 
would provide support like that of armrests and enhance patient 
stability if left in place after a transfer from a mobility device. Id.
    After review of the comment and the recommendations of the MDE 
Advisory Committee, the Access Board is persuaded that requiring 
armrests as well as transfer supports is redundant and has the 
potential to cause conflict between the two devices. Therefore, the 
Access Board has removed the provision requiring armrests from the 
final rule.
3. Lift Compatibility Exception
    The MDE NPRM proposed that diagnostic equipment used by patients in 
the supine, prone or side-lying position and diagnostic equipment used 
by patients in the seated position be usable with portable patient 
lifts. The proposed rule specified base clearance requirements to 
ensure lift compatibility (M301.4 and M302.4, respectively). The 
preamble to the MDE NPRM sought comment on whether the final rule 
should exempt certain diagnostic equipment from these requirements if 
the equipment was specifically designed to be used with a fixed 
overhead lift. NPRM, 77 FR at 6927, question 27.
    Eleven commenters responded to question 27. Six of the ten 
commenters (one manufacturer, three medical associations, and two 
government entities) concurred with the proposed scenario that if 
equipment was designed for use with overhead lifts then that equipment 
should be exempted from the proposed base clearance requirements. One 
commenter, a manufacturer, agreed that equipment designed for use with 
an overhead lift should be excepted, and also stated that portable 
floor lifts should be designed to be compatible with exam and procedure 
tables, not that the tables be redesigned to be compatible with floor 
lifts. Four of the commenters (three disability rights organizations 
and an accessibility consultant) were opposed to this exemption and 
expressed concern that the overhead lift would not be available when 
needed if the diagnostic equipment was moved to another room or the 
lift was not functioning. The final commenter, a manufacturer, opposed 
the exemption unless the overhead lift was included as part of the 
equipment when sold.
    The MDE Advisory Committee reviewed this issue and recommended the 
use of overhead lifts as an alternative for imaging equipment where 
portable floor lifts are not feasible. Specifically, the MDE Advisory 
Committee explained:

    Overhead lifts can provide an alternate means of access instead 
of clearances around the bases of imaging equipment required for 
portable lifts. Table structural design and/or room layout may be 
such that providing the clearances in and around the base may be 
either technically difficult or impractical. In these cases, a 
ceiling-mounted lift may be a better method for some types of 
imaging equipment because the portable lift would need to access the 
diagnostic imaging table from the side or far end. Some imaging 
systems already use overhead lifts to assist patients . . . 
[Overhead lifts] may offer flexibility over a portable lift because 
it can transfer the patient from either side placing the patient in 
the desired imaging orientation, and the ability to move completely 
out of the way when not needed. MDE Advisory Committee Report, 107, 
available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

    After review of the comments received and the recommendations from 
the MDE Advisory Committee, the Access Board has concluded that fixed 
overhead lifts may be appropriate and even preferred in certain 
circumstances. However, the Access Board believes that the 
determination of the circumstances where an exception is warranted and 
the types of diagnostic equipment that should be excepted from the 
portable floor lift requirement is more appropriately left to the 
enforcing authority. Accordingly, the final rule provides a limited 
exception to the lift compatibility requirements for fixed overhead 
lifts in situations where: (1) A fixed overhead lift is provided; (2) 
the diagnostic equipment is clearly labeled as not compatible with 
portable floor lifts; and (3) the use of the overhead lift with that 
diagnostic equipment is specifically permitted by the enforcing 
authority. The exception applies only if all three conditions are met.
4. Exception From the Requirements of M301 for Certain Examination 
Chairs That Comply With M302
    The Access Board proposed in M101.2 in the MDE NPRM to require 
diagnostic equipment to meet the standards for each patient position 
supported, meaning that if diagnostic equipment was designed to support 
a patient in multiple positions then the equipment would have to meet 
the technical criteria for each of those positions. The Access Board 
sought public input in question three in the preamble in the MDE NPRM, 
on whether organizing the technical criteria functionally by patient 
position was clear. 77 FR at 6919.
    Fifteen commenters responded, with only two disability advocates 
and one medical association agreeing that the division of the MDE 
Standards was clear. The manufacturers raised concerns about applying 
the MDE Standards for multiple patient positions to a single piece of 
equipment. Multiple commenters recommended that when diagnostic 
equipment that fits in multiple categories, one category should take 
precedence. Medical Association and Accessibility Consultants 
recommended reorganizing the standards by types of facilities or by 
feature and one manufacturer recommended harmonizing M301 and M302 into 
one requirement. Additionally, commenters raised concerns about 
diagnostic chairs which could be reclined into a supine position after 
transfer; such as podiatry and dental chairs. These commenters argued 
that requiring the equipment to be designed to accommodate transfer in 
both positions would not achieve any objective benefit and would impose 
transfer surface width requirements that would not be appropriate and 
would be overly burdensome. The MDE Advisory Committee did not make a 
recommendation on this provision. However, the subcommittee for tables 
and chairs did explain that while the primary function of examination 
chairs is to support patients in a seated position, they are also 
capable of being reclined. The ability to recline is a secondary, 
rather than a primary purpose. The subcommittee asserted that these 
types of chairs should be covered by M302.

[[Page 2822]]

    In response to the comments and Advisory Committee discussions, the 
Access Board acknowledges that one of the most important features of 
making diagnostic equipment used by patients in either the supine, 
prone, or side-lying position or the seated position accessible, is to 
ensure the patient has the opportunity to transfer independently to the 
maximum extent possible. The Access Board concurs with the commenters 
that there are certain examination chairs, such as dentistry and 
podiatry chairs, where the patient is only intended to transfer while 
the chair is in a seated position but is then reclined into a supine 
position while the diagnostic procedure is being performed. The Access 
Board concurs with commenters that in this limited situation it is 
unnecessary for the examination chair, which complies with the 
technical requirements in M302, to also have to comply with the 
technical requirements in M301. Therefore, in the final rule the Access 
Board has added an exception to M301.1 which states that examination 
chairs that comply with M302 and, after the patient transfers into the 
seat, reclines to facilitate diagnosis, do not have to comply with 
M301. Additionally, the Board has added a new definition for 
examination chair in M102.1 in the final rule to assist with the 
application of this exception. The other commenter concerns regarding 
the proposed application provision, M101.2, are addressed below in the 
Section-by-Section Analysis.
5. Exception From the Requirements of M302 for Weight Scales With 
Integral Seats
    The MDE NPRM proposed that diagnostic equipment which could be used 
by patients in multiple positions must comply with the technical 
criteria for all positions in which it could be used (proposed M101.2). 
In the preamble in the MDE NPRM the Access Board proposed an exception 
to this requirement for folding seats on diagnostic equipment used by 
patients seated in a wheelchair. The MDE NPRM proposed that this type 
of diagnostic equipment would have to meet the technical requirements 
of M302 (diagnostic equipment used by patients in the seated position) 
and M303 (diagnostic equipment used by patients seated in a 
wheelchair), with the exception of the lift compatibility requirements 
in M302.4. NPRM, 77 FR at 6927. The Board explained that because the 
patients can use the equipment while seated in their wheelchairs, the 
seat does not have to provide the clearance necessary to be usable with 
a portable floor lift. Id.
    In the MDE NPRM preamble the Access Board sought comment with two 
questions, 28 and 37. Question 37 asked whether a folding or removable 
seat should be required on weight scales for use in the standing 
position. NPRM, 77 FR at 6930. Four commenters responded: Three 
concurred (an accessibility consultant, disability rights organization, 
and a state agency concerned with accessibility); and one commenter (a 
manufacturer) agreed it should be an option, but not a requirement. Six 
commenters responded to question 28, which asked whether a folding seat 
provided on diagnostic equipment with a wheelchair space should be 
required to comply with the technical criteria in proposed M302 for 
transfer surfaces and supports. NPRM, 77 FR at 6927. Five of the 
commenters (three disability rights organizations, a state agency 
concerned with accessibility, and an accessibility consultant) asserted 
that if a seat is provided it should have to comply with the technical 
provisions for diagnostic equipment used by a patient in the seated 
position. One of these commenters explained that not all people with 
disabilities who need to transfer are wheelchair users and some 
wheelchair users may choose to transfer, even if the device is designed 
for use in a wheelchair. The remaining commenter, a medical 
association, noted that it was unaware of any diagnostic equipment with 
a folding seat, but asserted that if patients can use the equipment in 
wheelchairs, then they should not be transferred onto the folding seat, 
and the chair should not have to meet the requirements in proposed 
M302.
    The MDE Advisory Committee discussed weight scales, noting the 
importance of obtaining a patient's weight for medical treatment and 
the difficulty patients in wheelchairs confront with obtaining an 
accurate weight. See MDE Advisory Committee Report, 66, available at 
https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. However, the MDE 
Advisory Committee did not make specific recommendations for requiring 
a folding seat on diagnostic equipment used in the standing position, 
nor did it make any specific recommendations for an exception to M302 
for seats on weight scales with wheelchair spaces. The Subcommittee on 
Weight Scales, in explaining its recommendations on size and ramp 
slope, recognized that ``space constraints are of consideration . . . 
as medical equipment and adequate space in the acute care or in the 
medical office setting are often competing. Scales that can be wall 
mounted or that are portable would facilitate where there are space 
constraints.'' Subcommittee Report--Weight Scales, 7, available at 
https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-b-supporting-documents.
    After reviewing the comments and the Subcommittee on Weight Scales 
Report, the Access Board has determined that weight scales that are 
designed to be used by patients seated in a wheelchair, but also 
provides a seat integral to the equipment, present a unique situation 
which warrants an exception to the general provision of M302.1 in the 
final rule. The primary purpose of the technical requirements for 
diagnostic equipment used by patients in the seated position is to 
facilitate independent transfer from a mobility device onto the 
diagnostic equipment. Some wheelchair accessible scales also provide a 
seat for patients who ambulate onto the scale, but due to stability or 
fatigue issues, may need to sit in order to be weighed. On many of 
these scales the seat folds down into the wheelchair space to 
accommodate the ambulatory patient who needs to sit. The MDE Advisory 
Committee notes that space is already at a premium for weight scales. 
To require a seat integral to the weight scale to meet the provisions 
of M302, when it already meets the requirements of M303 would require 
the weight scale platform to be significantly larger than a weight 
scale which just provides a wheelchairs space. To accommodate both a 
wheelchair space and seat permitting transfer from a mobility device, 
the platform would have to be large enough to accommodate individuals 
in their mobility devices and also provide enough space to allow for a 
side or perpendicular transfer from the mobility device onto the seat. 
Because weight scales with wheelchair spaces and seats are intended to 
be used by patients remaining in their wheelchairs or ambulating onto 
the scale, the Access Board has concluded that it is not necessary to 
require the weight scale to provide the wheelchair space for the 
patient to use the weight scale in a wheelchair and also provide the 
space for the patient to wheel onto the weight scale and then transfer 
onto the seat. Accordingly, the Access Board has excepted integral 
seats on weight scales that also contain wheelchair spaces meeting all 
the requirements of M303 from complying with M302. Due

[[Page 2823]]

to the addition of this exception from all of the M302 requirements, 
the exception in proposed M302.4, which exempted the folding seat from 
complying with the lift compatibility requirements, has been removed 
from the final rule as it is now encompassed under the new exception.
    The Access Board acknowledges the comments recommending that 
accessible diagnostic equipment used in the standing position also 
provide a seat. However, the Access Board has declined to include such 
a provision in the final rule because of the potential space impact and 
because, it will ultimately be up to the enforcing authority to 
determine what types of diagnostic equipment and how many of each type 
must be provided in medical settings. However, if diagnostic equipment 
used in a standing position does provide a seat, but does not provide a 
wheelchair space, then it would have to comply with the requirements of 
M302 and M304 in the final rule.

C. M303 Diagnostic Equipment Used by Patients Seated in a Wheelchair

    M303 contains the technical requirements for diagnostic equipment 
used by patients seated in wheelchairs. In the final rule the Access 
Board made four significant changes to this section: Two significant 
changes to accommodate the unique challenges of mammography equipment; 
one significant change to the ramped running slope requirement; and a 
final significant change to the width and depth of wheelchair spaces.
1. Width and Depth of Wheelchair Spaces
    The MDE NPRM proposed to require diagnostic equipment to have a 
wheelchair space that is at least 36 inches wide (proposed M303.2.2). 
The MDE NPRM further proposed two alternative depth requirements: 48 
inches for wheelchair spaces that are entered from the front or rear, 
and 60 inches for wheelchair spaces entered from the side (proposed 
303.2.3). The MDE NPRM preamble also noted that the Access Board was 
considering adding exceptions in the final rule to the width and depth 
requirements for wheelchair spaces on raised platforms. NPRM, 77 FR at 
6928-6929. The Access Board sought input in questions 31, 32, and 33, 
regarding the required size of wheelchair spaces on raised platforms, 
the use of scooters on raised platforms, and the associated costs. Id.
    No commenters responded to questions 31 and 33; four commenters 
responded to question 32. Question 32 asked whether equipment with 
wheelchair spaces on raised platforms, such as weight scales, can 
accommodate patients who use scooters, and if they currently cannot, 
should the width and depth be changed so the equipment is usable by 
patients who use scooters. One commenter (a disability rights 
organization) asserted that if diagnostic equipment is accessible for 
wheelchairs it should also be accessible to scooters and recommended 
enlarging the space beyond 36 inches. Another disability rights 
organization opined that most weight scales in healthcare settings are 
inaccessible to wheelchair users, asserting that even the 
``accessible'' weight scales are only 24 inches wide by 30 inches deep 
and are too small to accommodate manual wheelchairs and definitely 
would not accommodate the longer wheelbases of many power wheelchairs 
and scooters. This commenter recommended taking a ``universal design'' 
approach with a requirement of 34 inches wide by 58 inches deep for 
raised platforms on weight scales. The other two commenters (an 
academic and state agency concerned with accessibility) agreed that 
diagnostic equipment with wheelchair spaces on raised platforms should 
be usable by scooters, but did not provide any suggested dimensions.
    The MDE Advisory Committee recommended a minimum platform size of 
32 inches clear width and 40 inches clear length (depth). The Committee 
noted that their proposed recommendation sought to address the unique 
considerations of weight scales with raised platforms. The Committee 
stated that this size ``accommodates both manual and power wheeled 
mobility devices including small and mid-size scooters.'' MDE Advisory 
Committee Report, 109, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Committee relied on the Wheeled Mobility 
Anthropometry Project findings of wheelbase measurements and the 
Wheeled Mobility Anthropometry Project's recommendation of a minimum 
flat surface of 40 inches in length for platforms to accommodate 
wheeled mobility devices, including scooters. Id. at 110. The Committee 
explained that ``[t]o have an accurate weight, the entire wheelbase 
(either 3 or 4 wheels) of a mobility device must rest on and make 
contact with the platform. The foot pedals, footrests, scooter deck and 
tip wheels can overhang or extend beyond the platform and still get an 
accurate weight.'' Id.
    In order to reconcile the public comments and the MDE Advisory 
Committee recommendations, the final rule retains the proposed M303.2.2 
requirement for minimum width of 36 inches for wheelchair spaces, but 
provides an exception to permit wheelchair spaces on raised platforms 
to be a minimum of 32 inches wide. This width restriction assumes that 
the elbows and hands of persons using mobility devices would overhang 
the width of the platform and they would still be able to propel 
themselves. Because the final rule also requires raised platforms over 
1\1/2\ inches in height to provide edge protection that is a minimum of 
2 inches high from the surface of the platform (See M303.2.6 final 
rule), it was necessary to restrict the height of this edge protection 
for platforms using the exception of 32 inches wide to 4 inches. This 
height restriction is to ensure that a clear space is provided above 
any edge protection to allow the mobility device's casters and 
footrests or other components to extend over the edge protection.
    For the depth of the wheelchair space, the final rule has retained 
both alternative depth requirements in proposed M303.2.3: 60 inches for 
wheelchair spaces entered from the side, and 48 inches for wheelchair 
spaces entered from the front or rear, discussed below in Section 
VI.10.c (Section-by-Section Analysis--M303.2.3). However, the Access 
Board has included an additional requirement for wheelchair spaces that 
are entered from the front or rear and permit pass-through from one end 
to the other. This provision requires wheelchair spaces that permit 
pass-through to have a minimum depth of 40 inches. Less space is 
required in these circumstances because the wheelchair user does not 
have to turn around or back out to exit the diagnostic equipment, but 
can enter and exit continuing on in one direction. Due to the addition 
of the new requirement, the Board reorganized this provision in the 
final rule to M303.2.3.1 (front or rear entry depth), M303.2.3.2 (Pass 
Through Entry), and M303.2.3.3 (side entry depth).
2. Equipment Clearances for Breast Platforms
    The MDE NPRM proposed knee and toe clearance requirements for 
diagnostic equipment used by patients seated in wheelchairs that 
paralleled the knee and toe clearance requirements from the 2004 ADA 
and ABA Accessibility Guidelines. NPRM, 77 FR at 6929. The proposed 
rule included a requirement that 17 inches minimum and 25 inches 
maximum of the 48-inch

[[Page 2824]]

wheelchair space depth include knee and toe clearance. The knee and toe 
clearance would be permitted to be located beneath the diagnostic 
equipment, such as an optometrist diopter. The proposed rule contained 
a different requirement for breast platforms on mammography equipment, 
that of the 48-inch depth minimum of the wheelchair space, the knee and 
toe clearance under a breast platform would be 25 inches deep (proposed 
M303.2.4).
    Two commenters, one manufacturer and one disability rights 
organization, commented on the knee and toe clearance under breast 
platforms. The disability rights organization raised concerns that 
existing machines do not provide deep enough clearance and that during 
the examination the breast platform will hit the patient's knees. The 
manufacturer also raised concerns with the size of the knee and toe 
clearance and recommended basing the requirements in relation to the 
height of the breast platform. Additionally, this commenter raised 
concerns that mammography equipment must have a stabilizing flange or 
foot at its base to prevent the equipment from tipping when the gantry 
is extended. This flange protrudes into the knee and toe clearance. 
Specifically, this commenter explained that the flange can be designed 
for optimal accessibility, but is necessary for the safety of the 
equipment.
    The MDE Advisory Committee reviewed this provision and gave 
multiple recommendations regarding the necessary clearances for breast 
platforms. The Advisory Committee noted that mammography equipment 
presents a unique challenge for individuals seated in wheelchairs 
because the mammography exam requires the patient's breasts to be 
placed on top of the breast platform thereby requiring the knees and 
toes to go deeper beneath the equipment. The MDE Advisory Committee 
recommended changes to the proposed requirements for knee and toe 
clearance to create a deeper knee space under breast platforms. The MDE 
Advisory Committee did not suggest revisions to the proposed knee and 
toe clearances for diagnostic equipment used by patients seated in 
wheelchairs, other than for mammography equipment.
    The knee and toe clearance requirements were adopted from the 2004 
ADA and ABA Accessibility Guidelines and typically will allow a person 
seated in a wheelchair to pull underneath a work surface or equipment 
component or permit forward access to a control located above equipment 
overhanging the knee and toe space. We are persuaded by the MDE 
Advisory Committee report that mammography equipment presents a unique 
use and requires different specifications for the knee and toe 
clearance to ensure that the patient's breast can rest on top of the 
platform. The knee and toe clearance underneath mammography equipment 
must provide sufficient space to allow the patient to get close enough 
for their breast to be placed on the breast platform in order for the 
diagnostic procedure to be performed. Thus, the Access Board has 
reorganized the equipment clearances provision in the final rule into 
two separate requirements; breast platforms and other equipment. The 
requirements for breast platforms (M303.2.4.2 in the final rule) 
account for obstructions in the knee and toe clearance necessary to 
stabilize the mammography equipment and the location of the patient's 
body within the depth of the wheelchair space, such that more of the 
overall space is allocated to knees and toes. As discussed above, these 
factors result in an exception to allow equipment components of a low 
profile to extend into the toe end of the wheelchair space. The 
requirements for other equipment (M303.2.4.2 in the final rule) are 
substantively unchanged from the NPRM, and are discussed below in the 
Section VI.C.10.d (Section-by-Section Analysis--M303.2.4).
a. Knee and Toe Clearance
    The proposed rule recommended a knee and toe clearance depth for 
breast platforms of 25 inches. There were no comments received on this 
requirement. The MDE Advisory Committee recommended increasing the 
overall knee and toe space to a minimum 28 inches deep. MDE Advisory 
Committee Report, 115-116, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee asserted that a 
minimum of 28 inches in overall knee and toe clearance would 
accommodate 95 percent of the population. Id.
    The Access Board concurs with the MDE Advisory Committee's 
conclusion that an increase in the overall knee and toe clearance under 
breast platforms is warranted. However, the Board is concerned that if 
the Advisory Committee's recommendation is adopted without change, it 
would significantly impact the requirement in the final rule for a 48-
inch deep wheelchair space. Because at least 25 inches of the space 
must accommodate knees and toes, only 23 inches remains to accommodate 
that portion of the occupied wheelchair not including knees and toes. 
If the Access Board were to require 28 inches minimum knee and toe 
clearance, only 20 inches would remain. After reviewing all the 
evidence before the MDE Advisory Committee, the Access Board has 
decided to make a number of changes to the requirements for the knee 
and toe clearances for breast platforms. These new requirements are 
described in the Section VI.C.10.d (Section-by-Section Analysis--
M303.2.4). The requirements are intended to ensure that there is 
adequate space for a patient seated in a wheelchair to position 
underneath the equipment and align themselves against the breast 
platform so that the diagnostic procedures can be performed.
b. Exception for Base Support Allowance and Unobstructed Knee and Toe 
Space
    In the proposed rule, obstructions were not permitted within the 
knee and toe clearance space. This is consistent with the requirement 
in the existing accessibility guidelines and standards. One 
manufacturer commented on this provision, asserting that mammography 
equipment poses unique challenges and requires separate consideration. 
The commenter explained that the gantry of a mammography machine 
includes a base lip which is required for structural and seismic 
stability, and protrudes into the knee and toe clearance. This 
commenter recommended revisions to allow for a base lip on mammography 
equipment.
    The MDE Advisory Committee recommended allowing obstructions into 
the knee and toe clear space, up to a height and depth that still 
permits the footrests of wheelchairs to pass over it. Specifically, the 
Committee recommended allowing base supports to be a maximum of 1\1/2\ 
inches high and allowing an additional sloped region above the base 
support at a depth of 25 inches from the front edge of the breast 
platform at 1\1/2\ inches above the floor, which can extend to a height 
of 4 inches above the floor at a depth of 28 inches. The MDE Advisory 
Committee explained its recommendation, noting that:

    The base support is of fundamental importance to mammography 
equipment and provides structural support, seismic stability, and 
installation safety. It does obstruct the floor space in front of 
the gantry and, thus, may limit how close a wheelchair can get to 
the equipment. To respond to this issue, industry proposed a 
configuration that would cause minimal obstruction to the floor 
space in front of the gantry and would allow footrests to ride over 
it.
    To discuss the maximum base support height, the sub-committee 
looked at anthropomorphic data regarding footrest

[[Page 2825]]

heights. The footrest height data measures the height from the floor 
to the top surface of the footrest at its proximal outside corner. 
To determine the necessary clearance for the footrests, the 
Committee used the footrest height data and subtracted the thickness 
of the footrests (~0.5 inch). Allowing a maximum base support height 
of 1.5 inches will provide room for the structural components 
necessary for an effective base support design and will also be 
accessible by around 92% of manual chair users and over 95% of power 
chair users. MDE Advisory Committee Report, 123-127, available at 
https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

    The Access Board concurs with the need for permitting base 
components in the knee and toe clear space for mammography equipment. 
While the Access Board recognizes that this is a deviation from 
existing accessibility guidelines and standards, the Board believes 
that mammography equipment presents special challenges due to the 
diagnostic, structural, and seismic requirements of the diagnostic 
equipment. In the final rule, the Access Board has created an exception 
to the height requirement for breast platforms. This exception permits 
the profile of base components to extend into the wheelchair space at a 
height of 1\1/2\ inches maximum between 17 inches minimum and 25 inches 
maximum in depth measured from the leading edge of the breast platform. 
In addition, the Access Board has found that the profile of the base 
components should increase toward the rear of the clearance space where 
a patient's foot and toes will be higher than the heel supporting 
portion of the footrest. Therefore, the final rule requires that from 
25 inches to 28 inches measured from the leading edge of the breast 
platform, the height of the component above 1\1/2\ inches must be 
beveled at a rate of 2.5:3. This exception preserves a 17-inch minimum 
of unobstructed floor space measured from the leading edge of the 
breast platform.
3. Exception to Ramp Running Slope
    The MDE NPRM proposed that where there is a change in level at the 
entry of a wheelchair space that is greater than 1\1/2\ inches, the 
entry shall be ramped and have a running slope not steeper than 1:12 
(proposed M303.3). The Access Board explained in the MDE NPRM preamble 
that this provision is consistent with the 2004 ADA and ABA 
Accessibility Guidelines' technical criteria for changes in level. 
NPRM, 77 FR at 6929. No commenters addressed this provision. The MDE 
Advisory Committee, during its discussion of wheelchair spaces on 
weight scales, extensively addressed the permissible slopes of ramps on 
raised platforms. Specifically, the Committee noted:
    [It] considered the needs of a ramped surface to access the 
platform on the accessible scale. Because there are different types of 
scales with different platform heights, the Committee developed a three 
tiered ramp slope proposal to fit different situations. The Committee 
reviewed and discussed the provisions on slopes for ramps as they apply 
to architectural elements in the built environment. The maximum slope 
for a ramp in the 2010 Standards is a rise of 1 vertical inch for each 
12 inches of horizontal distance slope. Under very limited conditions 
in the built environment, the 2010 Standards allow a steeper ramp for a 
limited rise. A ramp in the built environment to which this exception 
applies may use a 1:2 grade slope on a short rise ramp.
    Industry experts spoke to the concern for facility space often 
expressed by healthcare entities. The space constraints affect the 
desirability of accessible scales since space is often expensive and 
tight in many medical facilities. Scales that can be wall mounted or 
portable enhance the flexibility of scales and allow use in tight 
environments. Currently, these types of accessible scales use the short 
rise ramp to facilitate easy storage or mounting.
    Existing technology for weight cell load allows for a platform 
profile to go as low as \3/4\ to 1\1/2\ inches. As the height of the 
platform lowers, the length of the ramp can decrease. The trend in the 
scale industry is to develop lower weight cell technology. However, 
industry currently does not know if lower profiles are possible. MDE 
Advisory Committee Report, 111-112, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.
    The MDE Advisory Committee recommended a three tiered approach for 
allowable ramp runs on raised platforms: Allowing a slope of 1:2 at 0 
to 1\1/2\ inches, a slope of 1:8 at a height greater than 1\1/2\ inches 
to 2\1/2\ inches, and a slope of 1:12 at a height greater than 2\1/2\ 
inches. Id.
    The Access Board agrees with the MDE Advisory Committee that 
additional allowances in the slope of ramp runs of diagnostic equipment 
used by patients seated in a wheelchair with raised platforms, 
primarily weight scales, is appropriate. However, for usability and 
safety reasons, the Access Board has determined that slopes of such 
ramp runs should not exceed the long standing maximum slope for 
accessible ramps of 1:8 that is allowable in certain circumstances in 
the 2004 ADA and ABA Accessibility Guidelines. The Board also notes 
that the Guidelines only permit changes in level up to \1/2\ inch e.g., 
thresholds to be steeper than 1:8.
    Therefore, the Access Board has decided to add an exception in the 
final rule to the requirement that ramped entry wheelchair spaces have 
ramp runs with a running slope no steeper than 1:12 (M303.3.3.1). This 
exception permits a running slope not steeper than 1:8 for ramp runs 
with a maximum height of 2\1/2\ inches. Consistent with the MDE 
Advisory Committee recommendations, ramp runs over 2\1/2\ inches in 
height will have to comply with the general requirement of running 
slopes of not steeper than 1:12.
4. Breast Platform Adjustability
    The MDE NPRM proposed to require diagnostic equipment used by 
patients seated in a wheelchair that have components which are used to 
examine specific body parts to be capable of examining the body parts 
of a patient while seated in a wheelchair (proposed M303.4). 
Additionally, the Access Board proposed specific technical requirements 
for breast platforms of mammography equipment. The MDE NPRM proposed a 
height range for breast platforms of 30 inches minimum and 42 inches 
maximum above the floor (proposed M303.4.1). In the preamble to the MDE 
NPRM, the Access Board sought input in question 36, on whether the 
breast platform height range proposed was sufficient to accommodate a 
patient seated in a wheelchair. NPRM, 77 FR at 6930.
    Three commenters responded to this question. One commenter, a 
medical association, concurred with the proposed provisions. Two other 
commenters, a disability rights organization and a manufacturer 
disagreed. The disability rights organization recommended adopting a 
minimum height range of 24 to 26 inches. The manufacturer indicated 
that the proposed height range of 30 inches to 42 inches is sufficient, 
but also noted that several manufacturers lower the breast platform to 
25 to 28 inches due to requests for accessibility. This manufacturer 
also recommended requiring a minimum range of travel for the breast 
platform instead of a specific minimum and maximum height.
    The MDE Advisory Committee recommended changing the breast platform 
height requirement from a specified height range to a required minimum 
range bounded by a required high height of 42 inches and a required low 
height of 26 inches which

[[Page 2826]]

constitutes the minimum range of travel allowed. MDE Advisory Committee 
Report, 132, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee Report noted that industry 
representatives explained that:

equipment currently manufactured ranges anywhere between 25 and 28 
inches for the lowest measurement of the breast platform. There were 
various reasons cited for each of the positions. Recommendations 
from accessibility experts who developed mammography protocols for 
women with disabilities identified a need for a breast platform 
height of 24 inches. Because this recommendation evolved from 
technologist experience on equipment with less knee space, 
disability advocates supported the rationale for 26 inches as the 
minimum. One member cited the diversity of body types and sizes for 
persons with disabilities as the rationale for the 26 inches. 
Another member emphasized the importance of considering patients of 
short stature in addition to considering patients seated in a 
wheelchair. Many industry organization members supported the 28-inch 
minimum. Reasons cited included providing more flexibility for 
manufacturers and concern that the lower minimum could result in 
more leg injuries as the technologist lowered the breast platform so 
close to the lap of the patient using a wheelchair.

    The MDE Advisory Committee recommended, by strong majority, a 
minimum low height of 26 inches and a minimum high height of 42 inches. 
After review of the comments and the MDE Advisory Committee 
recommendations, the Access Board has accepted the MDE Advisory 
Committee's recommendation of low and high minimum heights. The Access 
Board believes that this requirement will ensure that the breast 
platform can be lowered or raised to the proper height for a patient 
seated in a wheelchair and is also within the range requested from 
manufacturers for patient accessibility. Therefore, the final rule 
requires at M303.4.1 that breast platforms have a minimum low height of 
26 inches, a minimum high height of 42 inches, and be continually 
adjustable between the minimum low and high heights.
5. Edge Protection
    The MDE NPRM proposed edge protection on the ramps leading up to 
the raised platform (proposed M303.3.3.4), but did not require edge 
protection on the raised platforms themselves. The Access Board sought 
public input with question 30 in the MDE NPRM preamble, on whether 
there is diagnostic equipment with wheelchair spaces on raised 
platforms that does not provide edge protection.
    The Access Board received two comments from disability rights 
organizations. These commenters recommended requiring edge protection 
on platforms and one commenter suggested that the edge protection 
should not encroach into the wheelchair space on the platform and 
should be designed according to the edge protection requirements from 
the 2010 ADA Standards.
    The Advisory Committee made two recommendations for requiring edge 
protection on raised platforms; for single ramped entry platforms, the 
Committee recommended requiring a minimum two-inch high edge protection 
on the back of the platform opposite the entry ramp and on the two 
sides of the platform, and for double ramped entry platforms, the 
Committee recommended a minimum two-inch high edge protection on both 
sides of the platform. The Advisory Committee explained that edge 
protection ``provides an additional safety feature and guides users of 
wheeled mobility devices onto the platform.'' The edge protection 
prevents the patient from over-shooting the platform, driving off 
either side, tipping, or falling. MDE Advisory Committee Report, 112-
113, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.
    The Access Board concurs with the Advisory Committee that edge 
protection is necessary on raised platforms to provide a mechanism to 
ensure that wheelchair users do not fall off the platform. Therefore, 
the final rule requires in M303.2.6 that platforms with wheelchair 
spaces that are raised more than 1\1/2\ inches in height to provide a 
minimum 2-inch-high edge protection, measured from the surface of the 
platform, on each side of the platform not providing entry to or exit 
from the diagnostic equipment.

D. M304 Diagnostic Equipment Used by Patients in a Standing Position

    M304 provides the technical requirements for diagnostic equipment 
used by patients in a standing position. There was only one significant 
change made to the requirement of standing supports on the diagnostic 
equipment.
1. Standing Supports
    The proposed rule included a provision requiring standing supports 
on each side of the standing surface and compliance with the technical 
requirements for standing supports in proposed M305.3 (proposed 
M304.3). Question 38 in the MDE NPRM preamble requested input on the 
standing support configurations currently provided, their effectiveness 
for patients with disabilities, whether alternative criteria would be 
appropriate, whether angled standing supports are effective, and 
whether there are any industry standards for structural strength 
requirements. NPRM, 77 FR at 6931.
    Two commenters responded to this question. One commenter, a medical 
association, indicated that standing supports for imaging equipment 
vary widely based on the type of environment and specific imaging 
equipment being used. For example, the standing support on a chest x-
ray machine and mammography equipment is much different than a support 
on a fluoroscopic room table that can be moved from a recumbent to 
standing position. The second commenter, a manufacturer, expressed 
concerns that the proposed rule was treating supports on breast 
platforms as standing supports, explaining that this was not the 
supports' intended purpose. This commenter argued that these supports 
are actually arm supports intended to ensure proper patient positioning 
during the diagnostic exam, and were not intended as an accessibility 
feature to assist the patient in standing.
    The MDE Advisory Committee addressed the issue of standing supports 
for mammography equipment as well as that of standing supports for 
wheelchair spaces with raised platforms. For mammography equipment, the 
MDE Advisory Committee came to a consensus agreeing with the commenter 
that the ``standing supports'' on mammography equipment were actually 
positioning supports and the ``primary use of these supports is for 
positioning of the arms during the imaging process to keep them out of 
the field of view of the image.'' MDE Advisory Committee Report, 135, 
available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The 
MDE Advisory Committee noted that ``[i]ndustry representatives posited 
that if a patient has limitations or balance issues severe enough to 
need standing assistance, then the healthcare provider should position 
her in a seated position for safe imaging.'' Id. The MDE Advisory 
Committee recommended removing the requirements for standing supports 
on mammography equipment and instead adding a requirement for 
positioning supports. Additionally, the MDE Advisory Committee noted 
that:


[[Page 2827]]


since the supports mount to the c-arm on many types of mammography 
equipment, they will move up and down with the breast platform. In 
these cases, they do not need to be as long as 18 inches to provide 
sufficient flexibility for patients to reach them. Industry 
representatives also indicated that there are controls in the area 
where these positioning supports are located. It is important that 
the patients' hands do not accidentally hit these controls when they 
are holding the positioning supports. For this reason, industry will 
sometimes intentionally shorten the length of these handholds to 
less than the 18-inch proposal. Considering these factors, the full 
Committee agreed that a 12-inch long positioning support would be 
sufficient if it moved with the movable breast platform. Id.

    The MDE Advisory Committee made two recommendations for standing 
supports on raised platforms with wheelchair spaces: One for single-
ramped entry raised platforms, and a second for dual-ramped entry 
raised platforms. These recommendations would apply when the diagnostic 
equipment is designed to accommodate both persons seated in wheelchairs 
and standing persons. For single-ramped entry raised platforms, the MDE 
Advisory Committee recommended maintaining the requirement for standing 
supports on both sides of the diagnostic equipment. To address concerns 
raised by industry representative on the MDE Advisory Committee 
regarding the space on the platform needed to attach two sets of 
standing supports which must be outside the minimum clear space 
required for a wheelchair, the Committee recommended that dual-ramped 
entry raised platforms require only one standing support on one side of 
the platform. The MDE Advisory Committee explained that patients may 
have a stronger side, right or left, and therefore with only one 
standing support provided, they would need to be able to use their 
preferred side to hold onto the standing support. With a single entry 
ramp, supports on both sides are necessary to allow patients to choose 
to use the right or left side of their body, but on a dual entry ramp 
the patient can enter or exit on opposing sides to allow them to use 
their preferred side of their body with only one support. Id.
    The Access Board concurs with the commenters and the MDE Advisory 
Committee that the supports on mammography equipment were intended as 
positioning supports, not standing supports. However, the Board has 
determined that an exception is not necessary due to the restructuring 
of this requirement in the final rule. In the final rule, standing 
supports are only required on diagnostic equipment used by patients in 
a standing position that provide a surface on which a patient would 
stand. This is discussed in greater detail below in Section V.C. 
(Section-by-Section Analysis--M304.2). Additionally, as discussed below 
in Section IV.E.1. (Significant Changes--Positioning Supports), the 
Access Board has elected not to include positioning supports for 
mammography equipment in the final rule.
    With regard to the MDE Advisory Committee recommendations regarding 
standing supports on diagnostic equipment with raised platforms, the 
Access Board has decided to include an exception in the final rule for 
diagnostic equipment with entry and exit that permit pass-through from 
one end to the other to provide a standing support on only one side of 
the standing surface, provided that the standing support complies with 
the requirements in M305.3 for standing supports in a horizontal 
position. This exception would not just apply to diagnostic equipment 
on a raised platform designed both for people seated in wheelchairs and 
in standing positions, it would also apply to equipment designed solely 
for patients in a standing position and would apply regardless of 
whether the standing surface is raised on a platform or combined with a 
wheelchair space. For all other standing surfaces, the Access Board has 
retained the original requirement of standing supports on two sides of 
the standing surface from the proposed rule. While the MDE Advisory 
Committee spoke in terms of raised platforms, the Access Board believes 
the exception should be permitted where entry and exit permits pass-
through from one end to the other, regardless of whether the standing 
surface is raised. Accordingly, the Access Board has decided to apply 
this exception to all diagnostic equipment which permits this type of 
entry and exit in final rule (M304.2.2).

E. M305 Supports

    M305 provides the technical requirements for supports on medical 
diagnostic equipment. There were multiple significant changes made to 
the transfer supports section, including the addition of new 
requirements as well as the removal of structural strength requirements 
from the final rule. Additionally, changes were made to the vertical 
and horizontal standing supports requirements.
1. Transfer Supports
    The MDE NPRM proposed requirements for transfer supports that 
applied to all transfer surfaces (proposed M305.2). The requirements 
were the same for transfer surfaces on diagnostic equipment used by 
patients in the supine, prone, or side-lying position, as well as 
diagnostic equipment used by patients in the seated position. The 
proposed standards required transfer supports to be located within 
reach of the transfer surface and not obstruct transfer, be capable of 
resisting vertical and horizontal forces of 250 pounds applied to all 
points, and not rotate in their fittings. The latter two requirements 
were taken from the 2004 ADA and ABA Accessibility Guidelines for grab 
bars. 36 CFR part 1191, App. D. In the preamble to the MDE NPRM, the 
Access Board posed multiple questions about whether the final rule 
should include more specific requirements regarding location, length, 
size, height, and angle for transfer supports; and whether transfer 
supports should be allowed to rotate in their fittings. The Access 
Board received 31 comments to these questions and the MDE Advisory 
Committee made 10 recommendations regarding the transfer support 
section.
    In response to the comments and the recommendations of the MDE 
Advisory Committee, and in consideration of the changes to the final 
rule regarding types of transfer surfaces, the Access Board has made 
multiple changes and additions to the transfer support requirements, 
located at M305.2. Specifically, the Access Board has added technical 
specifications to the requirements for location (M305.2.1) and length 
(M305.2.2) based on the type of transfer support required; has added 
new technical requirements for height (M305.2.3), cross section 
(M305.2.4), absence of surface hazards (M305.2.5), gripping surfaces 
(M305.2.6), and clearance (M305.2.7); and has made changes to the 
fittings provision (M305.2.8). These new and revised provisions are 
based on the 2004 ADA and ABA Accessibility Guidelines for grab bars 
and handrails, 36 CFR part 1191, App. D. Finally, the Access Board has 
removed the requirement for structural strength for transfer supports 
and has decided not to add any positioning support requirements in the 
final rule. Each requirement is discussed in detail in the Section-by-
Section Analysis below.
a. Structural Strength
    The MDE NPRM proposed to require transfer supports to be capable of 
resisting vertical and horizontal forces of 250 pounds at all points 
(proposed M305.2.2). The Access Board sought input in question 18, on 
whether current transfer supports are capable of

[[Page 2828]]

resisting vertical and horizontal forces of 250 pounds at all points. 
NPRM, 77 FR at 6925. Four commenters (three manufacturers and one 
accessibility consultant) addressed this requirement: The accessibility 
consultant concurred with the proposal and the other three commenters 
opposed this provision. Two of those opposing the 250-pound requirement 
asserted that very few supports would be able to withstand 250 pounds 
of force applied to all points in all directions and that the 
requirements should differ depending on the force vector or live load 
applied. The remaining opposing commenter supported compliance with the 
prevailing industry standard IEC 60601 instead of the proposed 
provision.
    The MDE Advisory Committee recommended revising the language 
proposed in the MDE NPRM to require transfer supports to resist 
vertical and horizontal forces of 250 pounds at locations determined by 
the intended use of the equipment. The Committee indicated that 
``during committee discussions manufacturers stated that industry is 
required to test the most vulnerable spots on the transfer support. 
Industry must follow testing parameters found in other standards.'' MDE 
Advisory Committee Report, 103, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.
    After reviewing the comments received and the recommendations from 
the MDE Advisory Committee, the Access Board has decided to remove this 
section in the final rule. The prevailing standard used by industry, 
IEC 60601 adopted under the ANSI/AAMI ES 60601 series in the U.S., 
contains provisions that address the structural strength of supports. 
ANSI/AAMI ES60601-1:2005/(R)2012, available at https://my.aami.org. The 
IEC 60601 Standard applies to a wide range of medical equipment 
including much of the diagnostic equipment covered by the MDE Standards 
and contains allowances for risk assessment not found in accessibility 
standards, such that support features on diagnostic equipment that will 
sustain transfers in a safe manner even without a specific provision in 
the MDE Standards. Id. Accordingly, it is not necessary for the Access 
Board to address the structural strength of transfer supports in the 
final rule as it is already covered by industry standards.
b. Positioning Supports
    The Access Board noted in the MDE NPRM preamble that it was 
considering adding positioning supports to the final rule and sought 
public input with question 24 on whether positioning supports should be 
required in the final rule. NPRM, 77 FR at 6927. Six commenters 
responded: Two commenters (disability rights organizations) recommended 
adding positioning supports; two commenters (manufacturers) recommended 
providing positioning supports within reach of the patient; one 
commenter (an accessibility consultant) recommended flexibility to 
allow for design based on use; and the final commenter (a manufacturer) 
raised concerns about the technical impact for MRI machines. 
Additionally, as discussed above in Section IV.D.1 (Significant 
Changes--Standing Supports) and below in Section V.C.17 (Section-by-
Section Analysis--M305.2), the MDE Advisory Committee made 
recommendations to add requirements for positioning supports on 
mammography equipment and imaging equipment with transfer surfaces 
having depths greater than 24 inches.
    After review of the comments and the MDE Advisory Committee's 
recommendations, the Access Board has decided not to require 
positioning supports in the final rule. Although the Access Board 
considers positioning supports to be helpful, even necessary in some 
instances, given the wide range of diagnostic equipment addressed by 
the final rule, we have insufficient information on which to base a 
meaningful requirement that could apply to all types of equipment. 
Additionally, where transfer supports are provided, they can also serve 
to assist patients to position themselves.
2. Standing Supports
    The proposed rule provided technical criteria for vertical and 
horizontal standing supports. For horizontal standing supports, the 
Access Board proposed a gripping surface of 4 inches long minimum, the 
top of which would be required to be located 34 inches minimum and 38 
inches maximum above the standing surface (proposed M305.3.1). For 
vertical standing supports, the Access Board proposed a gripping 
surface of 18 inches long minimum, the bottom of which would be 
required to be located 34 inches minimum and 37 inches maximum above 
the standing surface (proposed M305.3.2). In the preamble to the MDE 
NPRM the Access Board sought input with question 38 on: (a) The current 
configurations of standing supports, and their effectiveness for 
persons with disabilities; (b) if there were any alternative technical 
criteria that would be appropriate; (c) whether angled supports are 
effective; and (d) whether there are industry standards for the 
structural strength of standing supports. NPRM, 77 FR at 6931. The 
Access Board received two comments, one of which addressed standing 
supports on mammography equipment (discussed above in Section IV.D.1 
(Significant Changes--Standing Supports)) and one commenter (medical 
association) who noted that angled standing supports would be effective 
and that they are unaware of any industry standards regarding 
structural strength.
    The MDE Advisory Committee reviewed the standing supports provision 
and while it supported the technical criteria in the proposed rule, the 
MDE Advisory Committee recommended adding additional criteria for 
standing supports on raised platforms with wheelchair spaces based on 
the recommended changes in requirements for standing supports for such 
diagnostic equipment (discussed above in Section IV.D.1 (Significant 
Changes--Standing Supports)). The Committee recommended that for 
single-ramped entry raised platforms with wheelchair spaces, the 
standing supports located on two sides of the platform have a minimum 
of 34 inches between supports, be integrated into the platform, and be 
a minimum of 32 inches in length (at least 80 percent of the platform 
length) at the platform entry edge. MDE Advisory Committee Report, 136-
137, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. For standing supports on dual-ramped entry raised platforms 
with wheelchair spaces, the MDE Advisory Committee recommended the 
standing support, required on one side of the platform, be integrated 
into the platform and stretch the full length of the platform (40-inch 
minimum). Id.
    The Access Board concurs with most of the MDE Advisory Committee's 
recommendations; however, although the Committee's recommendations 
pertained to diagnostic equipment with wheelchair spaces and standing 
spaces on raised platforms, the Access Board has decided to apply the 
recommended criteria to all diagnostic equipment for patients in a 
standing position that also contains a wheelchair space, regardless of 
whether the equipment standing surface is raised. In addition, the 
exception permitting only one standing support is conditioned on that 
support being positioned horizontally in relation to the standing 
surface, not vertically. Additionally, the Access Board has adopted the 
Committee's recommendation regarding the length of

[[Page 2829]]

these standing supports necessitating the Access Board to restructure 
the standing support provision, dividing it into length and height. In 
the final rule the Access Board permits diagnostic equipment that is 
required to have standing supports that also provides a wheelchair 
spaces with one entry to have standing supports with a gripping surface 
length equal to or greater than 80 percent of the overall length of the 
platform. For such diagnostic equipment with wheelchair spaces that 
permit pass-through from one end to the other, the final rule requires 
the length of the gripping surface of the standing support to be at 
least equal to the length of the platform.

V. Section-by-Section Analysis

A. Chapter 1: Application and Administration

    In the final rule Chapter 1 establishes the purpose and the general 
requirements for the application of the MDE Standards. This chapter 
received 21 comments and no recommendations from the MDE Advisory 
Committee. The Access Board made a few editorial changes to some of the 
provisions, and added one provision M101.3 Existing Diagnostic 
Equipment, which is discussed below.
M101 General
    This is an introductory section.
M101.1 Purpose
    The MDE NPRM proposed that the purpose of the MDE Standards was to 
establish technical criteria for diagnostic equipment that is 
accessible to and usable by patients with disabilities and to provide 
patients with disabilities independent access to and use of diagnostic 
equipment to the maximum extent possible. One commenter, a 
manufacturer, responded to the proposed provision. The commenter 
asserted that this provision was unclear without a list of applicable 
disabilities and an explanation on how the maximum extent possible 
would be determined.
    In response to the commenter, the Access Board notes that the term 
``disability'' is defined in the Americans with Disabilities Act (ADA), 
42 U.S.C. 12102. None of the Standards and Guidelines promulgated by 
the Access Board include a list of applicable disabilities. Rather, 
they rely on the definition of disability provided in the ADA. As for 
determining whether diagnostic equipment provides independent access 
and egress to the maximum extent possible, that is a decision left to 
the enforcing authorities that adopt and implement this standard. The 
Access Board, therefore, declines to implement the commenter's 
suggested changes. The Access Board has, however, made two editorial 
changes to this provision clarifying that ``medical diagnostic 
equipment'' is referred to as ``diagnostic equipment,'' and that these 
standards are referred to as ``MDE Standards'' throughout the rule 
text.
M101.2 Application
    In the NPRM the Access Board proposed that the MDE Standards would 
be applied to diagnostic equipment based on the patient position the 
equipment is designed to support. Additionally, this provision stated 
that where the equipment was designed to support more than one patient 
position, the MDE Standards for each patient position supported would 
be applied to the equipment. Fifteen commenters responded to this 
provision asserting that some diagnostic equipment should not have to 
comply with more than one patient position requirement. These concerns 
have resulted in two added exceptions to the final rule. The first is 
to exempt examination chairs which comply with M302 and can be reclined 
to facilitate diagnosis after the patient transfers onto the seat from 
complying with M301. (M301.1, Exception). This exception is discussed 
above in Section IV.B.4 (Significant Changes--Exception from the 
Requirements of M301 for Certain Examination Chairs that Comply with 
M302). Additionally, the final rule also exempts weight scales which 
contain a wheelchair space complying with M303 and that have a seat 
integral to the equipment from complying with M302 (M302.1, Exception). 
This exception is discussed above in Section IV.B.5. (Significant 
Changes--Exception from the Requirements of M302 for Weight Scales with 
Integral Seats). In the final rule, the application provision was 
revised due to the addition of the exceptions and a few editorial 
changes were made for clarity. This provision now requires that 
sections M301 through M304 of the MDE Standards be applied to 
diagnostic equipment based on the patient position that the equipment 
supports during patient transfer and diagnostic use and sections M306 
and M307 will be applied to diagnostic equipment that contains 
communication features or operable parts that are provided for patient 
use.
M101.3 Existing Diagnostic Equipment
    The MDE NPRM did not address when or how the MDE Standards would be 
applied to existing medical diagnostic equipment. Commenters raised 
concerns about the cost of immediate compliance for the more expensive 
imaging equipment, noting the high cost and the concern that rooms are 
designed specifically for such equipment. Specifically, at the public 
hearing on March 14, 2012, two commenters recommended phasing in these 
requirements for imaging equipment based on when it is replaced. The 
public hearing transcript is available at https://www.regulations.gov/docket?D=ATBCB-2012-0003.
    The MDE Standards are advisory and are not binding until adopted by 
an enforcing authority. The Access Board's mandate was to establish 
only the minimum technical criteria, however enforcing authorities may 
establish scoping requirements in the future. In response to the 
commenters' concerns regarding existing equipment, the Access Board has 
decided to add a new provision which clarifies that the MDE Standards 
do not address the accessibility of existing diagnostic equipment and 
that the enforcing authority will determine whether and how diagnostic 
equipment will be regulated.
M101.4 Equivalent Facilitation
    The MDE NPRM proposed to permit the use of alternative designs or 
technologies that are substantially equivalent to or provide greater 
accessibility and usability than strict compliance with provisions in 
the MDE Standards. One commenter, a manufacturer, requested that the 
Access Board include examples of acceptable methods for providing 
equivalent facilitation.
    The Access Board is unable to provide examples of acceptable 
methods of equivalent facilitation, as this section is intended to 
encompass those design solutions which the Access Board is unaware at 
the time that this rule is published. Additionally, the final 
determination of whether a particular design or technology meets this 
provision will be determined by the enforcing authorities. Therefore, 
the only change to this provision was to adjust the section number to 
allow for the addition of the new provision, M101.3 Existing Diagnostic 
Equipment.
M101.5 Dimensions
    The MDE NPRM proposed that the MDE Standards be based on adult 
dimensions and anthropometrics. One commenter and the MDE Advisory 
Committee raised concerns about providing standards for obese patients 
and pediatric patients. While the Access Board acknowledges that these 
are additional issues of accessibility, the

[[Page 2830]]

final rule follows the MDE NPRM framework and provides technical 
requirements based on adult dimensions and anthropometrics, only. At 
this point in time the Access Board is focusing on adult dimensions and 
anthropometrics however, the Access Board may address potential 
expansions of the MDE Standards to other groups in future rulemakings. 
The only change to this provision was adjustment of the section number 
to allow for the addition of the new provision, M101.3 Existing 
Diagnostic Equipment.
M101.6 Dimensional Tolerances
    The MDE NPRM proposed that dimensions were to be subject to 
conventional industry tolerances for manufacturing processes, material 
properties, and field conditions. In the preamble of the MDE NPRM, the 
Access Board sought public input in question five on available 
information or resources concerning conventional industry tolerances 
for medical diagnostic equipment. NPRM, 77 FR at 6920. Six commenters 
responded to the question. Three commenters (two manufacturers and one 
medical association) indicated that tolerances vary based on the 
manufacturer, product design, and manufacturing process and that they 
are unaware of any industry standard. One commenter, a manufacturer, 
referenced ASME Y14.5-1994 for dimensional tolerances. Another 
commenter, a medical association, asserted that tolerances are in 
operator manuals. The final commenter, a manufacturer, recommended 
providing tolerances when dimensions are specified and recommended 
defining a specific tolerance, such as +/- 0.5 inch for linear 
dimensions.
    After considering the comments received, the Access Board has 
decided to retain the original provision. The Access Board was 
persuaded by arguments from the commenters that there is not one 
industry-wide standard that can be applied to all MDE and concurs that 
the Access Board should not attempt to establish manufacturing 
tolerances. Where available, tolerances are best addressed by industry 
standards for the specific materials and methods employed in the 
manufacturing process. The only change to this provision was to adjust 
the section number to allow for the addition of a new section, M101.3 
Existing Diagnostic Equipment.
M101.7 Units of Measurement
    In the MDE NPRM there was no explanation of the units of 
measurement used throughout the rule text. In order to avoid confusion 
and to align this final rule with the other accessibility guidelines 
and standards promulgated by the Access Board; this provision has been 
added to explain that the values stated in each system (U.S. customary 
and metric units) may not be exact equivalents, and each system must be 
used independently of the other.
M102 Definitions
    This is an introductory section.
M102.1 Defined Terms
    The MDE NPRM proposed definitions for enforcing authority, medical 
diagnostic equipment, operable parts, and transfer surface. The Access 
Board sought input in question six in the preamble of the MDE NPRM, on 
whether there were other terms in the proposed standards that should be 
defined. NPRM, 77 FR at 6920. Ten commenters responded to this 
question. One commenter, a medical association, did not offer other 
terms that should be defined, but stated that there were many instances 
where the Board used acronyms without a definition. However, this 
commenter failed to provide any examples. Another commenter, a 
disability rights organization, suggested modifying the definition of 
medical diagnostic equipment to clarify that the standard is intended 
for all medical equipment in which any part of the equipment is used 
for diagnostic purposes for any amount of time. Another commenter, a 
manufacturer, recommended changing the term ``operable part'' to 
``applied part'' and adding a new definition of operable part as 
``caregiver operated parts,'' asserting that this aligns with IEC 
60601. Other commenters (manufacturers, medical associations, 
disability rights organizations, and an individual) suggested the 
following terms be defined: health care provider, breast platform, 
patient support surface, transfer supports, positioning supports, prone 
position, supine position, examination tables, diagnostic purposes, 
maximum extent possible, landing area, exam table, procedure table, and 
procedure chair.
    After review of the comments, the Access Board declines to add any 
of the suggested terms to the defined terms section. The definition of 
medical diagnostic equipment was taken directly from Section 510 of the 
Rehabilitation Act and thus for consistency has not been altered. 29 
U.S.C. 794f. Some of the definitions proposed by commenters are not 
terms used in the MDE final rule and, therefore, providing the 
requested definitions would serve no purpose. The definitions for other 
proposed terms used in the final rule are the same as the ordinarily 
accepted meanings in the context that applies, and the Access Board 
does not believe that the reader would be significantly aided in 
understanding the final rule by adding the requested definitions. 
However, the Access Board has decided to add six additional terms to 
this section; end transfer surface, examination chair, imagining 
equipment with bores, imagining bed, side transfer surface, and 
wheelchair space. As described above in Section IV.B.1.b. (Significant 
Changes--Transfer Surface Location), the Access Board has added 
definitions for ``end transfer surface'' and ``side transfer surface'' 
to this provision to describe the two types of transfer surfaces for 
diagnostic equipment used by patients in the supine, prone, or side-
lying position. The ``wheelchair space'' definition was taken from the 
2004 ADA and ABA Accessibility Guidelines and adopted in the MDE final 
rule to provide consistency across Access Board rulemakings. 
Examination chair, imagining equipment with bores, and imagining bed 
were added to help clarify application of exceptions added in the final 
rule. (See M301.1, M301.2.3, and M305.2.2.2). Finally, the Access Board 
also made a minor editorial change to the title of ``operable part'' so 
that all components and parts are referred to in the plural.
M102.2 Undefined Terms
    The MDE NPRM proposed that the meaning of terms not defined in 
proposed M102.1 or in regulations or policies issued by an enforcing 
authority, be defined by collegiate dictionaries in the sense that the 
context implies. There were no comments and no MDE Advisory Committee 
recommendations on this provision. In the final rule, the Access Board 
has changed this provision to indicate that the meaning of terms not 
defined in M102.1 will be given their ordinarily accepted meaning in 
the context that applies.
M102.3 Interchangeability
    The MDE NPRM proposed that singular and plural words, terms, and 
phrases are used interchangeably. There were no comments on this 
requirement and no changes have been made.

B. Chapter 2: Scoping

    In the final rule, Chapter 2 establishes that the enforcing 
authority will determine the number and types of diagnostic equipment 
to which the MDE Standards will apply. The Access Board did not receive 
any comments regarding Chapter 2 as written; however, several 
commenters expressed concern

[[Page 2831]]

regarding the ability of certain types of diagnostic equipment to 
comply with the MDE Standards. These concerns, discussed above in 
Section IV.A.1. (Significant Changes--General Exception), resulted in 
the addition of the M201.2 General Exception, described below. In 
addition, the Access Board made one editorial change to M201.1.
M201 General
    This is an introductory section.
M201.1 Enforcing Authority
    The MDE NPRM proposed to explain that the enforcing authority would 
specify the minimum number of types of accessible diagnostic equipment 
that would be required to comply with the MDE Standards. There were no 
public comments regarding this provision. The Access Board has decided 
to make an editorial change to this section to clarify that the 
enforcing authority will specify the minimum number and types of 
accessible diagnostic equipment that will be required to comply with 
the MDE Standards.
M201.2 General Exception
    The MDE NPRM did not propose a general exception for diagnostic 
equipment that was not capable of meeting the MDE Standards. As 
described in Section IV.A.1. (Significant Changes--General Exception), 
the Access Board received public comments and MDE Advisory Committee 
recommendations regarding certain types of diagnostic equipment that 
are unable to meet all of the requirements in the MDE Standards. In 
response, the Access Board has added a new provision excepting 
diagnostic equipment from compliance with an applicable requirement in 
the MDE Standards in the rare circumstance where compliance would alter 
diagnostically required structural or operational characteristics of 
the equipment, and would prevent the use of the equipment for its 
intended diagnostic purpose. Any equipment falling under this exception 
must comply with the provision(s) in question to the maximum extent 
practicable, and must fully comply with all other provisions not 
utilizing this exception.

C. Chapter 3: Technical Requirements

    In the final rule, Chapter 3 establishes the technical requirements 
for accessible medical diagnostic equipment based on how the diagnostic 
equipment is used by the patients, including: Diagnostic equipment used 
by patients in a supine prone, or side-lying position (M301); 
diagnostic equipment used by patients in a seated position (M302); 
diagnostic equipment used by patients seated in a wheelchair (M303); 
and diagnostic equipment used by patients in a standing position 
(M304). Chapter 3 also provides technical criteria for supports (M305), 
communication (M306), and operable parts (M307). This chapter underwent 
significant reorganization and changes as described in Section IV.B 
through IV.E (Significant Changes--M301 through M305). Additionally, 
the Access Board made editorial changes which are described below in 
the applicable Section-by-Section Analysis.
M301 Diagnostic Equipment Used by Patients in a Supine, Prone, or Side-
Lying Position
    M301 in the final rule establishes the technical criteria for 
diagnostic equipment used by patients in a supine, prone, or side-lying 
position such as, examination tables, imaging tables, hospital beds, 
and stretchers.
M301.1 General
    The MDE NPRM proposed that all diagnostic equipment used by 
patients in a supine, prone, or side-lying position must comply with 
the technical requirements of proposed section M301. As discussed in 
Section IV.B.4. (Significant Changes--Exception from the Requirements 
of M301 for Certain Examination Chairs that Comply with M302), in 
response to public comment and recommendations from the MDE Advisory 
Committee, in the final rule the Access Board has added an exception to 
this requirement for examination chairs that can be reclined to 
facilitate diagnosis after the patient transfers. This new exception 
exempts these diagnostic chairs from compliance with M301's 
requirements, as long as the examination chairs comply with the 
requirements in M302.
M301.2 Transfer Surface
    This is an introductory section.
M301.2.1 Adjustability
    The MDE NPRM proposed a transfer surface height range for 
diagnostic equipment used by patients in the supine, prone, or side-
lying position of 17 inches minimum and 19 inches maximum. The Access 
Board received multiple comments on this provision and the MDE Advisory 
Committee provided four recommendations. As discussed in Section 
IV.B.1.a. (Significant Changes--Transfer Surface Adjustability), in the 
final rule the Access Board has renamed this provision and now requires 
the transfer surface height to be adjustable to: (1) A low transfer 
height of 17 inches minimum and 19 inches maximum; (2) a high transfer 
height of 25 inches; (3) at least four additional transfer heights 
located between the low and high transfer heights, separated by one 
inch minimum increments; and (4) the transfer surface height will be 
measured from the floor to the top of the uncompressed transfer 
surface.
M301.2.2 Sunset Provision
    As discussed in Section IV.B.1.a. (Significant Changes--Transfer 
Surface Adjustability), this is a new provision that was added to the 
final rule in conjunction with the new requirement of a low height 
range in M301.2.1. It provides a sunset for the low transfer height 
provision of five years from the date of publication of this rule in 
the Federal Register. The Access Board intends to complete the 
necessary research to determine an appropriate minimum low transfer 
height prior to the effective date of the sunset, and will update this 
provision in a subsequent rulemaking.
M301.2.3 Size
    The MDE NPRM proposed a transfer surface size for diagnostic 
equipment used in the supine, prone, or side-lying position of 30 
inches wide and 15 inches deep minimum. (proposed M301.2.2). The Access 
Board received multiple comments on this provision as well as multiple 
recommendations from the MDE Advisory Committee. As discussed in 
Section IV.B.1.c (Significant Changes--Transfer Surface Size), in the 
final rule the Access Board has revised this provision to account for 
the two types of transfer surfaces (end and side), requiring end 
transfer surfaces to be a minimum of 28 inches wide and 17 inches long 
and side transfer surfaces to be a minimum of 28 inches wide and 28 
inches long and has added an exception for transfer surfaces for 
imagining equipment with bores.
M301.2.4 Unobstructed Transfer
    In the MDE NPRM the Access Board proposed that each transfer side 
provide unobstructed access to the transfer surface, with an exception 
to permit temporary obstructions as long as they could be repositioned 
during transfer. Examples of temporary obstructions include folding 
armrests, removable side rails, retractable footrests, and stirrups. 
NPRM, 77 FR at 6924. There were no comments received on the proposed 
provision and the MDE Advisory Committee did not make any 
recommendations. The final rule retains the requirement for 
unobstructed

[[Page 2832]]

transfer, but has reworded the requirement to specify that each 
transfer surface must provide two unobstructed sides for the patient to 
transfer.
    Additionally, the Access Board sought public input on whether an 
additional exception to the requirement of unobstructed transfer should 
be added. NPRM, 77 FR at 6924. Specifically, the Access Board asked 
whether equipment parts should be permitted to extend a maximum of 
three inches horizontally beyond the edge of the transfer sides, 
provided they do not extend above the top of the transfer surface. The 
Access Board received multiple comments and recommendations from the 
MDE Advisory Committee on this topic. As discussed above in the Section 
IV.B.1.d. (Significant Changes--Unobstructed Transfer), the final rule 
includes a second exception to the unobstructed transfer provision 
which permits obstructions of no more than three inches to extend 
beyond the transfer side of the transfer surface, provided that such 
obstructions do not protrude above the top of the transfer surface.
M301.3 Supports
    This is an introductory section. An editorial change was made to 
this section as a result of the change in M301.3.2, described below, to 
replace the word ``stirrups'' with the term ``leg supports.''
M301.3.1 Transfer Supports
    The MDE NPRM proposed to require transfer supports to be provided 
for use with transfer sides on diagnostic equipment used by patients in 
the supine, prone, or side-lying position, and that these transfer 
supports comply with the technical requirements for transfer support in 
M305.2. There were no public comments and no recommendations by the MDE 
Advisory Committee on this provision. The only change in the final rule 
was to update the cross reference to applicable transfer surfaces to 
accommodate the changes made to transfer surfaces, described above in 
Section IV.B.1. (Significant Changes--Transfer Surface).
M301.3.2 Leg Supports
    In the MDE NPRM, the Access Board proposed to place the 
requirements for stirrups on diagnostic equipment used by patients in 
the supine, prone, or side-lying position in M301. In the final rule 
the Access Board has decided to move the technical requirements for 
stirrups to M305, which includes all of the technical requirements for 
supports. Therefore, in the final rule, this provision instructs that 
when stirrups are provided on diagnostic equipment used in the supine, 
prone, or side-lying position leg supports must also be provided and 
comply with the technical requirements in M305.4. Additionally, in the 
final rule, the Access Board has made an editorial change in 
terminology, from stirrups to leg supports, in response to an MDE 
Advisory Committee recommendation to draw a distinction between 
stirrups which often only support the feet and leg supports which would 
support the legs when the patient's feet are in the stirrups and to 
provide consistency with the headings of other support provisions which 
are based on the body part supported.
M301.3.3 Head and Back Support
    In the MDE NPRM the Access Board proposed to place the requirements 
for head and back support for diagnostic equipment used by patients in 
the supine, prone, or side-lying position in M301. In the final rule, 
the Access Board has decided to move the technical requirements for 
head and back support to M305, which includes all of the technical 
requirements for supports. Therefore, in the final rule, this provision 
instructs that where diagnostic equipment is used in a reclined 
position it must provide head and back support that complies with the 
technical requirements in M305.5.
M301.4 Lift Compatibility
    The MDE NPRM proposed to require that diagnostic equipment used by 
patients in the supine, prone, or side-lying position be usable with a 
patient lift and comply with either the proposed clearance in base 
(proposed M301.4.1) or clearance around base (proposed M301.4.2) 
technical requirements. One manufacturer commented on this provision, 
asserting that the proposed requirement was unclear and should clearly 
state that the diagnostic equipment only has to be compatible with 
either the clearance around base or the clearance in base provisions. 
The Access Board considered this comment, but finds that the language 
is clear as written. This provision clearly states that diagnostic 
equipment shall comply with clearance in base or clearance around base. 
In the final rule the Access Board has made an editorial change to 
clarify the type of lift; namely portable patient lift, and a change to 
clarify that the clearance provisions only apply when the diagnostic 
equipment is being used with the portable patient lift.
    Additionally, question 27 in the MDE NPRM preamble requested input 
on whether the final rule should provide an exception from the lift 
compatibility requirements where the diagnostic equipment is designed 
for use with overhead lifts. As discussed above in Section IV.B.3. 
(Significant Changes--Lift Compatibility Exception), the Access Board 
has decided to add this exception for diagnostic equipment that meets 
the following three criteria: Fixed overhead patient lifts are provided 
for use with the diagnostic equipment; the use with the fixed overhead 
patient lift with the diagnostic equipment is permitted by an enforcing 
authority; and the diagnostic equipment is clearly labeled as not 
compatible with portable patient lifts.
M301.4.1 Clearance in Base
    The MDE NPRM proposed certain clearance requirements beneath the 
diagnostic equipment to allow sufficient space for the legs of a 
portable patient lift to fit underneath the equipment so that the 
patient could be raised out of their mobility device, moved over to the 
medical diagnostic equipment, and then be lowered onto the transfer 
surface. The proposed requirement could be met by providing an open 
area beneath the equipment, or by configuring the equipment with a wide 
slot recessed into the base enclosure. NPRM, 77 FR at 6927. The MDE 
NPRM proposed a clearance in the base of 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 equipment is less than 36 inches wide, the proposed rule required 
the clearance to extend the full width of the equipment. Id. 
Additionally, the Access Board proposed to permit equipment components 
to be located within 8 inches maximum of the centerline of the 
clearance width. Id. The Access Board sought input in question 25 in 
the MDE NPRM preamble, on whether the proposed dimensions for the 
clearance in base requirement is sufficient to allow for the use of 
portable floor lifts. Id.
    Six commenters responded to the question. One commenter, a 
manufacturer, concurred with the proposed provision. Another commenter, 
a medical association, explained that portable lifts are a problem in 
older outpatient facilities due to limited space. Another commenter, a 
manufacturer, raised concerns about requiring floor based patient lifts 
with MRI systems, explaining the concern about the significant 
structural support required in the patient bed which makes the under 
bed clearance impractical and the concern about requiring non-ferrous 
materials in the MRI room. This commenter explained a preference for

[[Page 2833]]

fixed overhead lifts. Three commenters (two manufacturers and one 
medical association) raised concerns with the six-inch vertical 
clearance measured from the floor requirement. One manufacturer 
explained that the proposed six-inch vertical clearance requirement 
would encompass 100 percent of all portable patient lifts on the 
market, and that several portable patient lifts only require 2.5 inches 
clearance, such as those designed to be used with stretchers. This 
commenter asserted that the proposed six-inch vertical clearance would 
require redesign of every medical bed and stretcher on the market, and 
recommended reducing the required clearance. One commenter (medical 
association) noted that it would be difficult to meet the six-inch 
clearance from the floor when the table is lowered to 17 inches to 
allow for transfer. The final commenter explained that a standard that 
only required either compliance with clearance in the base or clearance 
around the base, was attainable, but warned that if both were required 
it would impose significant redesign costs and would increase product 
costs. This commenter further posited that it would be more cost 
effective to redesign the lift than the diagnostic equipment. These 
three commenters also raised concerns that this provision was in 
conflict with the prevailing standard used by manufacturers for medical 
beds and stretchers, IEC 60601-2-52, which contains requirements for 
lift clearance under the equipment.
    The MDE Advisory Committee recommended reducing the equipment base 
clearance for stretchers from 44 inches wide minimum to 39 inches wide 
minimum. The Committee noted that this was to harmonize the MDE 
Standards with IEC 60601-2-52, which provides requirements for 
stretchers and includes lift clearance at the 39-inch width. MDE 
Advisory Committee Report, 106-107, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.
    The Access Board has reviewed the comments and the recommendations 
from the MDE Advisory Committee and is persuaded by the arguments in 
favor of harmonizing the lift clearance requirements with the IEC 
60601-2-52. Accordingly, the Access Board has adopted the 
recommendation from the MDE Advisory Committee, but has decided to 
apply the reduction in lift clearance width to all medical diagnostic 
equipment that complies with the clearance in base provision because a 
lift that deploys effectively under a stretcher should also function 
properly under other less constrained diagnostic equipment. Secondly, 
the Access Board has decided to retain the six-inch height clearance 
requirement but agrees with the commenters that the diagnostic 
equipment should not have to meet the six-inch height clearance 
requirement when in position for independent transfer. Therefore, the 
final rule clarifies that the lift compatibility requirements only 
apply when the diagnostic equipment is being used with the portable 
lift, as a lift will only be used when independent transfer is not 
possible.
M301.4.2 Clearance Around Base
    The MDE NPRM proposed certain requirements to provide clearance 
around the base of the diagnostic equipment to allow the legs of the 
portable floor lift to straddle the base of the diagnostic equipment 
with a solid base that sits on or close to the floor. The proposed rule 
required a minimum clearance of 6 inches high measured from the floor 
and 36 inches deep measured from the edge of the examination surface. 
NPRM, 77 FR at 6927. The width of the base permitted within this 
clearance would be 26 inches maximum at the edge of the examination 
surface and was permitted to increase at a rate of 1 inch in width for 
every 3 inches in depth. Id. In addition, where the width of the 
examination surface is less than 26 inches, the clearance depth would 
be the full width of the examination surface. Id. The Access Board 
sought public input in question 26 in the MDE NPRM, on whether the 
proposed dimensions for clearance around the base of the equipment was 
sufficient to allow for the use of portable floor lifts. Id.
    Two commenters, both manufacturers, responded to this question. One 
commenter recommended clarifying that the exam table must be compatible 
with a patient lift and meet the six-inch clearance, but not when the 
table is at its lowest level for independent transfer. This 
manufacturer indicated that its adjustable table does not have a six-
inch minimum clearance when at its lowest position, but does meet the 
standard when the table is raised. The other commenter asserted that 
the proposed dimensions are not sufficient to accommodate the various 
portable floor lifts and recommended that the Access Board instead 
provide technical criteria for the portable patient lift to be usable 
with diagnostic equipment since it is more cost effective to change the 
floor lift, than to change the diagnostic equipment. Additionally, this 
manufacturer reported that all but one of its examination and procedure 
tables currently meet the clearance around base provision, but opined 
that if the proposed increase in width of the transfer surface of 
examination tables and chairs to 30 inches by 15 inches is adopted then 
it would be required to redesign the examination tables and chairs to 
have a larger base which would interfere with the ability to meet this 
clearance around base provision. The MDE Advisory Committee did not 
address this provision, and thus provided no recommendations on the 
clearance around the base requirements.
    The Access Board has reviewed the comments and has decided to 
retain the provision from the proposed rule. In the final rule, the 
Access Board has decided to decrease the size of the transfer surface 
(See final M301.2.3) and thus the commenter's concern regarding an 
increase in base size is not applicable. As described above, M301.4 
does not require the 6-inch height clearance to be maintained when the 
equipment is lowered to the minimum low height for independent transfer 
as required by M301.2.1, because portable patient lifts will only be 
used when independent transfer is not possible. Finally, a portable 
patient lift is not medical diagnostic equipment and, therefore, not 
within the purview of the Access Board's regulatory jurisdiction. 
However, portable patient lifts are integral to ensuring that patients 
with disabilities who are unable to independently transfer are 
otherwise able to use the medical diagnostic equipment. Therefore, the 
Access Board has provided the technical criteria necessary for the 
portable floor lift to be usable with medical diagnostic equipment.
M302 Diagnostic Equipment Used by Patients in a Seated Position
    M302 in the final rule establishes the technical criteria for 
diagnostic equipment used by patients in a seated position such as 
examination chairs.
M302.1 General
    The MDE NPRM proposed that all diagnostic equipment used by 
patients in a seated position must comply with the technical 
requirements of proposed section M302. As discussed in Section IV.B.5. 
(Significant Changes--Exception from the Requirements of M302 for 
Weight Scales with Integral Seats), in response to public comment and 
evidence presented to the MDE Advisory Committee, in the final rule the 
Access Board has added an exception to this requirement for weight

[[Page 2834]]

scales that contain wheelchair spaces and also provide a seat integral 
to the equipment. This new exception exempts these weight scales from 
compliance with M302's requirements for the seat, as long as the 
wheelchair space complies with the requirements in M303.
M302.2 Transfer Surface
    This is an introductory section.
M302.2.1 Adjustability
    The MDE NPRM proposed a transfer surface height range for 
diagnostic equipment used by patients in a seated position of 17 inches 
minimum and 19 inches maximum. The Access Board received multiple 
comments on this provision and the MDE Advisory Committee provided four 
recommendations. As discussed in Section IV.B.1.a. (Significant 
Changes--Transfer Surface Adjustability) in the final rule the Access 
Board has renamed this provision and now requires the transfer surface 
to be adjustable to: (1) A low transfer position height at or between 
17 inches and 19 inches; (2) a high transfer position of 25 inches; (3) 
at least four additional transfer positions located between the low and 
high transfer positions and separated by one inch minimum increments; 
(4) measured from the floor to the top of the uncompressed transfer 
surface.
M302.2.2 Sunset Provision
    As discussed in Section IV.B.1.a. (Significant Changes--Transfer 
Surface Adjustability), this is a new provision added to the final rule 
in conjunction with the new requirement of a low height range in 
M302.2.1. It provides a sunset for the low transfer height provision of 
five years from the date of publication of this rule in the Federal 
Register. The Access Board intends to complete the necessary research 
to determine an appropriate minimum low transfer height prior to the 
effective date of the sunset, and will update this provision in a 
subsequent rulemaking.
M302.2.3 Size
    The MDE NPRM proposed a transfer surface size for diagnostic 
equipment used by patients in the seated position of 21 inches wide and 
15 inches deep (proposed M302.2.2). The Access Board also solicited 
comment in question 16 on whether the transfer surface size proposed 
for seated position diagnostic equipment was sufficient to facilitate 
independent transfer. NPRM, 77 FR at 6924. Two of the seven commenters 
who responded supported the proposed requirements. One commenter, a 
manufacturer, although in agreement with the 21-inch width, stated that 
the 15 inches deep requirement should be increased to 17 inches, a 
disability advocate recommended increasing the width to 23 inches, two 
of the commenters, accessibility consultant and disability advocate, 
stated that the proposed dimensions were insufficient citing concerns 
for persons of larger stature or who are obese and may be unable to 
safely transfer to a surface of that size. One commenter, a 
manufacturer, recommended harmonizing with the requirements for the 
seated position with those of the supine, prone, or side-lying position 
transfer surface size.
    The MDE Advisory Committee considered the dimensions for 
rectangular seats in roll-in showers from the 2010 ADA Standards for 
Accessible Design and the ``ideal'' chair width recommended in 
Architectural Graphic Standards for auditorium seating. MDE Advisory 
Committee Report, 77, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Committee also reviewed anthropometric data 
from a variety of sources. Id. Many Committee members expressed concern 
about the adequacy of the transfer surface depth. Id. The Committee 
recommended increasing the minimum depth of the transfer surface from 
15 inches to 17 inches, noting that existing equipment already meets or 
exceeds this dimension. Id. The Committee recommended retaining the 21-
inch width requirement, noting that it was sufficient to facilitate 
independent transfer. Id.
    Based on the commenters' responses and the MDE Advisory Committee 
recommendations, the Access Board has decided to increase the transfer 
surface size for equipment used by patients in a seated position to 17 
inches deep and retain the 21-inch-wide requirement from the proposed 
rule.
M302.2.4 Transfer Sides
    In the MDE NPRM, the transfer side provision for diagnostic 
equipment used by patients in the seated position required transfer 
surfaces to have the option to transfer from a mobility device onto one 
short side (depth) and one long side (width) of the surface, and 
provide unobstructed transfer to the surface. The Access Board received 
multiple comments and recommendations from the MDE Advisory Committee, 
which are discussed above in Section IV.B.1.b. (Significant Changes--
Transfer Surface Location). In the final rule, the Access Board 
retained this provision, but made editorial changes to clarify the 
location of the transfer sides and to relocate the language concerning 
unobstructed transfer into a new section M302.2.5. The transfer sides 
are still intended to allow a patient to choose to transfer onto either 
of two adjoining sides of the transfer surface. Additionally, based on 
comments and recommendations from the MDE Advisory Committee, the 
Access Board has decided to add an exception to this provision to 
accommodate chairs with fixed footrests which prevent transfer onto the 
adjoining sides. This is discussed in Section IV.B.1.b. (Significant 
Changes--Transfer Surface Location). As explained above, in order to 
provide patients with the ability to choose what side of their body 
they use to transfer, chairs with fixed footrests will provide the 
ability to transfer from either opposing side of the transfer surface. 
This allows the patient to choose to transfer from their right or left 
side and prevents the patient from having to transfer onto a fixed 
footrest.
M302.2.5 Unobstructed Transfer
    In the MDE NPRM the Access Board proposed that each transfer side 
provide unobstructed access to the transfer surface, with an exception 
to permit temporary obstructions as long as they could be repositioned 
during transfer. This requirement is identical to the unobstructed 
transfer requirement in M301.2.4, and this provision is discussed in 
the Section V.C.2.d. (Section-by-Section Analysis--M301.2.4). The final 
rule retains the requirement for unobstructed transfer, but has been 
reworded to specify that each transfer surface must provide two 
unobstructed sides for the patient to transfer.
    Additionally, as discussed above in the Section IV.B.1.d. 
(Significant Changes--Unobstructed Transfer), the final rule includes a 
second exception to the unobstructed transfer provision which permits 
obstructions of no more than three inches to extend beyond the transfer 
side of the transfer surface, provided that such obstructions do not 
protrude above the top of the transfer surface.
M302.3 Supports
    This is an introductory section. An editorial change was made to 
this section as a result of the change in M302.3.2, described below, to 
replace the word ``stirrups'' with the term ``leg supports.''
M302.3.1 Transfer Supports
    In the MDE NPRM the Access Board proposed that transfer supports 
must be provided for use with transfer sides on

[[Page 2835]]

diagnostic equipment used by patients in the seated position, and that 
these transfer supports must comply with the technical requirements in 
M305.2 of the proposed rule. There were no comments on this provision 
and no recommendations by the MDE Advisory Committee. Based on the 
restructure of the transfer surface provisions, described above in 
Section IV.B.1.b. (Significant Changes--Transfer Surface Location), and 
the additional technical criteria added to the transfer supports 
provisions, discussed above in Section IV.E.1 (Significant Changes--
Transfer Supports), the Access Board has made editorial changes to this 
section. The technical requirements for transfer supports is in M305.2 
of the final rule and has been reorganized to mirror the two types of 
transfer surfaces (end and side) in the final rule for diagnostic 
equipment used by the patient in the supine, prone, or side-lying 
position. The transfer surface required for diagnostic equipment used 
by patients in the seated position is similar to the new end transfer 
surface and therefore, diagnostic equipment used by patients in the 
seated position is required to comply with the transfer support 
provisions for end transfer supports. Additionally, the Access Board 
has included cross-references to the new transfer support requirements 
in M305.2.
M302.3.2 Leg Supports
    The MDE NPRM did not propose to require stirrups to provide a 
method of supporting, positioning, and securing the patient's legs for 
diagnostic equipment used by patients in the seated position. However, 
in response to question 23, on whether diagnostic equipment used by 
patients in a seated position that provide stirrups should have to 
provide such support, the Board received six comments. NPRM, 77 FR at 
6926. All six commenters concurred that when stirrups are provided for 
use with diagnostic equipment used by patients in the seated position, 
a method must be provided for supporting, positioning, and securing the 
patient's legs. The MDE Advisory Committee did not address this 
provision.
    The Access Board concurs with the commenters, and the final rule 
requires that where stirrups are provided on seated diagnostic 
equipment, leg supports must also be provided and must comply with the 
technical requirements for leg supports in M305.4. This will ensure 
that patients with limited leg strength and control will be able to 
keep their legs in the appropriate position for examination.
M302.3.3 Head and Back Support
    In the MDE NPRM the Access Board proposed to place the requirements 
for head and back support for diagnostic equipment used by patients in 
the seated position in M302. In the final rule the Access Board has 
decided to move the technical requirements for head and back support to 
M305 which includes all of the technical requirements for supports. 
Therefore, in the final rule, this provision instructs that where 
diagnostic equipment is used in a reclined position it must provide 
head and back support that complies with the technical requirements in 
M305.5.
M302.4 Lift Compatibility
    The MDE NPRM proposed to require that diagnostic equipment used by 
patients in the seated position be usable with a patient lift and 
comply with either the proposed clearance in base (proposed M302.4.1) 
or clearance around base (proposed M302.4.2) technical requirements. 
This requirement is identical to the lift compatibility requirement for 
diagnostic equipment used by patients in the supine, prone, or side-
lying position, and is discussed in the Section-by Section Analysis for 
M301.4. In the final rule the Access Board has made an editorial change 
to clarify the type of lift; namely portable patient lift, reduced the 
lift clearance to 39 inches and clarified that the clearance provisions 
only apply when the diagnostic equipment is being used with the 
portable patient lift. See Section V.C.4. (Section-by-Section 
Analysis--M301.4.) Additionally, as discussed above in Section IV.B.3. 
(Significant Changes--Lift Compatibility Exception), the Access Board 
has added an exception for diagnostic equipment that meets the 
following three criteria: Fixed overhead patient lifts are provided for 
use with the diagnostic equipment; the use with the fixed overhead 
patient lift with the diagnostic equipment is permitted by an enforcing 
authority; and the diagnostic equipment is clearly labeled as not 
compatible with portable patient lifts.
M303 Diagnostic Equipment Used by Patients in a Wheelchair
    M303 in the final rule establishes the technical requirements for 
diagnostic equipment used by patients seated in a wheelchair, such as 
weight scales with wheelchair spaces and mammography equipment.
M303.1 General
    This is an introductory section.
M303.2 Wheelchair spaces
    This is an introductory section.
M303.2.1 Orientation
    The MDE NPRM proposed to require wheelchair spaces to be designed 
so that a patient in a wheelchair using diagnostic equipment would be 
oriented in the same direction that other non-wheelchair using patients 
using the equipment are typically oriented. NPRM, 77 FR at 6927. The 
Access Board received one comment about this requirement. The 
commenter, an accessibility consultant, recommended that patient 
positioning be addressed along with orientation of the wheelchair, 
noting that there are many cases where it is insufficient to simply 
position the user facing the same direction as a non-wheelchair user. 
The commenter asserted that body positioning is key for obtaining 
accurate results when using diagnostic devices, such as x-ray 
equipment, and recommends amending the rule text to require wheelchair 
spaces to be designed so that the patient orients and positions their 
body in the same position as someone who is not in a wheelchair. There 
was no recommendation from the MDE Advisory Committee on this 
requirement. The Access Board has retained the original requirement in 
the final rule. The Board did not include requirements for patient body 
positioning because the diagnostic equipment cannot override the 
position in which an individual is seated in his or her wheelchair. 
Wheelchairs often are contoured to fit the specific and unique needs of 
the user and to provide support where it is needed. However, the design 
of a wheelchair space often influences whether a wheelchair user can 
orient with respect to diagnostic components. For example, without knee 
and toe space beneath an optometrist diopter, the patient cannot look 
into the lens.
M303.2.2 Width
    The MDE NPRM proposed to require that diagnostic equipment used by 
patients seated in a wheelchair provide a wheelchair space that was at 
least 36 inches wide. There were no public comments and no MDE Advisory 
Committee recommendations regarding this requirement. Thus, the final 
rule retains the 36-inch wheelchair space width requirement. However, 
the Board added a new exception for wheelchair spaces on raised 
platforms, as discussed in Section IV.C.1. (Significant Changes--Width 
and Depth of Wheelchair Spaces), and discussed briefly below.

[[Page 2836]]

    In the preamble to the MDE NPRM, the Access Board sought input on 
whether an exception to the width requirement was needed for wheelchair 
spaces on raised platforms. Multiple commenters responded to this 
provision and the MDE Advisory Committee recommended reducing the width 
requirement for wheelchair spaces on raised platforms. The Access Board 
has added an exception in the final rule that permits wheelchair spaces 
on raised platforms to be 32 inches wide minimum with edge protection 
no higher than 4 inches, measured from the platform surface.
M303.2.3 Depth
    The MDE NPRM proposed two wheelchair space depth requirements based 
on how the wheelchair user enters the space: For spaces entered from 
the front or rear, 48 inches deep minimum; and for spaces that can only 
be entered from the side, 60 inches deep minimum. In the preamble in 
the MDE NPRM, the Access Board noted it was considering increasing the 
minimum depth for wheelchair spaces entered from the front or rear to 
58 inches and sought input in question 29 on whether the Access Board 
should increase this minimum depth requirement. NPRM, 77 FR at 6928.
    The Access Board received eight comments in response to this 
question. Three commenters (two disability rights organizations and a 
state agency concerned with accessibility) recommended increasing the 
depth of front or rear entered spaces to 58 inches. The other five 
commenters (manufacturers, medical associations and accessibility 
consultants) recommended retaining the proposed requirement in the MDE 
NPRM of 48 inches minimum, raising concerns that the size of the rooms 
in which the diagnostic equipment are located are insufficient to 
provide additional space. The MDE Advisory Committee did not make 
recommendations regarding the general requirement for depth for 
wheelchair spaces, but did make recommendations regarding the depth of 
wheelchair spaces on raised platforms, which is discussed in above in 
Section IV.C.1. (Significant Changes--Width and Depth of Wheelchair 
Spaces).
    First, the Access Board clarifies that this provision is not a 
clear space requirement for wheelchair approach, but is instead the 
wheelchair space integral to diagnostic equipment for a patient seated 
in a wheelchair, such as mammography equipment or wheelchair accessible 
scales. Second, based on the comments received and the absence of 
recommendations from the MDE Advisory Committee to change the proposed 
requirement, the Access Board has retained the MDE NPRM's requirements 
for a minimum depth of 48 inches for wheelchair spaces entered from the 
front or rear, and a minimum depth of 60 inches for wheelchair spaces 
entered from the side. However, the Access Board has reorganized this 
provision into three separate requirements based on how the wheelchair 
space is entered, made an editorial change to clarify that front or 
rear entry is where the wheelchair space entry and exit is provided at 
only one end, and as discussed in Section IV.C.1. (Significant 
Changes--Width and Depth of Wheelchair Spaces), added an additional 
requirement to the depth provision for wheelchair spaces entered from 
the front or rear to permit a minimum of 40 inches if the wheelchair 
space provides pass-through from one end to the other.
M303.2.4 Equipment Clearances
    The MDE NPRM proposed knee and toe clearance for diagnostic 
equipment used by patients seated in wheelchairs to allow for 
components in the wheelchair space which the patient could approach 
successfully to use for its intended diagnostic purpose. The proposed 
requirements for equipment clearances paralleled the knee and toe 
clearance requirements from the 2004 ADA and ABA Accessibility 
Guidelines. The proposed rule provided one additional requirement for 
breast platforms on mammography equipment, proposing the knee and toe 
clearance under a breast platform to be 25 inches deep (proposed 
M303.2.4). The MDE NPRM preamble sought input with question 34 on 
whether the dimensions recommended by the Wheeled Mobility 
Anthropometry Project should be adopted.\10\ Three commenters 
responded. A manufacturer asserted that adopting a different 
requirement than what is already required under existing accessibility 
guidelines and standards would cause confusion and increase costs. A 
medical association asserted that to the best of their knowledge, 
imaging equipment already meets the Wheeled Mobility Anthropometry 
Project recommendations. The final commenter, a state agency concerned 
with accessibility, recommended adopting the new Wheeled Mobility 
Anthropometry Project recommendations. The MDE Advisory Committee only 
provided recommendations pertaining to the knee and toe clearance for 
mammography equipment.
---------------------------------------------------------------------------

    \10\ The Wheeled Mobility Anthropometry Project recommended a 
toe clearance that is 5 inches deep maximum at 14 inches above the 
floor and a knee clearance that is 12 inches deep minimum at 28 
inches above the floor.
---------------------------------------------------------------------------

    The Access Board has determined that mammography equipment presents 
a unique challenge. Mammography equipment contains breast platforms 
which patients seated in wheelchairs must approach, and successfully 
maneuver their lower body under the platform enough to allow their 
chest to be flush with the leading edge of the platform. A separate set 
of equipment clearance requirements is necessary to address the unique 
positioning at mammography equipment. Therefore, in the final rule the 
Access Board has separated out the knee and toe clearance requirements 
into two provisions; breast platforms and other equipment. Breast 
platform requirements address the knee and toe clearance requirements 
for mammography equipment which is usable by patients seated in a 
wheelchair and is discussed in Section IV.C.2. (Significant Changes--
Equipment Clearances for Breast Platforms). All other diagnostic 
equipment used by patients seated in a wheelchair must comply with the 
other equipment clearances requirements.
    For all other equipment, the Access Board has decided to retain the 
original requirements in the proposed rule for knee and toe clearance. 
The Access Board is not persuaded to adopt the Wheeled Mobility 
Anthropometry Project recommendations for knee and toe clearances at 
this time. These recommendations represent a significant departure from 
the 2004 ADA and ABA Accessibility Guidelines. Therefore, the Board has 
elected in the final rule to retain the proposed provisions in the NPRM 
for knee and toe clearance for other equipment (M303.2.4.2). Due to the 
reorganization of the equipment clearances provision in the final rule, 
the knee and toe clearance requirements for the other equipment section 
have been renamed depth and height and relocated to M303.2.4.2. In 
addition, the Access Board has made an editorial change to the toe 
height requirement to clarify that the measurement is taken from the 
toe end of the wheelchair space.
M303.2.5 Surfaces
    The MDE NPRM proposed to require diagnostic equipment used by 
patients seated in a wheelchair to provide a wheelchair space with a 
surface that does not slope more than 1:48 in any direction. This 
provision is consistent with the 2004 ADA and ABA Accessibility 
Guidelines. There were no comments on this section and it was not 
addressed by the MDE Advisory

[[Page 2837]]

Committee. There have been no changes made to this provision.
M303.2.6 Edge Protection
    The MDE NPRM proposed edge protection on the ramps leading up to 
the raised platform (proposed M303.3.3.4), but did not require edge 
protection on the raised platforms themselves. The Access Board 
received two comments and two recommendations from the MDE Advisory 
Committee regarding edge protection on raised platforms. As discussed 
in Section IV.C.5. (Significant Changes--Edge Protection), the final 
rule requires platforms with wheelchair spaces that are raised more 
than 1\1/2\ inches in height to provide a minimum 2-inch-high edge 
protection, measured from the surface of the platform, on each side of 
the platform not providing entry to or exit from the diagnostic 
equipment.
M303.3 Entry
    This is an introductory section.
M303.3.1 Vertical
    The MDE NPRM proposed that for equipment with a change in level at 
the entry to the wheelchair space, level changes of up to \1/4\ inch 
high are permitted to be vertical. This provision is consistent with 
the 2004 ADA and ABA Accessibility Guidelines. There were no comments 
on this section and it was not addressed by the MDE Advisory Committee. 
There have been no changes made to this provision.
M303.3.2 Beveled
    The MDE NPRM proposed that for equipment with a change in level at 
the entry to the wheelchair space, level changes greater than \1/4\ 
inch but not greater than \1/2\ inch would be required to be beveled 
with a slope not steeper than 1:2. This provision is consistent with 
the 2004 ADA and ABA Accessibility Guidelines. There were no comments 
on this section and it was not addressed by the MDE Advisory Committee. 
There have been no changes made to this provision.
M303.3.3 Ramped
    The MDE NPRM proposed that for equipment with a change in level at 
the entry of a wheelchair space, level changes greater than \1/2\ inch 
high would be required to be ramped and comply with technical 
requirements for running slope, cross slope, clear width, edge 
protection, and handrails. The Access Board received one comment on 
this provision. The commenter, a medical association, concurred with 
the requirement for handrails on diagnostic equipment with ramps over 
six inches in height. The MDE Advisory Committee only reviewed and gave 
recommendations on the portion of the provision addressing running 
slope. Therefore, the Access Board has retained the proposed 
requirements for cross slope, clear width, edge protection, and 
handrails in the final rule.
    Regarding running slope, the MDE NPRM proposed that ramp runs have 
a running slope not steeper than 1:12. There were no comments on this 
section; however, as discussed in Section IV.C.3. (Significant 
Changes--Exception to Ramp Running Slope), the MDE Advisory Committee 
made a three-tiered recommendation for the allowable running slope. 
After careful consideration of the Advisory Committee's 
recommendations, the Access Board has retained in the final rule the 
original requirement for running slope, but has added an exception that 
permits a running slope not steeper than 1:8 for ramp runs with a 
maximum height of 2\1/2\ inches. See Section IV.C.3. (Significant 
Changes--Exception to Ramp Running Slope) for a full discussion of the 
rationale for this exception.
M303.4 Components
    The MDE NPRM proposed to require diagnostic equipment used by 
patients seated in a wheelchair which has components that are used to 
examine specific body parts, be capable of examining those body parts 
of the patient while the patient is seated in a wheelchair. For 
example, an x-ray platform on which a patient places an arm or hand 
would have to be capable of examining the arm or hand of the patient 
while seated in a wheelchair. NPRM, 77 FR at 6930. There were no 
comments on this requirement and it was not addressed by the MDE 
Advisory Committee. There have been no changes made to this 
requirement.
M303.4.1 Breast Platform Adjustability
    The MDE NPRM proposed a mammography breast platform height range of 
30 inches high minimum and 42 inches high maximum above the floor. The 
Access Board received three comments on this provision, and the MDE 
Advisory Committee made several recommendations for changes. As 
discussed above in the Section IV.C.4. (Significant Changes--Breast 
Platform Adjustability), the Access Board has revised this provision to 
require the breast platform to be continually adjustable from a low 
height of 26 inches to a high height of 42 inches above the floor and 
made an editorial change to the provision title changing it from height 
to adjustability.
M304 Diagnostic Equipment Used by Patients in Standing Position
    M304 in the final rule establishes the technical criteria for 
diagnostic equipment used by patients in a standing position such as a 
weight scale or x-ray equipment that is used in a standing position for 
certain diagnostic procedures.
M304.1 General
    This is an introductory section.
M304.2 Standing Surface
    The MDE NPRM proposed to require that the standing surface on which 
patients stand be slip resistant. In preparing the final rule, the 
Board has determined that as previously drafted this provision 
unintentionally placed requirements on the facility floor, as opposed 
to restricting the requirements to the diagnostic equipment itself. 
While the Access Board may choose to promulgate requirements for the 
building under its other rulemaking authority at a later date, this 
type of requirement is outside the scope of the MDE Standards and 
therefore M304 in the final rule has been restructured. The requirement 
for slip resistant and standing supports has been moved under this new 
requirement applying to standing surfaces. This reorganization ensures 
that only diagnostic equipment used by patients in a standing position 
that provides a surface for the patient to stand on must be slip 
resistant (M304.2.1) and provide standing supports (M304.2.2) in the 
final rule. Both of these requirements are discussed below.
M304.2.1 Slip Resistant
    The MDE NPRM proposed to require that the standing surface on which 
patients stand be slip resistant. One manufacturer commented on this 
requirement, requesting that the rule provide clarification on how to 
define or measure a standing surface as ``slip resistant.'' This 
provision was not addressed by the MDE Advisory Committee. The Access 
Board has decided to retain the original requirement in the final rule 
as it is the Board's understanding that various industries employ 
different testing methods, there is no universally adopted or specified 
test for slip resistance, and the assessed level varies according to 
the measuring method used. Other than the change to clarify that the 
provision applies only to standing surfaces that are part of the

[[Page 2838]]

diagnostic equipment, there have been no changes to this provision.
M304.2.2 Standing Supports
    The MDE NPRM proposed requiring standing supports on each side of 
the standing surface of diagnostic equipment used by patients in the 
standing position, and compliance with the technical requirements for 
standing supports in proposed M305.3. The Access Board received 
multiple comments and two recommendations from the MDE Advisory 
Committee. As discussed above in the Section IV.D.1. (Significant 
Changes--Standing Supports) and IV.E.2. (Significant Changes--Standing 
Supports), the final rule retains the general requirement that standing 
supports be provided on two sides of the standing surface. In addition, 
the Access Board has added a new exception for diagnostic equipment 
with entry and exit that permits pass-through from one end to another 
to provide one standing support provided it complies with the 
requirements for standing supports in the horizontal position in M305.3 
in the final rule.
M305 Supports
    M305 in the final rule provides the technical requirements for 
transfer supports, standing supports, leg supports, and head and back 
supports. Transfer supports are required for diagnostic equipment 
complying with M301 and M302 and standing supports are required for 
diagnostic equipment complying with M304. Leg supports and head and 
back supports apply, where provided, to diagnostic equipment complying 
with M301 and M302.
M305.1 General
    This is an introductory section.
M305.2 Transfer Supports
    This is an introductory section. As discussed above in Section 
IV.E.1. (Significant Changes--Transfer Supports), the Access Board 
strengthened the transfer support requirements and added additional 
requirements in the final rule to ensure that supports are capable of 
assisting with independent transfer onto and off of the diagnostic 
equipment. With the changes to the final rule, the Board sought to 
harmonize as much as possible, these requirements with the 2004 ADA and 
ABA Accessibility Guidelines for grab bars.
M305.2.1 Location
    The MDE NPRM proposed that transfer supports be located within 
reach of the transfer surface and not obstruct transfer onto or off of 
the surface when in position (proposed M305.2.1). In the preamble to 
the MDE NPRM, the Access Board noted it was considering requiring 
transfer supports to be located no further than 1\1/2\ inches from the 
transfer surface, when measured horizontally, and requiring the 
transfer support to be located on the side of the transfer surface 
opposite the transfer side. NPRM, 77 FR at 6925. The Access Board 
sought public comment with question 19, which asked for input on 
multiple proposed changes to the transfer support provision, including 
whether the proposed location of the transfer support, and the 
requirement that it be located 1\1/2\ inches from the transfer surface, 
would be sufficient to facilitate transfers. Id.
    Eight commenters responded to question 19, but only six of the 
commenters addressed the location of transfer supports. Two commenters, 
a manufacturer and a state agency concerned with accessibility, 
concurred with the technical requirements proposed in question 19 for 
the transfer support location. Another commenter, a disability rights 
organization, stated that transfer supports should be required on both 
sides of the equipment. A manufacturer noted that if the proposed 
transfer surface size of 30 inches wide is adopted, then a transfer 
support opposite the transfer side would be useless as the patient 
would be unable to reach the support until nearly fully on the 
diagnostic equipment. This commenter noted that an adjacent transfer 
support would be more effective, but would conflict with the provider 
expectations of bed and stretcher side rails. The final two commenters, 
a manufacturer and a medical association, raised concerns about 
requiring any transfer supports on imaging equipment, specifically MRI 
and CT machines, asserting that the supports may interfere with the 
image quality.
    The MDE Advisory Committee made three separate recommendations for 
the location of transfer supports: A general requirement, a requirement 
for stretchers, and a requirement for imaging equipment. For the 
general provision, the MDE Advisory Committee recommended requiring 
transfer supports on both sides of the transfer surface that can be 
removed or repositioned during transfer and are located at a maximum 
distance of 1\1/2\ inches from the transfer surface. The Committee 
explained that ``transfer supports or handholds on adjustable medical 
equipment facilitate transfers onto a transfer surface by giving the 
individual something to hold or grab onto while transferring. This 
recommendation for placement of supports on both sides of the equipment 
will increase the options during patient transfers.'' MDE Advisory 
Committee Report, 86, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.
    For stretchers, the MDE Advisory Committee noted that patients 
enter from either of the long sides, rather than on one long side and 
one short side, and this change in orientation necessitated a different 
location for the transfer supports so that the support would be 
reachable during transfer. The MDE Advisory Committee recommended 
locating the transfer support ``along the long side of the transfer 
surface on the opposite side of the transfer.'' MDE Advisory Committee 
Report, 87-88, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. Additionally, the Committee recommended a horizontal 
distance from the transfer surface of no more than 3 inches from the 
edge of the patient support surface, indicating that stretcher transfer 
supports are part of a rail system that needs to fold and store out of 
the way and therefore require more space to articulate. Id. at 96.
    For imaging equipment, the MDE Advisory Committee recommended 
requiring transfer supports when the transfer surface was 24 inches 
deep or less, and requiring positioning supports for transfer surface 
depths of greater than 24 inches. Id. at 88-89. The Committee 
recommended requiring one support on the opposite side of the transfer 
side regardless of whether it was a transfer support or positioning 
support. The Committee noted that:

Because of the size, diversity, and use of diagnostic imaging 
tables, this support will carry out different functions on different 
tables . . . This two-part recommendation recognizes the different 
use of the supports based on the table width. The Committee used a 
24-inch dividing point for table width to accommodate the dimensions 
for the maximum reach range. For transfer surface depths on tables 
less than 24 inches wide, a transfer support must be available on 
the side opposite the entry of the transfer surface . . . For 
transfer surface depths on tables greater than 24 inches wide, a 
positioning support must be available on the side opposite the entry 
to the transfer surface. Id.

    After review of the public comments and the MDE Advisory Committee 
recommendations, the Access Board has determined that there is a need 
for two types of transfer supports, based on the orientation of the 
transfer surface. As

[[Page 2839]]

described in Section IV.B.1.b.(Significant Changes--Transfer Surface 
Location), the Access Board has designated two types of transfer 
surfaces based on orientation for diagnostic equipment used by patients 
in the supine, prone, or side-lying position: End and side transfer 
surfaces, either of which can be employed depending on the 
configuration and use of the particular equipment. Here, a similar dual 
approach is warranted for transfer supports. While the MDE Advisory 
Committee recommended separate requirements based on the type of 
diagnostic equipment, stretchers and imaging equipment, the Access 
Board believes that the type of support should be based on where the 
transfer surface is located on the examination surface. Therefore, the 
Access Board has separated the location provision into end transfer 
supports and side transfer supports. End transfer supports cover 
diagnostic equipment used by patients in the supine, prone, or side-
lying position with end transfer surfaces, M301.2.3.1 in the final 
rule, and all diagnostic equipment with transfer surfaces used by 
patients in the seated position, M302.2 in the final rule. Side 
transfer supports cover diagnostic equipment used by patients in the 
supine, prone, or side-lying position with side transfer surfaces, this 
includes stretchers and most imaging equipment, M301.2.3.2.
    In the final rule the Access Board has decided for end transfer 
supports to require at least one support located on the long side of 
the transfer surface, opposite the transfer side. For side transfer 
supports, the Access Board has decided to require a transfer support 
which is capable of supporting transfer on each side of the transfer 
surface. A side transfer surface could contain one transfer support 
which is capable of being repositioned from one side to the other side 
depending on which side the patient chooses to transfer or it is 
acceptable to have two transfer supports, one on each long side, which 
are both capable of being removed or repositioned on the side the 
patient chooses to transfer. Additionally, the final rule requires both 
end and side transfer supports to be located a maximum of 1\1/2\ inches 
measured horizontally from the nearest edge of the transfer surface to 
the transfer support. In reviewing the MDE Advisory Committee's 
recommendations, the Access Board agrees that transfer supports that 
fold, collapse, or articulate need more space, but disagrees with the 
MDE Advisory Committee that an allowance for more space should apply 
only to stretchers and imaging equipment. The Access Board finds that 
other types of diagnostic equipment, such as hospital beds, also have 
transfer supports that collapse on either side to allow transfer. 
Therefore, the Access Board has provided an exception to the general 
provision which permits supports that fold, collapse, or articulate to 
be located three inches maximum from the nearest edge of the transfer 
surface to the transfer support. Additionally, as discussed in Section 
IV.E.1.b (Significant Changes--Positioning Supports), the Access Board 
has decided not to include positioning supports in the final rule.
M305.2.2 Length
    In the MDE NPRM there was no requirement for length of the transfer 
support; however, the MDE NPRM preamble noted that the Access Board was 
considering requiring the transfer supports to extend the entire depth 
of the transfer surface and be a minimum of 15 inches in length. NPRM, 
77 FR at 6925. The Access Board specifically sought public input with 
question 19, asking if the proposed length of the transfer supports 
would be sufficient to facilitate transfer and maintain position on the 
diagnostic equipment. Id.
    Three commenters responded to this issue, two manufacturers and a 
state agency concerned with accessibility. The state agency concurred 
with the 15-inch requirement. One commenter did not support a 15-inch 
length transfer support. This commenter (a manufacturer) stated that a 
transfer support that is a minimum of 15 inches in length would make it 
even more difficult to comply with load bearing requirements and 
recommended that this length requirement be reduced. The second 
commenter, a manufacturer, recommended revising the proposed provision 
from requiring the transfer support to extend horizontally the entire 
depth of the transfer surface, to extend horizontally along the 
transfer surface to within three inches, to allow for manufacturing 
tolerances.
    The MDE Advisory Committee made three transfer support length 
recommendations, one for each type of transfer support recommended by 
the Committee, described above. For the general provision, the MDE 
Advisory Committee recommended a transfer support with a length of 15 
inches minimum, that overlaps the minimum depth of the transfer surface 
by 80 percent. The Committee explained that the transfer support length 
provides the gripping surface for the patient to grasp or maintain 
balance while transferring. MDE Advisory Committee Report, 90, 
available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. For 
stretchers, the MDE Advisory Committee also recommended 15 inches in 
length stating that this would provide continuous support for patients 
and still accommodate the articulation that is necessary for the head 
and back support on stretchers. Id. For imaging equipment with transfer 
surfaces less than or equal to 24 inches deep, the Committee 
recommended requiring a transfer support to extend horizontally along 
the side of the patient table at the designated transfer location for 
at least the minimum width of the transfer surface, with a minimum 
length of 28 inches. For transfer surfaces greater than 24 inches deep, 
the MDE Advisory Committee recommended requiring a positioning support 
instead of a transfer support, which extends horizontally along the 
side of the patient table 12 to 16 inches and is located at a position 
to accommodate clinical use. Id. at 91-92.
    The Access Board agrees with the MDE Advisory Committee that the 
addition of a requirement for a transfer support length provision is 
necessary and has adopted many of the MDE Advisory Committee's 
recommendations for transfer support length in the final rule. The 
Board restructured the Committee's recommendations to fit within the 
end and side transfer supports discussed above. For end transfer 
supports the Access Board has adopted the general provision recommended 
by the MDE Advisory Committee and determined that the required length 
will be 15 inches minimum. Additionally, the Access Board acknowledges 
that manufacturers need some flexibility with respect to the location 
of the support to account for clearances with other equipment 
components that may articulate or move. Therefore, the final rule 
requires that the 15-inch minimum length transfer support be positioned 
along 13\1/2\ inches minimum of the depth of the transfer surface.
    For side transfer supports the Access Board adopted the MDE 
Advisory Committee recommendation for imaging equipment, that this 
support be a minimum of 28 inches long positioned along the width of 
the transfer surface. In addition, the Board has added two exceptions 
to the requirements for side transfer supports to address the concerns 
raised by the MDE Advisory Committee. The first exception addresses 
articulating patient surfaces, primarily stretchers, where a continuous 
28[hyphen]inch transfer support may conflict with other supports or 
railings as the

[[Page 2840]]

equipment is adjusted. In such cases, the support may be reduced to no 
less than 15 inches in length. The second exception applies to transfer 
supports on imaging bed surfaces of more than 24 inches in width, such 
as large x[hyphen]ray tables, where the support is likely to be used in 
the latter stages of a transfer from a prone or side[hyphen]lying 
position. In these cases, the Access Board finds that permitting the 
transfer support to be no less than 12 inches long is appropriate. 
While the exception is based on an Advisory Committee recommendation 
using the term ``positioning support,'' this is still transfer support, 
that can assist with transfer onto the transfer surface and will likely 
be used to reposition in the later stages of a transfer.
    In question 19 part (e) the Access Board sought input on whether 
angled or vertical transfer supports should be permitted. 77 FR at 
6925. Three commenters, a manufacturer, an accessibility consultant, 
and a disability rights organization, responded and all concurred with 
the proposal. The MDE Advisory Committee did not specifically address 
this proposal, however, in its recommendations for the length of 
transfer supports on imaging equipment, it did recommend that the 
transfer support should extend horizontally along the side of the 
patient table. MDE Advisory Committee Report, 90-91, available at 
https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Access Board 
considered the public comments and the MDE Advisory Committee's 
recommendation, and has decided not to require that transfer supports 
be horizontal, allowing manufacturers flexibility to contour supports 
appropriate for the diagnostic purpose of the equipment.
M305.2.3 Height
    In the MDE NPRM there was no specific requirement regarding the 
height of the transfer support, only that it be ``within reach'' of the 
patient (proposed M305.2.1). The Access Board sought input from the 
public in question 20 of the MDE NPRM preamble, on whether a transfer 
support height requirement of 6 inches minimum and 19 inches maximum 
above the transfer surface would be usable by patients with 
disabilities. NPRM, 77 FR at 6925. Six commenters responded to question 
20. Four commenters (two manufacturers, one disability rights 
organization, and a state agency concerned with accessibility) 
supported the proposed height range. Three commenters (a manufacturer, 
a medical association, and a disability rights organization) did not 
support the proposal. The manufacturer opposing the proposed range 
raised concerns with its ability to attain a 19-inch height on its 
diagnostic equipment. The medical association asserted that radiography 
exam tables are not equipped with transfer bars, and if required should 
retract fully into the surface of the table and the disability rights 
organization expressed concern that 19 inches was too high to 
facilitate safe transfer.
    The MDE Advisory Committee supported adding a requirement setting 
the height of transfer supports within the range described in question 
20 in the MDE NPRM preamble, of 6 inches minimum and 19 inches maximum. 
The MDE Advisory Committee explained that the manufacturers on the 
Committee determined that this recommendation did not conflict with the 
IEC 60601-2-52, which provides requirements for side rails to prevent 
entrapment hazards, and would allow the equipment to be designed to 
provide accessibility and safety from entrapment hazards. MDE Advisory 
Committee Report, 94, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. Additionally, for transfer surfaces that are 
greater than 24 inches deep, the MDE Advisory Committee recommended 
requiring a positioning support instead of a transfer support, with a 
height of three to six inches above the transfer surface. Id.
    The Access Board considered the public comments and the MDE 
Advisory Committee's recommendations, and has decided to include a new 
provision, M305.2.3 in the final rule, that requires the tops of 
transfer support gripping surfaces to be located 6 inches minimum and 
19 inches maximum higher than the top of the associated uncompressed 
transfer surface during use. This range allows the manufacturer to 
choose a height between 6 inches and 19 inches to place their transfer 
supports; it does not require that the transfer supports be 19 inches 
high. The transfer support is permitted to be horizontal, angled, 
curved, or a combination of these as long as the top of any point along 
the gripping surface is located at or between 6 inches and 19 inches. 
Thus, the commenter's concern about reaching the 19-inch height is not 
warranted. Secondly, as discussed above in Section IV.E.1.b 
(Significant Changes --Positioning Supports), the Access Board has 
declined to include the MDE Advisory Committee's recommended 
positioning supports in the final rule; however, the Access Board does 
concur with the MDE Advisory Committee that for imaging equipment with 
transfer surfaces that exceed 24 inches in width, a lower transfer 
support is warranted. Therefore, in the final rule, the Access Board 
has provided an exception that permits transfer supports to be located 
three inches minimum and six inches maximum higher than the tops of the 
transfer surfaces for imagining beds that are greater than 24 inches 
wide.
M305.2.4 Cross Section
    The proposed rule did not provide specific requirements for the 
cross section of transfer supports. However, in the MDE NPRM preamble, 
the Access Board noted that it was considering adopting the cross 
sectional dimensions for grab bars from the 2004 ADA and ABA 
Accessibility Guidelines for transfer supports. NPRM, 77 FR at 6925-
6926. Specifically, the Access Board indicated it was considering 
requiring circular cross sections to have an outside diameter of 1\1/4\ 
inches minimum and 2 inches maximum, and transfer supports with non-
circular cross sections to have a cross section dimension of 2 inches 
maximum, and a perimeter dimension of 4 inches minimum and 4.8 inches 
maximum. Id. The Access Board sought input in MDE NPRM preamble 
question 21, on whether the gripping surfaces of current transfer 
supports on different types of equipment meet the cross sectional 
dimensions specified above and whether handholds that meet the above 
cross section dimensions could be integrated into armrests that are 
also cushioned to support arms and elbows. Id.
    Five commenters responded to question 21. Two commenters (one 
manufacturer and one accessibility consultant) were opposed to 
permitting non-rounded cross sections, noting concern that harsh edges 
or angles may not allow users to comfortably and adequately grasp the 
support. One commenter (a manufacturer) asserted that because currently 
there are no standards, existing products would likely not meet the 
proposed provision. Another commenter (a manufacturer) was concerned 
that the requirement could preclude the use of cushioned arm pads.
    The MDE Advisory Committee expressed confidence ``in reliance on 
the cross section dimensions in the 2010 Standards.'' MDE Advisory 
Committee Report, 99, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Committee further opined:


[[Page 2841]]


    Allowing both noncircular cross sections and circular cross 
sections gives manufacturers flexibility to employ the best 
configuration for use of the equipment, hand, grip strength, and 
power grab functions. While a majority of the Committee members 
supported a recommendation allowing both noncircular and circular 
cross sections, some members noted ergonomic considerations support 
the better functionality of circular cross section gripping surface. 
Id.

    After review of the comments and the MDE Advisory Committee's 
recommendations, the Access Board has decided to apply the 2004 ADA and 
ABA Accessibility Guidelines for grab bar cross sections to transfer 
supports in the final rule. Accordingly, the final rule includes a new 
provision, M305.2.4, requiring transfer supports to have one of two 
cross sections: circular cross sections, with an outside diameter of 
1\1/4\ inches minimum and 2 inches maximum; or non[hyphen]circular 
cross sections, a cross section dimension of 2 inches maximum and a 
perimeter dimension of 4 inches minimum and 4.8 inches maximum.
M305.2.5 Surface Hazards
    The proposed rule did not provide any specific restrictions 
regarding surface hazards around the transfer supports. No public 
comments were submitted on this issue, but the MDE Advisory Committee 
voiced concern about surface hazards stating, ``gripping surface 
configurations must provide an effective and safe surface for patients 
to hold onto. Sharp edges or abrasive elements may injure and cause the 
patient to lose their grip during positioning or transfer.'' The MDE 
Advisory Committee recommended that a provision be added to the final 
rule requiring ``gripping surfaces to be free of sharp or abrasive 
elements and have rounded edges.'' The Committee based this 
recommendation on related provisions in the 2004 ADA and ABA 
Accessibility Guidelines for handrails and grab bars. MDE Advisory 
Committee Report, 101, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.
    The Access Board concurs with the MDE Advisory Committee's 
recommendation and views the proposed provision as beneficial and 
consistent with the cross section requirements of M305.2.4, above. 
Therefore, the Access Board has added a new provision to the final 
rule, M305.2.5 Surface Hazards, to ensure that transfer supports and 
surfaces adjacent to transfer supports are free of sharp or abrasive 
components and have eased edges.
M305.2.6 Gripping Surfaces
    The proposed rule did not provide any specific requirements 
regarding gripping surfaces on transfer supports. However, in the MDE 
NPRM preamble the Access Board repeatedly noted that it was considering 
applying many of the provisions from the 2004 ABA and ADA Accessibility 
Guidelines for grab bars and handrails to transfer supports. NPRM, 77 
FR at 6924-6926. The MDE Advisory Committee explained that:

[t]ransfer supports may contain elements to provide structural 
support or prevent patient entrapment. The elements, bars, pickets, 
spacers, panels, and similar features, connect to the transfer 
support and may interrupt the gripping surface. At the point of 
connection, these features impede the ability to grasp completely 
around the cross section of the gripping surface. MDE Advisory 
Committee Report, 102, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Committee recommended requiring the 
bottom of the transfer support to have no obstructions affecting 
more than 20 percent of the transfer support's length. Id.

    The Access Board concurs with the recommendation of the MDE 
Advisory Committee and views the proposed provision as beneficial and 
consistent with the existing accessibility guidelines. Therefore, the 
Access Board has added this new provision to the final rule, M305.2.6, 
which ensures that an adequate surface area for gripping is provided to 
the patient.
M305.2.7 Clearance
    In the MDE NPRM, the Access Board did not provide any specific 
requirements for clearances around the transfer support. However, in 
the preamble to the MDE NPRM the Access Board noted that it was 
considering applying the 2004 ADA and ABA Accessibility Guidelines for 
clearance around grab bars to the transfer support provision in the 
final rule. NPRM, 77 FR at 6926. Specifically, the Access Board sought 
input from the public in question 22, on whether transfer supports on 
diagnostic equipment could provide 1\1/2\ inches minimum clearance 
around the gripping surface. Id. Two commenters responded, both 
manufacturers, and indicated that transfer supports could provide 1\1/
2\ inches minimum clearance around the transfer support. The MDE 
Advisory Committee concurred with the commenters and expressed support 
for the use of the 2010 ADA Standards and International Building Code 
Requirements (ICC/ANSI A117.1-2009), and recommended adding the 
requirements to the final rule. MDE Advisory Committee Report, 100, 
available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.
    Based on public commenter responses and MDE Advisory Committee 
recommendations, the Access Board has added a new provision to the 
final rule, M305.2.7, requiring a 1\1/2\ inch minimum clearance between 
the transfer support gripping surface and adjacent surfaces or 
obstructions.
M305.2.8 Fittings
    The MDE NPRM proposed to require that transfer supports not rotate 
in their fittings (proposed M305.2.3). Five commenters addressed this 
provision. Four of the commenters disagreed with this requirement and 
explained the need for transfer supports to be able to rotate in their 
fittings. Specifically, one commenter (manufacturer) asserted that the 
technical criteria from the 2004 ADA and ABA Accessibility Guidelines 
for grab bars in bathrooms should not be applied to exam tables as they 
would restrict the ability for the transfer supports to be moved out of 
the way after transfer. Further, this commenter noted that the 
requirement conflicts with proposed M302.2.3, which allows for 
temporary obstructions such as armrests, footrests, and side rails that 
can be repositioned to allow for transfer. Another commenter 
(manufacturer) pointed out that bed rails, which are common on hospital 
beds, require a latched position and an unlatched position, which 
allows them to rotate in their fittings when not latched. A different 
manufacturer stated that its seated diagnostic equipment uses armrests 
as transfer supports, which can be pushed back toward the rear of the 
equipment to allow entry. An accessibility consultant recommended 
swing-away or removable armrests for chairs to allow for transfer on 
either side. The only commenter (accessibility consultant) opposed to 
allowing transfer supports to rotate in their fittings, expressed 
concern for the potential for injury if transfer supports rotated 
unexpectedly during transfer.
    The MDE Advisory Committee recommended amending this provision to 
allow transfer supports to rotate in their fittings, but to require 
that they not rotate when they are locked into place for transfer. The 
Committee noted that it is advantageous to allow supports to perform 
the needed movement, but they should not do so when locked. MDE 
Advisory Committee Report, 102-103, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

[[Page 2842]]

    The Access Board concurs with the majority of the commenters and 
the MDE Advisory Committee. As noted in proposed M302.2.3, the Access 
Board intended to allow manufacturers to provide temporary obstructions 
such as armrests and bedrails that can be repositioned, or rotate in 
their fittings, and then be locked into place when needed as a transfer 
support. Therefore, the Access Board has revised this provision in the 
final rule to require that transfer supports do not rotate in their 
fittings when in place for transfer (M305.2.8).
M305.3 Standing Supports
    M305.3 provides the technical requirements for standing supports 
which are required on diagnostic equipment covered by M304. This 
provision has been reorganized in the final rule into requirements for 
length and height, as opposed to vertical and horizontal.
    In the MDE NPRM preamble, the Access Board noted that it was 
considering adopting the cross section dimensions for grab bars from 
the 2004 ADA and ABA Accessibility Guidelines and applying them to 
standing supports. The Access Board sought public input in questions 39 
and 40 in the MDE NPRM preamble on whether the cross section dimensions 
for gripping surfaces should be applied to standing supports and 
whether standing supports can provide a 1\1/2\ inch minimum clearance 
around the gripping surface. Three commenters responded to question 39 
(a medical association, accessibility consultant, and a state agency 
concerned with accessibility). All three concurred with adding cross 
section dimension requirements to standing supports. Two commenters 
responded to question 40 (one medical association and a state agency 
concerned with accessibility), and both concurred that diagnostic 
equipment could provide a 1\1/2\ inch minimum clearance around the 
gripping surface of standing supports. The MDE Advisory Committee did 
not address the cross section and clearance proposal for standing 
supports. Unlike transfer supports, standing supports can be horizontal 
or vertical and thus there will be variations in the configuration of 
standing supports dependent on the equipment configuration. Due to this 
wide variety of allowable standing supports and the significant 
difference in the nature of how a standing support is used versus a 
transfer support, the Access Board has decided not to adopt cross 
section dimensions or require a minimum clearance around the gripping 
surface for standing supports in the final rule.
    Additionally, one commenter (manufacturer) requested that 
requirements for structural strength be added to the standing support 
provision. For the same reasons the Access Board has removed the 
requirement of structural strength for transfer supports (See Section 
IV.E.1.a. (Significant Changes--Structural Strength) the Access Board 
declines to adopt such a requirement for standing supports in the final 
rule.
M305.3.1 Length
    In the MDE NPRM, the Access Board proposed a gripping surface 
length of four inches minimum for horizontal standing supports. No 
public comments were submitted on this requirement. The MDE Advisory 
Committee supported the proposed technical provisions, but recommended 
adding additional criteria for standing supports on raised platforms 
with wheelchair spaces. As discussed above in the Section IV.E.2. 
(Significant Changes--Standing Supports), the final rule requires that 
horizontal standing supports be positioned horizontally in relation to 
standing surfaces and retains the proposed requirement of four inches 
minimum length. The Access Board added a new provision applying to 
diagnostic equipment containing a wheelchair space that also requires 
standing supports. This provision, M305.3.1.2 in the final rule, has 
added two new requirements for this type of equipment. First, for 
diagnostic equipment containing wheelchair spaces with one entry that 
also serves as the exit, the length of the gripping surface for 
horizontal standing supports must be equal to or greater than 80 
percent of the overall length of the platform. Second, for diagnostic 
equipment with wheelchair spaces that permit pass-through from one end 
to the other, the length of the gripping surface for the horizontal 
standing support must be at least equal to the length of the platform. 
In the final rule these requirements are located in M305.3.1.1 
Horizontal Position and M305.3.1.2 Diagnostic Equipment Containing a 
Wheelchair Space.
    For vertical standing supports, the MDE NPRM proposed a gripping 
surface length of 18 inches minimum. There were no public comments 
submitted on this requirement, and the MDE Advisory Committee supported 
the proposed technical provisions. In the final rule, the Access Board 
retained the original requirement for gripping surface length and 
clarified that the vertical standing supports must be positioned 
vertically in relation to the standing surface. Both requirements are 
included in the new M305.3.1.3 Vertical Position provision in the final 
rule.
M305.3.2 Height
    For horizontal supports, the MDE NPRM proposed a gripping surface 
height of 34 inches minimum and 38 inches maximum above the standing 
surface. There were no public comments on this requirement, and the MDE 
Advisory Committee supported the proposed technical provisions. In the 
final rule the Access Board retains the original requirement. This 
requirement has been relocated to M305.3.2.1 in the final rule.
    For vertical supports, the MDE NPRM proposed that the bottom end of 
the support be 34 inches high minimum and 37 inches high maximum above 
the standing surface. There were no public comments on this 
requirement, and the MDE Advisory Committee supported the proposed 
technical provisions. In the final rule the Access Board retains the 
original requirement, but made a few minor editorial changes to the 
text. This requirement has been relocated to M305.3.2.2 in the final 
rule.
M305.3.3 Fittings
    The MDE NPRM proposed to prohibit standing supports from rotating 
in their fittings. There were no comments on this section and it was 
not addressed by the MDE Advisory Committee. The Access Board made no 
changes to this provision.
M305.4 Leg Supports
    As discussed above in Section V.C.3.b (Section-by-Section 
Analysis--M301.3.2) and Section V.C.7.b (Section-by-Section Analysis--
M302.3.2), the technical requirements for leg supports from M301 and 
M302 have been relocated to M305 Supports. The MDE NPRM proposed that 
where stirrups are provided, they must provide a method to support, 
position, and secure the patients legs. Four commenters (medical 
association, accessibility consultant, disability rights organization, 
and a state agency) agreed with requiring leg supports when stirrups 
are provided.
    The MDE Advisory Committee agreed that, for procedures that use 
stirrups and require the leg to be stable, there must be a method to 
support the patient's legs. The Committee referenced 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 the 
appropriate position.'' MDE Advisory Committee

[[Page 2843]]

Report, 105, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee recommended adding additional 
language to this provision to clarify that ``where the equipment 
provides stirrups, it must also provide an alternate method to support, 
position, and secure the patients legs (specifically including 
sufficient support of the patient's thigh, knee, and calf to stabilize 
the leg). This method will either supplement or serve as a substitute 
for the stirrups.'' Id.
    After reviewing the MDE Advisory Committee recommendations, the 
Access Board has decided that the proposed provision is sufficient to 
require the leg support advocated by the MDE Advisory Committee and has 
therefore not adopted the MDE Advisory Committee recommendation to 
require an alternate method of leg supports. However, in the final rule 
the Access Board has made an editorial change in terminology, from 
stirrups to leg supports, in response to the MDE Advisory Committee 
recommendation and to provide consistency with the headings of other 
support provisions that are based on the body part supported.
M305.4 Head and Back Support
    As discussed above in Section V.C.3.c (Section-by-Section 
Analysis--M301.3.3) and Section V.C.7.c. (Section-by-Section Analysis--
M302.3.3), the technical requirements for head and back supports from 
M301 and M302 have been relocated to M305 Supports. The MDE NPRM 
proposed to require diagnostic equipment used by patients in the 
supine, prone, or side-lying position and the seated position that can 
be adjusted to a reclined position to provide head and back support 
throughout the entire range of the incline. Three manufacturers 
commented on this provision. One manufacturer asserted that this 
requirement was ambiguous and that he had to read it multiple times to 
understand it; however, this commenter also indicated that the tables 
it currently manufactures meet the proposed requirement. Another 
manufacturer noted that existing MRI equipment meets this requirement. 
The final manufacturer asserted that a reclining backrest necessarily 
provides head and back support, unless the Access Board intended a 
different meaning for ``support.'' The MDE Advisory Committee did not 
review the proposed requirement for head and back support, and thus 
provided no recommendations on this requirement.
    After review of the comments, the Access Board has decided not to 
make any changes to this provision in the final rule. All of the 
commenters on this topic agree that current diagnostic equipment meets 
the proposed requirement and the Access Board believes that this 
requirement is clearly articulated. Therefore, the final rule requires 
that where diagnostic equipment can be adjusted to a reclined position, 
head and back support must be provided.
M306 Communication
    M306 in the final rule provides the technical criteria for 
communication from the diagnostic equipment to the patient.
M306.1 General
    The MDE NPRM proposed that, where diagnostic equipment communicates 
instructions or other information to the patient, the instructions or 
information must be provided in at least two of the following methods: 
Audible, visible, or tactile (proposed M306.1). The Access Board sought 
public input in question 41 in the preamble to the MDE NPRM, on whether 
diagnostic equipment that communicates instructions or other 
information to the patient should provide information in all three 
methods of communication, and what the cost to provide all three 
methods would be. NPRM, 77 FR at 6931. Seven commenters responded. 
Three commenters (a manufacturer, a medical association, and a state 
agency concerned with accessibility) concurred with the proposed 
requirement to provide two methods of communication. Three commenters 
(two disability rights organizations and one medical association) 
supported requiring all three modes of communication, and the final 
commenter (a manufacturer) recommended requiring one mode of 
communication if the medical provider is present and three modes of 
communication for home use devices. The MDE Advisory Committee did not 
address this provision.
    The Access Board carefully considered the public comments; however, 
it has decided to retain the provision from the proposed rule, 
requiring diagnostic equipment that communicates instructions or other 
information to the patient to provide the communication in two methods. 
The commenters were split in their support of two or three methods of 
communication and the commenters supporting the increase to three 
methods of communication provided no additional information to warrant 
the increase. The commenter that recommended different requirements for 
home-use equipment is not dispositive as this rule does not cover any 
home use equipment. The Access Board has concluded that providing two 
means of communication will serve the majority of people and that there 
was not enough information provided to warrant an increase in this 
requirement in the final rule.
M307 Operable Parts
    M307 in the final rule provides the technical criteria for operable 
parts used by patients to activate, deactivate, or adjust the 
diagnostic equipment. 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. There were no comments 
received on the proposed provisions, and as discussed below, the 
provisions from the proposed rule have been retained in the final rule.
    The Access Board did receive comments in response to question 43, 
which sought public input on whether the final rule should include 
reach range requirements such as those in the 2004 ADA and ABA 
Accessibility Guidelines for an unobstructed forward reach or side 
reach for the operable parts provision. Five commenters responded, one 
commenter (state agency concerned with accessibility) recommended 
adopting the reach ranges and four commenters (one medical association, 
one academic, and two disability rights organizations) recommended 
against adding reach ranges for operable parts to the final rule. One 
of these commenters (disability rights organization) explained that the 
2004 ADA and ABA requirements are not appropriate for application to 
operable parts of medical diagnostic equipment. The MDE Advisory 
Committee did not address this provision. Based on the majority of the 
commenters response, the Access Board has decided not to add reach 
ranges to the operable parts section at this time.
M307.1 General
    This is an introductory section.
M307.2 Tactilely Discernible
    The MDE NPRM proposed that operable parts intended for patient use 
be tactilely discernible without activation. Patients who are blind or 
have low vision have difficulty

[[Page 2844]]

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. There were no public comments on this section 
and it was not addressed by the MDE Advisory Committee. There have been 
no changes made to this provision.
M307.3 Operation
    The MDE NPRM proposed to require operable parts to be operable with 
one hand and not require tight grasping, pinching, or twisting of the 
wrist. There were no public comments on this section and it was not 
addressed by the MDE Advisory Committee. There have been no changes 
made to this provision.
M307.4 Operating Force
    The MDE NPRM proposed to restrict the force required to activate 
operable parts to 5 pounds. The Access Board sought public input on 
this provision in question 42 on whether the operating force should be 
reduced to 2 pounds. NPRM, 77 FR at 6932. One commenter, a state agency 
concerned with accessibility, responded and concurred with the 
suggested reduction. The MDE Advisory Committee did not address this 
requirement. Although the Access Board initially considered a reduction 
in the force required to activate operable parts, upon further 
consideration, the Board found no reason to deviate from the long-
established maximum of 5 pounds in the 2004 ADA and ABA Accessibility 
Guidelines. 36 CFR part 1191, App. D 309.4. Therefore, there have been 
no changes made to this provision.

VI. Regulatory Process Matters

A. Final Regulatory Assessment (E.O. 13563 and E.O. 12866)

    Executive Orders 13563 and 12866 direct 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. Important goals of regulatory 
analysis are to (1) establish whether federal regulation is necessary 
and justified to achieve a market failure or other social goal and (2) 
demonstrate that a range of reasonably feasible regulatory alternatives 
have been considered and that the most efficient and effective 
alternative has been selected. Executive Order 13563 also recognizes 
that some benefits are difficult to quantify and provides that, where 
appropriate and permitted by law, agencies may consider and discuss 
qualitatively those values that are difficult or impossible to 
quantify, including equity, human dignity, fairness, and distributive 
impacts.
    The final rule, which sets forth the MDE Standards, is a 
significant regulatory action within the meaning of Executive Order 
12866. See E.O. 12866 Sec.  3(f)(4), 58 FR 51735 (Oct. 4, 1993) 
(defining ``significant regulatory action'' as, among other things, 
regulatory action that raises novel legal or policy issues). 
Accordingly, we prepared a final regulatory assessment (Final RA) to 
accompany the MDE Standards. The Final RA is available on the Access 
Board's Web site (www.access-board.gov), as well the federal 
government's online rulemaking portal (www.regulations.gov). Summarized 
below are some of the key findings of this regulatory assessment.
    Section 510 of the Rehabilitation Act, as amended by the Patient 
Protection and Affordable Care Act, requires the Access Board, in 
coordination with the Food and Drug Administration, to issue 
accessibility standards that contain minimum technical criteria to 
ensure that medical diagnostic equipment is accessible to and usable by 
patients with disabilities. Examples of such diagnostic equipment 
include examination tables and chairs, weight scales, mammography 
equipment, and other imaging equipment. The Access Board is now issuing 
the final rule pursuant to this authority.
    The MDE Standards set forth minimum technical criteria for medical 
diagnostic equipment to facilitate access and use of medical diagnostic 
equipment by persons with disabilities, most particularly those with 
mobility- or communication-related impairments. However, under Section 
510, the Access Board is statutorily tasked only with promulgation (and 
revision) of these Standards. Although the MDE Standards do not have 
legal effect until adopted (in whole or in part) by an enforcing 
authority, they can advance accessibility to medical services for 
persons with disabilities by providing specific guidance concerning 
accessible medical diagnostic equipment that can be used by service 
providers in a voluntary manner.
    At this point, the Board does not know whether enforcing 
authorities will adopt the MDE Standards, nor (if they do) to what 
extent health care practices or particular types of medical diagnostic 
equipment will be required to comply with the Standards' technical 
requirements. For this reason, the Board cannot estimate the 
incremental monetary or quantitative impacts of the final rule.
    Nevertheless, the Board is able to characterize qualitatively some 
of the potential impacts of these Standards. If enforcing agencies 
adopt the MDE Standards as mandatory for entities regulated under their 
jurisdiction, the Standards could affect health care providers, medical 
device manufacturers, and individuals with disabilities. Once health 
care providers and facilities are required to acquire accessible 
medical equipment, they could incur compliance costs, to the extent 
that their equipment is not already accessible. Medical device 
manufacturers would then decide whether to incur incremental costs to 
meet the demand for accessible equipment, and some or many 
manufacturers may have an economic incentive to produce accessible 
equipment. Finally, given the many barriers to health care that 
patients with disabilities encounter due to inaccessible medical 
diagnostic equipment, individuals with mobility and communication 
disabilities will benefit from access to and use of diagnostic 
equipment meeting the MDE Standards. Consequently, they may be able to 
receive health care comparable to that received by their non-disabled 
counterparts.
    In addition, the Standards could yield some immediate benefits, 
even before any adoption by implementing agencies in formal rulemaking. 
First, the technical specifications for accessible MDE incorporated in 
the Standards will benefit enforcing agencies that are considering 
similar accessibility requirements for entities under their 
jurisdiction. Although enforcing agencies have full authority over 
whether to adopt the Access Board's final rule (in whole or in part), 
the technical specifications in the MDE Standards reflects the input 
from a diverse set of stakeholders and provide solid groundwork for any 
future rulemaking pertaining to the accessibility of medical diagnostic 
equipment. Second, the Standards will serve as a best-practice document 
for the medical device industry and for health care providers and 
facilities. While the MDE Standards are non-binding, health care 
providers can use this final rule as

[[Page 2845]]

guidance on how to provide equitable access to medical diagnostic 
equipment for people with mobility and communication disabilities. 
Manufacturers can also use the MDE Standards as they target their 
research and development efforts at producing diagnostic equipment that 
can be used by a larger segment of population--one that includes more 
people with disabilities and older adults.
    The Board thus concludes that the potential benefits of the MDE 
Standards justify the potential costs; that the MDE Standards will 
impose the least burden on society, consistent with achieving the 
regulatory objectives; and that the regulatory approach selected will 
maximize net benefits.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) requires federal agencies to 
analyze the impact of regulatory actions on small entities, unless an 
agency certifies that the rule will not have a significant impact on a 
substantial number of small entities. 5 U.S.C. 604, 605(b). The MDE 
Standards do not impose any mandatory requirements on any entity, 
including small entities. Therefore, we did not prepare a final 
regulatory flexibility analysis for the final rule.

C. Executive Order 13132: Federalism

    The MDE Standards do not impose any mandatory requirements on state 
and local governments. The MDE 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 MDE 
Standards do not preempt state law. Therefore, the consultation and 
other requirements of Executive Order 13132 (Federalism) do not apply.

D. 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.

E. Paperwork Reduction Act

    Under the Paperwork Reduction Act (PRA), federal agencies are 
generally prohibited from conducting or sponsoring a ``collection of 
information'' as defined by the PRA, absent OMB approval. See 44 U.S.C. 
3507 et seq. The MDE Standards do not impose any new or revised 
collections of information within the meaning of the PRA.

List of Subjects in 36 CFR Part 1195

    Health care, Individuals with disabilities, Medical devices.

    Approved by vote of the Board on September 14, 2016.
David M. Capozzi,
Executive Director.


0
For the reasons stated in the preamble, the Access Board adds 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. 
Advisory sections and figures that illustrate the technical 
requirements in the appendix to part 1195 are available on the Internet 
at: www.access-board.gov. These advisory materials provide guidance 
only and do not contain mandatory requirements.

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

Table of Contents

Chapter 1: Application and Administration

M101 General
M102 Definitions

Chapter 2: Scoping

M201 General

Chapter 3: Technical Requirements

M301 Diagnostic Equipment Used by Patients in Supine, Prone, or 
Side-Lying Position
M302 Diagnostic Equipment Used by Patients in Seated Position
M303 Diagnostic Equipment Used by Patients Seated in a Wheelchair
M304 Diagnostic Equipment Used by Patients in Standing Position
M305 Supports
M306 Communication
M307 Operable Parts

Chapter 1: Application and Administration

M101 General

    M101.1 Purpose. These Standards (MDE Standards) contain scoping 
and technical requirements for medical diagnostic equipment 
(diagnostic equipment) to ensure accessibility to, and usability of 
the diagnostic equipment by patients with disabilities. The MDE 
Standards provide for independent access to, and use of, diagnostic 
equipment by patients with disabilities to the maximum extent 
possible.
    M101.2 Application. Sections M301 through M304 shall be applied 
to diagnostic equipment, based on the patient positions that the 
equipment supports, during patient transfer and diagnostic use. 
Sections M306 and M307 shall be applied to diagnostic equipment 
where communication features or operable parts are provided for 
patient use.
    M101.3 Existing Diagnostic Equipment. The MDE Standards do not 
address the applicability of scoping or technical requirements to 
existing diagnostic equipment. Enforcing authorities, such as the 
Department of Justice or the Department of Health and Human 
Services, have authority over the accessibility of existing 
equipment and any regulation of that equipment will be effective 
only to the extent required by such enforcing authorities.
    M101.4 Equivalent Facilitation. The use of alternative designs 
or technologies that result in substantially equivalent or greater 
accessibility and usability than specified in the MDE Standards is 
permitted.
    M101.5 Dimensions. The MDE Standards are based on adult 
dimensions and anthropometrics. Dimensions that are not stated as 
``maximum'' or ``minimum'' are absolute.
    M101.6 Dimensional Tolerances. Dimensions are subject to 
conventional industry tolerances for manufacturing processes, 
material properties, and field conditions.
    M101.7 Units of Measurement. Measurements are stated in U.S. 
customary and metric units. The values stated in each system (U.S. 
customary and metric units) may not be exact equivalents, and each 
system shall be used independently of the other.

M102 Definitions

    M102.1 Defined Terms. For the purpose of the MDE Standards, the 
following terms have the indicated meaning:
    End Transfer Surface. A transfer surface located at one end of 
an examination surface that allows patient transfer at the end and 
one adjoining side of the examination surface.
    Enforcing Authority. An agency or other governmental entity that 
adopts the MDE Standards as mandatory requirements for entities 
subject to its jurisdiction. Enforcing authorities may include, but 
are not limited to the United States Departments of Justice and 
Health and Human Services.
    Examination Chair. Diagnostic equipment with a seat in which a 
patient typically is positioned with buttocks approximately parallel 
to the ground and shins approximately perpendicular to the ground. 
Examination chairs typically have back support and may recline to 
properly position the patient during examination. Such chairs may 
also have footrests or stirrups. Examination chairs include, but are 
not limited to, equipment used for dental, ophthalmic, podiatric, 
gynecological,

[[Page 2846]]

urological, and ear, nose, and throat examinations.
    Imaging bed. A component of diagnostic scanning equipment that 
accommodates patients in supine, prone, or side-lying positions.
    Imaging equipment with bores. Diagnostic scanning equipment 
using magnets, x-rays, or detectors into which a patient and the 
table on which the patient lies is inserted into the equipment 
through a cylindrical opening (bore) in order to achieve the 
positioning accuracy needed during the scan. Such equipment 
includes, but is not limited to, computerized axial tomography (CT 
or CAT), positron emission tomography (PET), and nuclear medicine 
(NM) scanning equipment or a combination thereof.
    Medical Diagnostic Equipment (Diagnostic Equipment). Equipment 
used in, or in conjunction with, medical settings by health care 
providers for diagnostic purposes.
    Operable Parts. Components of diagnostic equipment that are used 
by the patient to activate, deactivate, or adjust the equipment.
    Side Transfer Surface. A transfer surface located within the 
length of the examination surface that allows patient transfer on 
two opposing sides of the examination surface.
    Transfer Surface. Part of diagnostic equipment onto which 
patients who use mobility devices or aids transfer when moving onto 
and off of the equipment.
    Wheelchair Space. Space for a single wheelchair and its 
occupant.
    M102.2 Undefined Terms. Terms not defined in M102.1 or in 
regulations or policies issued by an enforcing authority shall be 
given their ordinarily accepted meaning 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 2: Scoping

M201 General

    M201.1 Application by Enforcing Authority. The enforcing 
authority shall specify the number and type of diagnostic equipment 
that are required to comply with the MDE Standards.
    M201.2 General Exception. Medical diagnostic equipment shall not 
be required to comply with one or more applicable requirements in 
the MDE Standards in the rare circumstances where compliance would 
alter diagnostically required structural or operational 
characteristics of the equipment and would prevent the use of the 
equipment for its intended diagnostic purpose. Diagnostic equipment 
subject to M201.2 shall comply to the maximum extent practicable.

Chapter 3: Technical Requirements

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

    M301.1 General. Diagnostic equipment that supports patients in a 
supine, prone, or side-lying position shall comply with M301.
    Exception: Examination chairs complying with M302 that recline 
to facilitate diagnosis after patients transfer onto the chair shall 
not be required to comply with M301.
    M301.2 Transfer Surface. A transfer surface shall be provided 
and shall comply with M301.2.
    M301.2.1 Adjustability. Transfer surfaces shall be adjustable in 
height measured from the floor to the top of the uncompressed 
transfer surface and shall provide the following:
    A. A low transfer position at a height of 17 inches (430 mm) 
minimum and 19 inches (485 mm) maximum;
    B. A high transfer position at 25 inches (635 mm); and
    C. At least 4 additional transfer positions located between the 
low and high transfer positions and separated by 1 inch (25 mm) 
minimum.
    M301.2.2 Sunset. The low transfer position height, Item A of 
M301.2.1, shall cease to have effect on January 10, 2022.
    M301.2.3 Size. The size of the transfer surface shall comply 
with M301.2.3.1 or M301.2.3.2. The size of transfer surfaces shall 
be measured from center points of their opposing sides.
    M301.2.3.1 End Transfer Surface. End transfer surfaces shall be 
28 inches (710 mm) wide minimum and 17 inches (430 mm) long minimum.
    Exception: Transfer surfaces for imaging equipment with bores 
shall be permitted to be 21 inches (535 mm) wide minimum but shall 
not be permitted to be less than the full width of the examination 
surface provided for the patient.
    M301.2.3.2 Side Transfer Surface. Side transfer surfaces shall 
be 28 inches (710 mm) wide minimum and 28 inches (710 mm) long 
minimum.
    Exception: Transfer surfaces for imaging equipment with bores 
shall be permitted to be 21 inches (535 mm) wide minimum but shall 
not be permitted to be less than the full width of the examination 
surface provided for the patient.
    M301.2.4 Unobstructed Transfer. Each transfer surface shall 
provide two unobstructed sides for patient transfer.
    Exceptions: 1. Obstructions no more than 3 inches (75 mm) deep 
shall be permitted to extend beyond transfer sides of transfer 
surfaces provided that such obstructions do not protrude above the 
tops of transfer surfaces.
    2. Temporary obstructions shall be permitted provided that they 
can be repositioned during transfer to comply with M301.2.4, 
including Exception 1.
    M301.3 Supports. Transfer supports, leg supports, and reclining 
surfaces shall comply with M301.3.
    M301.3.1 Transfer Supports. Transfer surfaces required by M301.2 
shall provide transfer supports and shall comply with M305.2.
    M301.3.2 Leg Supports. Where stirrups are provided, leg supports 
shall also be provided and shall comply with M305.4.
    M301.3.3 Head and Back Support. Where the diagnostic equipment 
is used in a reclined position, head and back support shall be 
provided and shall comply with M305.5.
    M301.4 Lift Compatibility. Diagnostic equipment shall be usable 
with portable patient lifts and, when in use with such lifts, shall 
comply with M301.4.1 or M301.4.2.
    Exception: Where fixed overhead patient lifts are provided, and 
when their use with diagnostic equipment is permitted by an 
enforcing authority, diagnostic equipment shall not be required to 
meet the lift compatibility requirements of this section provided 
that such equipment is clearly labeled as not compatible with 
portable floor lifts.
    M301.4.1 Clearance in Base. The base of diagnostic equipment 
shall provide a clearance 39 inches (990 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 examination surfaces is less than 36 inches (915 
mm), the clearance depth shall extend the full width of the 
equipment. Components of diagnostic equipment 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 diagnostic 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. Diagnostic equipment that supports patients in a 
seated position shall comply with M302.
    Exception: Where weight scales contain wheelchair spaces 
complying with M303 and also provide a seat integral to the 
equipment, the scales shall not be required to comply with M302.
    M302.2 Transfer Surface. A transfer surface shall be provided 
and shall comply with M302.2.
    M302.2.1 Adjustability. Transfer surfaces shall be adjustable in 
height measured from the floor to the top of the uncompressed 
transfer surface and shall provide the following:
    A. A low transfer position at a height of 17 inches (430 mm) 
minimum and 19 inches (485 mm) maximum;
    B. A high transfer position at 25 inches (635 mm); and
    C. At least 4 additional transfer positions located between the 
low and high transfer positions and separated by 1 inch (25 mm) 
minimum.
    M302.2.2 Sunset. The low transfer position height, Item A of 
M302.2.1, shall cease to have effect on January 10, 2022.
    M302.2.3 Size. Transfer surfaces shall be 21 inches (610 mm) 
wide minimum and 17 inches (430 mm) deep minimum. The size of 
transfer surfaces shall be measured from center points of their 
opposing sides.
    M302.2.4 Transfer Sides. Options to transfer from a mobility 
device shall be provided on two adjoining sides of transfer 
surfaces.
    Exception: Options to transfer to or from a mobility device onto 
opposing sides of

[[Page 2847]]

transfer surfaces shall be permitted where the transfer surface is 
obstructed by fixed footrests.
    M302.2.5 Unobstructed Transfer. Each transfer side complying 
with M302.2.4 shall provide unobstructed access to transfer 
surfaces.
    Exceptions: 1. Obstructions no more than 3 inches (75 mm) deep 
shall be permitted to extend beyond transfer sides of transfer 
surfaces provided that such obstructions do not protrude above the 
tops of transfer surfaces.
    2. Temporary obstructions shall be permitted provided that they 
can be repositioned during transfer to comply with M302.2.5, 
including Exception 1.
    M302.3 Supports. Transfer supports, leg supports and reclining 
surfaces shall comply with M302.3.
    M302.3.1 Transfer Supports. Transfer supports shall be provided 
for use with transfer sides required by M302.2.4 and shall comply 
with M305.2.1.1, M305.2.2.1, and M305.2.3 through M305.2.8.
    M302.3.2 Leg Supports. Where stirrups are provided, leg supports 
shall also be provided and comply with M305.4.
    M302.3.3 Head and Back Support. Where the diagnostic equipment 
is used in a reclined position, head and back support shall be 
provided and shall comply with M305.5.
    M302.4 Lift Compatibility. Diagnostic equipment shall be usable 
with portable patient lifts and, when in use with such lifts, shall 
comply with M302.4.1 or M302.4.2.
    Exception: Where fixed overhead patient lifts are provided, and 
when their use with diagnostic equipment is permitted by an 
enforcing authority, diagnostic equipment shall not be required to 
meet the lift compatibility requirements of this section provided 
that such equipment is clearly labeled as not compatible with 
portable floor lifts.
    M302.4.1 Clearance in Base. The base of the diagnostic equipment 
shall provide a clearance 39 inches (990 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 diagnostic 
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. Wheelchair spaces complying with 
M303.2 shall be provided at diagnostic equipment.
    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.
    Exception: Wheelchair spaces located on raised platforms shall 
be permitted to be 32 inches (815 mm) wide minimum to a height of 4 
inches (100 mm) measured from the platform surface.
    M303.2.3 Depth. The depth of wheelchair spaces shall comply with 
M303.2.3.
    M303.2.3.1 Front or Rear Entry. Where wheelchair space entry and 
exit is provided at only one end (front or rear) the wheelchair 
space shall be 48 inches (1220 mm) deep minimum.
    M303.2.3.2 Pass Through Entry. Where wheelchair space entry and 
exit permits pass through from one end to the other, the wheelchair 
space shall be 40 inches deep (1015 mm) minimum.
    M303.2.3.3 Side Entry. Where wheelchair space entry is only from 
the side, the wheelchair space shall be 60 inches (1525 mm) deep 
minimum.
    M303.2.4 Equipment Clearances. Where wheelchair spaces are 
entered from the rear and includes space beneath components, 
wheelchair spaces shall include knee and toe clearances complying 
with M303.2.4.1 for breast platforms and M303.2.4.2 for all other 
equipment.
    M303.2.4.1 Breast Platforms. Wheelchair spaces beneath breast 
platforms shall comply with M303.2.4.1.
    M303.2.4.1.1 Depth. Wheelchair spaces shall include knee and toe 
clearance 25 inches (635 mm) deep minimum and 28 inches (710 mm) 
deep maximum.
    M303.2.4.1.2 Height. Wheelchair spaces shall include toe 
clearance 9 inches (230 mm) high minimum above the floor measured to 
a depth of 6 inches (150 mm) maximum from the toe end of the 
wheelchair space. Knee clearance shall be provided at a depth of 19 
inches (485 mm) minimum and 22 inches (560 mm) maximum at 9 inches 
(230 mm) above the floor and at a depth of 16 inches (405 mm) 
minimum at 27 inches (685 mm) above the floor measured from the 
leading edge of the breast platform. 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.
    Exception: Components shall be permitted to extend into the 
wheelchair space at a height of 1\1/2\ inches (38 mm) maximum 
between 17 inches (430 mm) minimum and 25 inches (635 mm) maximum in 
depth measured from the leading edge of the breast platform. From 25 
inches (635 mm) to 28 inches (710 mm) in depth the height of a 
component above 1\1/2\ inches (38 mm) shall be beveled at a rate of 
2.5:3 maximum.
    M303.2.4.2 Other Equipment. Wheelchair spaces beneath diagnostic 
equipment other than breast platforms shall comply with M303.2.4.2.
    M303.2.4.2.1 Depth. Wheelchair spaces shall include knee and toe 
clearance 17 inches (430 mm) deep minimum and 25 inches (635 mm) 
deep maximum.
    M303.2.4.2.2 Height. Wheelchair spaces shall include toe 
clearance 9 inches (230 mm) high minimum above the floor measured to 
a depth of 6 inches (150 mm) maximum measured from the toe end of 
the wheelchair space. 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 measured from the 
leading edge of the equipment. 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.
    M303.2.6 Edge Protection. Where wheelchair spaces are provided 
on a platform raised more than 1\1/2\ inches (38 mm) in height, edge 
protection 2 inches (51 mm) high minimum measured from the surface 
of the platform shall be provided on each side not providing entry 
to or exit from the equipment.
    M303.3 Entry. Where there is a change in level at the entry to 
wheelchair spaces, 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.
    Exception: A running slope not steeper than 1:8 shall be 
permitted for ramp runs with a maximum height of 2\1/2\ inches (64 
mm).
    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 with a drop off.
    M303.3.3.5 Handrails. Ramps with a rise greater than 6 inches 
(150 mm) shall provide handrails on both sides.
    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 Platform Adjustability. Breast platforms shall 
be continuously adjustable from a low height of 26 inches (660 mm) 
to a high height of 42 inches (1065 mm) above the floor.

[[Page 2848]]

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. Equipment surfaces on which patients 
stand must comply with M304.2
    M304.2.1 Slip Resistant. The surface on which the patient stands 
shall be slip resistant.
    M304.2.2 Standing Supports. Standing supports shall be provided 
on two sides of the standing surface and shall comply with M305.3.
    Exception: Diagnostic equipment with entry and exit permitting 
pass-through from one end to the other shall be permitted to provide 
one standing support on one side of the standing surface provided 
that the standing support complies with the requirements for 
standing supports in a horizontal position in M305.3.

M305 Supports

    M305.1 General. Supports shall comply with M305.
    M305.2 Transfer Supports. Transfer supports shall comply with 
M305.2.
    M305.2.1 Location. Transfer supports shall comply with 
M305.2.1.1 or M305.2.1.2 and shall be located 1\1/2\ inches (38 mm) 
maximum measured horizontally from the plane defined by the nearest 
edge of the transfer surface.
    Exception: Where the support folds, collapses, or articulates, 
the transfer support shall be permitted to be located 3 inches (75 
mm) maximum from the plane defined by the nearest edge of the 
transfer surface.
    M305.2.1.1 End Transfer Supports. Transfer supports for transfer 
surfaces complying with M301.2.3.1 and M302.2 shall be located on 
the short side (length) opposite the transfer side.
    M305.2.1.2 Side Transfer Supports. Transfer supports for 
transfer surfaces complying with M301.2.3.2 shall be capable of 
supporting transfer on each side of the transfer surface.
    M305.2.2 Length. The length of transfer supports shall comply 
with M305.2.2.1 or M305.2.2.2.
    M305.2.2.1 End Transfer Supports. Transfer supports for transfer 
surfaces complying with M301.2.3.1 and M305.2.2.1 shall be 15 inches 
(380 mm) long minimum. Transfer supports shall be positioned along 
13\1/2\ inches (345 mm) minimum of the depth of the transfer 
surface.
    M305.2.2.2 Side Transfer Supports. Transfer supports for 
transfer surfaces complying with M301.2.3.2 shall be 28 inches (710 
mm) long minimum and shall be positioned along the width of transfer 
surfaces.
    Exceptions: 1. Where transfer surfaces are part of an 
articulating surface, the support shall be permitted to be 15 inches 
(380 mm) long minimum.
    2. Where the width of an imaging bed is more than 24 inches (533 
mm), transfer supports shall be permitted to be 12 inches (305 mm) 
long minimum.
    M305.2.3 Height. During use, the tops of transfer support 
gripping surfaces shall be 6 inches (150 mm) minimum and 19 inches 
(485 mm) maximum higher than the top of the associated uncompressed 
transfer surface.
    Exception: Where the width of the transfer surface for imaging 
beds exceed 24 inches (610 mm), the tops of the gripping surfaces 
shall be permitted to be 3 inches (75 mm) minimum and 6 inches (150 
mm) maximum higher than the top of the associated uncompressed 
transfer surface.
    M305.2.4 Cross Section. Transfer supports shall have a cross 
section complying with 305.2.4.1 or 305.2.4.2.
    M305.2.4.1 Circular Cross Section. Transfer supports with 
circular cross sections shall have an outside diameter of 1\1/4\ 
inches (32 mm) minimum and 2 inches (51 mm) maximum.
    M305.2.4.2 Non-Circular Cross Section. Transfer supports with 
non-circular cross sections shall have a cross-section dimension of 
2 inches (51 mm) maximum and a perimeter dimension of 4 inches (100 
mm) minimum and 4.8 inches (120 mm) maximum.
    M305.2.5 Surface Hazards. Transfer supports and surfaces 
adjacent to transfer supports shall be free of sharp or abrasive 
components and shall have eased edges.
    M305.2.6 Gripping Surface. Transfer support gripping surfaces 
shall be continuous along their length and shall not be obstructed 
along their tops or sides. The bottoms of transfer support gripping 
surfaces shall not be obstructed for more than 20 percent of their 
length.
    M305.2.7 Clearance. Clearance between the transfer support 
gripping surface and adjacent surfaces or obstructions shall be 1\1/
2\ inches (38 mm) minimum.
    M305.2.8 Fittings. Transfer supports shall not rotate within 
their fittings when in place for transfer.
    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 Length. The length of gripping surfaces for standing 
supports shall be based on the position of the standing supports in 
relation to the standing surfaces they serve. Horizontal standing 
support gripping surfaces shall comply with M305.3.1.1, horizontal 
standing support gripping surfaces on diagnostic equipment 
containing a wheelchair space shall comply with M305.3.1.2 and, 
vertical standing support gripping surfaces shall comply with 
M305.3.1.3.
    M305.3.1.1 Horizontal Position. The length of gripping surfaces 
on horizontal standing supports shall be 4 inches (100 mm) minimum 
except for diagnostic equipment containing a wheelchair space which 
shall comply with M305.3.1.2.
    M305.3.1.2 Diagnostic Equipment Containing a Wheelchair Space. 
On diagnostic equipment containing wheelchair spaces with one entry 
that also serves as the exit, the length of the gripping surface of 
horizontal standing supports shall be equal to or greater than 80 
percent of the overall length of the platform. On diagnostic 
equipment containing a wheelchair space and permitting pass-through 
from one end to the other, the length of the gripping surface on 
horizontal standing supports shall be at least equal to the length 
of the platform.
    M305.3.1.3 Vertical Position. The length of the gripping surface 
on vertical standing supports shall be 18 inches (455 mm) minimum.
    M305.3.2 Height. The height of gripping surfaces for standing 
supports shall be based on the position of the standing supports in 
relation to the standing surfaces they serve. Horizontal standing 
support gripping surfaces shall comply with M305.3.2.1 and vertical 
standing support gripping surfaces shall comply with M305.3.2.2.
    M305.3.2.1 Horizontal Position. The height of the top of the 
gripping surface on horizontal standing supports shall be 34 inches 
(865 mm) minimum and 38 inches (965 mm) maximum above the standing 
surface.
    M305.3.2.2 Vertical Position. The height of the lowest end of 
the gripping surface on vertical standing supports shall be 34 
inches (865 mm) minimum and 37 inches (940 mm) maximum above the 
standing surface.
    M305.3.3 Fittings. Standing supports shall not rotate within 
their fittings.
    M305.4 Leg Supports. Leg supports shall provide a method of 
supporting, positioning, and securing the patient's legs.
    M305.5 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.

M306 Communication

    M306.1 General. Where instructions or other information 
necessary for performance of the diagnostic procedure 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.

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. 2016-31186 Filed 1-6-17; 8:45 am]
 BILLING CODE 8150-01-P