Standards for Accessible Medical Diagnostic Equipment, 60307-60314 [2024-16266]

Agencies

• Architectural and Transportation Barriers Compliance Board

[Federal Register Volume 89, Number 143 (Thursday, July 25, 2024)]
[Rules and Regulations]
[Pages 60307-60314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16266]


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ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD

36 CFR Part 1195

[Docket No. ATBCB-2023-0001]
RIN 3014-AA45


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 
(hereafter, ``Access Board'' or ``Board''), is issuing this final rule 
to remove the sunset provisions in the Board's existing accessibility 
standards for medical diagnostic equipment related to the low height 
specifications for transfer surfaces, and replace them with a final 
specification for the low transfer height of medical diagnostic 
equipment used in the supine, prone, side-lying, and the seated 
position.

DATES: The final rule is effective September 23, 2024.

FOR FURTHER INFORMATION CONTACT: Accessibility Specialist Bobby 
Stinnette, (202) 272-0021, board.gov">stinnette@access-board.gov; or Attorney 
Advisor Wendy Marshall, (202) 272-0043, board.gov">marshall@access-board.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

    The Access Board issues this final rule to amend 36 CFR part 1195 
to establish a 17-inch low transfer height specification for transfer 
surfaces of medical diagnostic equipment used in the supine, prone, 
side-lying, and seated position. This final rule also removes the 
sunset provisions at 36 CFR 1195.1, appendix, M301.2.2 and M302.2.2, 
that were promulgated in 2017 to allow the Board additional time to 
determine the appropriate low height specification.

II. Legal Authority

    Section 510 of the Rehabilitation Act charges the Access Board with 
developing and maintaining minimum technical criteria to ensure that 
``medical diagnostic equipment used in or in conjunction with 
physician's offices, dental 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.

[[Page 60308]]

794f. The Access Board's minimum technical criteria do not impose any 
mandatory requirements on health care providers or medical device 
manufacturers. Agencies or entities may issue regulations or adopt 
policies requiring health care providers to acquire accessible medical 
diagnostic equipment that complies with the technical criteria set 
forth by the Access Board. Agencies would be permitted to ``propose or 
adopt [such enforceable regulations] only upon a reasoned determination 
that the benefits of the intended regulation justify its costs,'' E.O. 
12866 section 1(b)(6), a determination the Access Board has not made. 
These agencies or entities would have to develop the appropriate 
scoping provisions to determine how to apply these technical criteria 
and could strengthen or lessen the requirements.

III. Rulemaking History

    In January 2017, the Board issued a final rule establishing 
technical criteria for medical diagnostic equipment. 82 FR 2810 
(codified at 36 CFR part 1195). The Accessibility Standards for Medical 
Diagnostic Equipment (MDE Standards) set forth technical criteria to 
ensure that medical diagnostic equipment used by health care providers 
(such as examination tables, weight scales, and imaging equipment) is 
accessible to, and usable by, individuals with disabilities. One of the 
areas covered by the MDE Standards is the adjustability of transfer 
surfaces for diagnostic equipment used by patients in a supine, prone, 
side-lying, or seated position. The MDE Standards currently specify the 
following adjustability requirements for transfer-height surfaces: a 
high height of 25 inches, a low height of 17-19 inches, and four 
unspecified intermediate heights between the high and low transfer 
height, which are separated by a minimum of one inch. 36 CFR part 1195, 
appendix, M301.2.1 and M302.2.2. Unlike the other transfer height 
specifications, the low transfer height was set as a temporary range 
with a five-year sunset provision. Id.
    As explained in the preamble to the final rule, the Board took this 
approach because ``there was insufficient information to designate a 
single minimum low height requirement at [that] time. Specifically, 
there [was] insufficient data on the extent to which and how many 
individuals would benefit from a transfer height lower than 19 
inches.'' 82 FR 2816. The Board explained that the MDE Advisory 
Committee was unable to come to an agreement on a single low height 
transfer position.
    In the 2013 MDE Advisory Committee Report, minority reports 
submitted by disability advocates and academics supported a minimum low 
height of 17 inches. See Minority Reports from Boston Center for Living 
Inc., National Network for ADA Centers, and Medical Diagnostic 
Equipment Advisory Committee, available at https://www.regulations.gov/docket/ATBCB-2013-0009/document (last visited Dec. 4, 2023). These 
reports referenced the importance of accessible care, ensuring as many 
independent transfers as possible, and minimizing the risk of injury to 
both patient and provider if an assisted transfer is necessary. The 
reports asserted that the 17-inch low height provides ``the greatest 
number of individuals the opportunity to transfer independently.'' 82 
FR 2810, 2815 (Jan. 9, 2017).
    The minority reports submitted in 2013 by manufacturers supported a 
minimum low height of 19 inches. See Minority Reports from Hologic, 
Inc., Midmark Corporation, Medical Imaging and Technology Alliance 
(MITA) Advisory Committee Members, and Recommendation of 19-inch Lower 
Adjustable Height as the Minimum Accessibility Standard (Joint Report), 
available at https://www.regulations.gov/docket/ATBCB-2013-0009/document (last visited Dec. 4, 2023). The exam table manufacturers 
asserted that they would incur costs to comply with the 17-inch low 
height, but not similarly for the 19-inch low height. The manufacturers 
asserted that, at that time, there were no accessible diagnostic tables 
on the market that met a 17-inch low height requirement. Id.
    Thus, the Board decided to specify a five-year sunset period to 
afford time for needed research and subsequent promulgation of a final 
specification for the low transfer height position. Id. On February 3, 
2022, the Board issued a direct final rule extending the sunset 
provision until January 10, 2025. 87 FR 6037 (Feb. 3, 2022).
    The Board commissioned Dr. D'Souza to complete a secondary analysis 
of occupied seat heights based on the 2010 Anthropometry of Wheeled 
Mobility Project to address some of the concerns raised about the 
original study. In 2021 Dr. D'Souza completed the 2021 Analysis of Low 
Wheelchair Seat Heights and Transfer Surfaces for Medical Diagnostic 
Equipment Final Report. The report was presented at the Access Board's 
public meeting on May 12, 2022, and the Board solicited public comments 
on the report.
    On May 23, 2023, following the completion of this research and 
review of the public comments received, the Access Board issued a 
notice of proposed rulemaking of Standards for Accessible Medical 
Diagnostic Equipment proposing to remove the sunset provision and 
replace the low-transfer-height specification range with a 17-inch 
requirement for medical diagnostic equipment used in the supine, prone, 
side-lying, and seated position. 88 FR 33056 (2023 MDE NPRM).

IV. Comment Review

    In response to the 2023 MDE NPRM the Board received 76 comments: 60 
from individuals, 7 from disability rights organizations, 2 from 
independent living centers, 6 comments from 4 manufactures and 
manufacturer/trade associations, and one comment from a health delivery 
system. In response to a request from MITA for an extension of the 
comment period to allow them to provide a more thorough comment, the 
Board extended the comment period by 30 days to August 31, 2023. Notice 
of proposed rulemaking extension of comment period, 88 FR 50096 (Aug. 
1, 2023). Below the Board addresses each group of comments received.
    The Board first acknowledges a few comments received from various 
individuals and entities suggesting there was some confusion about the 
sunset provision. The Board emphasizes that this final rule removes the 
sunset provision, the effect of which is to make the low transfer 
height of 17 inches and a high transfer height of 25 inches the 
applicable standard as of the effective date for this final rule. 
However, the MDE Standards are not enforceable unless adopted by an 
enforcement agency, and that agency would determine any effective date 
during its rulemaking process, which could include a delayed effective 
date for the low transfer height if appropriate.
    There were also a few comments concerning whether equipment 
currently on the market that meets the MDE Standards as issued in 2017 
would be exempt from the 17-inch low transfer height or would be deemed 
as ``not complying.'' That determination will be made by enforcement 
agencies if they adopt these or other requirements for MDE as 
enforceable standards.
    Additionally, a few commenters raised concerns about a potential 
overlap or conflict between the MDE Standards and FDA's oversight and 
review of medical devices. In accordance with Section 510 of the 
Rehabilitation Act, the Access Board consulted with the Food and Drug 
Administration in the promulgation of this rule. 29 U.S.C. 794f(a). FDA 
advised

[[Page 60309]]

that the low transfer height standard generally does not appear to 
present safety or effectiveness issues, and FDA does not anticipate 
design changes implemented solely to conform to such a standard would 
preclude market authorization. FDA further advised that conformance or 
nonconformance with the MDE Standards low transfer height provision 
would not factor into FDA's evaluation of whether a device has 
satisfied the applicable legal standard to support marketing 
authorization. Based on that consultation, the Board has determined 
that there is no conflict between the MDE Standards and FDA's oversight 
and review of medical device.

A. Comments From Individuals

    The Board received 60 comments from individuals, most of whom 
identified as having disabilities. The vast majority support the 
proposal and explain the commenters' experiences with inaccessible 
medical diagnostic equipment. Some of the commenters expressed a 
preference for a transfer height higher than 17 inches (which can be 
accomplished under the final rule requiring that the MDE be adjustable 
in height between 17 and 25 inches), and a few thought the transfer 
height should be as low as possible without specifying a height. None 
of the individual commenters, however, opposed the low transfer height 
of 17 inches.

B. Manufacturers and Trade Associations

    The Access Board received comments from two manufacturers of 
medical diagnostic equipment, one trade association representing 
manufacturers of medical imaging equipment, and one association 
representing radiologists. The two manufacturers previously commented 
on the 2021 Analysis of Low Wheelchair Seat Heights and Transfer 
surfaces for Medical Diagnostic Equipment Final Report. These 
manufacturers also participated in the MDE Advisory Committee for the 
original rulemaking and provided comments during the public comment 
period for the original 2016 rulemaking. Many of the Comments submitted 
in response to the 2023 MDE NPRM reiterated previous comments received 
during the rulemaking process, including comments about the D'Souza 
research study, concerns about costs, and the ability of the table/
chair to raise to a level comfortable for the medical professionals. 
Below we address the manufacturers' and trade association's comments, 
but also adopt the explanations provided in the preamble to the 2023 
MDE NPRM. See 88 FR 33056, 33058-33060 (May 23, 2023).
(1) General Exception
    One manufacturer of exam tables and chairs asserted that having to 
reduce the low transfer height to 17 inches would force manufacturers 
to alter structural or operational characteristics of MDE and would 
prevent the intended diagnostic purpose of the equipment. Additionally, 
the two associations voiced concern that height-adjustability may not 
be feasible for medical imaging devices due to technical limitations, 
and one asked for an exemption for advanced diagnostic imaging 
equipment from the adjustability requirement.
    The MDE Standards address these concerns at M201.2 with a general 
exception that states that MDE ``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.'' 36 CFR 1195.1, appendix, M201.2.
    In the preamble to the 2017 MDE final rule, the Board explained 
that this exception applies when the ``diagnostically required 
structural or operational characteristics cannot be made to comply with 
the technical requirements without preventing the use of the equipment 
for its intended purpose.'' See Standards for Accessible Medical 
Diagnostic Equipment, 82 FR 2810, 2813 (Jan. 9, 2017). In that case, 
this exception would require the equipment to lower as close to 17 
inches as possible without affecting the diagnostic characteristics. In 
the 2017 MDE final rule, the Board specifically explained its 
expectation that some medical imaging equipment may have to rely on 
this general exception to ensure that the diagnostic characteristics 
are not compromised. The Board believes this exception may also be used 
in some cases for medical diagnostic equipment that does not currently 
reach 17 inches; however, the Board has not determined how often this 
would be the case as it will depend on the state of the market 
conditions and scoping requirements if this rule is adopted as an 
enforceable standard.
    With respect to exam tables and chairs, one commenter asserted that 
a 17-inch low transfer height would make it impossible to move patients 
into the Trendelenburg position (head lower than feet), where required 
for medical and dental care. Although the general exception may be 
appropriate if such a position would not be attainable with a 17-inch 
low height requirement, the vast majority of dental chairs on the 
market already have a low transfer height at or below 17 inches. See 
notice of proposed rulemaking, Standards for Accessible Medical 
Diagnostic Equipment, 88 FR 33056, 33060 (May 23, 2023).
(2) Scoping
    One comment from a manufacturer explained that while the number of 
height adjustable tables in the market is increasing in the United 
States, noting an increase from 5 percent in 2001 to 45 percent in 
2023, the majority of tables on the market are still the fixed height 
table (32 inches) due to the cost. This commenter asserted that the 
adoption rate of adjustable tables would be further impeded with a 
requirement that the accessible MDE have a low transfer height of 17 
inches. In response to the commenter's concern, the Board notes that if 
enforcement agencies adopt the MDE Standards, those agencies may 
provide scoping requirements prescribing the minimum percentage of MDE 
that would need to meet the MDE Standards. If an enforcement agency 
were to adopt the MDE Standards, only the percentage of MDE that the 
agency's regulation specified would have to meet them.
(3) Maintain the Current Range 17-19 Inches as the Final Specification
    Two of the commenters recommend maintaining the 17-19-inch range as 
the final specification, asserting that it is consistent with existing 
accessibility standards for fixed elements where transfer is expected, 
such as water closets and toilet seats. These commenters stated that 
the widely accepted existing transfer height range of 17-19 inches 
suggest the importance of maintaining this standard for exam tables and 
procedure chairs. The Access Board refers these commenters to the 
preamble to the 2023 MDE NPRM where the Board addressed this concern 
and explained the difference between the height range provided for a 
fixed element in the ADA Accessibility Guidelines versus the low height 
provision for an adjustable transfer surface on MDE. There, we 
explained that the two situations are not the same, ``as [water closets 
and toilet seats] only provide one height for transfer, so in 
determining that height, the Board had to specify a range for a static 
height that would effectuate transfer for the majority of users. With 
MDE and the ability to have 6 different transfer points, the goal is to 
accommodate all people with disabilities who are able to

[[Page 60310]]

effectuate an independent transfer.'' Id. at 33061.
(4) Legacy Clause
    One commenter recommended that a ``legacy clause'' be added to the 
MDE Standards that would allow MDE that complied with the MDE Standards 
prior to the finalization of the 17-inch low height to be considered 
accessible until replaced. As previously noted, if enforcement agencies 
adopt these technical standards, they will determine how previously 
compliant equipment should be treated.
(5) Use of 2010 Anthropometry of Wheeled Mobility Project Data
    One of the commenters reasserted concerns with the methodology of 
the 2010 Anthropometry of Wheeled Mobility Project Data previously 
raised in response to D'Souza's 2021 Analysis of Low Wheelchair Seat 
Heights and Transfer Surfaces for Medical Diagnostic Equipment Final 
Report. Available at https://www.access-board.gov/research/human/wheelchair-seat-height/. The commenter again requested that the Board 
conduct additional studies on how level transfer can be achieved by 
individuals with disabilities and requests a definition of level 
transfer. The Board previously addressed these concerns in the preamble 
to the 2023 MDE NPRM and reiterates that based on the risk of falls and 
injuries to patients and providers, the success of transfer at a height 
level to a user's wheelchair, and the exertion needed for vertical 
transfer, providing a level transfer height for medical diagnostic 
equipment whenever possible ensures that almost everyone, if not 
everyone, who is capable of an independent transfer would be able to 
transfer to this adjustable height surface from 17 to 25 inches. Id. at 
33059-33060.
(6) Cost and Time To Implement
    One manufacturer responded to the questions posed in the 2023 MDE 
NPRM about the cost to manufacturers to modify current 18-19-inch MDE 
to comply with 17-inch low height requirements. This manufacturer 
asserted that its exam tables and chairs cannot be modified and would 
need to be completely redesigned in order to comply; that the 
development costs for redesign would be around $6 million and would 
take at least 17 years, assertedly what it took to reach 19 inches; and 
that the cost increase to the product itself would be 20-30%, which 
would not diminish over time. Later, the same commenter asserted it 
would take 10 years to redesign the equipment. Based on the change in 
availability of height adjustable exam tables and chairs since the 
publication of the MDE Standards in 2017, the Board is not convinced 
that compliant equipment would take 17 years to be redesigned, 
especially if this Standard is adopted and market demand for compliant 
equipment increases. However, the Board recommends that any agency 
adopting the MDE Standards consider the state of the market at the time 
of its adoption to determine if a delayed effective date for low 
transfer height is warranted.

C. Disability Rights Organizations/Independent Living Centers

    The Board received 9 comments from disability rights organizations 
and independent living centers. These comments fully supported the 
Board's proposed 17-inch low height. The Paralyzed Veterans of America 
(PVA) noted that accessible MDE is essential for full and equal access 
to healthcare services for wheelchair users. Available at https://www.regulations.gov/comment/ATBCB-2023-0001-0058. PVA explained that 
numerous studies show that people with disabilities cannot access 
routine medical exams and procedures because of inaccessible basic MDE, 
like exam tables and chairs, noting a longstanding devaluation of the 
lives of people with disabilities. Id.
    Another commenter explained its enthusiastic support for the 17-
inch provision, noting its awareness and understanding of the 
persistent and systemic barriers disabled people encounter when seeking 
medical care and that a 17 to 19-inch range would simply be akin to 
establishing a 19-inch low height. Available at https://www.regulations.gov/comment/ATBCB-2023-0001-0060.
    Another commenter asserted that the older adult population is 
projected to dramatically increase in the coming years, climbing from 
61.6 million today to 94.7 million by 2060 which will result in the 
increase of use of mobility devices as nearly 10 percent of older 
adults adopt mobility devices each year. Available at https://www.regulations.gov/comment/ATBCB-2023-0001-0059. Finally, one 
commenter strongly supports the largest range possible to provide 
access to the greatest number of people and recommended a low transfer 
height of 15 inches. Available at https://www.regulations.gov/comment/ATBCB-2023-0001-0071.

D. Health Care System

    The Access Board received one comment from a health care system, 
Sutter Health, a not-for-profit health delivery system that operates 24 
acute care hospitals and 200 clinics in Northern California. Sutter 
Health supports the change to a 17-inch low transfer height and noted 
that this change will ``improve access for people with disabilities.'' 
Sutter Health also explained that some manufacturers already produce 
medical equipment that meets this slightly stricter standard, and that 
its ``healthcare system has already made the 17'' low height transfer 
surface [its] standard for purchasing accessible medical equipment, and 
[it is] very pleased with the results.'' Sutter Health further stated, 
``Cost has not been an issue.'' Comment of Sutter Health, available at 
https://www.regulations.gov/comment/ATBCB-2023-0001-0065 (last visited 
Dec. 4, 2023).

V. Current Status of Accessible Medical Diagnostic Equipment

    The Access Board informally reviewed publicly available information 
on current medical diagnostic equipment, specifically examination 
tables and chairs, to discern the current low transfer height and cost 
of adjustable MDE for the 2023 MDE NPRM. There, the Board provided an 
analysis of the current status of accessible medical diagnostic 
equipment and provided the Access Board Review of MDE Low Height and 
MSRP (December 2022). 88 FR 33056 (May 23, 2023) and https://www.regulations.gov/docket/ATBCB-2023-0001. The Board has again 
reviewed all of the MDE listed in the Access Board Review of MDE Low 
Height and MSRP and found two discrepancies in regard to Midmark 
podiatry chairs that were listed at 19 inches in the NPRM but are now 
listed at 21 inches on the manufacturer's website. The changes of these 
two heights to 21 inches instead of 19 inches does not change the 
overall conclusion that 17 inches is the appropriate height. Therefore, 
we adopt the evaluation in the 2023 MDE NPRM here for this final rule.
    The Board reviewed information on individual products to determine 
what low height the product could achieve; it did not undertake a 
systematic review of every feature of each product to assess potential 
compliance with the MDE Standards. The level of specificity of publicly 
available information regarding each product varies by manufacturer and 
product line, limiting the ability to compare every feature of every 
product. Further, such a detailed study would be inappropriate at this 
point, given that the MDE Standards have no mandatory

[[Page 60311]]

application. For most of the products, the Board was able to find 
publicly available price information.
    A number of online MDE suppliers listed both a manufacturer 
suggested retail price (MSRP) and discounted prices. As the actual 
price paid for a certain piece of medical equipment can vary widely 
depending on the supplier from which it is purchased and the type of 
contract a purchaser may have, the Access Board focused on the MSRP. 
The prices reported here are likely higher than the actual prices the 
MDE purchasers would pay, because purchasers typically pay less than 
MSRP due to special sales, volume discounts, or other reasons. The 
information the Board collected, including links to the public websites 
where the Access Board obtained the product and price information, is 
available in the 2023 Review of MDE Low Heights and MSRP. See Access 
Board Review of MDE Low Height and MSRP, dated Dec. 5, 2023, available 
at https://www.regulations.gov/docket/ATBCB-2023-0001.
    The Board relied on the suppliers' and manufactures' websites for 
its information collection, including photographs, schematics, and 
other specification lists and descriptions provided by the manufacturer 
or supplier online. The Board did not directly contact any 
manufacturers or suppliers to discuss their products.

Adjustable Height Exam Tables

    The Access Board reviewed 28 adjustable exam tables currently on 
the market, 21 of which meet the current requirement with low heights 
within the 17-to-19-inch range. Of these 21 exam tables, five have a 
low height of 19 inches and an MSRP range of $5,923.01 to $12,74 2.00, 
or an average cost of $8,290.40; 16 exam tables have a low height of 18 
inches and a MSRP range of $2,127.08 to $14,144, or an average cost of 
$4,635.11; and one exam table has a low height of 15.5 inches and a 
MSRP of $10,644. The other seven exam tables have low heights between 
20 to 27 inches, falling outside of the current low transfer height 
requirement and have a MSRP range of $3,114.82 to $6,699.42, or an 
average cost of $4,173.33. The Board also reviewed 18 fixed height exam 
tables with a height range of 27 to 33 inches and a MSRP range of 
$548.90 to $3,966.38, with an average cost of $1,505.07.
    In comparing the average MSRP of these adjustable exam tables, we 
found the difference between the one exam table that currently reaches 
below 17 inches and the average cost of exam tables in the 18-to-19-
inch range to be a $5,138.58 difference. It would be an additional 
$1,332 if comparing the 15.5-inch exam table to exam tables that were 
adjustable but outside of the current MDE Standard low height range.
    It is important to note that the Board did not evaluate them to 
determine if they comply with the other provisions of the MDE 
Standards, and given the large range of cost for exam tables within the 
18-to-19-inch range ($2,127.08 to $14,144), it is difficult to 
ascertain the actual specific cost of moving from a low height range of 
17 to 19 inches to a single specification of 17 inches. Additionally, 
the Board believes that with this final rule, other manufacturers will 
produce tables that reach a low height of 17 inches, which will cause 
the cost to decrease, as we saw an increase in lower exam table 
transfer heights since the promulgation of the original MDE Standards 
in 2017.

Adjustable Height Exam Chairs

    The Board also reviewed specialized adjustable height exam chairs. 
Specifically, Obstetrics and Gynecological (OB-GYN) chairs, phlebotomy 
chairs, podiatry chairs, optometry/ophthalmology chairs, and dental 
chairs. Only the dental chairs met the requirement for a 17-inch low 
transfer height. Consequently, for the other types of chairs, we were 
not able to determine the approximate additional cost per unit that 
would be required to comply with this rule.
    The Access Board reviewed three OB/GYN chairs, one of which has a 
low height of 22 inches and a MSRP of $3,450, and two which have a low 
height of 18 inches and 18.5 inches and a MSRP range of $3,972.67 to 
$5,470, with an average cost of $4,721.34. The Board also reviewed six 
fixed height OB-GYN chairs, finding a height range of 31 to 33 inches 
and a MSRP range of $543.82 to $2,624.08, with an average cost of 
$1,554.54.
    The Board reviewed 12 phlebotomy chairs, two of which have low 
heights of 18 and 18.5 inches with a MSRP range of $1,199 to $2,249, 
and an average cost of $1,724. The other ten phlebotomy chairs have low 
heights from 20.25 inches to 22 inches and a MSRP range of $1,474 to 
$2,959, with an average cost of $2,05.64. The Board also reviewed 16 
fixed height phlebotomy chairs, finding a height range from 18 to 26 
inches with a MSRP range of $500 to $3,015.49, with an average cost of 
$1,432.98.
    All 16 dental chairs that the Access Board reviewed have a low 
height of 19 inches or lower. Three of the chairs have a low height 
from 18 to 19 inches; however, the Board was only able to obtain the 
cost for one of these chairs, which is a refurbished price at $3,568. 
The other 13 chairs have a low height from 13.5 inches to 17 inches, 
with five having a low height below 14 inches. The Board was only able 
to ascertain an MSRP for six of these 13 chairs, which have an MSRP 
range from $5,598.00 to $9,490, with an average cost of $7,492.95. It 
is difficult to compare costs between these sets of dental chairs, as 
the only cost information the Board was able to obtain for a chair at 
18 inches was a refurbished cost. However, based on the fact that the 
vast majority of dental chairs' low height was well below 17 inches and 
the other differences in the features of these chairs, low height 
doesn't appear to be a significant driver of cost difference for dental 
chairs.
    The Access Board reviewed four podiatry chairs, two of which have a 
low height between 18 and 19 inches. For one of these podiatry chairs 
the Board was able to ascertain a MSRP of $15,241.38.\1\ The other two 
podiatry chairs have a low height of 21-24 inches and a MSRP range of 
$4,995 to $11,299 or an average cost of $8,147.
---------------------------------------------------------------------------

    \1\ The Board was unable to obtain a MSRP for the UMF Power 
Podiatry Chair, Model number 5015.
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    Finally, the Board reviewed 11 optometry/ophthalmology chairs, all 
of which fall outside the current low height range. The seat height of 
these chairs ranged from 19.75 to 23 inches; the MSRP range was from 
$4,200 to $10,352; and the average cost was $6,073. However, the Board 
notes that since the original rulemaking a new type of optometry/
ophthalmology chair has entered the market, which allows the 
examination chair to spin out of the way to permit patients in 
wheelchairs to move up to and use the equipment while remaining in 
their personal chairs. This examination chair with the accompanying 
stand for the equipment is $8,900, the chair alone is $4,650. This 
specific chair also provides a headrest, movable armrests and a chair 
the moves up and down and reclines, but the Board was unable to 
determine the low height. The Board acknowledges that for examinations 
where transfer is not necessary for a complete and accurate 
examination, such as an eye examination, there is a benefit to allowing 
patients to remain in their wheelchairs and avoid any potential for 
injury that accompanies transfer. In this situation the equipment would 
need to meet the requirements for diagnostic equipment used by patients 
seated in a wheelchair at M303. Enforcement authorities would need to 
address applicable specifications in the scoping

[[Page 60312]]

of an enforceable rule for dual use equipment that allows patients 
either to remain in their wheelchairs or to transfer to the examination 
chair. However, one possibility would be to exempt MDE from the low 
transfer height requirement where transfer is not required for 
examination.

VI. Regulatory Process Matters

A. Regulatory Planning and Review (Executive Orders 12866, 13563 and 
14094)

    The Access Board has examined the impact of this final rulemaking 
under Executive Orders 12866, 13563, and 14094. These Executive orders 
direct agencies to assess the costs and benefits of available 
regulatory alternatives and, if regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety effects, distributive 
impacts, and equity). This final rule is a significant regulatory 
action within the meaning of Executive Order 12866, as amended by 
Executive Order 14094. See E.O. 14094 section 1(b), 88 FR 21879 (April 
11, 2023) (defining ``significant regulatory action'' as, among other 
things, regulatory actions that have an annual effect on the economy of 
$200 million or more or adversely affect in a material way the economy, 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or Tribal 
governments or communities, or raise legal or policy issues for which 
centralized review would meaningfully further the President's 
priorities or the principles set forth in Executive Order 12866).
    It is not possible to assess the costs or benefits of this rule 
with precision. The Board has analyzed the potential costs and benefits 
of a 17-inch low transfer height standard from a qualitative 
perspective, and the costs and benefits of an enforceable 17-inch low 
transfer height would depend in part on any scoping requirements that 
enforcement agencies might establish specifying the percentage of MDE 
that must be accessible. Unlike many of the Board's other rulemakings 
that provide minimum guidelines that enforcement agencies must adopt as 
minimum standards for accessibility, Section 510 of the Rehabilitation 
Act (the statutory provision under which the Board promulgated the MDE 
Standards) does not require enforcement agencies to adopt the technical 
criteria set forth in the MDE Standards as minimum standards or at all. 
Enforcement agencies must undertake their own cost/benefit analysis 
pursuant to Executive Order 12866 before they can adopt the MDE 
Standards--or portions thereof, such as the 17-inch low transfer height 
standard set forth in this rule--as enforceable requirements and 
establish scoping requirements. In the final regulatory impact analysis 
for the MDE Standards issued in 2017 (FRIA 2017), the Board explained 
that it was unable to estimate what costs (if any) manufacturers, 
providers, or others would incur as a result of the rule, or what level 
of social benefits would be accrued. Available at https://www.access-board.gov/files/mde/mde-assessment.pdf. Instead, that FRIA provided a 
brief overview of commonly used MDE in the current U.S. market to give 
a sense of how the technical requirements in the MDE Standards were or 
were not met among products being sold. Id. The FRIA 2017 analyzed the 
potential costs and benefits of the MDE Standards from a qualitative 
perspective. The change from a range of 17 to 19 inches to one 
specification of 17 inches would not have changed the analysis in the 
original FRIA, nor does the Access Board believe that finalizing this 
provision with a specification within the already proposed range would 
have an annual effect on the economy of $200 million or more. For this 
final rule the Access Board has followed the same methodology of 
analyzing the potential costs and benefits from a qualitative 
perspective.
    The MDE FRIA 2017 reviewed the market cost of particular models of 
MDE but did not assess the cost of compliance with the MDE Standards. 
During our market research for the 2023 MDE NPRM and this final rule, 
we again looked at the cost of MDE on the market and also assessed the 
low transfer heights, when available on manufacturer or other third 
party websites; however, there were other differences in the MDE, 
beyond just a lower transfer height, so we are unable to attribute all 
of the cost difference to simply a lower transfer height. For example, 
we saw a wide range in the adjustable examination table market; tables 
with a low height of 18 to 19 inches had an MSRP range of $2,127 to 
$14,144. Currently, on the market there is one examination table that 
reaches a low transfer height below 17 inches, the Midmark 626 Barrier-
Free examination chair, which reaches a low height of 15.5 inches and 
has an MSRP of $10,644. 2023 Access Board Review of MDE Low Height and 
MSRP Available at https://www.regulations.gov/docket/ATBCB-2023-0001/document.
    The Board received a couple of comments in response to the 
questions posed regarding this regulatory assessment in the 2023 MDE 
NPRM. In Section 7 above, we summarize and address comments regarding 
cost and implementation time. Additionally, one commenter raised 
concerns about the data collected from manufacturer websites and 
asserted that the seat heights collected from company websites were 
marketing or advertised seat heights and not based on actual 
measurements. This commenter suggested the Access Board physically 
measure each product referenced in 2023 MDE NPRM document, the Access 
Board Review of MDE Low Height and MSRP to determine height. Available 
at https://www.regulations.gov/document/ATBCB-2023-0001-0002.
    In creating the market review for the 2023 MDE NPRM and this final 
rule, the Access Board followed the same protocols that it relied on in 
the 2017 MDE FRIA, and again relied on publicly available information 
to determine the current status of MDE on the market. The Board relies 
on the information that manufacturers have put in their marketing 
specifications for the seat height of MDE for this assessment.
    The benefits of establishing technical specifications for 
accessible MDE were well documented throughout the original MDE 
rulemaking process, including the extensive explanation in the Final 
Regulatory Analysis (FRIA 2017). Available at https://www.access-board.gov/files/mde/mde-assessment.pdf. These arguments continue to be 
valid today; as noted above, 60 percent of examination rooms still 
provide only a fixed-height table which is completely inaccessible to a 
person in a wheelchair.
    In 2020, the National Council on Disability (NCD) issued a report 
titled Enforceable Accessible Medical Equipment Standards--A Necessary 
Means to Address the Health Care Needs of People with Mobility 
Disabilities. Available at https://ncd.gov/publications/2021/enforceable-accessible-medical-equipment-standards.
    In this report, NCD describes the difficulty people with mobility 
disabilities still face in trying to access medical care. NCD explains 
that ``[a]dults with physical disabilities are at higher risk of 
foregoing or delaying necessary care and having unmet medical, dental, 
and prescription needs compared to adults without disabilities. Lack of 
timely access to primary and preventive care can result in the 
development of chronic and secondary conditions as well as exacerbation 
of the original disability condition itself, resulting in poorer health 
outcomes. Of

[[Page 60313]]

the 61 million people with disabilities in the United States, more than 
20 million people over the age of 18 years have a disability that 
limits their functional mobility; this can pose challenges to accessing 
standard medical diagnostic equipment.'' Id. at 13. Further, NCD 
explains that ``[i]f patients are not transferred to an examination 
table, when it is clinically appropriate, it may be difficult if not 
impossible to conduct a comprehensive examination, which may lead to 
missed or delayed diagnosis.'' Id. at 17. NCD explains, and the Access 
Board concurs, that accessible MDE not only benefits the quality of 
care of patients with disabilities, but also impacts ``the occupational 
health and safety of health care workers, especially nurses and nursing 
assistants.'' Id. at 19. NCD notes that research is showing a 
relationship between musculoskeletal injuries and workers' compensation 
claims for health care professionals and safe patient handling, ``due 
in part to the overreliance on manual transfers to inaccessible 
equipment.'' Id.
    While there are many provisions within the MDE Standards that 
address all aspects of the equipment, including the requirement for the 
ability to use a lift with the MDE (M301.4), to ensure that a person is 
able to be examined on the diagnostic equipment, the low transfer 
height selected should provide access to independent transfers to the 
largest percentage of people who use wheeled mobility devices that are 
capable of such a transfer. Independent transfer is safer for the 
patient and provides a safer environment for the health care provider 
in reducing the risk of injury during an assisted transfer.
    As explained above in Dr. D'Souza's report, if the Board was to 
adopt a low transfer height of 19 inches, then between 39 to 42 percent 
of wheelchair users would not be able to effectuate a level transfer. 
However, by requiring a low height of 17 inches and high height of 25 
inches and at least four other intermediate heights in between, the 
adjustable height transfer surface should be accessible to and usable 
by almost all (95 percent) of wheelchair users that can independently 
transfer.
    The Board asserts that the benefits of establishing a low transfer 
height standard of 17 inches, both for the millions of Americans that 
use mobility devices and for the medical professionals and caregivers 
assisting those individuals transfer, outweighs the potential costs of 
establishing a low transfer height standard of 17 inches. Specifically, 
the Board finds that there is a significant need for accessible medical 
diagnostic equipment and that the safety of both the patient and 
caregiver are affected by ensuring as many individuals as possible who 
are capable of independent transfer are provided the opportunity to 
effectuate that transfer with a height specification for medical 
diagnostic equipment that is level to their current mobility device. 
These benefits, outweigh the costs of establishing a 17-inch low 
transfer height standard. However, as noted above, the Access Board has 
not assessed who would incur these potential costs and to what extent. 
Agencies considering whether to adopt the 17-inch transfer height as a 
requirement would be required to analyze the costs and benefits of 
doing so, including by assessing factors not included in the Access 
Board's analysis, such as the number of accessible devices required at 
facilities, when full compliance would be required, and whether covered 
entities would be allowed to rely on compliance with the 17- to 19-inch 
range for MDE procured during the pendency of the sunset provision and 
during any time thereafter. Therefore, the Access Board expects that if 
rulemaking agencies propose to adopt the 17-inch low transfer height 
standard as enforceable, they will carry out regulatory assessments 
that provide specific cost and benefit estimates relevant to their 
rules.

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.

C. Federalism (Executive Order 13132)

    The Access Board has evaluated this final rule in accordance with 
the principles and criteria set forth in Executive Order 13132. We have 
determined that this action will not have a substantial direct effect 
on the States, the relationship between the Federal Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, and, therefore, does not have federalism 
implications.

D. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (codified at 2 U.S.C. 1531 
et seq.) (``UMRA'') generally requires that Federal agencies assess the 
effects of their discretionary regulatory actions that may result in 
the expenditure of $100 million (adjusted for inflation) or more in any 
one year by the private sector, or by state, local, and Tribal 
governments in the aggregate. The MDE 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.

F. Congressional Review Act

    This final rule is not a major rule within the meaning of the 
Congressional Review Act (5 U.S.C. 801 et seq.)

List of Subjects in 36 CFR Part 1195

    Health care, Individuals with disabilities, Medical devices.

    For the reasons stated in the preamble, and under the authority of 
29 U.S.C. 794f, the Board amends 36 CFR part 1195 as follows:

PART 1195--STANDARDS FOR ACCESSIBLE MEDICAL DIAGNOSTIC EQUIPMENT

0
1. The authority citation for part 1195 continues to read as follows:

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


0
2. Amend appendix by:
0
a. Revising M301.2.1, paragraph A;
0
b. Removing and reserving M301.2.2;
0
c. Revising M302.2.1, paragraph A; and
0
d. Removing and reserving M302.2.2.
    The revisions read as follows:

[[Page 60314]]

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

* * * * *

Chapter 3 * * *

M301 * * *

* * * * *

M301.2.1 * * *

    A. A low transfer position at a height of 17 inches (430 mm);
* * * * *

M302 * * *

* * * * *

M302.2.1 * * *

    A. A low transfer position at a height of 17 inches (430 mm);
* * * * *

    Approved by vote of the Access Board on January 24, 2024.
Christopher Kuczynski,
General Counsel, U.S. Access Board.
[FR Doc. 2024-16266 Filed 7-24-24; 8:45 am]
BILLING CODE 8150-01-P