Standards for Accessible Medical Diagnostic Equipment, 33056-33063 [2023-10827]

Agencies

• Architectural and Transportation Barriers Compliance Board

[Federal Register Volume 88, Number 99 (Tuesday, May 23, 2023)]
[Proposed Rules]
[Pages 33056-33063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10827]


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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: Notice of proposed rulemaking.

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SUMMARY: The Architectural and Transportation Barriers Compliance Board 
(hereafter, ``Access Board'' or ``Board''), is issuing this notice of 
proposed rulemaking 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 
position and the seated position.

DATES: Send comments on or before July 24, 2023.

ADDRESSES: You may submit comments by any one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Email: board.gov">[email protected]board.gov. Include docket number 
ATBCB-2023-0001 in the subject line of the message.
     Mail: Office of General Counsel, U.S. Access Board, 1331 F 
Street NW, Suite 1000, Washington, DC 20004-1111.
    Instructions: All submissions must include the docket number 
(ATBCB-2023-0001) for this regulatory action. All comments received 
will be posted without change to https://www.regulations.gov, including 
any personal information provided.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov/docket/ATBCB-2023-0001.

FOR FURTHER INFORMATION CONTACT: Accessibility Specialist Bobby 
Stinnette, (202) 272-0021, board.gov">[email protected]board.gov; or Attorney 
Advisor Wendy Marshall, (202) 272-0043, board.gov">[email protected]board.gov.

SUPPLEMENTARY INFORMATION: 

I. Legal Authority

    Section 510 of the Rehabilitation Act charges the Access Board with 
developing and maintaining minimum

[[Page 33057]]

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. 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 choose to 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, however, these agencies or entities would 
have to develop the appropriate scoping provisions to determine how to 
apply these technical criteria and would be free to strengthen or 
lessen the requirements as they so determine.

II. 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 certain types of medical diagnostic equipment. 
Specifically, 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 
positions: 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 & 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 at 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 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 April 
5, 2023). These reports strongly supported a 17-inch low height, 
referencing 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 by 
manufacturers supported a minimum low height of 19 inches. See Minority 
Reports from Hologic, Inc., Midmark Corporation, 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 April 5, 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 manufactures 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 21089 (Apr. 11, 2022).

III. Research on Transfer Height

    The Access Board has supported multiple research projects over the 
years regarding the height of wheelchairs, independent transfer, and 
the height of the transfer surface. In 2010, the Board commissioned a 
research study, the Anthropometry of Wheeled Mobility Project, which 
was conducted by the University of Buffalo's Center for Inclusive 
Design and Environmental Access (IDeA). This research study focused on 
the anthropometry of 500 wheeled mobility device users in the United 
States and analyzed the seat height of manual chairs, power chairs, and 
scooters. The study explained that ``keeping the height of a transfer 
surface close to the height of a wheelchair seat reduces the effort 
necessary to transfer and provides a safer environment, especially in 
bathing and toilet rooms.'' pg. 89 available at https://idea.ap.buffalo.edu/projects/anthropometry. The study analyzed 
wheelchair seat heights and found that for manual chair users, the 
``5th--95th percentile range of wheelchair seat heights was 430mm-566mm 
(17 in-22.3 in).'' Id. at 85. The study also opined that in applying 
these findings, if the purpose is to accommodate the 5th percentile 
occupied manual chair user seat height and the 95th percentile scooter 
user height, a range of 430 mm-635 mm (17 in.-25 in.) is needed. Id.
    In November 2015, a final report was issued for a study 
commissioned by the Access Board on Independent Wheelchair Transfers in 
the Built Environment: How Transfers Setup Impacts Performance 
conducted by Human Engineering Research Laboratories (HERL). While this 
study focused on transfers in the built environment, including clear 
floor space dimensions, impact of grab bars, and finding a fixed height 
that can accommodate the largest percentage of users, it provides some 
information that is pertinent to the issue of an appropriate adjustable 
height range for independent transfers in a medical setting. In this 
study, the researchers explained that for wheelchair users, ``transfers 
are required to perform essential tasks of daily living such as 
bathing, toileting, and driving. On average, transfers are performed 
between 11 and 20 times per day. Independent transfers are ranked among 
the most strenuous tasks of daily living because of the high mechanical 
demands they place on upper limbs. The built environment can either 
increase or decrease the effort required to perform independent 
transfers. Environments that require more effort to transfer ultimately 
limit the number of WMD users who can access them.'' Independent 
Wheelchair Transfers in the Built Environment: How Transfer Setup 
Impacts Performance Phase 2: Final Report, pg. 8, available at https://www.herl.pitt.edu/ab/ABTransferSetupReportPhaseII.pdf (last accessed 
April 5, 2023). In this study, all participants were able to complete a 
level transfer, meaning they successfully transferred

[[Page 33058]]

from their wheeled mobility device to a transfer surface that was level 
with the seat of their chair. Id. at 49. The researchers noted that 
``transfers are easiest and safest to obtain when they are as close to 
level as possible''. Id. The participants of this study had wheelchair 
seat heights which ranged from 19 inches minimum to 27.5 inches 
maximum. Based on the study participants, this study recommended an 
adjustable platform height from 19 to 27.5 inches as ``all participants 
can make a level transfer.'' Id. at 49.
    In 2021, the Access Board commissioned 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, specifically that the participants were not 
statistically representative of the wheelchair-user community. This new 
analysis took the ``data on occupied seat heights for manual and 
powered wheelchair users (N= 466 of 500 users in the AWM database) 
[and] statistically resampled to create virtual samples that were 
proportionally representative of the total population of wheelchair 
users in the U.S. in terms of device type (manual vs. powered), gender 
(men vs. women) and age category (younger 18-64 vs. older 65+). 
Analysis of Low Wheelchair Seat Heights and Transfer surfaces for 
Medical Diagnostic Equipment Final Report, Clive D'Souza, available at 
https://www.access-board.gov/research/human/wheelchair-seat-height/. 
The proportions were obtained from the 1994-97 National Health 
Interview Survey on Disability (NHIS-D) study findings presented by 
LaPlante and Kay (2010).'' \1\ In the Final Report, Dr. D'Souza 
explains that the ``occupied seat height of wheeled mobility devices is 
important for determining the necessary height ranges for adjustable 
transfer surfaces of MDE. Generally, maintaining a transfer surface at 
the same height as the wheelchair seat reduces the effort needed to 
transfer, since occupants would not have to lift their body weight to 
make up the difference between the two surface heights, in one 
direction or the other.'' Id.
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    \1\ The 1994-97 National Health Interview Survey on disability 
is the most recent survey on wheelchair use within the United 
States.
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    In his final report, Dr. D'Souza used demographically 
representative virtual samples to determine the proportion of manual 
and power wheelchair users who would be excluded from a level transfer 
if the lower height limit of the MDE transfer surfaces were set to 17 
inches, 18 inches, or 19 inches. Dr. D'Souza's analysis found that at a 
17-inch low transfer height, 4.5 percent of wheelchair users would be 
excluded; at an 18-inch low transfer height, 21 percent of wheelchair 
users would be excluded; and at a 19-inch low transfer height, 43 
percent of wheelchair users would be excluded. Id. Additionally, Dr. 
D'Souza conducted further analysis to account for the predictable 
increase in power wheelchair users since the last available survey of 
the total population of wheelchair users in the United States in terms 
of device type, gender, and age was last conducted in 1994-1997. Id. 
Dr. D'Souza accounted for a 10 percent increase and a 20 percent 
increase in power wheelchair use. This increase in power wheelchair 
proportions indicated ``that the percent excluded would show a small 
decrease (i.e., increased accommodation) at intermediate values (e.g., 
at 19 inches, a 10% increase in powered wheelchair proportions 
decreased the percent excluded from 42% to 39%). However, at lower 
heights such as 17 inches, there is no substantial change in 
percentiles, since most wheelchair users, regardless of device type, 
are already accommodated (i.e., at 17 in., a 10% increase in powered 
wheelchair proportions decreased the percent excluded from about 4.5% 
to 4%).'' Dr. D'Souza opined that setting the low transfer height 
requirement ``closer to the tails of the distribution (e.g., 17 or 17.5 
in.)'' would continue to ensure a level transfer despite future changes 
in population demographics. Id.

IV. Public Meeting and Comments on Research Study

    On May 12, 2022, after the publication of the final report Analysis 
of Low Wheelchair Seat Heights and Transfer Surfaces for Medical 
Diagnostic Equipment, the Access Board held a public meeting to obtain 
further information on the appropriate low-height specification of 
transfer surfaces for medical diagnostic equipment. The Access Board 
also invited public comment on the findings in Dr. D'Souza's final 
report and any new information regarding the low transfer height 
provision, since the issuance of the MDE Final Rule in 2017.\2\ The 
Access Board had disability rights organizations, members of the 
public, and a manufacturer attend the public meeting and provide 
comment. Most of those commenters also provided written comments. In 
all, the Access Board received 107 comments in response to its request. 
Available at https://www.regulations.gov/docket/ATBCB-2022-0002/comments.
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    \2\ Comments in response to the public meeting are available on 
Docket ATBCB-2022-0002, available at https://www.regulations.gov/docket/ATBCB-2022-0002/comments.
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    Of those comments, 12 were from disability rights organizations. 
These organizations unanimously support adoption of 17 inches as the 
low transfer height specification. Specifically, multiple organizations 
point out the importance of ensuring that the greatest number of people 
with disabilities can access medical services by being able to transfer 
onto the exam table. Additionally, one organization in the state of 
Mississippi asserts that it disagrees with the premise that more people 
are moving to power wheelchairs. The organization claims that the 
majority of users it encounters use manual wheelchairs and that a 
significant number of the population would require the 17-inch low 
height to be able to transfer to MDE. See Comment ATBCB-2022-0002-0028, 
available at https://www.regulations.gov/comment/ATBCB-2022-0002-0028.
    The Access Board received approximately 90 comments from members of 
the public, who almost unanimously supported a low height of 17 inches. 
Many commenters explained the continued struggle to obtain proper 
medical care and diagnosis as a result of inaccessible medical 
diagnostic equipment. A few commenters explained their preference for 
higher height MDE between 18 to 25 inches to allow level transfer with 
their specific wheelchair, but most of those commenters also 
highlighted the importance of the lower specification of 17 inches to 
accommodate those in wheelchairs that sit lower to the ground. The 
Board also received two comments from medical professionals, one 
recommending 17 inches to accommodate patients with specific medical 
conditions and the other recommending a low height of 18 inches.
    Finally, the Board received two comments from manufactures of exam 
tables, both supporting a 19-inch low height for MDE transfer surfaces. 
Both of these manufacturers also served on the MDE Advisory Committee 
and filed minority reports to the Advisory Committee Report supporting 
a 19-inch low height specification. In its public comment, one 
manufacturer explains that in the U.S. ``approximately 62 percent of 
physicians, hospitals, and other health care providers use examination 
and procedures tables with a 32-inch fixed height. Industry commonly 
refers to these tables as `box tables.' These tables provide an often-

[[Page 33059]]

insurmountable barrier to health care for people with accessibility 
needs. Since 2001, the number of adjustable-height tables has steadily 
increased from 5% but continues to represent a minority of examination 
and procedure tables in the United States with cost being one of the 
factors that limits full adoption.'' See Comment ATBCB-2022-0002-0073, 
available at https://www.regulations.gov/comment/ATBCB-2022-0002-0073. 
This manufacturer goes on to explain that while it makes an accessible 
exam table that has a low transfer height of 15.5 inches, it still 
supports a low-height specification for MDE of 19 inches, as it 
considers the lower exam table to be cost prohibitive. Additionally, if 
a specification lower than 19 inches is adopted, then the adjustable 
tables in exam rooms currently would be deemed inaccessible. Id. 
Concerning the latter point, the effect of the proposed change in this 
NPRM on existing MDE will depend on if and in what manner enforcement 
authorities decide to adopt them. For example, agencies may decide to 
delay the effective date or implementation date of any rules they 
adopt, they may deem MDE acquired prior to their rulemaking or this 
rulemaking to be ``accessible'' if it complied with the low transfer 
height range currently provided for, or it may make changes to the 
Access board's technical criteria during adoption, such as by 
continuing to allow for a range of low transfer heights between 17 and 
19 inches.
    Another manufacturer that also strongly supports a low-height-
specification of 19 inches asserts that lowering the height to 17 
inches would be cost prohibitive, would prevent the table from raising 
to a level comfortable for the medical professional examining the 
patient, and would cause a reduction in length of the table once 
reclined into a supine position. The commenter also raises concerns 
about the methodology behind our low height specification 
determination, asserting that the Board should be conducting a study to 
determine the heights to which people in wheelchairs can transfer, 
instead of attempting to provide for a level transfer by requiring MDE 
that aligns with the patient's wheeled mobility device. This 
manufacturer also raises concerns with the methodology of the original 
2010 Study, in measuring to the seat of the wheelchair at the back, 
instead of measuring to the front of the wheelchair. Finally, the 
comment includes an opinion from Don Wardell, a professor of operations 
management from the University of Utah. Dr. Wardell raises three 
concerns about Dr. D'Souza's statistical resampling: (1) that the data 
set used to derive the proportions of people using powered vs. manual 
wheelchairs is old; (2) that there is not sufficient evidence to assert 
that a percentage of the population would be excluded if not provided a 
level transfer, since the ability to transfer from one surface height 
to another involves many assumptions regarding individual abilities and 
methods as well as equipment characteristics; and (3) that the 
sensitivity analysis is inaccurate as there is no date or new 
information to suggest that the height of manual wheelchairs today are 
the same as they were in 1994.
    As to Dr. Wardell's first and third concerns, the 1994-97 data from 
the National Health Interview Survey on Disability (NHIS-D) was only 
used to determine the proportions of the wheelchair user population by 
gender, use of powered vs. manual wheelchairs, and age. The heights of 
wheelchairs were from data collected in the Anthropometry of Wheeled 
Mobility Project from 2010. While we do understand the concern with 
using the statistics of wheelchair users in the United States from 
1994-97, this is the most recent collection of data by the Center for 
Disease Control (CDC), and the most recent sufficient data the Board 
and Dr. D'Souza were able to obtain.
    Question 1. The Board seeks additional information about more 
recent available studies regarding the population of wheelchair users 
in the United States, by gender, age, and device type.
    Regarding the second assertion about level transfer, much of the 
research conducted on transfer to and from a mobility device has found 
that a level transfer requires less effort or upper body strength and 
has the highest success rate. In the Independent Wheelchair Transfers 
in the Built Environment: How Transfers Setup Impacts Performance study 
mentioned above, 100 percent of the participants that were capable of 
independent transfer could effectuate a transfer to a surface that is 
level with the height of their wheelchair. Available at https://www.herl.pitt.edu/ab/ABTransferSetupReportPhaseII.pdf. (last visited 
April 5, 2023). The ability to transfer vertically, on the other hand, 
is difficult to determine, as it differs among individuals depending on 
factors such as their disability, upper body strength, physical body 
make up, weight, etc. Id. Additionally, the same study references 
multiple journal articles which explain that most individuals in a 
wheelchair transfer many times per day, and their capabilities may be 
different depending on the number of times they have transferred on a 
particular day. Id.
    Patient and provider safety during transfer is another reason the 
Board believes that an independent level transfer is imperative. A 
level transfer provides less risk of injury to both the patient and 
provider by preventing the need for the patient to transfer vertically. 
Wheelchair related trip and falls are a yearly occurrence in the United 
States and can result in injury, decreased independence and affect the 
quality of life of someone who uses a wheelchair. D. Gavin-Dreschnack, 
A. Nelson, S. Fitzgerald, J. Harrow, A. Sanchez-Anguiano, S. Ahmed, and 
G. Powell-Cope, ``Wheelchair-related Falls: Current Evidence and 
Directors for Improved Quality Care'', Journal of Nursing Care Quality 
20, no. 2 (2005) 119. It is estimated that in the U.S. there is an 
average of 36, 559 nonfatal wheelchair related accidents each year that 
require emergency room visits. Id. Transfers to and from a wheelchair 
are one of five hazardous conditions that give rise to trips, falls, 
and fall-related injuries. Id. Specifically, this study showed that 
injuries can occur to the patient and the caregiver when an independent 
transfer is not possible and the caregiver is assisting with the 
transfer. Id. at 122. ``Tripping and falling are the most common form 
of incidents, accounting for 68.5% of fatal accidents and 73.2% of 
nonfatal accidents. . .among elderly long-term care residents, the 
majority of wheelchair-related injuries appeared to be connected with 
failed attempts to independently transfer into or out of a wheelchair 
and leaning forward.'' Id. at 123.
    Additionally, in a recent report by the National Council on 
Disability (NCD) entitled Enforceable Accessible Medical Equipment 
Standards NCD explains that a ``growing body of research has 
demonstrated a relationship between musculoskeletal injuries, workers 
compensation claims, and safe patient handling, due in part to the 
overreliance on manual transfers to inaccessible equipment. 
Inaccessible equipment leads health care workers to use awkward body 
posture and poor ergonomics that heighten the risk of injury. In a 
vicious cycle, musculoskeletal injuries among healthcare workers can 
also create a greater risk of injury to patients'' during transfer. 
National Council on Disability, Enforceable Accessible Medical 
Equipment Standards: A Necessary Means to Address the Health Care Needs 
of People with Mobility Disabilities, available at https://ncd.gov/

[[Page 33060]]

sites/default/files/Documents/NCD_Medical_Equipment_Report_508.pdf 
(last visited Apr. 5, 2023). Based on the risk of falls, injuries to 
patients and providers, the success of transfer at a level transfer, 
and the exertion needed for vertical transfer, the Board has determined 
that providing for 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.

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. 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, and it would have been 
impossible to compare every feature of every product. Further, such a 
robust, systematic study would be inappropriate at this point, given 
that the MDE Standards have no mandatory 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 is focusing on 
the MSRP. The prices reported here are likely higher than the actual 
prices the MDE purchasers would pay, because purchases typically pay 
less than MSRP, due to special sale, volume discount, 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 2022 Review of MDE Low Heights and 
MSRP. See Access Board Review of MDE Low Height and MSRP, dated Dec. 5, 
2022, 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 heights 
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.
    In comparing the costs of these exam tables it is important to note 
that the Board did not evaluate the exam tables 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 NPRM, 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. None of the chairs other than the dental chairs met the 
requirement for a 17-inch low transfer height. Consequently, for those 
chairs, we were not able to determine the approximate additional cost 
per unit that would be required to comply with this proposed 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 at 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 these chairs, low height doesn't appear to be 
a significant driver of cost difference for dental chairs.
    The Access Board reviewed five podiatry chairs, four of which have 
a low height between 18 and 19 inches. For three of these podiatry 
chairs the Board was able to ascertain a MSRP range of $8,063 to 
$15,241.38,\3\ and an

[[Page 33061]]

average cost of $11,534.49. The other podiatry chair has a low height 
of 24 inches and a MSRP of $4,995.
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    \3\ 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 
also need to meet M303, the requirements for diagnostic equipment used 
by patients seated in a wheelchair. Enforcement authorities would need 
to address applicable specifications in the scoping 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 is to exempt MDE from the low transfer height requirement 
where transfer is not required for examination.

VI. Low Transfer Height

    Obtaining medical diagnostic care is imperative for everyone, 
including people with disabilities, and the first step of obtaining 
adequate medical care is being able to transfer onto the MDE for 
examination. Historically, MDE has been, and continues to be, 
inaccessible to the vast majority of people in wheelchairs, as 
commenters have noted throughout the original MDE rulemaking, 
inaccessible equipment can lead to misdiagnosis and inability to access 
care or even basic exams. In response to the Board's call for comments 
on Dr. D'Souza's Report, a manufacturer of examination tables explained 
that over 60 percent of the examination tables in exam rooms today 
still have a fixed height of 32-inches. The Board determined early on 
in the original MDE rulemaking process that specifying an adjustable 
height transfer surface with at least six different height options 
(high height, low height, and 4 intermediate heights) would best be 
able to encompass the largest percentage of wheelchair users that are 
able to independently transfer. While we know some users are unable to 
independently transfer, those who are able should not be hindered by 
the height of the MDE. In this NPRM, the Board has determined that the 
low height of this adjustable height transfer surface should be 17 
inches.
    Multiple commenters, supportive of both 17 and 19 inches as a low 
transfer height, reference the transfer heights for fixtures in the 
built environment in the Board's Americans with Disabilities Act 
Accessibility Guidelines (36 CFR part 1191). However, the low transfer 
height specification for MDE is uniquely different from the 
specifications for transfer heights that the Access Board has 
instituted for the built environment. In the built environment, the 
Board has required that fixtures such as water closets (toilets), 
shower and bathtub seats be installed within a range of 17 to 19 inches 
for the height of these fixed elements to provide access for transfer 
to people with disabilities. See 36 CFR part 1191, appendix D, 604. 
This is not comparable to MDE, as these fixed elements 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 effectuate an independent transfer. As 
explained above in Dr. D'Souza's Report, if the Board was to adopt a 
low height of 19 inches, then between 39 to 42 percent of wheelchair 
users would not be able to effectuate a level transfer. However, by 
providing a low height of 17 inches, with at least five other heights 
between 17 and 25 inches, the adjustable height transfer surface should 
be able to accommodate at least 95 percent of wheelchair users who can 
independently transfer.
    When the Board initially undertook this rulemaking, there was no 
MDE on the market with a height lower than 19 inches, and most of what 
was on the market was well above 19 inches. See Final Regulatory 
Assessment, (December 2016) available at https://www.access-board.gov/files/mde/mde-assessment.pdf. Since 2016, the market has changed. More 
examination tables and chairs provide a low-height within the current 
range of 17 to 19 inches, many in the 18-to-19-inch range. There is 
also an examination table currently on the market that provides a 15.5-
inch low transfer height. Finally, the vast majority of dental chairs 
on the market have a low transfer height at or below 17 inches.
    Based on the findings of Dr. D'Souza's report and the other 
research discussed herein, as well as the changes to the market since 
the issuance of the MDE Standards in 2017, the Board has decided to 
propose a low transfer height of 17 inches. The Board expects that the 
market will continue to progress to low transfer heights and believes 
that at the time of any adoption by any enforcement authorities if a 
specific exception is needed for a specific regulated party, that 
enforcement authority could do so at that time. Additionally, 
enforcement authorities could address any lack of available equipment 
on the market by utilizing the exception already provided within the 
MDE Standards (M201.2) or could propose a delayed or phased-in 
effective date for the low height transfer position.

VII. Regulatory Process Matters

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

    The Access Board has examined the impact of this notice of proposed 
rulemaking under Executive Orders 12866 and 13563. 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 NPRM is a significant regulatory action as 
it raises a novel legal or policy issue within the meaning of Executive 
Order 12866. See E.O. 12866 Sec.  3(f), 58 FR 51735 (Oct. 4, 1993) 
(defining ``significant regulatory action'' as, among other things, 
regulatory actions that has an annual effect on the economy of $100 
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 novel legal or policy issues).
    This proposed rule does not impose any incremental costs. Unlike 
many of the Access Board's other rulemakings that provide minimum 
guidelines which enforcement agencies must adopt as minimum standards 
for accessibility, Section 510 of the Rehabilitation Act does not 
require any enforcement

[[Page 33062]]

agency to adopt these technical criteria as minimum standards or at 
all. Additionally, the Access Board has not provided any scoping 
provisions, as the Board does not have the authority to determine who 
should comply with these provisions or how many of each particular type 
of medical diagnostic equipment would need to comply in any given 
facility. Therefore, because the MDE Standards are more akin to 
technical guidance, even if they are subsequently adopted by another 
Federal agency, that agency would have the ability to make changes to 
any part of the technical criteria as deemed necessary or appropriate 
(e.g., as the result of conducting a cost/benefit analysis) and would 
be required to undertake its own regulatory assessment before issuing 
enforceable Standards. Finally, this NPRM is restricted to one 
provision regarding the low transfer height, which was already set at 
the range of 17 to 19 inches, in this NPRM we are proposing to change 
that to a single specification of 17 inches. In the final regulatory 
impact analysis (FRIA 2017) for the MDE Standards issued in 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 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 $100 million.
    The benefits of providing accessible MDE were well documented 
throughout the original MDE rulemaking process, including the extensive 
explanation in the Final Regulatory Analysis (December 2016). Available 
at https://www.access-board.gov/files/mde/mde-assessment.pdf. These 
arguments continue to be valid in 2022, 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 
the 61 million people with disabilities in the United States, more than 
20 million people over the age of 18 years of age 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 which 
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, it is imperative that 
the low transfer height selected 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 MDE FRIA 2017 reviewed the overall cost of MDE on the market 
but did not address the incremental cost of each provision. During our 
information collection for this NPRM, we again looked at the overall 
cost of the MDE and also assessed the low transfer heights of the 
respective MDE; 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 examination 
tables, we saw a wide range in the adjustable table market, for tables 
with a low height of 18 to 19 inches, we saw a MSRP range of $2,127 to 
$14,144. Currently, on the market there is one examination table which 
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. Over 75 percent of the adjustable examination 
tables the Access Board reviewed have a low height of 18 to 19 inches, 
and 50 percent of those are at 18 inches. Currently, the Board is 
unable to determine the incremental cost for these manufacturers to 
lower the low height of the transfer surface from 18 to 17 inches or 
from 19 to 17 inches.
    Question 2. The Board seeks additional information regarding the 
estimated cost of modifying current examination tables that have a low 
transfer height of 18 or 19 inches in order to comply with the 17-inch 
low transfer height requirement, or, if it is not possible to modify 
existing MDE, the difference in the cost of manufacturing MDE with a 
low transfer height of 18 or 19 inches and the cost of manufacturing 
MDE that meets the 17-inch low transfer height.
    Question 3. The Board seeks additional information regarding the 
estimated cost of modifying current examination chairs, specifically 
phlebotomy, OB-GYN, podiatry, and optometry/ophthalmology chairs, that 
have a low transfer height of 18 or 19 inches in order to comply with 
the 17-inch low transfer height requirement, or, if it is not possible 
to modify existing MDE, the difference in the cost of manufacturing MDE 
with a low transfer height of 18 or 19 inches and the cost

[[Page 33063]]

of manufacturing MDE that meets the 17-inch low transfer height. The 
Board also seeks information about whether transfer to a phlebotomy 
chair would be necessary, or whether procedures can be performed on 
patients while they remain in their wheelchairs.
    Question 4. How much time would manufacturers need to be able to 
develop a sufficient number of examination chairs (other than dental 
chairs) and tables with a minimum low transfer height of 17 inches to 
meet market demand? How long will it take the market to adjust so that 
prices for examination tables and chairs with a minimum low transfer 
height of 17 inches are comparable to those that are 18 and 19 inches? 
Does this length of time, if any, vary depending on the specialty in 
which the equipment is used?
    Question 5. Are there other resources, data, or information the 
Board should consider with respect to its proposed minimum low transfer 
height requirement of 17 inches?
    The Board asserts that the benefits provided to the millions of 
Americans that use mobility devices and medical professionals and 
caregivers assisting those individuals transfer outweighs the potential 
costs of requiring a low transfer height of 17 inches for medical 
diagnostic equipment. 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 that are capable of independent 
transfer are provided the opportunity to effectuate that transfer with 
a height of medical diagnostic equipment that is level to their current 
mobility device. These benefits, which include the health care cost 
savings from preventing injuries to the patient and health care worker 
outweigh the costs to comply with the proposed 17-inch low height 
provision, especially considering the significant increase of MDE that 
currently attains a lower transfer height than even five years ago; 
However, as noted above, the Access Board is unaware of who would incur 
these potential costs and to what extent, based on the structure of 
this rulemaking. Additionally, the Access Board expects that when 
rulemaking agencies propose to enforce the MDE Standards, 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 notice of proposed rulemaking 
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 notice of proposed rulemaking 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 proposes to amend 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 to part 1195 by:
0
a. Revising M301.2.1;
0
b. Removing M301.2.2;
0
c. Revising M302.2.1; and
0
d. Removing M302.2.2.
    The revisions read as follows:

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

* * * * *

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

* * * * *

M301.2.1 * * *

    A. A low transfer position at a height of 17 inches (430 mm);
* * * * *
    M302 Diagnostic Equipment Used by Patients in Seated Position
    M302.2.1 * * *
    A. A low transfer position at a height of 17 inches (430 mm);
* * * * *

    Approved by vote of the Access Board.
Christopher Kuczynski,
General Counsel.
[FR Doc. 2023-10827 Filed 5-22-23; 8:45 am]
BILLING CODE 8150-01-P