[Federal Register Volume 77, Number 27 (Thursday, February 9, 2012)]
[Proposed Rules]
[Pages 6915-6939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-2795]



[[Page 6915]]

Vol. 77

Thursday,

No. 27

February 9, 2012

Part III





 Architectural and Transportation Barriers Compliance Board





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36 CFR Part 1195





 Medical Diagnostic Equipment Accessibility Standards; Proposed Rule

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

[[Page 6916]]


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ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD

36 CFR Part 1195

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


Medical Diagnostic Equipment Accessibility Standards

AGENCY: Architectural and Transportation Barriers Compliance Board.

ACTION: Notice of proposed rulemaking.

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

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

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

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

SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

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

1. Public Participation and Request for Comments

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

2. Establishment of Advisory Committee

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

3. Background

A. Access Board

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

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[[Page 6917]]

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

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

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

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

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

[[Page 6918]]

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

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

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

G. ANSI/AAMI HE 75

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

H. Barriers Affecting Accessibility and Usability of Medical Diagnostic 
Equipment

    The Rehabilitation Engineering Research Center on Accessible 
Medical Instrumentation conducted a national survey in 2004 to collect 
information on the types of medical equipment that is most difficult 
for individuals with disabilities to access and use.\9\ The survey was 
completed by a diverse sample of individuals with a wide range of 
disabilities, including mobility disabilities and sensory disabilities. 
Survey respondents who had experience with specific medical equipment 
rated their degree of difficulty when attempting to access or use the 
equipment as follows:
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    \9\ The results of the survey are reported in Jill M. Winters, 
Molly Follette Story, Kris Barnekow, June Isaacson Kailes, Brenda 
Premo, Erin Schier, Sarma Danturthi, and Jack M. Winters, ``Results 
of a National Survey on Accessibility of Medical Instrumentation for 
Consumers,'' in ``Medical Instrumentation Accessibility and 
Usability Considerations,'' edited by Jack M. Winters and Molly 
Follette Story (Boca Raton, CRC Press, 2007), 13-27.
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     75 percent rated examination tables as moderately 
difficult to impossible to use;
     68 percent rated radiology equipment as moderately 
difficult to impossible to use;
     53 percent rated weight scales as moderately difficult to 
impossible to use; and
     50 percent rated examination chairs as moderately 
difficult to impossible to use.

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

[[Page 6919]]

armrests, side rails), controls (e.g., ease of operation), and displays 
and devices (e.g., legibility, understandability).
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    \10\ The results of the focus group sessions are reported in 
Molly Follette Story, Erin Schwier, and June Isaacson Kailes, 
``Perspectives of Patients with Disabilities on the Accessibility of 
Medical Equipment: Examination Tables, Imaging Equipment, Medical 
Chairs, and Weight Scales,'' Disability and Health Journal 2 (2009), 
169-179.
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    The Access Board held a public meeting in July 2010 that featured 
panel discussions and presentations by experts and researchers on 
medical equipment accessibility, health care providers, medical device 
manufacturers, and other interested parties to provide information for 
developing the proposed standards. The transcript of the meeting is 
available at: http://www.access-board.gov/medical-equipment.htm.
    The technical criteria in the proposed standards address most of 
the barriers that have been identified as affecting the accessibility 
and usability of medical diagnostic equipment. However, it is not 
possible to address every barrier in the proposed standards, especially 
given the statutory deadline for issuing the standards. Research may be 
needed on some equipment characteristics that affect the accessibility 
and usability of equipment such as stiffness, comfort, and color 
contrast of contact surfaces. Section 510 of the Rehabilitation Act 
requires the Access Board to periodically review and amend the 
standards, as appropriate. The Access Board will address other barriers 
in future updates to the standards.
    Question 2. What other barriers that affect the accessibility and 
usability of medical diagnostic equipment should be addressed in future 
updates to the standards? Comments should include information on 
sources to support the development of technical criteria to address the 
barriers, where possible.

4. Organization of Technical Criteria

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

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

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

5. Discussion of Proposed Standards

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

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

Chapter M1 Application and Administration

M101.1 Purpose

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

M101.2 Application

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

M101.3 Equivalent Facilitation

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

M101.4 Dimensions

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

M101.5 Dimensional Tolerances

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

M102.1 Defined Terms

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

M102.2 Undefined Terms

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

M102.3 Interchangeability

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

Chapter M2 Scoping

M201.1 Enforcing Authority

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

Chapter M3 Technical Criteria

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

[[Page 6921]]

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

Sources for Technical Criteria

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

2004 ADA and ABA Accessibility Guidelines

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

Wheeled Mobility Anthropometry Project

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

ANSI/AAMI HE 75

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

Other Sources

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

Economic and Technical Impacts

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

[[Page 6922]]

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

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

M302 Diagnostic Equipment Used by Patients in Seated Position

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

Transfer Surface (M301.2 and M302.2)

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

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

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

Adjustable Height Range Considered

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

[[Page 6923]]

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

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

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

[[Page 6924]]

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

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

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

Transfer Sides (M301.2.3 and M302.2.3)

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

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

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

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

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

[[Page 6925]]

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

Additional Technical Criteria Considered for Transfer Supports

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

Location and Size

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

Height

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

Cross Section of Gripping Surfaces

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

[[Page 6926]]

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

Clearances Around Gripping Surfaces

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

Stirrups (M301.3.2)

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

Armrests (M302.3.2)

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

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

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

Positioning Supports Considered

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

Lift Compatibility (M301.4 and M302.4)

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

[[Page 6927]]

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

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

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

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

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

Overhead Lifts

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

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

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

M303 Diagnostic Equipment Used by Patients Seated in Wheelchair

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

Wheelchair Spaces (M303.2)

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

[[Page 6928]]

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

Exceptions Considered for Wheelchair Spaces on Raised Platforms

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

[[Page 6929]]

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

Knee and Toe Clearance (M303.2.4)

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

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

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

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

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

Additional Technical Criteria Considered for Handrails on Ramps

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

[[Page 6930]]

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

Components (M303.4)

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

M304 Diagnostic Equipment Used by Patients in Standing Position

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

Standing Supports (M304.3 and M305.3)

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

[[Page 6931]]

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

M305 Supports

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

M306 Communication

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

M307 Operable Parts

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

[[Page 6932]]

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

6. Regulatory Analyses

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

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

Need for and Benefits of the Proposed Standards

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

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

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

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

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

[[Page 6933]]

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

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

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

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

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

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

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

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

Entities Potentially Affected by Proposed Standards

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

Health Care Providers

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

Medical Device Manufacturers

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

[[Page 6934]]

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

Product Data and Unit Costs

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

Examination Tables

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

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

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

[[Page 6935]]

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

Weight Scales

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

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

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

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

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

Regulatory Flexibility Act: Initial Regulatory Flexibility Analysis

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

Reason the Access Board Is Issuing the Proposed Standards

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

Objective of, and Legal Basis for, the Proposed Standards

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

Small Entities Potentially Affected by Proposed Standards

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

Health Care Providers

    As discussed under Department of Justice Activities Related to 
Health Care Providers and Medical Equipment, health care providers must 
provide individuals with disabilities full and equal access to their 
health care services and facilities to comply with the ADA

[[Page 6936]]

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

Medical Device Manufacturers

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

Compliance Requirements in Proposed Standards

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

Other Relevant Federal Rules and Guidance Documents

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

Significant Alternatives

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

[[Page 6937]]

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

Executive Order 13132 (Federalism)

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

Unfunded Mandates Reform Act

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

List of Subjects in 36 CFR Part 1195

    Health care, Individuals with disabilities, Medical devices.

Nancy Starnes,
Chair.

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

PART 1195--STANDARDS FOR ACCESSIBILE MEDICAL DIAGNOSTIC EQUIPMENT

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

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


Sec.  1195.1  Standards.

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

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

Chapter M1: Application and Administration

M101 General

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

M102 Definitions

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

Chapter M2: Scoping

M201 General

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

Chapter M3: Technical Criteria

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

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

[[Page 6938]]

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

M302 Diagnostic Equipment Used by Patients in Seated Position

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

M303 Diagnostic Equipment Used by Patients Seated in a Wheelchair

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

M304 Diagnostic Equipment Used by Patients in Standing Position

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

[[Page 6939]]

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

M305 Supports

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

M306 Communication

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

M307 Operable Parts

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

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