6916 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules 

1The 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. 

2The 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. 

3The following Federal agencies have adopted 

the Access Board’s guidelines and standards as 

mandatory requirements for entities subject to their 

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. 

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: docket@access-board.gov. 

Include docket number ATBCB–2012– 

0003 in the subject line of the message. 

• Fax: 202–272–0081. 

• Mail or Hand Delivery/Courier: 

Office of Technical and Informational 

Services, Access Board, 1331 F Street 

NW., Suite 1000, Washington, DC 

20004–1111. 

All comments, including any personal 

information provided, will be posted 

without change to 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 

sesker@access-board.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents for Preamble 

1. Public Participation and Request for 

Comments 

2. Establishment of Advisory Committee 

3. Background 

A. Access Board 

B. Patient Protection and Affordable Care 

Act and Section 510 of the Rehabilitation 

Act 

C. Americans With Disabilities Act and 

Section 504 of the Rehabilitation Act 

D. Department of Justice Activities Related 

to Health Care Providers and Medical 

Equipment 

E. Private Enforcement Efforts 

F. Consultation With Food and Drug 

Administration 

G. ANSI/AAMI HE 75 

H. Barriers Affecting Accessibility and 

Usability of Medical Diagnostic 

Equipment 

4. Organization of Technical Criteria 

5. Discussion of Proposed Standards 

6. Regulatory Analyses 

1. Public Participation and Request for 

Comments 

The preamble includes questions that 

request comments on issues that the 

Access Board is particularly interested 

in receiving information from the 

public. The Access Board encourages all 

persons interested in the rulemaking to 

submit comments on the proposed 

standards and the questions in the 

preamble. Instructions for submitting 

and viewing comments are provided 

above under Addresses. The Access 

Board will consider all the comments 

and may change the proposed standards 

based on the comments. 

2. Establishment of Advisory Committee 

The Access Board has used advisory 

committees consisting of representatives 

of interest groups that are affected by its 

guidelines and standards to assist in 

developing the guidelines and 

standards. Advisory committees provide 

significant expertise on issues and an 

opportunity for interest groups to reach 

consensus on issues. The Access Board 

plans to convene an advisory committee 

when the comment period on the 

rulemaking closes to assist the Board in 

reviewing the comments and make 

recommendations on issues addressed 

in the rulemaking. The Access Board 

will issue a separate notice in the 

Federal Register announcing the 

establishment of the advisory committee 

and seeking nominations for 

membership on the advisory committee 

to represent the interests of individuals 

with disabilities, medical device 

manufacturers, health care providers, 

standards setting organizations, and 

other interested parties. Advisory 

committee meetings will be announced 

in advance in the Federal Register and 

will be open to the public. 

3. Background 

A. Access Board 

The Access Board is an independent 

Federal agency established by Section 

502 of the Rehabilitation Act (29 U.S.C. 

792).1 The Access Board is responsible 

for developing accessibility guidelines 

and standards under various laws to 

ensure that individuals with disabilities 

have access to and use of buildings and 

facilities, transportation vehicles, and 

information and communication 

technology.2 Pursuant to these laws, 

other Federal agencies have adopted the 

Access Board’s guidelines and standards 

as mandatory requirements for entities 

subject to their jurisdiction.3

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Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules 6917 

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.accessboard.gov/ada-aba/dod-memorandum.htm. Some 

agencies have adopted the guidelines and standards 

with additions and modifications. 

4The 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. 

6The 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. 

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

D. Department of Justice Activities 

Related to Health Care Providers and 

Medical Equipment 

Pursuant to the ADA and Section 504 

of the Rehabilitation Act, health care 

providers must provide individuals 

with disabilities full and equal access to 

their health care services and facilities. 

DOJ has entered into settlement 

agreements with health care providers 

to enforce the ADA and Section 504 of 

the Rehabilitation Act.6

In July 2010, DOJ and the Department 

of Health and Human Services issued a 

guidance document for health care 

providers regarding their 

responsibilities to make their services 

and facilities accessible to individuals 

with mobility disabilities under the 

ADA and Section 504 of the 

Rehabilitation Act. See Access to 

Medical Care for Individuals with 

Mobility Disabilities available at: 

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 

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6918 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules 

7The 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. 

8The 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. 

9The 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. 

10The 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. 

under the ADA for covered entities to 

provide accessible equipment and 

furniture, it was considering amending 

its regulations implementing Titles II 

and III of the ADA to include specific 

standards for the design and use of 

accessible equipment and furniture that 

is not fixed or built into a facility in 

order to ensure that programs and 

services provided by state and local 

governments and by public 

accommodations are accessible to 

individuals with disabilities.7 See 75 FR 

43452 (July 26, 2010). Among other 

things, the ANPRM stated that DOJ was 

considering amending its ADA 

regulations to specifically require health 

care providers to acquire accessible 

medical equipment and that it would 

consider adopting the standards issued 

by the Access Board. DOJ also indicated 

its intention to include in its ADA 

regulations scoping requirements that 

specify the minimum number of types 

of accessible medical equipment 

required in different types of health care 

facilities. If DOJ proposes to amend its 

ADA regulations as announced in the 

ANPRM, it will publish a notice of 

proposed rulemaking (NPRM) 

requesting public comment. 

E. Private Enforcement Efforts 

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

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/. 

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: 

• 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, 

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Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules 6919 

armrests, side rails), controls (e.g., ease 

of operation), and displays and devices 

(e.g., legibility, understandability). 

The Access Board held a public 

meeting in July 2010 that featured panel 

discussions and presentations by 

experts and researchers on medical 

equipment accessibility, health care 

providers, medical device 

manufacturers, and other interested 

parties to provide information for 

developing the proposed standards. The 

transcript of the meeting is available at: 

http://www.access-board.gov/medicalequipment.htm. 

The technical criteria in the proposed 

standards address most of the barriers 

that have been identified as affecting the 

accessibility and usability of medical 

diagnostic equipment. However, it is not 

possible to address every barrier in the 

proposed standards, especially given the 

statutory deadline for issuing the 

standards. Research may be needed on 

some equipment characteristics that 

affect the accessibility and usability of 

equipment such as stiffness, comfort, 

and color contrast of contact surfaces. 

Section 510 of the Rehabilitation Act 

requires the Access Board to 

periodically review and amend the 

standards, as appropriate. The Access 

Board will address other barriers in 

future updates to the standards. 

Question 2. What other barriers that 

affect the accessibility and usability of 

medical diagnostic equipment should be 

addressed in future updates to the 

standards? Comments should include 

information on sources to support the 

development of technical criteria to 

address the barriers, where possible. 

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. 

Patient positions equipment 

designed to support 

Equipment features addressed in technical 

criteria 

Types of equipment to which 

technical criteria applies 

Supine, prone, or side-lying position (M301) .... Transfer surface, including height, size, and 

transfer sides.

Examination tables. 

Transfer supports, stirrups, and head and 

back support.

Imaging equipment designed for use with platform beds. 

Lift compatibility ................................................ Examination chairs designed to recline and be 

used as examination tables. 

Seated position (M302) ..................................... Transfer surface, including height, size, and 

transfer sides.

Examination chairs. 

Transfer supports, armrests, and head and 

back support.

Imaging equipment designed for use with a 

seat. 

Lift compatibility ................................................ Weight scales designed for use with a seat. 

Seated in a wheelchair (M303) ......................... Wheelchair space, including orientation, width, 

depth, knee and toe clearance, and surface 

slope.

Imaging equipment designed for wheelchair 

use. 

Changes in level at entry to wheelchair space, 

including ramps.

Weight scales designed for wheelchair use. 

Components capable of examining body parts 

of patients seated in a wheelchair, including 

height of breast platforms.

Standing position (M304) ................................... Slip resistant standing surface ......................... Imaging equipment 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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6920 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules 

addresses scoping. Chapter M3 contains 

the technical criteria. The sections in 

each chapter are discussed below. 

Although the standards do not impose 

any mandatory requirements on health 

care providers or medical device 

manufacturers, the standards use 

mandatory language (i.e., shall) because 

other agencies, referred to as an 

enforcing authority in the standards, 

may issue regulations or adopt policies 

that require health care providers 

subject to their jurisdiction to acquire 

accessible medical diagnostic 

equipment that conforms to the 

standards. Sections marked as advisory 

provide guidance on the standards and 

are not mandatory. 

The Access Board is committed to 

writing standards that are clear, concise, 

and easy to understand so that persons 

who use the standards know what is 

required. 

Question 4. Is there language in the 

proposed standards that is ambiguous or 

not clear? Comments should identify 

specific language in the proposed 

standards that is ambiguous or not clear 

and, where possible, recommend 

alternate language that is clear. 

Chapter M1 Application and 

Administration 

M101.1 Purpose 

The proposed standards contain 

technical criteria for medical diagnostic 

equipment that is accessible to and 

usable by patients with disabilities. The 

standards provide for independent 

access to and use of diagnostic 

equipment by patients with disabilities 

to the maximum extent possible. 

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 sidelying position (see M301); equipment 

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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.accessboard.gov/medical-equipment.htm. The 

figures are provided to help readers 

understand how the technical criteria 

apply to diagnostic equipment. 

Question 7. Comments are requested 

on whether the figures can be improved 

to help readers better understand how 

the technical criteria apply to diagnostic 

equipment. 

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.accessboard.gov/medical-equipment.htm. In 

addition, the Access Board considered 

public comments relating to medical 

equipment that were submitted in 

response to DOJ’s ANPRM on 

equipment and furniture. The public 

comments on DOJ’s ANPRM on 

equipment and furniture are available at 

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 

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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 

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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-ofseat-height-for-wheeled-mobilitydevices. The seat heights ranged from 

16.3 inches to 23.9 inches for manual 

wheelchair users; 16.2 inches to 28.9 

inches for power wheelchair users; and 

18.8 inches to 25.3 inches for scooter 

users. Seat heights for males were 

typically higher than for females. Thirty 

(30) percent of male manual wheelchair 

users and 6 percent of male power 

wheelchair users had seat heights equal 

to or less than 19 inches. All the male 

manual wheelchair users and 92 percent 

of the male power wheelchair users had 

seat heights equal to or less than 25 

inches. Thus, transfer surfaces that are 

adjustable from 17 inches minimum to 

25 inches maximum during patient 

transfer accommodate significantly 

more patients who use mobility devices. 

Ideally, transfer surfaces should be 

adjustable to any height within the 17 

inches minimum and 25 inches 

maximum range. However, intermediate 

heights may need to be established 

within the range because of different 

methods for providing adjustability 

(e.g., power, mechanical) or other 

equipment limitations. The distance 

between the intermediate heights 

should be small. 

Question 14. Comments are requested 

on the following questions regarding the 

adjustable height range (17 inches 

minimum to 25 inches maximum during 

patient transfer) that the Access Board is 

considering requiring in the final 

standards for transfer surfaces on 

diagnostic equipment used by patients 

in a supine, prone, or side-lying 

position, and diagnostic equipment 

used by patients in a seated position: 

(a) What types of equipment currently 

provide patient support surfaces that are 

height adjustable? If there are several 

models of the same type of equipment, 

does at least one model provide patient 

support surfaces that are height 

adjustable? What is the range of 

adjustable heights? If the range of 

adjustable heights does not include 17 

inches to 25 inches, what would be the 

incremental costs to achieve this range? 

(b) What types of equipment do not 

currently provide patient support 

surfaces that are height adjustable? 

What would be the incremental costs for 

the design or redesign and manufacture 

of the equipment to provide patient 

support surfaces that are height 

adjustable within the above range? 

(c) Are there types of equipment that 

cannot provide patient support surfaces 

that are height adjustable within the 

above range because of the structural or 

operational characteristics of the 

equipment? Comments should discuss 

alternative methods for making the 

equipment accessible to patients with 

disabilities. 

(d) Should intermediate heights be 

established within the above range? 

What intermediate heights within the 

above range would be appropriate to 

facilitate independent transfer by 

patients who use mobility devices and 

aids? 

Transfer Surface Size: Equipment Used 

by Patients in Supine, Prone, or SideLying Position (M301.2.2) 

As noted earlier, the technical criteria 

do not address the overall width and 

depth of patient support surfaces 

because of the diverse shape and size of 

these surfaces. ANSI/AAMI HE75 

recommends that patient support 

surfaces ‘‘should allow patients to 

transfer themselves on and off safely 

and easily and to assume and maintain 

positions safely and comfortably.’’ For 

surfaces on which patients lie down, 

ANSI/AAMI HE75 recommends that 

‘‘patients should be able to roll to a side 

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: 

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(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 sidelying position. 

On diagnostic equipment used by 

patients in a seated position, M302.2.2 

would require the size of the transfer 

surface to be 21 inches wide minimum 

and 15 inches deep minimum. The 21 

inches minimum width is based on the 

ideal chair width recommended in 

Architectural Graphic Standards for 

auditorium seating. See The American 

Institute of Architects, Architectural 

Graphic Standards (10th edition, 2000), 

page 919. The 15 inches minimum 

depth is generally consistent with the 

dimension specified in the 2004 ADA 

and ABA Accessibility Guidelines for 

rectangular seats in roll-in showers. 

The transfer surface dimensions do 

not include headrests, footrests, or 

similar supports for body extremities 

that do not support the patient’s overall 

body position. A transfer surface is 

permitted to be contoured; however, the 

minimum dimensions would have to fit 

within the contoured surface and cannot 

be reduced to accommodate an 

asymmetrical shape. 

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 

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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 11⁄2 inches 

maximum measured horizontally from 

the adjacent edge of the transfer surface. 

This would ensure that the transfer 

support is within reach and can be 

effectively used during transfers. 

The above technical criteria would 

likely result in the transfer surface being 

located at the foot end of examination 

tables and allow the use of transfer 

supports similar to the side rails 

described in the information provided 

by Midmark Corporation. 

Question 19. Comments are requested 

on the following questions regarding the 

above technical criteria for the location 

and size of transfer supports on 

diagnostic equipment used by patients 

in a supine, prone, or side-lying 

position, and diagnostic equipment 

used by patients in a seated position: 

(a) Are the above technical criteria for 

the location and size of transfer 

supports sufficient to facilitate transfer 

and maintain position on the 

equipment? 

(b) Can transfer supports on different 

types of equipment meet the above 

technical criteria for the location and 

size of the supports? 

(c) What would be the incremental 

costs for the design or redesign and 

manufacture of transfer supports that 

meet the above criteria? 

(d) Would alternative technical 

criteria be appropriate for the location 

and size of transfer supports? Comments 

should include information on sources 

to support the alternative technical 

criteria, where possible. 

(e) Should angled or vertical transfer 

supports be permitted? 

Height 

The Access Board is considering 

whether 6 inches minimum and 19 

inches maximum above the transfer 

surface would be an appropriate height 

for transfer supports on diagnostic 

equipment used by patients in a supine, 

prone, or side-lying position, and 

diagnostic equipment used by patients 

in a seated position. The minimum 

height is consistent with the 

information provided by Midmark 

Corporation on examination table side 

rails, and the maximum height is 

generally consistent with the height of 

grab bars above shower seats in the 2004 

ADA and ABA Accessibility Guidelines. 

Question 20. Comments are requested 

on the following questions regarding the 

above height range (6 inches minimum 

and 19 inches maximum above the 

transfer surface) for transfer supports on 

diagnostic equipment used by patients 

in a supine, prone or side-lying 

position, and diagnostic equipment 

used by patients in a seated position: 

(a) Are transfer supports within the 

above height range usable by patients 

with disabilities? 

(b) Can transfer supports on different 

types of equipment meet the above 

height range? 

(c) Would alternative technical 

criteria be appropriate for the height of 

transfer supports? Comments should 

include information on sources to 

support the alternative technical 

criteria, where possible. 

Cross Section of Gripping Surfaces 

The 2004 ADA and ABA Accessibility 

Guidelines specify the following 

dimensions for grab bars to enable 

individuals with disabilities to firmly 

grasp the grab bars and support 

themselves during transfers: 

• Grab bars with circular cross 

sections must have an outside diameter 

of 11⁄4 inches minimum and 2 inches 

maximum. 

• Grab bars with non-circular cross 

sections must have a cross section 

dimension of 2 inches maximum and a 

perimeter dimension of 4 inches 

minimum and 4.8 inches maximum. 

The Access Board is considering 

whether the above cross section 

dimensions would be appropriate for 

the gripping surfaces of transfer 

supports on diagnostic equipment used 

by patients in a supine, prone, or sidelying position, and diagnostic 

equipment used by patients in a seated 

position. 

Question 21. Comments are requested 

on the following questions regarding the 

above cross section dimensions for the 

gripping surfaces of transfer supports on 

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diagnostic equipment used by patients 

in a supine, prone, or side-lying 

position, and diagnostic equipment 

used by patients in a seated position: 

(a) Can the gripping surfaces of 

transfer supports on different types of 

equipment meet the above cross section 

dimensions? 

(b) Can handholds that meet the above 

cross section dimensions be integrated 

into the design of armrests that are 

cushioned to support arms and elbows? 

(c) Are there alternative designs for 

the gripping surfaces of transfer 

supports that enable patients with 

disabilities to firmly grasp the supports 

and support themselves during transfer? 

Clearances Around Gripping Surfaces 

The 2004 ADA and ABA Accessibility 

Guidelines specify the following 

clearances around grab bars to ensure 

sufficient space for a person to grasp the 

grab bar: 11⁄2 inches absolute clearance 

between grab bars and the adjacent wall 

surfaces; 11⁄2 inches minimum clearance 

between grab bars and projecting objects 

below and at the ends of grab bars; and 

12 inches minimum clearance between 

grab bars and projecting objects above 

grab bars. 

The Access Board is considering 

whether 11⁄2 inches minimum clearance 

around the gripping surface would be 

appropriate for transfer supports on 

diagnostic equipment used by patients 

in a supine, prone, or side-lying 

position, and diagnostic equipment 

used by patients in a seated position. 

Question 22. Can transfer supports on 

different types of equipment provide 

11⁄2 inches minimum clearance around 

the gripping surface? 

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 

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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 

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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 

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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 based on 2004 ADA and ABA 

accessibility guidelines 

Dimensions recommended by wheeled mobility 

anthropometry project 

Toe Clearance ............................. 6 inches deep maximum at 9 inches above the floor 5 inches deep maximum at 14 inches above the 

floor. 

Knee Clearance .......................... 11 inches deep minimum at 9 inches above the floor, 

and 8 inches deep minimum at 27 inches above 

the floor.

12 inches deep minimum at 28 inches above the 

floor. 

Between 9 inches and 27 inches above the floor, 

knee clearance is permitted to reduce at rate of 1 

inch in depth for every 6 inches in height.

Knee clearance is same depth throughout and not 

sloped. 

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: 

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6930 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules 

(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-ofseat-height-for-wheeled-mobilitydevices. Other anthropometric data 

show the heights of the midpoint of the 

breast to be 13 inches for the 5th 

percentile woman and 18 inches for the 

95th percentile woman when measured 

from seat height. See Laura Peebles and 

Beverley Norris, Adultdata: The 

Handbook of Adult Anthropometric and 

Strength Measurements: Data for Design 

Safety (London, Department of Trade 

and Industry, 1998), page 71. The 

proposed height range for the breast 

platform is based on the above 

anthropometric data. Breast platforms 

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 

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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 11⁄4 inches minimum and 2 inches 

maximum. 

• Grab bars with non-circular cross 

sections must have a cross section 

dimension of 2 inches maximum and a 

perimeter dimension of 4 inches 

minimum and 4.8 inches maximum. 

The Access Board is considering 

whether the above cross section 

dimensions would be appropriate for 

the gripping surfaces of standing 

supports on diagnostic equipment used 

by patients in a standing position. 

Question 39. Comments are requested 

on the following questions regarding the 

above cross section dimensions for the 

gripping surfaces of standing supports 

on diagnostic equipment used by 

patients in a standing position: 

(a) Can the gripping surfaces of 

standing supports on different types of 

equipment meet the above cross section 

dimensions? 

(b) Are there alternative designs for 

the gripping surfaces of standing 

supports that enable patients with 

disabilities to firmly grasp the supports? 

The Access Board is also considering 

whether a 11⁄2 inches minimum 

clearance around the gripping surface of 

standing supports would be appropriate 

to ensure that the surface can be 

grasped. 

Question 40. Can standing supports 

on different types of equipment provide 

11⁄2 inches minimum clearance around 

the gripping surface without 

encountering obstructions? 

M305 Supports 

M305 provides the technical criteria 

for transfer supports and standing 

supports. The technical criteria for 

transfer supports are discussed under 

M301 Diagnostic Equipment Used by 

Patients in Supine, Prone, or Side-Lying 

Position and M302 Diagnostic 

Equipment Used by Patients in Seated 

Position. The technical criteria for 

standing supports are discussed under 

M304 Diagnostic Equipment Used by 

Patients in Standing Position. 

M306 Communication 

Where diagnostic equipment 

communicates instructions or other 

information to the patient, M306 would 

require the instructions or other 

information to be provided in at least 

two of the following methods: audible, 

visible, or tactile. For example, magnetic 

resonance imaging (MRI) and X-ray 

computed tomography (CT) equipment 

may instruct the patient to hold their 

breath for a short period during a scan 

by means of a flashing light or icon. A 

flashing light or icon would be 

sufficient to notify a patient who is deaf 

to hold their breath, but a voice prompt, 

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. 

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11 ‘‘Americans with Disabilities: 2005’’ (2008) 

available at: http://www.census.gov/prod/ 

2008pubs/p70-117.pdf. 

12 ‘‘A Profile of Older Americans: 2010’’ available 

at: http://www.aoa.gov/AoARoot/Aging_Statistics/ 

Profile/index.aspx. 

13See footnote 11. 

14The 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. 

M307.3 would require operable parts 

such as dials, switches, and levers to be 

operable with one hand without tight 

grasping, pinching, or twisting of the 

wrist. M307.4 would require the force to 

activate operable parts to not exceed 5 

pounds. M307.3 and M307.4 are based 

on provisions for operable parts in the 

2004 ADA and ABA Accessibility 

Guidelines. M307.3 and M307.4 are also 

consistent with recommendations in 

ANSI/AAMI HE 75 that ‘‘devices should 

have at least one mode of use that does 

not require fine motor control or the 

performance of simultaneous actions.’’ 

ANSI/AAMI HE 75 includes additional 

recommended practices for accessible 

controls. See ANSI/AAMI HE 75, section 

16.3.3. 

The Wheeled Mobility Anthropometry Project recommended that 

‘‘operable parts that require fine grips 

preferably should not require exertion of 

lateral pinch grip forces in excess of 2 

pounds force to accommodate the vast 

majority of * * * users having at least 

some grasping capability.’’ The Wheeled 

Mobility Anthropometry Project 

recommended that the 5 pounds 

maximum force be retained for other 

types of operable parts. See Final Report 

of the Wheeled Mobility Anthropometry 

Project, page 105. The Access Board is 

considering requiring in the final 

standards that operable parts used by 

patients that require fine grips to not 

exceed 2 pounds maximum operating 

force. 

Question 42. Comments are requested 

on the following questions regarding the 

operating force (2 pounds maximum) 

that the Access Board is considering 

requiring in the final standards for 

operable parts used by patients that 

require fine grips: 

(a) What would be the incremental 

costs for the design or redesign and 

manufacture of the equipment to 

provide operable parts that meet the 

above operating force? 

(b) Are there types of equipment that 

cannot provide operable parts that meet 

the above operating force because of the 

structural or operational characteristics 

of the equipment? 

The 2004 ADA and ABA Accessibility 

Guidelines require that operable parts 

be placed within certain reach ranges. 

For an unobstructed forward reach or 

side reach, the reach ranges are 48 

inches maximum for a high reach and 

15 inches minimum for a low reach. 

ANSI/AAMI HE 75 provides guidance 

on reach ranges based on provisions in 

an earlier version of accessibility 

guidelines for buildings and facilities 

issued by the Access Board, the 1991 

Americans with Disabilities Act 

Accessibility Guidelines (ADAAG). 

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: 

• 27.4 million (11.9 percent) had 

difficulty with ambulatory activities of 

the lower body; 

• 22.6 million (9.8 percent) had 

difficulty walking a quarter of a mile; 

• 21.8 million (9.4 percent) had 

difficulty climbing a flight of stairs; 

• 10.2 million (4.4 percent) used a 

cane, crutches, or walker to assist with 

mobility; 

• 3.3 million (1.4 percent) used a 

wheelchair or other wheeled mobility 

device; 

• 7.8 million (3 percent) had 

difficulty seeing words or letters in 

ordinary newspaper print, including 1.8 

million who are completely unable to 

see; and 

• 7.8 million (3 percent) had 

difficulty hearing conversations, 

including 1 million who are unable to 

hear conversations at all. 

The prevalence of disability increases 

with age. The Administration on Aging 

reports that there were 39.6 million 

persons age 65 or older in the United 

States in 2009, and that this population 

is expected to increase to 55 million in 

2020.12 Among this population, 37 

percent reported some type of disability 

in 2005.13

A national survey collected 

information on the types of medical 

equipment that is most difficult for 

individuals with disabilities to access 

and use.14 The survey was completed by 

a diverse sample of individuals with a 

wide range of disabilities, including 

mobility disabilities and sensory 

disabilities. Survey respondents who 

had experience with specific medical 

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15The 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. 

16The report is available at: http://www.ncd.gov/ 

publications/2009/Sept302009. 

17The report is available at: http:// 

www.cdihp.org/products.html#tables. 

18Lifting 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. 

equipment rated their degree of 

difficulty when attempting to access or 

use the equipment as follows: 

• 75 percent rated examination tables 

as moderately difficult to impossible to 

use; 

• 68 percent rated radiology 

equipment as moderately difficult to 

impossible to use; 

• 53 percent rated weight scales as 

moderately difficult to impossible to 

use; and 

• 50 percent rated examination chairs 

as moderately difficult to impossible to 

use. 

Survey respondents reported 

difficulties with getting on and off the 

equipment, positioning their bodies on 

the equipment, physical comfort and 

safety, and communication issues. 

Focus group sessions of individuals 

with disabilities reported that 

participants find examination tables, 

imaging equipment, and other 

diagnostic equipment not only difficult 

but unsafe to use, and that these 

negative health care experiences can 

result in their not scheduling regular 

medical examinations and diagnostic 

procedures.15

A report on the ‘‘The Current State of 

Health Care for People with 

Disabilities’’ issued by the National 

Council on Disability found that 

individuals with disabilities 

experienced significant health 

disparities and barriers to health care, as 

compared to individuals without 

disabilities.16 Among the key barriers 

cited in the report is the lack of 

accessible examination equipment. A 

report on the ‘‘Importance of Accessible 

Examination Tables, Chairs and Weight 

Scales’’ issued by the Center for 

Disability Issues and the Health 

Professions discusses how the lack of 

accessible equipment reduces the 

likelihood that individuals with 

disabilities will receive timely and 

appropriate health care.17 Health care 

providers may not perform some 

diagnostic procedures for patients with 

disabilities because they lack accessible 

equipment. This can result in 

suboptimal examinations, missed or 

delayed diagnoses, and worsening 

conditions that require more expensive 

and extensive treatments. 

The proposed standards address many 

of the barriers that have been identified 

as affecting the accessibility and 

usability of diagnostic equipment by 

individuals with disabilities. The 

standards will improve the quality of 

health care for individuals with 

disabilities and ensure that they receive 

examinations, diagnostic procedures, 

and other health care services equal to 

those received by individuals without 

disabilities. The standards will facilitate 

independent transfers by individuals 

with disabilities onto and off of 

diagnostic equipment, and enable them 

to maintain their independence, 

confidence, and dignity. The standards 

will lessen the need for health care 

personnel to assist individuals with 

disabilities when transferring on and off 

of diagnostic equipment. Where assisted 

transfers are necessary, the proposed 

standards will also facilitate such 

transfers. The proposed standards will 

reduce the risk of injury during transfers 

to both health care personnel and 

patients.18 The proposed standards will 

result in more positive health care 

experiences for individuals with 

disabilities and health care providers. 

Entities Potentially Affected by 

Proposed Standards 

The proposed standards do not 

impose any mandatory requirements on 

health care providers or medical device 

manufacturers. Thus, there are no 

compliance costs that can be attributed 

to the proposed standards. As discussed 

below, if an enforcing authority such as 

DOJ adopts the standards as mandatory 

requirements for entities subject to its 

jurisdiction, health care providers may 

experience some compliance costs. 

Medical device manufacturers may have 

an economic incentive to produce 

accessible products that conform to the 

standards for health care providers who 

need to acquire accessible medical 

diagnostic equipment. 

Health Care Providers 

As discussed under Department of 

Justice Activities Related to Health Care 

Providers and Medical Equipment, 

health care providers must provide 

individuals with disabilities full and 

equal access to their health care services 

and facilities to comply with the ADA 

and Section 504 of the Rehabilitation 

Act. Both the Federal government 

through DOJ and private parties, 

including individuals with disabilities, 

have entered into settlement agreements 

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 

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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. 

Table type Products Products in 

sample 

Lower cost 

products 

MSRP 

Higher cost 

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 

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measured from the floor to the top of the 

table. Manual tables typically have 

cabinets, drawers, or shelves. 

Power tables have an electric motor 

that can adjust the table height to as low 

as 18 inches and as high as 40 inches 

above the floor on some products. The 

higher cost products have a fully 

articulated, pneumatic or powered, 

backrest that can support patients in a 

seated position and recline to a lying 

position. Some power tables have 

armrests, grab rails, side rails, and 

cabinets or drawers. 

Weight Scales 

Product data and unit costs were 

collected for weight scales produced by 

eight manufacturers. The scales are 

grouped by the following types: Standon scales and wheelchair scales. Within 

each group, there are mechanical and 

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. 

Stand-on scales Products Products in 

sample 

Lower cost 

products 

MSRP 

Higher cost 

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 standon 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. Standon 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. 

Wheelchair scales Products Products in 

sample 

Lower cost 

products 

MSRP 

Higher cost 

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 

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6936 Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules 

and Section 504 of the Rehabilitation 

Act. Both the Federal government 

through DOJ and private parties, 

including individuals with disabilities, 

have entered into settlement agreements 

with health care providers to enforce the 

ADA and Section 504 of the 

Rehabilitation Act. In July 2010, DOJ 

and the Department of Health and 

Human Services issued a guidance 

document for health care providers 

regarding their responsibilities to make 

their services and facilities accessible to 

individuals with mobility disabilities 

under the ADA and Section 504 of the 

Rehabilitation Act. See Access to 

Medical Care for Individuals with 

Mobility Disabilities available at: 

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 

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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. 

§ 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 builtin folding seat, or standing and holding onto 

supports. The technical criteria in M303 for 

diagnostic equipment used by patients seated 

in a wheelchair; in M302 for diagnostic 

equipment used by patients in a seated 

position; and in M304 for diagnostic 

equipment used by patients in a standing 

position apply. 

M101.3 Equivalent Facilitation. The use 

of alternative designs or technologies that 

result in substantially equivalent or greater 

accessibility and usability than specified in 

the standards is permitted. 

M101.4 Dimensions. The standards are 

based on adult dimensions and 

anthropometrics. 

Dimensions that are not stated as 

‘‘maximum’’ or ‘‘minimum’’ are absolute. 

M101.5 Dimensional Tolerances. 

Dimensions are subject to conventional 

industry tolerances for manufacturing 

processes, material properties, and field 

conditions. 

M102 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 

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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. 

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Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Proposed Rules 6939 

M304.3 Standing Supports. Standing 

supports shall be provided on each side of 

the standing surface and shall comply with 

M305.3. 

M305 Supports 

M305.1 General. Supports shall comply 

with M305, as applicable. 

M305.2 Transfer Supports. Transfer 

supports shall comply with M305.2. 

M305.2.1 Location. Transfer supports 

shall be located within reach of the transfer 

surface and shall not obstruct transfer onto or 

off of the surface when in position. 

M305.2.2 Structural Strength. Transfer 

supports and their connections shall be 

capable of resisting vertical and horizontal 

forces of 250 pounds (1,112 N) applied at all 

points on the transfer support. 

M305.2.3 Fittings. Transfer supports shall 

not rotate within their fittings. 

M305.3 Standing Supports. Standing 

supports shall provide continuous support 

throughout use of the diagnostic equipment 

and shall comply with M305.3. 

M305.3.1 Horizontal Position. Where the 

support is horizontal, the top of the gripping 

surface shall be 34 inches (865 mm) 

minimum and 38 inches (965 mm) maximum 

above the standing surface. The gripping 

surface shall be 4 inches (100 mm) long 

minimum. 

M305.3.2 Vertical Position. Where the 

support is vertical, it shall be 18 inches (455 

mm) minimum in length and the bottom end 

of the support shall be 34 inches (865 mm) 

high minimum and 37 inches (940 mm) high 

maximum above the standing surface. 

M305.3.3 Fittings. Standing supports 

shall not rotate within their fittings. 

M306 Communication 

M306.1 General. Where instructions or 

other information is communicated to the 

patient through the diagnostic equipment, 

the instructions and other information shall 

be provided in at least two of the following 

methods: audible, visible, or tactile. 

Advisory M306.1 General. Patients 

should not be required to adjust position to 

receive audible, visible, or tactile 

communications. A volume control can be 

helpful, particularly in diagnostic equipment 

where hearing aids cannot be worn. In 

selecting the methods of communication it is 

important to consider the diagnostic 

equipment characteristics. For example, 

audible communication may not be effective 

for magnetic resonance imaging (MRI) 

equipment due to the noise level when the 

equipment is in use. 

M307 Operable Parts 

M307.1 General. Operable parts for 

patient use shall comply with M307. 

M307.2 Tactilely Discernible. Operable 

parts shall be tactilely discernible without 

activation. 

M307.3 Operation. Operable parts shall 

be operable with one hand and shall not 

require tight grasping, pinching, or twisting 

of the wrist. 

M307.4 Operating Force. The force 

required to activate operable parts shall be 5 

pounds (22.2 N) maximum. 

[FR Doc. 2012–2795 Filed 2–8–12; 8:45 am] 

BILLING CODE 8150–01–P 

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