36 CFR Part 1195 Proposed Accessibility Standards for Medical Diagnostic Equipment NPRM - Preamble
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
1 The Access Board consists of 13 members appointed by the President from the public, a majority of which are individuals with disabilities, and the heads of 12 federal agencies or their designees whose positions are Executive Level IV or above. The federal agencies are: The Departments of Commerce, Defense, Education, Health and Human Services, Housing and Urban Development, Interior, Justice, Labor, Transportation, and Veterans Affairs; General Services Administration; and United States Postal Service.
2 The Access Board has issued accessibility guidelines and standards under the following laws: Section 504 of the Americans with Disabilities Act (42 U.S.C. 12204) for buildings and facilities, and transportation vehicles; Section 502 of the Rehabilitation Act (29 U.S.C. 792) for buildings and facilities; Section 508 of the Rehabilitation Act (29 U.S.C. 794d) for electronic and information technology; and Section 255 of the Telecommunications Act (47 U.S.C. 255) for telecommunications equipment and customer premises equipment. Additional information on the guidelines and standards is available at: http://www.access-board.gov.
3 The following federal agencies have adopted the Access Board’s guidelines and standards as mandatory requirements for entities subject to their jurisdiction: Department of Justice (see 28 CFR 35.104 and 35.151; and 28 CFR 36.104 and 36.401 to 36.406); Department of Transportation (see 49 CFR 37.9 and Appendix A to 49 CFR part 37; and 49 CFR part 38); Federal Acquisition Regulatory Council (see 48 CFR 39.203); Federal Communications Commission (see 47 CFR part 6); General Services Administration (see 41 CFR 102‒77.65); and United States Postal Service (see 39 CFR 254.1). See also Deputy Secretary of Defense Memorandum on Access for People with Disabilities, October 31, 2008 at: http://www.access-board.gov/ada-aba/dod-memorandum.htm. Some agencies have adopted the guidelines and standards with additions and modifications.
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 USC 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
ETA Editor's Note
The paragraph above references Title III of the ADA as 42 U.S.C. 12189 to 12189. However, Title III begins with section 12181.
4 The Department of Transportation is responsible for issuing regulations to implement certain sections of Titles II and III of the ADA relating to transportation.
5 In its regulations implementing Title II of the ADA, DOJ has delegated responsibility for investigating complaints and conducting compliance reviews in specific subject matter areas to other federal agencies, but at its discretion DOJ may retain complaints for investigation and appropriate disposition. See 28 CFR 35.190. DOJ has delegated responsibility for investigating complaints and conducting compliance reviews relating to the provision of health care services by state and local governments to the Department of Health and Human Services. Federal agencies that provide federal financial assistance also investigate complaints and conduct compliance reviews regarding compliance with Section 504 of the Rehabilitation Act by recipients of such assistance. See Appendix A to 28 CFR part 41. The federal agencies can refer matters that are not resolved successfully to DOJ for enforcement.
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 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.
6 The settlement agreements by DOJ with health care providers and matters addressed in the agreements include: United States of America v. Inova Health System (March 30, 2011) auxiliary aids and services, including sign language interpreters; HCA Health Services of New Hampshire (Portsmouth Regional Hospital) (November 23, 2010) auxiliary aids and services, including sign language interpreters; Beth Israel Deaconess Medical Center (October 22, 2009) accessible facilities and accessible medical equipment; Gillespie v. Dimensions Health Corporation (July 12, 2006) auxiliary aids and services, including sign language interpreters; Washington Hospital Center (November 2, 2005) accessible facilities and accessible medical equipment; Valley Radiologists Medical Group, Inc. (November 2, 2005) accessible imaging equipment; Exodus Women's Center (March 26, 2005) accessible examination tables; Dr. Robila Ashfaq (January 12, 2005) accessible examination table; and Georgetown University Hospital (October 31, 2001) providing assistance for transferring from a wheelchair to an examination table The settlement agreements are available at: http://www.ada.gov/settlemt.htm.
7 The ANPRM requested public comment on several categories of equipment and furniture, including medical equipment (e.g., medical examination and treatment tables and chairs, scales, radiological diagnostic equipment, lifts, infusion pumps, rehabilitation equipment, hospital beds and gurneys, ancillary equipment such as positioning straps or cushions, protective padding, leg supports for gynecological examinations, rails and bars for patient safety and comfort, and call buttons); exercise equipment and furniture; accessible golf cars; beds in accessible guest rooms and sleeping rooms; beds in nursing homes and other care facilities; and electronic and information technology such as kiosks (i.e., interactive computer terminals that provide services), interactive transaction machines, point of sale devices, and automated teller machines.
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
8 The settlement agreements by private parties and matters addressed in the agreements include: Massachusetts General Hospital and Brigham and Women’s Hospital (June 26, 2009) accessible facilities, accessible medical equipment, and auxiliary aids and services; Thompson v. Sutter Health (July 11, 2008) accessible facilities, accessible medical equipment, and auxiliary aids and services; University of Southern California Medical Center (May 15, 2008) accessible facilities, accessible medical equipment, and auxiliary aids and services; and Metzler v. Kaiser Permanente (March 2001) accessible facilities and accessible medical equipment. The settlement agreements are available at: http://thebarrierfreehealthcareinitiative.org/?page_id=16.
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. Chapter16 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, 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.
9 The results of the survey are reported in Jill M. Winters, Molly Follette Story, Kris Barnekow, June Isaacson Kailes, Brenda Premo, Erin Schier, Sarma Danturthi, and Jack M. Winters, “Results of a National Survey on Accessibility of Medical Instrumentation for Consumers,” in “Medical Instrumentation Accessibility and Usability Considerations,” edited by Jack M. Winters and Molly Follette Story (Boca Raton, CRC Press, 2007), 13‒27.
10 The results of the focus group sessions are reported in Molly Follette Story, Erin Schwier, and June Isaacson Kailes, “Perspectives of Patients with Disabilities on the Accessibility of Medical Equipment: Examination Tables, Imaging Equipment, Medical Chairs, and Weight Scales,” Disability and Health Journal 2 (2009), 169‒179.
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