36 CFR Part 1195 Standards for Accessible Medical Diagnostic Equipment - Preamble

II. Rulemaking History

Section 510 of the Rehabilitation Act requires the Access Board to issue standards for medical diagnostic equipment to ensure such equipment is accessible to, and usable by, individuals with disabilities no later than 24 months after the date of the enactment of the ACA. 29 U.S.C 794f.¹ On July 29, 2010, after the Rehabilitation Act was amended, the Access Board held a 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 to provide information for developing the proposed standards. The transcript of the meeting is available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/background/public-information-meeting.

On February 9, 2012, the Access Board formally commenced the rulemaking process and issued a notice of proposed rulemaking proposing accessibility standards for medical diagnostic equipment. Notice of Proposed Rulemaking – Medical Diagnostic Equipment Accessibility Standards, 77 FR 6916 (February 9, 2012) (hereinafter MDE NPRM). The proposed standards contained minimum technical criteria to ensure that medical diagnostic equipment, including, but not limited to, examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment used by health care providers for diagnostic purpose is accessible to, and usable by, individuals with disabilities. Id. The Access Board held two public hearings during the comment period, March 14, 2012 in Washington, DC and May 8, 2012 in Atlanta, GA. At the public hearings, 27 witnesses presented testimony regarding the need for accessibility standards for medical diagnostic equipment, the difficulty of obtaining health care for persons with disabilities, the current state of medical equipment and, the ability of medical diagnostic equipment to meet the proposed standards. The transcripts of the public meetings are available at https://www.regulations.gov/docket?D=ATBCB-2012-0003.

The public comment period for the proposed rule ended on June 6, 2012. Comments were submitted by persons with disabilities, governmental agencies, disability rights organizations, and representatives of the medical diagnostic equipment industry and the medical community. In all, 59 comments were received; twenty-four from individuals, thirteen from the medical diagnostic equipment industry and the medical community, nine from disability rights organizations, four from accessibility consultants, three from academics, two from state and federal organizations, and four duplicate submissions. The public comments are available at https://www.regulations.gov/docket?D=ATBCB-2012-0003.

On March 13, 2012, the Access Board published a notice of intent to establish an advisory committee to advise the Board on matters addressed in the MDE NPRM and issues raised in the public comments. Notice of Intent to Establish Advisory Committee - Medical Diagnostic Equipment Accessibility Standards, 77 FR 14706 (March 13, 2012). On July 5, 2012, the Access Board established the Medical Diagnostic Equipment Accessibility Standards Advisory Committee (MDE Advisory Committee). Notice of Establishment; Appointment of Members – Medical Diagnostic Equipment Accessibility Standards Advisory Committee, 77 FR 39656 (July 5, 2012). The MDE Advisory Committee was comprised of individuals from 24 organizations representing a range of stakeholders and ex officio members from the FDA, Department of Justice, and the Department of Veterans Affairs.² The MDE Advisory Committee met from September 2012 through May 2013 and much of the work occurred within five subcommittees that addressed the major categories of MDE and the issues raised by commenters: Examination Tables and Chairs; Stretchers; Diagnostic Imaging Equipment; Mammography Equipment; and Weight Scales. In June 2013, the MDE Advisory Committee presented 54 recommendations to the Access Board. The committee members reached a consensus on all of their recommendations, except for the recommended lowest or minimum height for adjustable-height transfer surfaces. The MDE Advisory Committee made recommendations regarding transfer surface height, transfer surface size, transfer sides, transfer supports, armrests, stirrups, lift compatibility, wheelchair spaces, and standing supports. The final report of the Medical Diagnostic Equipment Accessibility Standards Advisory Committee (December 6, 2013), is available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report (hereinafter, MDE Advisory Committee Report).