Promulgation of the MDE Standards completes a rulemaking process that began four years ago. First, in July 2010, the Access Board kicked off its regulatory efforts with an informal, on-the-record public meeting that featured panel discussions and presentations on medical diagnostic equipment and accessibility by, among others, experts, researchers, manufacturers, and disability advocates.

Thereafter, in February 2012, the Access Board formally began the rulemaking process by issuing a notice of proposed rulemaking (NPRM), which set forth proposed technical accessibility criteria for equipment that health care providers use for diagnostic purposes in medical settings (e.g., examination tables and chairs, weight scales, mammography equipment, and other types of imaging equipment).3 The proposed accessibility standards, as discussed in the preamble to the NPRM, were informed by a variety of sources, including: research studies addressing barriers affecting the accessibility and usability of medical diagnostic equipment by persons with disabilities; recommended consensus practices on human factors design principles for medical devices (i.e., ANSI/AAMI HE 75, Chapter 16); consultations with the FDA’s Center for Device and Radiological Health; implementation and enforcement efforts by other federal agencies (including the Departments of Justice (DOJ) and Health and Human Services (HHS)) concerning the accessibility of medical equipment under their own statutory authorities; and the agency’s own existing accessibility guidelines and standards for the built environment.4 Collectively, the technical standards in the proposed rule were aimed at addressing the most significant barriers identified as affecting the accessibility and usability of medical diagnostic equipment, which were barriers faced by persons with mobility and communication disabilities.5

Public comment on the proposed MDE standards was received in two forms. First, during the comment period, the Access Board held two public hearings on the NPRM – one in Washington DC and the other in Atlanta, Georgia – at which 27 individuals testified. The written comments and the transcripts of two public hearings are available at https://www.regulations.gov/docket?D=ATBCB-2012-0003. Second, fifty-six individuals and organizations submitted written comments during the 120-day comment period.

In July 2012, following the close of the public comment period, the Access Board established a Medical Diagnostic Equipment Accessibility Standards Advisory Committee (MDE Advisory Committee) to assist on matters raised by public comments, provide technical expertise, and provide an opportunity for interest groups to reach consensus on regulatory issues.6 The MDE Advisory Committee consisted of representatives from 24 organizations, including medical services providers and diagnostic equipment manufacturers, among others.7 The Committee held meetings over a 10-month period. In December 2013, the Committee presented 54 recommendations to the Access Board on accessibility specifications for medical diagnostic equipment, including recommendations addressing transfer surface size and height, transfer supports, armrests, stirrups, lift compatibility, and wheelchair space. The committee members reached a consensus on all of their recommendations except for the minimum height of transfer surfaces. The Committee’s final report is available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

After carefully considering the public comments, the MDE Advisory Committee report, and other relevant materials from the Committee meetings, the Access Board is now promulgating a final rule that establishes minimum technical criteria for accessibility of medical diagnostic equipment for persons with mobility and communication disabilities. The agency is promulgating these MDE Standards in compliance with its statutory obligations under Section 510 of the Rehabilitation Act. See, supra, Executive Summary, Sections 1 & 2 (summarizing the Access Board’s mandate under Section 510 to promulgate minimum technical standards for MDE accessibility); see also Sections 5.1 & 5.2 (describing the barriers to medical equipment and health care facing people with mobility and communication disabilities).