As part of a flurry of activity in the final days of the Obama Administration, the U.S. the Architectural and Transportation Barriers Compliance Board (the “Access Board”) has finally announced the release of its Accessibility Standards for Medical Diagnostic Equipment (the “MDE Standards”). Published in the Federal Register on Monday, January 9, 2017, the MDE Standards are a set of design criteria intended to provide individuals with disabilities access to medical diagnostic equipment such as examination tables and chairs (including those used for dental or optical exams), weight scales, radiological equipment, mammography equipment and other equipment used by health professionals for diagnostic purposes. (The Access Board was established in 1973 to develop and maintain standards for accessible design in the built environment, transit vehicles and systems, telecommunications equipment and electronic and information technology. It also functions as a coordinator among federal agencies.). It is important to note that at this time the MDE Standards are not technically binding on health care providers or medical equipment manufacturers and do not have the force of law until they are formally adopted by government agencies such as the U.S. Department of Justice and U.S. Department of Health and Human Services.
The MDE Standards were prepared by the Access Board’s 24 member MDE Accessibility Standards Advisory Committee, comprised of representatives from disability groups, equipment manufacturers, heath care providers, and other standard-setting organizations, and incorporates data based on research studies as well as comments received during several public comment periods.
A link to the final MDE Standards is provided here:
Effective Date and Current Enforcement
The final rule is set to become effective Wednesday, February 8, 2017. However, as noted above, as these Standards have not yet been adopted by any Federal enforcing authorities, the MDE Standards do not currently impose any mandatory requirements on health care providers or medical device manufacturers. (Moreover, it is worth noting on January 20, 2017, White House Chief of Staff Reince Priebus issued a memorandum from the White House to the heads of executive departments and agencies calling for a sixty (60) day postponement of the effective date of regulations that have been published in the Federal Registry but not yet taken effect. Therefore, this date may yet be delayed.)
Notwithstanding, during the Access Board’s briefing held on Tuesday, January 10, 2017, the MDE Accessibility Standards Advisory Committee noted that its mission was to develop technical accessibility requirements that would be adopted by Federal enforcing authorities (such as the DOJ, FDA, HHS, and VA), at which point health care providers subject to their jurisdiction will be required to acquire accessible medical diagnostic equipment that complies with the MDE Standards. Until then, the Access Board strongly recommends that health care providers incorporate the MDE Standards as part of its new equipment procurement policy. (And plaintiff’s counsel and disability rights advocacy groups bringing lawsuits against health care providers under accessibility laws are likely to rely on the MDE Standards to establish their view of what constitutes appropriate accessible medical equipment.)
It should be noted that the current version of the MDE Standards provide MDE technical requirements only. As stated in the Scoping section of the MDE Standards (Chapter 2), “The enforcing authority shall specify the number and type of diagnostic equipment that are required to comply with the MDE Standards”.
We will continue to provide updates as enforcing authorities adopt the MDE Standards.