Seyfarth Synopsis: Many years in the making, today the Access Board issued design criteria and other standards for medical diagnostic equipment.
Today, the U.S. Access Board issued new accessibility standards for medical diagnostic equipment (MDE). The final rule will be effective February 8 – 30 days from today’s publication of the final rule containing the standards in the Federal Register.
The standards provide design criteria and other requirements for the accessibility of examination tables and chairs, weight scales, radiological and mammography equipment, and other diagnostic equipment. They are divided into separate technical criteria based on how the diagnostic equipment is used by the patient: (1) supine, prone, or side lying position (M301); (2) seated position (M302); (3) while seated in a wheelchair (M303); and (4) standing position (M304); and include technical criteria for supports (M305), for instructions or other information communicated to patients through the equipment (M306), and for operable parts used by patients (M307).
The Access Board is an independent federal agency established by the Rehabilitation Act of 1973, 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. Section 510 of the Rehabilitation Act (as amended by the Affordable Care Act in 2010) instructs the Access Board to promulgate, in consultation with the Food and Drug Administration, technical standards regarding accessibility of medical diagnostic equipment; but it does not give the Access Board authority to enforce these standards. In other words, these standards do not have the force of law and are not technically not binding on health care providers and equipment manufacturers unless and until a federal agency such as the Department of Justice of the Department of Health and Human Services adopts them as part of their own regulations. That said, now that there are standards from the Access Board as to what constitutes an accessible piece of medical diagnostic equipment, plaintiffs and possibly the DOJ will argue that acquiring such equipment is required under the existing requirement to make reasonable modifications to policies, practices and procedures. Thus, manufacturers and purchasers of new medical diagnostic equipmement should take these standards into account in making future acquisitions.
The publication of this final rule completes a process the Access Board began in 2012 – as we have previously reported – with issuance of a proposed rule; public comment; review and preparation of a report based on the public comments by an MDE Advisory Committee of 24 stakeholders comprised of representatives from disability groups, equipment manufacturers, health care providers, and standard-setting organizations; and, finally, and the Access Board’s review of the report, revision, then adoption of the final standards.
Significant changes that were made from the notice of proposed rulemaking to this final rule in response to the comments received, recommendations from the MDE Advisory Committee, and other information that came to the Access Board’s attention during the rulemaking process; and there will still be more changes to come. For example, citing substantial disagreement amongst stakeholders regarding appropriate transfer height standards, the Access Board decided to establish in the final rule, for five years only, a range for the minimum low height requirement of 17 inches to 19 inches. It has commissioned a study to quantify the portion of the population that would benefit from a low transfer height below 19 inches, and intends to amend this portion of the final rule with a subsequent rulemaking to establish a minimum low transfer surface height once the study has been completed and before the five-year sunset provision takes effect.
In its press release announcing the new standards, Regina Blye, Vice Chair of the Access Board, stated: “The new standards will be instrumental in ensuring access to health care services…The Board is pleased to fill this gap in accessibility because diagnostic equipment has remained problematic for many people with disabilities due largely to the lack of design specifications for making such equipment accessible.”