Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities, Advisory Committee Final Report

1.1 Statutory Authority, Scope, and Objectives of Committee

Section 4203 of the Patient Protection and Affordable Care Act (Public Law 111-148, 124 Stat. L. 119), which became law on March 23, 2010, amended Title V of the Rehabilitation Act of 1973 (29 U.S.C. 794f) by adding Section 510. This new section requires the Architectural and Transportation Barriers Compliance Board (U.S. Access Board), in consultation with the Food and Drug Administration (FDA), to issue accessibility standards for medical diagnostic equipment (MDE). Section 510 considers "medical diagnostic equipment" to be equipment that is used by health care professionals in medical settings for diagnostic purposes

As described below (Section 1.3), the U.S. Access Board published a Notice of Proposed Rulemaking (NPRM) proposing MDE accessibility standards (see 77 FR 6916, February 9, 2012). The draft standards proposed minimum technical criteria to ensure that medical diagnostic equipment, including examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment used by health care providers for diagnostic purposes are accessible to and usable by individuals with disabilities. At its January 11, 2012 meeting, the Access Board voted to establish an advisory committee to make recommendations to the Board on issues raised by the comments it would receive and responses to questions included in the February 2012 NPRM (the comment period extended through June 8, 2012).

The Access Board published a notice of intent in the Federal Register (77 FR 14706, March 13, 2012) to establish this advisory committee and to seek nominations from a variety of stakeholder organizations, including:

• Medical device manufacturers;

• Health care providers;

• Standards setting organizations;

• Organizations representing individuals with disabilities;

• Federal agencies; and

• Other organizations affected by the providers.

The March 2012 notice indicated, “The number of Committee members will be limited so that the Committee’s work can be accomplished effectively. The Committee will be balanced in terms of interests represented” (p. 14707). The MDE Advisory Committee members would not be considered special government employees and therefore would not need to file confidential financial disclosure reports. However, the Committee would operate in accordance with the Federal Advisory Committee Act, 5 U.S.C. app 2, and each meeting would be open to the public. Notices announcing each meeting would be published in the Federal Register at least 15 days beforehand.