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

A. Chapter 2: M201 Scoping

In the final rule, Chapter 2 establishes that the enforcing authority will determine the number and types of diagnostic equipment to which the MDE Standards will apply. There was only one significant change to this section, which added a general exception for diagnostic equipment that is unable to meet one or more of the requirements in the final rule.

1. General Exception

The MDE NPRM proposed several limited exceptions to certain provisions addressing the limitations of current technology and design. Through testimony at the public hearings, comments, and MDE Advisory Committee discussions, the manufacturers of imaging equipment consistently raised concerns about inherent barriers to compliance with the proposed MDE Standards due to the location of imaging and mechanical components necessary to achieve the diagnostic aims. Some specific examples include: Dual Energy X-Ray Absorptiometry (DXA) machines, with a mechanism that moves imaging components along a track beneath the patient surface precluding height adjustability for the transfer surface; prone biopsy tables that must be of a sufficient height to permit health care providers access beneath the patient surface to perform procedures, precluding the equipment from meeting the minimum transfer surface height; and mammography machines with low dose radiation detectors that are larger in size than conventional configurations and required to be in locations that partially obstruct clearances for knee and toe space beneath the breast platform. While the MDE NPRM proposed several specific technical exceptions in Chapter 3, the exceptions did not address the manufacturers’ overall concerns regarding imaging equipment. Section 510 of the Rehabilitation Act requires the MDE Standards to provide independent access “to the maximum extent possible.” The Access Board interprets this language as recognizing that, in some situations, current technology may preclude diagnostic equipment from meeting all of the technical requirements in the MDE Standards. Therefore, the Access Board has added a general exception to Chapter 2 allowing compliance to the maximum extent practicable for the rare circumstance where full compliance would alter diagnostically required structural or operational characteristics of the equipment, and would prevent the use of the equipment for its intended diagnostic purpose. Any equipment utilizing this exception is still required to meet all other applicable provisions of the MDE Standards. We anticipate that this exception will be employed on a very limited basis for a few specialized equipment types, primarily imaging equipment. This provision is not intended to exempt a piece of diagnostic equipment from the MDE Standards as a whole. Limitations resulting from existing equipment designs or manufacturing practices that could be altered to meet the requirements are not a basis for invoking this exception; only diagnostically required structural or operational characteristics that cannot be made to comply with the technical requirements without preventing the use of the equipment for its intended diagnostic purpose are covered by this provision.