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

M102 Definitions (Section-by-Section Analysis)

This is an introductory section.

M102.1 Defined Terms (Section-by-Section Analysis)

The MDE NPRM proposed definitions for enforcing authority, medical diagnostic equipment, operable parts, and transfer surface. The Access Board sought input in question six in the preamble of the MDE NPRM, on whether there were other terms in the proposed standards that should be defined. NPRM, 77 FR at 6920. Ten commenters responded to this question. One commenter, a medical association, did not offer other terms that should be defined, but stated that there were many instances where the Board used acronyms without a definition. However, this commenter failed to provide any examples. Another commenter, a disability rights organization, suggested modifying the definition of medical diagnostic equipment to clarify that the standard is intended for all medical equipment in which any part of the equipment is used for diagnostic purposes for any amount of time. Another commenter, a manufacturer, recommended changing the term “operable part” to “applied part” and adding a new definition of operable part as “caregiver operated parts,” asserting that this aligns with IEC 60601. Other commenters (manufacturers, medical associations, disability rights organizations, and an individual) suggested the following terms be defined: health care provider, breast platform, patient support surface, transfer supports, positioning supports, prone position, supine position, examination tables, diagnostic purposes, maximum extent possible, landing area, exam table, procedure table, and procedure chair.

After review of the comments, the Access Board declines to add any of the suggested terms to the defined terms section. The definition of medical diagnostic equipment was taken directly from Section 510 of the Rehabilitation Act and thus for consistency has not been altered. 29 U.S.C. 794f. Some of the definitions proposed by commenters are not terms used in the MDE final rule and, therefore, providing the requested definitions would serve no purpose. The definitions for other proposed terms used in the final rule are the same as the ordinarily accepted meanings in the context that applies, and the Access Board does not believe that the reader would be significantly aided in understanding the final rule by adding the requested definitions. However, the Access Board has decided to add six additional terms to this section; end transfer surface, examination chair, imagining [sic] equipment with bores, imagining [sic] bed, side transfer surface, and wheelchair space. As described above in Section IV.B.1.b. (Significant Changes – Transfer Surface Location), the Access Board has added definitions for “end transfer surface” and “side transfer surface” to this provision to describe the two types of transfer surfaces for diagnostic equipment used by patients in the supine, prone, or side-lying position. The “wheelchair space” definition was taken from the 2004 ADA and ABA Accessibility Guidelines and adopted in the MDE final rule to provide consistency across Access Board rulemakings. Examination chair, imagining [sic] equipment with bores, and imagining [sic] bed were added to help clarify application of exceptions added in the final rule. (See M301.1, M301.2.3, and M305.2.2.2). Finally, the Access Board also made a minor editorial change to the title of “operable part” so that all components and parts are referred to in the plural.

M102.2 Undefined Terms (Section-by-Section Analysis)

The MDE NPRM proposed that the meaning of terms not defined in proposed M102.1 or in regulations or policies issued by an enforcing authority, be defined by collegiate dictionaries in the sense that the context implies. There were no comments and no MDE Advisory Committee recommendations on this provision. In the final rule, the Access Board has changed this provision to indicate that the meaning of terms not defined in M102.1 will be given their ordinarily accepted meaning in the context that applies.

M102.3 Interchangeability (Section-by-Section Analysis)

The MDE NPRM proposed that singular and plural words, terms, and phrases are used interchangeably. There were no comments on this requirement and no changes have been made