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

A. Chapter 1: Application and Administration (Section-by-Section Analysis)

In the final rule Chapter 1 establishes the purpose and the general requirements for the application of the MDE Standards. This chapter received 21 comments and no recommendations from the MDE Advisory Committee. The Access Board made a few editorial changes to some of the provisions, and added one provision M101.3 Existing Diagnostic Equipment, which is discussed below.

M101 General (Section-by-Section Analysis)

This is an introductory section.

M101.1 Purpose (Section-by-Section Analysis)

The MDE NPRM proposed that the purpose of the MDE Standards was to establish technical criteria for diagnostic equipment that is accessible to and usable by patients with disabilities and to provide patients with disabilities independent access to and use of diagnostic equipment to the maximum extent possible. One commenter, a manufacturer, responded to the proposed provision. The commenter asserted that this provision was unclear without a list of applicable disabilities and an explanation on how the maximum extent possible would be determined.

In response to the commenter, the Access Board notes that the term “disability” is defined in the Americans with Disabilities Act (ADA), 42 USC 12102. None of the Standards and Guidelines promulgated by the Access Board include a list of applicable disabilities. Rather, they rely on the definition of disability provided in the ADA. As for determining whether diagnostic equipment provides independent access and egress to the maximum extent possible, that is a decision left to the enforcing authorities that adopt and implement this standard. The Access Board, therefore, declines to implement the commenter’s suggested changes. The Access Board has, however, made two editorial changes to this provision clarifying that “medical diagnostic equipment” is referred to as “diagnostic equipment,” and that these standards are referred to as “MDE Standards” throughout the rule text.

M101.2 Application (Section-by-Section Analysis)

In the NPRM the Access Board proposed that the MDE Standards would be applied to diagnostic equipment based on the patient position the equipment is designed to support. Additionally, this provision stated that where the equipment was designed to support more than one patient position, the MDE Standards for each patient position supported would be applied to the equipment. Fifteen commenters responded to this provision asserting that some diagnostic equipment should not have to comply with more than one patient position requirement. These concerns have resulted in two added exceptions to the final rule. The first is to exempt examination chairs which comply with M302 and can be reclined to facilitate diagnosis after the patient transfers onto the seat from complying with M301. (M301.1, Exception). This exception is discussed above in Section IV.B.4 (Significant Changes – Exception from the Requirements of M301 for Certain Examination Chairs that Comply with M302). Additionally, the final rule also exempts weight scales which contain a wheelchair space complying with M303 and that have a seat integral to the equipment from complying with M302 (M302.1, Exception). This exception is discussed above in Section IV.B.5. (Significant Changes – Exception from the Requirements of M302 for Weight Scales with Integral Seats). In the final rule, the application provision was revised due to the addition of the exceptions and a few editorial changes were made for clarity. This provision now requires that sections M301 through M304 of the MDE Standards be applied to diagnostic equipment based on the patient position that the equipment supports during patient transfer and diagnostic use and sections M306 and M307 will be applied to diagnostic equipment that contains communication features or operable parts that are provided for patient use.

M101.3 Existing Diagnostic Equipment (Section-by-Section Analysis)

The MDE NPRM did not address when or how the MDE Standards would be applied to existing medical diagnostic equipment. Commenters raised concerns about the cost of immediate compliance for the more expensive imaging equipment, noting the high cost and the concern that rooms are designed specifically for such equipment. Specifically, at the public hearing on March 14, 2012, two commenters recommended phasing in these requirements for imaging equipment based on when it is replaced. The public hearing transcript is available at https://www.regulations.gov/docket?D=ATBCB-2012-0003.

The MDE Standards are advisory and are not binding until adopted by an enforcing authority. The Access Board’s mandate was to establish only the minimum technical criteria, however enforcing authorities may establish scoping requirements in the future. In response to the commenters’ concerns regarding existing equipment, the Access Board has decided to add a new provision which clarifies that the MDE Standards do not address the accessibility of existing diagnostic equipment and that the enforcing authority will determine whether and how diagnostic equipment will be regulated.

M101.4 Equivalent Facilitation (Section-by-Section Analysis)

The MDE NPRM proposed to permit the use of alternative designs or technologies that are substantially equivalent to or provide greater accessibility and usability than strict compliance with provisions in the MDE Standards. One commenter, a manufacturer, requested that the Access Board include examples of acceptable methods for providing equivalent facilitation.

The Access Board is unable to provide examples of acceptable methods of equivalent facilitation, as this section is intended to encompass those design solutions which the Access Board is unaware at the time that this rule is published. Additionally, the final determination of whether a particular design or technology meets this provision will be determined by the enforcing authorities. Therefore, the only change to this provision was to adjust the section number to allow for the addition of the new provision, M101.3 Existing Diagnostic Equipment.

M101.5 Dimensions (Section-by-Section Analysis)

The MDE NPRM proposed that the MDE Standards be based on adult dimensions and anthropometrics. One commenter and the MDE Advisory Committee raised concerns about providing standards for obese patients and pediatric patients. While the Access Board acknowledges that these are additional issues of accessibility, the final rule follows the MDE NPRM framework and provides technical requirements based on adult dimensions and anthropometrics, only. At this point in time the Access Board is focusing on adult dimensions and anthropometrics however, the Access Board may address potential expansions of the MDE Standards to other groups in future rulemakings. The only change to this provision was adjustment of the section number to allow for the addition of the new provision, M101.3 Existing Diagnostic Equipment.

M101.6 Dimensional Tolerances (Section-by-Section Analysis)

The MDE NPRM proposed that dimensions were to be subject to conventional industry tolerances for manufacturing processes, material properties, and field conditions. In the preamble of the MDE NPRM, the Access Board sought public input in question five on available information or resources concerning conventional industry tolerances for medical diagnostic equipment. NPRM, 77 FR at 6920. Six commenters responded to the question. Three commenters (two manufacturers and one medical association) indicated that tolerances vary based on the manufacturer, product design, and manufacturing process and that they are unaware of any industry standard. One commenter, a manufacturer, referenced ASME Y14.5-1994 for dimensional tolerances. Another commenter, a medical association, asserted that tolerances are in operator manuals. The final commenter, a manufacturer, recommended providing tolerances when dimensions are specified and recommended defining a specific tolerance, such as +/- 0.5 inch for linear dimensions.

After considering the comments received, the Access Board has decided to retain the original provision. The Access Board was persuaded by arguments from the commenters that there is not one industry-wide standard that can be applied to all MDE and concurs that the Access Board should not attempt to establish manufacturing tolerances. Where available, tolerances are best addressed by industry standards for the specific materials and methods employed in the manufacturing process. The only change to this provision was to adjust the section number to allow for the addition of a new section, M101.3 Existing Diagnostic Equipment.

M101.7 Units of Measurement (Section-by-Section Analysis)

In the MDE NPRM there was no explanation of the units of measurement used throughout the rule text. In order to avoid confusion and to align this final rule with the other accessibility guidelines and standards promulgated by the Access Board; this provision has been added to explain that the values stated in each system (U.S. customary and metric units) may not be exact equivalents, and each system must be used independently of the other.

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