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

III. Summary of Comments

In all 60 comments were received; the comments are available at: https://www.regulations.gov/docket?D=ATBCB-2012-0003. Overall the comments provided detailed responses to the questions posed in the preamble to the MDE NPRM. They provided many alternatives and recommended changes to the proposed requirements, which are discussed throughout this preamble. The disability rights organizations generally supported the proposed rule and recommended multiple ways to increase accessibility. The manufacturers provided a great deal of information on what types of accessible equipment is currently on the market, what the providers are requesting for accessible equipment, and the limitations of certain diagnostic equipment in meeting some of the requirements in the proposed standards. Most of these comments and recommendations are discussed below in the Significant Changes and the Section-by-Section Analysis. In addition, some commenters also raised concerns with the accessibility of diagnostic equipment to providers who have disabilities, weight and patient load, the need for training of staff on how to properly assist patients with disabilities, and requirements to ensure the room is accessible. While valid and important issues about accessibility, most of these concerns are outside the purview of the Access Board as they relate to issues unrelated to the equipment itself or the built environment, and therefore, have not been addressed by the MDE Standards.

In the preamble to the MDE NPRM, the Access Board identified the following barriers to accessibility, as documented in the Rehabilitation Engineering Research Center on Accessible Medical Instrument National Survey,³ including equipment characteristics that affect patients ability to access and use medical equipment, such as: dimensions of the equipment (e.g. height, width, length,) contact surfaces (e.g., stiffness, comfort, color contrast), supports for transferring onto and off of equipment and positioning their bodies on the equipment (e.g., handholds, armrests, side rails), controls (e.g., ease of operation), and displays and devices (e.g., legibility and understandability). The Access Board sought public input on what other barriers affect the accessibility and usability of medical diagnostic equipment. NPRM, 77 FR at 6919, question 2. Nine commenters responded (two manufacturers, four accessibility consultants, three disability rights organizations, and an individual) and provided examples of additional barriers that they believe should be addressed in future updates of the MDE Standards. These recommendations included the accessibility of offices of healthcare providers, user positioning, communication, device operation, feature controls, compatibility of medical diagnostic equipment with assistive technology, weight capacity, and adding space to accommodate a patient’s durable medical equipment. Additionally, the commenters noted that the proposed standards focused mostly on individuals with mobility disabilities and recommended providing standards to encompass individuals with autism, Alzheimer’s, sensory disabilities, cognitive disabilities, and bariatric patients.

The technical criteria in the final rule addresses most of the barriers that were identified in the study as affecting the accessibility and usability of medical diagnostic equipment. However, at this time it is not possible for the MDE Standards to address every barrier. The Access Board is very interested in the additional barriers raised by public commenters and believes that further research is needed on some of the recommendations; such as equipment characteristics of stiffness, comfort, and color contrast of contact surfaces, and ensuring the accessibility of people with sensory and cognitive disabilities, and pediatric and bariatric patients. Section 510 of the Rehabilitation Act requires the Access Board to periodically review and amend the standards, as appropriate. The Access Board will address other barriers in future updates to the MDE Standards.

Additionally, commenters noted other areas of medical diagnostic equipment and issues of patient accessibility and recommended multiple changes or additions to the final rule. Specifically, commenters recommended adding weight capacity or patient load requirements, ensuring that the room is accessible, developing a manner to evaluate and measure the accessibility of equipment to give to patients, requiring staff training on how to use accessible equipment and how to provide assistance to people with disabilities, and requiring patient support surfaces. Based on the Access Board’s review of these issues, many of the commenters concerns are outside the scope of this rulemaking but are issues that may be addressed by enforcing authorities when they provide scoping and application requirements in adopting the MDE Standards. Additionally, the Board may elect to address the accessibility of examination rooms and other spaces containing diagnostic equipment under its authority to develop guidelines for buildings and facilities subject to the ADA and ABA. The other issues of weight capacity and patient support surfaces will be added to the additional barriers list above, and considered for inclusion when the MDE Standards are updated.

The Access Board received nine comments asserting that figures help the reader to better understand the technical criteria; these commenters recommended some minor changes to the advisory figures and strongly supported the usefulness of the figures. The Office of the Federal Register does not permit advisory materials to be published in the Code of Federal Regulations. Consequently, as the figures are advisory, only the version of the final rule posted on the Access Board’s website will include advisory text and figures. The online version of the final rule, as well as other materials related to this rulemaking, can be found here http://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking.