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

4. Exception from the Requirements of M301 for Certain Examination Chairs that Comply with M302

The Access Board proposed in M101.2 in the MDE NPRM to require diagnostic equipment to meet the standards for each patient position supported, meaning that if diagnostic equipment was designed to support a patient in multiple positions then the equipment would have to meet the technical criteria for each of those positions. The Access Board sought public input in question three in the preamble in the MDE NPRM, on whether organizing the technical criteria functionally by patient position was clear. 77 FR at 6919.

Fifteen commenters responded, with only two disability advocates and one medical association agreeing that the division of the MDE Standards was clear. The manufacturers raised concerns about applying the MDE Standards for multiple patient positions to a single piece of equipment. Multiple commenters recommended that when diagnostic equipment that fits in multiple categories, one category should take precedence. Medical Association and Accessibility Consultants recommended reorganizing the standards by types of facilities or by feature and one manufacturer recommended harmonizing M301 and M302 into one requirement. Additionally, commenters raised concerns about diagnostic chairs which could be reclined into a supine position after transfer; such as podiatry and dental chairs. These commenters argued that requiring the equipment to be designed to accommodate transfer in both positions would not achieve any objective benefit and would impose transfer surface width requirements that would not be appropriate and would be overly burdensome. The MDE Advisory Committee did not make a recommendation on this provision. However, the subcommittee for tables and chairs did explain that while the primary function of examination chairs is to support patients in a seated position, they are also capable of being reclined. The ability to recline is a secondary, rather than a primary purpose. The subcommittee asserted that these types of chairs should be covered by M302.

In response to the comments and Advisory Committee discussions, the Access Board acknowledges that one of the most important features of making diagnostic equipment used by patients in either the supine, prone, or side-lying position or the seated position accessible, is to ensure the patient has the opportunity to transfer independently to the maximum extent possible. The Access Board concurs with the commenters that there are certain examination chairs, such as dentistry and podiatry chairs, where the patient is only intended to transfer while the chair is in a seated position but is then reclined into a supine position while the diagnostic procedure is being performed. The Access Board concurs with commenters that in this limited situation it is unnecessary for the examination chair, which complies with the technical requirements in M302, to also have to comply with the technical requirements in M301. Therefore, in the final rule the Access Board has added an exception to M301.1 which states that examination chairs that comply with M302 and, after the patient transfers into the seat, reclines to facilitate diagnosis, do not have to comply with M301. Additionally, the Board has added a new definition for examination chair in M102.1 in the final rule to assist with the application of this exception. The other commenter concerns regarding the proposed application provision, M101.2, are addressed below in the Section-by-Section Analysis.