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

M306 Communication (Section-by-Section Analysis)

M306 in the final rule provides the technical criteria for communication from the diagnostic equipment to the patient.

M306.1 General (Section-by-Section Analysis)

The MDE NPRM proposed that, where diagnostic equipment communicates instructions or other information to the patient, the instructions or information must be provided in at least two of the following methods: audible, visible, or tactile (proposed M306.1). The Access Board sought public input in question 41 in the preamble to the MDE NPRM, on whether diagnostic equipment that communicates instructions or other information to the patient should provide information in all three methods of communication, and what the cost to provide all three methods would be. NPRM, 77 FR at 6931. Seven commenters responded. Three commenters (a manufacturer, a medical association, and a state agency concerned with accessibility) concurred with the proposed requirement to provide two methods of communication. Three commenters (two disability rights organizations and one medical association) supported requiring all three modes of communication, and the final commenter (a manufacturer) recommended requiring one mode of communication if the medical provider is present and three modes of communication for home use devices. The MDE Advisory Committee did not address this provision.

The Access Board carefully considered the public comments; however, it has decided to retain the provision from the proposed rule, requiring diagnostic equipment that communicates instructions or other information to the patient to provide the communication in two methods. The commenters were split in their support of two or three methods of communication and the commenters supporting the increase to three methods of communication provided no additional information to warrant the increase. The commenter that recommended different requirements for home-use equipment is not dispositive as this rule does not cover any home use equipment. The Access Board has concluded that providing two means of communication will serve the majority of people and that there was not enough information provided to warrant an increase in this requirement in the final rule.