36 CFR Part 1195 Proposed Accessibility Standards for Medical Diagnostic Equipment NPRM - Preamble

M306 Communication

Where diagnostic equipment communicates instructions or other information to the patient, M306 would require the instructions or other information to be provided in at least two of the following methods: audible, visible, or tactile. For example, magnetic resonance imaging (MRI) and X-ray computed tomography (CT) equipment may instruct the patient to hold their breath for a short period during a scan by means of a flashing light or icon. A flashing light or icon would be sufficient to notify a patient who is deaf to hold their breath, but a voice prompt, sound alert, or tactile vibration would be needed to notify a patient who is blind to hold their breath. For MRI equipment, auditory methods may not be effective due to the noise generated by the equipment and a tactile vibration may be the only effective method to notify a patient who is blind to hold their breath. ANSI/AAMI HE 75 recommends that vibration “be used as a redundant mode for transmitting information such as an attention getting signal.” See ANSI/AAMI HE 75, section 16.3.5.6.

Question 41. Comments are requested on the following questions regarding methods of communication provided by diagnostic equipment:

a) Should diagnostic equipment that communicates instructions or other information to the patient be required to provide the instructions or other information in all three methods of communication (i.e., audible, visible, and tactile)?

b) What would be the incremental costs for the design or redesign and manufacture of the equipment to provide all three methods of communication (i.e., audible, visible, and tactile)?