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

This is the Preamble to the Final MDE Standards. Click here to view the Final MDE Standards.

M307 Operable Parts (Section-by-Section Analysis)

M307 in the final rule provides the technical criteria for operable parts used by patients to activate, deactivate, or adjust the diagnostic equipment. For example, equipment used for an auditory examination may require the patient to press a button when sounds are heard. M307 does not apply to controls used only by health care personnel or others who are not patients. There were no comments received on the proposed provisions, and as discussed below, the provisions from the proposed rule have been retained in the final rule.

The Access Board did receive comments in response to question 43, which sought public input on whether the final rule should include reach range requirements such as those in the 2004 ADA and ABA Accessibility Guidelines for an unobstructed forward reach or side reach for the operable parts provision. Five commenters responded, one commenter (state agency concerned with accessibility) recommended adopting the reach ranges and four commenters (one medical association, one academic, and two disability rights organizations) recommended against adding reach ranges for operable parts to the final rule. One of these commenters (disability rights organization) explained that the 2004 ADA and ABA requirements are not appropriate for application to operable parts of medical diagnostic equipment. The MDE Advisory Committee did not address this provision. Based on the majority of the commenters response, the Access Board has decided not to add reach ranges to the operable parts section at this time.

M307.1 General (Section-by-Section Analysis)

This is an introductory section.

M307.2 Tactilely Discernible (Section-by-Section Analysis)

The MDE NPRM proposed that operable parts intended for patient use be tactilely discernible without activation. Patients who are blind or have low vision have difficulty distinguishing a flat membrane button or similar control unless it is tactilely discernible from the surrounding surface and any adjacent controls. The most common method to ensure that buttons and similar controls are tactilely discernible is to raise part or all of the control surface above the surrounding surface and at a distance from any adjacent controls such that a relief of each individual control can be determined by touch. There were no public comments on this section and it was not addressed by the MDE Advisory Committee. There have been no changes made to this provision.

M307.3 Operation (Section-by-Section Analysis)

The MDE NPRM proposed to require operable parts to be operable with one hand and not require tight grasping, pinching, or twisting of the wrist. There were no public comments on this section and it was not addressed by the MDE Advisory Committee. There have been no changes made to this provision.

M307.4 Operating Force (Section-by-Section Analysis)

The MDE NPRM proposed to restrict the force required to activate operable parts to 5 pounds. The Access Board sought public input on this provision in question 42 on whether the operating force should be reduced to 2 pounds. NPRM, 77 FR at 6932. One commenter, a state agency concerned with accessibility, responded and concurred with the suggested reduction. The MDE Advisory Committee did not address this requirement. Although the Access Board initially considered a reduction in the force required to activate operable parts, upon further consideration, the Board found no reason to deviate from the long-established maximum of 5 pounds in the 2004 ADA and ABA Accessibility Guidelines. 36 CFR part 1191, App. D 309.4. Therefore, there have been no changes made to this provision.

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