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This is the Preamble to the Proposed MDE Standards NPRM (2012). Click here to view the Preamble to the Final MDE Standards (2017).

Stirrups (M301.3.2)

Where stirrups are provided on diagnostic equipment used by patients in a supine, prone, or side-lying position, M301.3.2 would require the stirrups to provide a method of supporting, positioning, and securing the patient’s legs. This is consistent with ANSI/AAMI HE75 which recommends that “[f]or patients with limited leg strength and control, instead of stirrups that support only the foot and require active user leg strength, leg supports that support both the foot and the leg should be used to assist patients in keeping their legs in an appropriate position.” See ANSI/AAMI HE 75, section 16.4.7 (g).

Question 23. Comments are requested on the following questions regarding stirrups:

a) What would be the incremental costs for the design or redesign and manufacture of stirrups that provide a method of supporting, positioning, and securing the patient’s legs?

b) Should diagnostic equipment used by patients in a seated position that provide stirrups such as urodynamics study chairs be required to provide a method of supporting, positioning, and securing the patient’s legs?

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