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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).

Positioning Supports Considered

The Board is considering requiring in the final standards positioning supports such as rails, bars, or panels with handholds to be provided along the sides of diagnostic equipment used by patients in a supine, prone or side-lying position, and diagnostic equipment used by patients in a seated position that can be adjusted to a reclined position. As noted above, ANSI/AAMI recommends that handholds be “integrated into the device . . . [to] increase safety and assist patients in transferring on and off, positioning or repositioning their bodies, and maintaining static position.” See ANSI/AAMI HE 75, section 16.4.6. Pillows, wedges, and other padding can be used to stabilize and position patients on diagnostic equipment, but are not addressed in the proposed standards because they are not part of the diagnostic equipment.

Question 24. Comments are requested on the following questions regarding positioning supports along the sides of diagnostic equipment used by patients in a supine, prone or side-lying position, and diagnostic equipment used by patients in a seated position that can be adjusted to a reclined position:

a) Should the technical criteria address the configuration of positioning supports (e.g., length, height above the patient support surface, location) to ensure their effectiveness? Or should the technical criteria require that positioning supports be provided within reach and provide flexibility for designing the supports based on the intended use of the equipment?

b) What would be the incremental costs for the design or redesign and manufacture of positioning supports?

c) Are there types of equipment that cannot provide positioning supports along the sides of the equipment because of the structural or operational characteristics of the equipment? Comments should discuss alternative methods to assist patients with disabilities safely position or reposition their bodies, and maintain a static position.

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