The World Health Organization (WHO)’s “Global Model Regulatory Framework for Medical Devices Including IVDs” draft document, released this last July, includes recommendations for regulatory authorities to adopt a policy whereby SUD reprocessing is subject to the same standards as applied to original device manufacturers.
AMDR wholly supports and endorses the WHO approach as regulated SUD reprocessing has proven to curtail, if not stop, inappropriate and unregulated in-house reuse, and promote a proper, regulated marketplace for lower cost and environmentally responsible reprocessed and remanufactured SUDs.
Global Model Regulatory Framework for Medical Devices Including IVDs
Excerpt from Reprocessing of single use medical devices:
“In adopting a policy on the reprocessing of SUMDs, the regulatory authority should consider the following: reprocessing of a SUMD as labelled by its manufacturer is not permitted unless the reprocessed SUMD meets the same initial standards as those of the original manufacturer. In order to allow their reuse, a party that reprocesses and distributes medical devices labelled by their original manufacturer for single-use only will be held to the same requirements of safety, quality and performance as manufacturers of new devices. This applies equally to a health-care facility fully reprocessing single-use medical devices for reuse within its own facility…”