The Business Case for Reprocessing
FDA-regulated reprocessed devices are as safe and effective as original equipment, but much less costly – typically about half of the cost of an original device.
Association of Medical Device Reprocessors (AMDR): Informed Consent – State Legislative Update; by Daniel J. Vukelich
Because reprocessors are held to the same requirements as all other device manufacturers (FDA Guidance of 2000) and FDA has stated that it believes reprocessed devices to be “as safe and effective as [a] new device
American College of Cardiology
Letter to Senator Richard Durbin
GAO Reprocessing Report
FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk
Association for Professionals in Infection Control & Epidemiology, Inc. (APIC): Reprocessing of Single Use Medical Devices
The Food and Drug Administration (FDA) requires that certain medical devices once intended for single use only, can be approved for re-use as described in the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
