Regulations and Statements

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 …

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 …

EP Lab Digest: AcuNav Reprocessing: An Evaluation of Safety, Clinical Effectiveness and Cost Savings

Reprocessing AcuNav catheters has been a big success because the foundation for this science has been thoroughly tested and widely used with diagnostic electrophysiology catheters.