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).
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.
NASPE Position Statement
A Report of the NASPE Task Force on Reprocessing of Electrophysiological Catheters.
GAO Single Use Medical Devices Report
Little Available Evidence of Harm From Reuse, but Oversight Warranted