Reports

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

February, 2006 – 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.

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Association of Medical Device Reprocessors (AMDR): Reprocessed Single-Use Medical Devices — FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk

January, 2008

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Association of Medical Device Reprocessors (AMDR): Informed Consent – State Legislative Update; by Daniel J. Vukelich

September 1, 2010 – 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

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Association for Professionals in Infection Control & Epidemiology, Inc. (APIC): Reprocessing of Single Use Medical Devices

August 31, 2007 – 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).

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FDA, Dr. Shulz Statement

September 26, 2006

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GAO Single Use Medical Devices Report

June, 2000 – Little Available Evidence of Harm From Reuse, but Oversight Warranted

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GAO Reprocessing Report

January, 2008 – FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk

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American College of Cardiology

June 25, 2009 – Letter to Senator Richard Durbin

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IFUs