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Key documents

GAO Report to Congress (January 2008)

"Reprocessed single-use medical devices: FDA oversight has increased, and available information does not indicate that use presents an elevated health risk”

This report notes that FDA has analyzed its data on reported adverse events related to reprocessed SUDs and has concluded that there are no patterns that point to these devices creating such risks. After reviewing FDA’s processes for monitoring and investigating its adverse event data, [GAO] found no reason to question FDA’s analysis.

Download (.pdf) (553KB),
or go to: http://www.gao.gov/new.items/d08147.pdf

GAO Report to Congress (June 2000)

"Single Use Medical Devices: Little Available Evidence of Harm from Reuse, but Oversight Warranted."

This report indicated that clinical evidence supports some SUDs can be safely reprocessed and reused on other patients if appropriate cleaning, testing and sterilization procedures are carefully followed, with hospitals reporting significant savings.

Download (.pdf) (254 KB), or go to:
http://www.gao.gov/new.items/he00123.pdf

FDA Survey on reuse trends in hospitals (2002)

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm121678.htm

Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance
/GuidanceDocuments/ucm073758.htm

Enforcement Priorities for Single-Use
Devices Reprocessed by Third Parties and Hospitals

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm107164.htm

Medical Devices 2003 Reprocessed Single-Use Devices

"Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data, 2003" (Federal Register 4/30/2003)

http://www.fda.gov/OHRMS/DOCKETS/98fr/03-10413.html

Medical Devices 2005 Reprocessed Single- Use Devices

"Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data, 2005" (Federal Register 9/29/2005)

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-19510.pdf

FDA Reuse home page

The FDA's reuse home page maintains all documents on reuse of SUDs, frequently asked questions, standards, and events (calendar of meetings and copies of slide presentations). All historical documents may be located there as well. The FDA guidance applies existing regulations to original equipment manufacturers (OEMs), third parties, and hospitals to minimize risks associated with reprocessed SUDs.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
ReprocessingofSingle-UseDevices/default.htm

Labeling requirements

Additional regulations were imposed by the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), which amended sections of MDUFMA. As of August 1, 2006 all reprocessed device must contain information on the device to identify the manufacturer of the original device.

http://www.fda.gov/ohrms/dockets/98fr/05d-0401-gdl0002.pdf and,
http://www.fda.gov/cdrh/comp/guidance/1217.html

Premier's white paper

Key decision parameters to consider: selection of a third-party reprocessor

Download a white paper - a summary of reprocessing decision issues (.doc) (47 KB)

MedWatch forms

This form now includesa category for reprocessed SUDs and the name of reprocessor

http://www.fda.gov/medwatch/how.htm

Reporting problems with medical devices

Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse event (AE) information from manufacturers, importers, and user facilities, so AEs can be detected and corrected quickly. The FDA's Web site posts current updates and information. The FDA has published revised forms for health care facilities and others to use in reporting adverse events involving single-use medical devices that have been reprocessed for reuse. The revised forms and instructions, for voluntary and mandatory reporting to MedWatch, are in effect. Download the forms:

Voluntary (.pdf) (54 KB)

Mandatory (.pdf) (52 KB), or go to:

http://www.fda.gov/medwatch/getforms.htm