Key documents
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/cdrh/Reuse/survey-execsum.html
Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme
http://www.fda.gov/cdrh/reuse/1156.html
Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals
http://www.fda.gov/cdrh/reuse/1168.html
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 All historical documents may be located there as well.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/cdrh/reuse/
Status of previously exempted devices
This document provides links to legally marketed, no longer legally marketed devices
http://www.fda.gov/cdrh/reuse/svs/svslist-nolegal.html
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
Locating information on specific devices
501(k) database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Listing by reprocessor name
http://www.fda.gov/cdrh/reuse/svs/svslist-nolegal.html
FDA Device Advice database
http://www.fda.gov/cdrh/devadvice/
Registration and Device listing
http://www.fda.gov/cdrh/reglistpage.html
FDA Inspection reports are available through
the Freedom of Information Act
http://www.fda.gov/cdrh/foicdrh.html
For questions about a specific device, contact the specific reprocessing company or the Premarket Review Staff (510(k)) at FDA at 301.594.1190.