Reporting Tip: Reporting Problems with Reprocessed Single Use Devices to FDA
MedSun: Newsletter #29, October 2008

Medical Device Reporting (MDR) is the mechanism by which the FDA receives significant medical device adverse events from manufacturers, importers and user facilities (e.g., hospitals, nursing homes), in order to detect and correct the problems http://www.fda.gov/cdrh/mdr/mdr-general.html. This information is used to protect the public health as well as ensure that devices are not adulterated or misbranded and are safe and effective for their intended uses. If you are a consumer or health professional you should use the MedWatch program at http://www.fda.gov/medwatch/ for reporting significant adverse events or problems with medical products. This Reporting Tip is meant to clarify how health professionals can best report an adverse event that occurs with a reprocessed single use device to the FDA.

What is a Single Use Device (SUD)?

An SUD is a device that is intended for one use on a single patient during a single procedure. (See Medical Device User Fee and Modernization Act of 2002, Public Law 107-250, Title III, Section 302).

What is a reprocessed SUD?

A reprocessed SUD is one that has been used on a patient and subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. (See Medical Device User Fee and Modernization Act of 2002, Public Law 107-250, Title III, Section 302).

What are common examples of reprocessed SUDs?

Some examples include: pneumatic compression sleeves, surgical blades, bits and burrs, trocars and electrophysiology (EP) catheters.

How should information about the reprocessor be noted when reporting a problem with a reprocessed SUD to the FDA through MedWatch?

Third party firms and hospitals reprocessing SUDs are part of the same regulatory framework as original equipment manufacturers (OEMs) and their products and quality processes must meet prescribed standards. For this reason, when you report a problem with a reprocessed SUD you should list the reprocessor as the manufacturer of the device. For more information about how to fill out the device section of a MedWatch form go to http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ucm149236.htm#E3

Where should defective reprocessed SUDs be sent for evaluation?

When a defective product, or one which may have been involved in a death or serious injury, is to be returned for evaluation, be sure that you return it to the reprocessor, not to the original manufacturer of that device.

The FDA is interested in reports on reprocessed single use devices and their performance in the clinical environment.

Additional Information:

For general information about reporting medical device adverse events, go to:
http://www.fda.gov/cdrh/mdr/mdr-general.html

For more information about reprocessed single use devices go to:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/default.htm


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