ing IRBs. Some clinical trials have special data monitoring committees (or—in NIH terminology—data and safety monitoring boards) with special responsibilities for monitoring the safety of clinical trials, including evaluating adverse event reports and outcome data. FDA has issued guidance on the use of such bodies (FDA, 2001c).

Alternative Summary Reporting for Manufacturers

Although required reporting is not limited to unexpected adverse events involving medical devices, FDA is most interested in the detection of unexpected, serious problems or recognized problems that are occurring more frequently than expected (e.g., given the data from clinical studies on which marketing approval was based). FDA has created an Alternative Summary Reporting program that allows manufacturers to submit abbreviated reports for certain well-known and well-documented problems. Examples include breast implant ruptures and shearing of central line catheters (FDA, 2004b).

Approximately 80 manufacturers and 40 different types of classified devices were participating in this alternative reporting program in 2004 (personal communication, Thomas P. Gross, M.D., Director, Division of Postmarket Surveillance, CDRH, October 8, 2004). Participation in the program requires FDA agreement (FDA, 2000c). Summary reports do not include information that allows identification of events involving children.

Voluntary Reporting for Health Professionals and Consumers

In addition to the mandatory reporting requirements for manufacturers, importers, and user facilities, FDA also provides health professionals and consumers the opportunity to report adverse events on a voluntary basis through its MedWatch program.14 (See Chapter 4 for further discussion.) MedWatch covers drugs, biologics, and nutritional supplements as well as devices. It also provides information about medical product safety, including recall announcements and safety advisories. The introductory online reporting information provided to health care professionals emphasizes that MedWatch is not to be for reporting adverse events associated with clinical studies, vaccines, veterinary products, or mandatory reporting

14  

The MedWatch website also includes information and forms for mandatory reporting. FDA uses the term medical device reporting or MDR to refer to mandatory reporting while describing MedWatch as its program for voluntary reporting for consumers and health professionals (FDA, 2002l). The MedWatch website, however, has the banner “The FDA Safety and Adverse Event Reporting Program” (see website at http://www.fda.gov/medwatch/).



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