Medical device reporting
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled. Consumers and health professionals report any adverse event caused by the device to MedWatch program for reporting significant adverse events or product problems with medical products. History Legislation requiring device user facility reporting was enacted by Congress to increase the amount of information the Food and Drug Administration (FDA) and device manufacturers receive about problems with medical devices. Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous studies have shown widespread underreporting. A 1986 General Accounting Office (GAO) study showed that less than one percent of device problems occurring in hospitals are reported to the FDA, and that the more serious the problem with a device, the less likely it was to be reported. A GAO follow-up study in 1989 concluded that despite full implementation of the Medical Device Reporting (MDR) regulation, serious shortcomings still existed. Under the