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Medical devices: FDA should take steps to ensure that high -Risk device types are approved through the most stringent premarket review process.
Medical Device Reporting (MDR)
Medical Device Reporting (MDR) is the name of the Act that allocates control to the Food and Drug Administration to monitor results of medical devices in order to make sure that no adverse effects results to society. The FDA receives information on this account from all manufacturers, users, and importers of medical devices who, if they experience a problem, are obligated to report this problem to the FDA so that these problems can be treated directly. User Facilities (e.g., hospitals, nursing homes), moreover, are required to report these problems to both the FDA and the manufacturer. Even if the user facility only suspects a serious result to have occurred because of the device but is not certain, nonetheless, the suspicions should still be reported to both FDA and manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to the FDA.
The FDA urges that:
If you are a consumer or health professional you should use the MEDWATCH program for reporting significant adverse...
A 1986 General Accounting Office (GAO) study showed that less than one percent of device problems occurring in hospitals were being reported to FDA, and that the more serious the problem with a device, the less likely it was to be reported. In 1989, a GAO follow-up study showed that serious lapses of reporting to FDA still existed. Incidents that involved device-related deaths, serious injuries, and certain malfunctions were still being seriously under-reported.
The Safe Medical Devices Act of 1990 (SMDA) obligated device user facilities to report device-related deaths to the FDA and to the manufacturer. On November 28, 1991, SMDA also required that device user facilities submit to FDA, every six months, a summary of all reports submitted during that time period. This Amendment became law on June 16, 1992,…
Source
Medical Device Reporting - General Information www.rcb.ca.gov/forms_pubs/attach6.pdf
FDA - Medical Device Reporting (MDR) http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm
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