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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.
Linear accelerator Animation of the operation of a medical use linear accelerator. The French company CGR manufactured the Neptune and Sagittaire linear accelerators.. In the early 1970s, CGR and the Canadian public company Atomic Energy of Canada Limited (AECL) collaborated on the construction of linear accelerators controlled by a DEC PDP-11 minicomputer: the Therac-6, which produced X-rays ...
An adverse event is any undesirable experience associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary supplements, cosmetics, medical foods, and infant formulas). As of the summer of 2011 ...
The FDA provides a database for reporting of adverse medical device events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1]. The data consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996, and is open for public view.
The FDA uses FAERS to monitor for new adverse events and medication errors that might occur with these products. It is a system that measures occasional harms from medications to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular drug and to identify correctable and preventable problems in ...
Causal factors are analyzed, focusing on systems and processes, not individual performance. Potential improvements, called an "action plan", are identified and implemented to decrease the likelihood of such events in the future. Each accredited organization is encouraged, but not required, to report any sentinel event to The Joint Commission.
Variations in healthcare provider training & experience [45] [52] and failure to acknowledge the prevalence and seriousness of medical errors also increase the risk. [53] [54] The so-called July effect occurs when new residents arrive at teaching hospitals, causing an increase in medication errors according to a study of data from 1979 to 2006.
The U.S. congressional review concluded medical devices would require actual device experience in a clinical setting and sufficient reporting of adverse data events. The legislation would encompass medical devices demonstrating the potential for life-threatening events and accurate adverse data collection would be required for informed ...