According to an analysis published in JAMA Internal Medicine, almost half of the Medical Device Reports (MDRs) were directly from the Medical Device Safety Communications (MDSC) sent by the U.S. Food and Drug Administration (FDA). From this report, it was more clear to recognize the need for improving the Manufacturer and User Facility Device Experience (MAUDE) database to recognize and display adverse event reports due to the fact that the medical device reports represent a disproportional amount of fatal adverse events. To ensure post market safety for the devices and other products running through the database, the FDA has been advised to improve their report-collecting practices by having physicians report directly to the agency to circumvent any issues with underreporting, lack of certainty, and reliance on manufacturers for reporting. Additionally, the report acknowledged the need to mandate the disclosure of unique device identifiers for the MAUDE system to identify safety signals.
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