ARTICLE
Many patient deaths may go uncounted by taking the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database at face value, researchers found. Adverse event reporting to MAUDE is mandated for manufacturers, importers, and device user facilities, although voluntary for physicians. Each event is categorized as a malfunction, injury, or death. A close look at the publicly available postmarketing medical device database turned up 17.5% of total patient deaths with one device having been misclassified as malfunction or injury — and it was worse for another device at 24.7%. In many cases, event reports used words like “died” or “passed away” or "autopsy" even while listing these events as injury or device malfunction. Researchers demonstrate that the FDA had allowed device manufacturers to file reports of malfunctions in a hidden database. Such “alternative summary reporting” was then formally shut down by the agency in June. "Both the miscategorization of deaths in FDA adverse-event reporting and hidden adverse-events reports can lead to inaccurate public and physician perception of the safety of medical devices and can compromise informed decision-making. "This is yet another study showing the inadequacy of the FDA device adverse-event reporting system. The FDA and others are actively seeking new approaches that can provide more timely, more accurate methods of ascertaining safety issues,” the report notes. “For now, the current system, which is expensive and slow, fails to provide clinicians and patients with the information they need to make informed choices.” Source: https://www.medpagetoday.com/cardiology/pci/82628