Reporting Device-Associated Death Events to the FDA—Reply

Abstract

To the Editor We write to respond to a recent report by Dr Lalani and colleagues 1 regarding device-associated adverse events reported to the US Food and Drug Administration (FDA). Adverse event reports submitted to the MAUDE (Manufacturer and User Facility Device Experience) database 2 are an important tool in the postmarket surveillance of medical devices. The FDA provides public access to these data to promote transparency and the opportunity for research and analyses. We write to address the following points.First, Dr Lalani and colleagues cited a statement from the Office of the Inspector General that "the FDA must review all adverse events reported as deaths, which is not the case for other reporting categories." 1,3 In fact, the FDA reviews all medical device reports using a risk-based prioritization approach that considers, among other factors, the severity of the event, and the intended use and risk of the device, including whether it is life sustaining.Second, in our view, the data set was not broadly representative of the reports that the FDA receives. A small number of certain high-risk and/or recalled products accounted for a disproportionately high number of the reports selected for review by the authors. 1 Lastly, Dr Lalani and colleagues stated that "a large percentage of adverse event reports in the FDA's MAUDE database that involved a patient death were classified in categories other than death by the reporter," and noted potential implications for the FDA's ability to identify safety signals. 1 Per FDA regulations, an adverse event report is to be categorized as a death when information reasonably suggests that the device may have caused or contributed to the death. 4 The analysis did not take this point into account, and therefore, did not assess whether death reports were necessary. Furthermore, multiple reports may be submitted to fulfill reporting obligations for related adverse events. An analysis should take related reports into account, including related death reports, when determining if reporting requirements have been met.The FDA takes patient safety and postmarket surveillance seriously. After a medical device is marketed, the FDA continually monitors safety issues through review of all medical device reports, as well as other postmarket information. Agency officials are available to answer questions about public FDA databases, and relevant regulations and procedures. 5