In the US, most postmarket medical device safety data are obtained through adverse event reports that are submitted to the US Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database. Adverse event reports are classified by the reporter as injury, malfunction, death, or other. If the device may have caused or contributed to a death, or if the cause of death is unknown, the FDA requires that the adverse event be reported as a death.OBJECTIVE To determine the percentage of medical device adverse event reports submitted to the MAUDE database that were not classified as death even though the patient died. DESIGN, SETTING, AND PARTICIPANTSIn this study, a natural language processing algorithm was applied to the MAUDE database, followed by manual text review, to identify reports in the injury, malfunction, other or missing categories that included at least 1 term that suggested a patient death, such as patient died or patient expired, from December 31, 1991, to April 30, 2020, for any medical device.EXPOSURES Manual review of a random sample of 1000 adverse event reports not classified as death and of selected reports for 62 terms that are associated with deaths but were not classified as death.MAIN OUTCOMES AND MEASURES Percentage of adverse event reports in which the patient was said to have died in the narrative section of the report but the reporter classified the report in a category other than death. RESULTSThe terms in the natural language processing algorithm identified 290 141 reports in which a serious injury or death was reported. Of these, 151 145 (52.1%) were classified by the reporter as death and 47.9% were classified as malfunction, injury, other, or missing. For the overall sample, the percentage of reports with deaths that were not classified as deaths was 23% (95% CI, 20%-25%), suggesting that approximately 31 552 reports in our sample had deaths that were classified in other categories. The overall percentage of missed deaths, defined as the percentage of deaths that were classified in other categories, was 17% (95% CI, 16%-19%).CONCLUSIONS AND RELEVANCE Many of the findings of this study suggest that many medical device adverse event reports in the FDA's MAUDE database that involved a patient death are classified in categories other than death. As the FDA only routinely reviews all adverse events that are reported as patient deaths, improving the accuracy of adverse event reporting may enhance patient safety.
Risk of fracture among older adults with primary hyperparathyroidism receiving parathyroidectomy vs nonoperative management. JAMA Intern Med.
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
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