Lou Portero

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<div><span style="font-size: medium;">A recent study in <em>JAMA Internal Medicine</em>, revealed that a review of the FDA&#8217;s Manufacturer and User Facility Device Experience (MAUDE) database found patient deaths associated with the use of medical devices were being mislabeled in the system and potentially being missed by the agency. In a manual review of 1,000 adverse event medical device reports identified by a natural language processing algorithm, used to identify mislabeled patient death reports in the MAUDE system, 23% of reports were labeled as injury, malfunction, missing, or other, rather than death.</span></div>
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<div><span style="font-size: medium;">Madris Kinard, CEO of Device Events, and co-author of the JAMA study developed the software used to identify reports in the FDA&#8217;s database for the study, said identifying the correct number of deaths or serious injuries in mislabeled reports is crucial as it could potentially change the safety status of some devices.</span></div>
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<div><span style="font-size: medium;">“There are now 11.8 million reports to the FDA for medical device adverse events and they (The FDA) haven’t increased the staffing to keep up with that,” Kinard said.</span></div>
<div><span style="font-size: medium;">More needs to be done to hold manufacturers accountable for marketing dangerous products, she said. “There are no fines being imposed on these manufacturers so the remediations can take years and the device remains on the market when there are known problems.”</span></div>
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<div><span style="font-size: medium;">A case in point is the 32,000 women who reported adverse events associated with the Essure permanent birth control device to the manufacturer between 2002 and 2013. The FDA received just 1,023 events, according to the study.  </span>Yet the authors uncovered that over 95% of adverse event reports were made by manufacturers, not physicians or healthcare facilities, which presents a conflict of interest.</div>
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<div><span style="font-size: medium;">An FDA spokesperson said in an emailed statement that the agency reviews all medical device reports, not just those classified as death. The spokesperson added that the FDA has reached out to the lead author of the study for medical device reports believed to be misclassified to perform the agency&#8217;s own evaluation.</span></div>
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<div><span style="font-size: medium;">Sources</span></div>
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<div><span style="font-size: medium;"><a href="https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2782344" target="_blank" rel="noopener noreferrer" data-saferedirecturl="https://www.google.com/url?q=https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2782344&amp;source=gmail&amp;ust=1629755155790000&amp;usg=AFQjCNFvrttXRHJK2X5eGqvZ3IV2Ew3M_w">https://jamanetwork.com/<wbr />journals/jamainternalmedicine/<wbr />article-abstract/2782344</a><br />
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<div><span style="font-size: medium;"><a href="https://www.icij.org/investigations/implant-files/medical-device-related-deaths-being-miscategorized-in-key-us-database-study-finds/" target="_blank" rel="noopener noreferrer" data-saferedirecturl="https://www.google.com/url?q=https://www.icij.org/investigations/implant-files/medical-device-related-deaths-being-miscategorized-in-key-us-database-study-finds/&amp;source=gmail&amp;ust=1629755155790000&amp;usg=AFQjCNHbDEyrIZpIkI4Syfh7VGXXXyJBcg">https://www.icij.org/<wbr />investigations/implant-files/<wbr />medical-device-related-deaths-<wbr />being-miscategorized-in-key-<wbr />us-database-study-finds/</a><br />
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A recent study in JAMA Internal Medicine, revealed that a review of the FDA&#8217;s Manufacturer and User Facility ...