Devices

FDA Dismisses JAMA Report on ‘Misclassified’ Death Reports

FDA has dismissed concerns raised in a JAMA Internal Medicine report (see earlier story) that many medical device adverse event reports (MDRs) involving a patient death are classified in categories other than death in the agency’s Manufacturer and User Facility Device Experience (MAUDE) database. An FDA spokeswoman told FDA Webview 7/30 that notwithstanding many MDRs containing the term “death,” this does not automatically mean they would and should be classified as death “unless the reporter believes the patient’s cause of death was or may have been attributed to the device or the device was or may have been a factor in the death.”

In the JAMA report, researchers at the University of California San Francisco and other locations said they applied a natural language processing algorithm to the MAUDE database to identify reports in the injury, malfunction, other, or missing categories that included at least one term that suggested a patient death. The algorithm identified 290,141 reports from 12/31/1991 to 4/30/2020 in which a serious injury or death was reported. For the overall sample, the study said, the percentage of reports with deaths that were not classified as deaths was 23%, suggesting that some 31,552 reports in the sample had deaths that were classified in other categories.

The spokeswoman said FDA reviews all MDRs, not just those classified as death. MDRs may include the word “death” or a related term in the text of the report. “Any analysis of MDRs needs to evaluate the totality of information provided in the original MDR, and any MDR supplements subsequently provided, as well as the context in which the word ‘death’ or related terms are used,” she said. “This is part of the analysis the FDA performs. For example, many of the MDRs in the JAMA Internal Medicine study that were characterized as having been misclassified were for Class 3 devices which often are used in sick individuals who may be at high risk of death from their underlying illness.”

FDA has reached out to the lead author for additional information, including copies of the MDRs they believe are misclassified to perform its own evaluation, the spokeswoman said.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome