Devices

Many Reports of Medical Device Deaths Misclassified: Study

Researchers at the University of California San Francisco and other locations say that many medical device adverse event reports that involve a patient death are classified in categories other than death in the FDA Manufacturer and User Facility Device Experience (MAUDE) database. “As FDA only routinely reviews all adverse events that are reported on patient deaths, improving the accuracy of adverse event reporting may enhance patient safety,” the researchers say in a JAMA Internal Medicine report.

The researchers say they applied a natural language processing algorithm to the MAUDE database, followed by manual text review, 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. Of them, 52% were classified by the reporter as death and 48% were classified as malfunction, injury, other, or missing.

For the overall sample, the study says, 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 overall percentage of missed deaths (the percentage of deaths that were classified in other categories) was 17%.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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