23% of medical device deaths not labeled as deaths in adverse reporting system, study finds

Twenty-three percent of patient deaths attributed to medical devices were classified as something other than patient deaths in the FDA's adverse events database, a study published July 26 in JAMA Internal Medicine found. 

For the study, researchers looked at thousands of adverse event reports in the FDA's manufacturer and user facility device experience database.

The researchers found that 23 percent of the adverse event reports they studied — or 31,552 — that involved a patient death were classified as "injury," "malfunction," "other" or "missing," instead of "death," though a patient death was said to have occured in the narrative section of the report. 

In the U.S., most safety data for medical devices once they hit the market is obtained through adverse event reports submitted to the FDA. They are classified by the company that makes the device, and if the device may have caused or contributed to a death, or if the cause of death is unknown, the FDA requires the adverse event to be reported as a death. 

The FDA only routinely reviews all adverse events that are reported as patient deaths, according to the researchers. Improving the accuracy of adverse event reporting may improve patient safety, they concluded. 

Find the full study here.

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