Medical device-related deaths being ‘miscategorized’ in key US database, study finds (23% of adverse event deaths were classified as “injuries, malfunctions or other.”)

Implant makers and others obligated to tell United States regulators about harm arising from medical devices are significantly underreporting deaths, increasing the odds that dangerous products stay on the market for longer than they would otherwise, a new study concludes.

The research, published online by the JAMA Internal Medicine journal last month and based on data from the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database, appears to corroborate a key finding from the International Consortium of Investigative Journalists’ Implant Files investigation.

The study found that 23% of reports about patients with medical devices who died were classified instead as “injuries, malfunctions or other.”

The findings were based on a review of a sample of 1,000 adverse event reports, which are documents filed to the FDA by medical professionals, patients and medical device manufacturers every time there is a significant issue with a medical device.

The Implant Files investigation found that the FDA and other national health authorities have too often greenlit the marketing of undertested medical devices and have often been too slow to remove a product for sale once evidence of serious problems emerge. An ICIJ analysis, and later reporting from Kaiser Health News, showed that people who file the so-called adverse event reports — device makers, doctors, and others — routinely fail to correctly note that a problematic device caused a patient’s death.

[3 Minute Video: A global investigation into medical device harm | Implant Files - YouTube]

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“There are now 11.8 million reports to the FDA for medical device adverse events and they haven’t increased the staffing to keep up with that,” Kinard said.

The new research appears to corroborate a key finding from the Implant Files investigation, which showed revealed how deaths linked to medical devices were being underreported.