A recent study shows that the number of deaths due to malfunctioning medical devices may be higher than previously known. An analysis of FDA adverse event filings showed that over 20-year period medical device-related deaths may be 23% higher than identified. The rate of medical device-related deaths is estimated at 8,000 per year and if study results are accurate, may be as high as 10,000 deaths per year, attributed to faulty, failing, or defective medical devices.
Problems with medical devices can take years to begin, and in some cases may be untreatable. Medical devices which are intended to be permanently implanted may be complicated to remove, may result in permanent injury, or may cause death.
JAMA Study Shows Inadequate Death Classification
The study, reported in JAMA Internal Medicine (Journal of the American Medical Association), examined 290,141 serious adverse medical event reports filed in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database between December 1991 and April 2020. According to the evaluation, just over half of these events (52.1%) were reported as deaths, while the remaining reports were listed as injury, malfunction or were missing a classification.
The study analysis showed that about 23% of the reports which included written occurrence of death, were not classified in the death category. This means that over 31,500 more deaths over the 20 -year period occurred due to malfunctioning medical devices than previously known.
Medical Device Reporting Mainly Done by Manufacturers
The MAUDE database is maintained and operated by the U.S. Food and Drug Administration however, most reports are submitted by a physician or by the manufacturer.
The underreporting of deaths in the MAUDE database may be further complicated by the fact that the FDA is required to review all cases categorized as “death” but is not required to review other categories. This may mean that dangerous medical devices are left to cause serious harm without an FDA official reviewing the reports, instead relying on the manufacturer to address serious trends.
Further, the great majority of reports are filed by manufacturers who may have a vested interest in failing to identify serious problems within a timely manner. As an example, between 2002 and 2013, 32,000 adverse events were reported to be associated with use of Essure birth control device, however the FDA only received 1,023 MAUDE filings for the same period. Though hospitals, physicians and patients may report adverse events on their own, many do not do so or are unaware that they should.
FDA Fast-Track Approval May Reduce Safety
Many medical devices are now approved with little-to-no human testing. The FDA 510K pathway for medical devices allows for manufacturers to avoid costly clinical testing. Manufacturers may apply for a “Premarket Notification (PMA)” also known as an FDA 510(k) for a device without testing it in humans if they claim that a device is the same, or substantially similar to a device already on the market. It essentially allows the company to “inform” the FDA they will be introducing a product without requiring the Agency “approve” an application.
While this may not have negative repercussions for low risk and non-invasive medical devices, for those that are implanted or support life functions, a lack of testing may have serious implications if the device malfunctions, fails or is faulty.
The FDA classifies medical devices according to risk:
- Class I – low risk such as medical supplies (e.g., bandages, dental floss, examination gloves)
- Class II – medium risk (e.g., infusion pumps, surgical instruments, powered mobility devices)
- Class III – high risk (e.g., implanted devices, pacemakers, high-concentration drug infusion devices)
The medical device industry is estimated to be valued at around $200 billion per year and some evidence shows that the rate of adverse events may be increasing, particularly in those that are high risk and marketed under 510(k).