Investigation reveals medical device safety testing concerns

Editor's Note

Published December 21, a year-long investigation by KFF Health News into medical device malfunctions found that the FDA allows the sale of most medical devices, including many implants, without requiring tests for safety or effectiveness. Instead, manufacturers need to show only that they have “substantial equivalence” to an existing product in the marketplace. 

Problems resulting from this lack of oversight include artificial knees sold in Florida with packaging issues that could cause premature wear, as well as metal hip implants that snapped in two patients.

One major concern involved insulin heart pumps made by Medtronic which were intended to monitor and dispense insulin as needed. Although the pumps were lauded by the FDA, they later had to be urgently recalled in 2019 and again in 2021. An FDA inspection found that Medtronic had received 74,000 complaints, and the company now faces more than 60 lawsuits filed by injured patients and their families. Lawsuits filed since 2019 claim improper dispensing of insulin contributed to at least a dozen deaths. 

According to the report, worries about the safety risks of the 510(k) clearance process—the guidelines requiring devices to have “substantial equivalence”—have persisted for years. Under the 510(k) review, which requires no clinical trials, the FDA clears some 3,000 medical devices every year for a fee of $22,000, compared to just 30 approvals a year through the stricter premarketing requirements, which cost nearly $500,000 per device.