Devices

‘Deep Flaws’ in FDA Device Oversight: KFF Health News

David McFarland

— 2 min read
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A lengthy, deeply-researched KFF Health News report into its year-long investigation of FDA efforts to determine the safety and effectiveness of medical devices approved through the 510(k) pathway says they found “deep flaws” in FDA activities that resulted in “patient harm, exposed in lawsuits and records.” The report includes several patient case studies involving different medical devices.

KFF Health News says it investigated these medical device malfunctions:

  • artificial knees manufactured by a Florida company that remained on the market for more than 15 years despite packaging issues that the company said could have caused more than 140,000 of the implants to wear out prematurely;
  • metal hip implants that snapped in two inside patients who reported in lawsuits that they needed urgent surgery;
  • last-resort heart pumps that FDA records say may have caused or contributed to thousands of patient deaths; and
  • a dental device used without FDA approval that lawsuits alleged caused catastrophic harm to teeth and jawbones.

“The investigation has found that most medical devices, including many implants, are now cleared for sale by FDA without tests for safety or effectiveness,” the report says. “Instead, manufacturers must simply show they have ‘substantial equivalence’ to a product already in the marketplace, an approval process some experts view as vastly overused and fraught with risks.”

The article quotes former FDA drug reviewer Joshua Sharlin as saying,

“Patients believe they are getting an implant that’s been proven safe. No, it hasn’t.”

Once the devices reach the marketplace, the article says, FDA “struggles to track malfunctions, including deaths and injuries, while injured patients face legal barriers trying to hold manufacturers accountable for product defects.”

In a statement to the media outlet, FDA said it “has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices.”

The report notes that in 7/2011, the Institute of Medicine concluded that the 510(k) was not intended to evaluate the safety and effectiveness of medical devices and said a move away from that clearance process should happen as soon as reasonably possible. “More than a decade later,” it says, “that hasn’t happened, even amid mounting controversy over the clearance of hundreds of devices that employ artificial intelligence.”

The agency clears about 3,000 low- to moderate-risk devices through the 510(k) pathway each year, KFF says, compared with about 30 approvals a year through the stricter PMA premarket approval process.

National Center for Health Research president Diana Zuckerman told KFF that many doctors don’t realize that devices cleared for sale typically have not undergone clinical tests to establish their safety. “Doctors are shocked to learn this,” she said. “Patients aren’t going to know it when their doctors don’t.”

Asked by Health News for comment, FDA said it “continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices.”

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