By Emma Yasinski
Earlier this year, a Kaiser Health News (KHN) investigation found millions of reports of faulty medical devices in an obscure FDA database. Among them were 2.1 million filings related to bad dental implants.
After medical devices—including dental implants—are approved for use, their manufacturer must continue to report any malfunctions to the FDA; the agency normally catalogs these malfunctions in a public database called Manufacturer and Use Facility Device Experience (MAUDE). Along with flagging problematic products, this can help patients and practitioners make educated decisions about risk in certain procedures.
But KHN found that millions of device malfunctions don’t make it into the public database. Instead, the FDA allows them to file these reports in a “secret” database, invisible to doctors, dentists, and the general public.
About 20 years ago, the FDA started a program that allowed certain manufacturers to submit summary spreadsheets to the hidden database regularly. The idea, according to the FDA, was to enable the FDA employees reviewing the reports—of whom there were very few—to do so more efficiently, identifying new problems or trends instead of pouring over thousands of reports of the same known malfunction.
The consequence is that healthcare providers and patients are using devices, from pacemakers to surgical staples to dental implants, without knowing the associated risks.
“A lot of people have gone out and gotten these and probably don’t know about these risks,” Madris Tomes, a former FDA manager, told Kaiser Health News. The investigation included stories from patients who suffered from comas, disabilities, and even death after surgical staplers and pacemakers malfunctioned.
Manufacturers of more than 5,000 devices successfully applied for “exemption” from the usual reporting guidelines, asking permission to report through this alternative portal. Most experts and even a former FDA manager were unaware of the database, according to the investigation.
The FDA says the database is shutting down, and there weren’t many malfunctions recorded in it after the end of 2017, but KHN has been slowly receiving all the reports in the system as a result of their Freedom of Information Act Request. One of the big takeaways so far, the organization reported, is that there were 2.1 million reports regarding malfunctioning dental implants. More than 100,000 of those reports came in last year, as dental implants were some of the last devices to forfeit the option to report these flaws outside of MAUDE.
Even with the program ending, there will be other ways for device manufacturers to avoid MAUDE. The organization opened a new Voluntary Summary Reporting program in 2017, for which more than 5,000 devices are eligible. If a company reports a summary of 100 malfunctions, it will show up in MAUDE as if it were only one reported incident.
“The FDA is basically giving away its authority over device manufacturers,” said Tomes. “If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.”
Author: Contributing writer Emma Yasinski received her Master’s of Science (MS) in science and medical journalism from Boston University. Her articles have also appeared at TheAtlantic.com, Kaiser Health News, NPR Shots, and Genetic Engineering and Biotechnology News.
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