The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which leave doctors and medical sleuths in the dark.
Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.
Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.
Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.
“I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.
The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows. Since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.
Deaths must still be reported in MAUDE. But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries. They have included surgical staplers, balloon pumps snaked into vessels to improve circulation and mechanical breathing machines.