The Food and drug Administration 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, reported KHN writer Christina Jewett.
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. An FDA official told KHN that the program is for issues that are “well-known and well-documented with the FDA” and that it was reformed in 2017 as a new voluntary summary reporting program was put in place for up to 5,600 devices. Yet the program, in all its iterations, has been so obscure that it is unknown to many of the doctors and engineers dedicated to improving device safety, wrote Jewett. Even a former FDA commissioner said he knew nothing of the program.
After months of questions to the FDA, the agency confirmed the existence of reporting-exemption programs and thousands of never-before-acknowledged instances of malfunctions or harm.
Amid the blackout in information about device risks, patients have been injured, hundreds of times in some cases, lawsuits and FDA records show.
The FDA has also opened additional — and equally obscure — pathways for device makers to report thousands of injuries brought to light by lawsuits or even deaths that appear in private registries that medical societies use to track patients. Those exemptions apply to risky and controversial products, including pelvic mesh and devices implanted in the heart.
FDA spokeswoman Deborah Kotz confirmed that the “registry exemption” was created without any public notice or regulations.
