Bureaucrats let medical device makers hide 1 million reports of patient harms

Kaiserexempt-300x205If a surgical staple gun malfunctioned so seriously that it generated not a few dozen formal complaints but more than 10,000 reported incidents, shouldn’t patients, doctors, and hospitals have the right to know that information from the federal agency overseeing the safety of medical devices?

Apparently not. Or maybe not without a big kick in the pants from journalists.

Instead, the staff at the federal Food and Drug Administration turned a move to ease paperwork and bureaucracy into a giant and little-known system that lets medical device makers hide serious and significant numbers of reports about failures and flaws with at least 100 products, a Kaiser Health News Service investigation found.

As KHN’s Christina Jewett reported:

The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions… 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.

Critics have ripped the agency for granting by fiat “exemptions” from what are supposed to be rigorous laws to safeguard the public by forcing makers to fess up whenever they learn about problems with their products that cause patient injuries.

Madris Tomes, a former FDA manager who now runs Device Events, a website that makes FDA device data user-friendly, said the widespread excusing of makers from mandatory harm reporting means, “The FDA is basically giving away its authority over device manufacturers. If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.”

Reporter Jewett found that the agency two decades ago fretted that the two dozen or so staffers it had to accept, register, and review complaints about medical devices might get buried in paperwork. The FDA, instead, told makers they could seek a formal exemption, collecting incidents, summarizing them, and sending the agency a periodic summary of data. Though the original intent had been for robust FDA oversight to monitor, spot, and act on injuries and deaths caused by medical devices, the exemption program seemed to affect agency work little. Few makers sought exemptions.

But over time, the program and other agency-created reporting loopholes have exploded, even as they remained sufficiently secretive that former commissioners didn’t know about them, Jewett found, writing:

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.

Though Jewett details some of the other loopholes—which have been disclosed and include makers filing “placeholders,” a single report that may summarize dozens of damaging incidents—she details the human toll of the FDA’s bureaucratic boondoggle, describing patients injured and who died after malfunctions involving the surgical staple gun.

That device, often used in so-called key-hole or minimally invasive operations, was supposed to work much like its ordinary, household cousin might: It is meant to cut and seal tissues. Doctors, hospitals, and patients began to have their doubts about the gun quickly, as it misfired, damaging tissues and cutting into veins and arteries causing dangerous bleeding during operations.

The incidents seemed serious and frequent enough that doctors and medical researchers sought to write them up in medical journals, finding, however, that the FDA recorded only around 80 or so formal complaints. In reality, in the secretive, exempted files the agency had received more than 10,000 reports of stapler gun malfunctions.

The guns and staples have become the subject of lawsuits, asserting they injured or led to deaths of patients. Public FDA records show them implicated in 250 deaths since 2001. It also is clear the difference the exemption program made with the staples alone, with a large maker of them reporting 1,000 malfunctions or injuries in 2015 (before) versus 11,000 in 2018 (after).

The FDA has tried to downplay or dismiss outrage over its hidden records on medical device harms, arguing that changes it made in 2017 have dealt with the issue with a voluntary reporting program affecting 5,600 devices.

Still, the agency isn’t throwing open its safety complaint records, instead allowing the public and reporters access to them only by filing file Freedom of Information Act requests to get data and only after long delays.

The FDA, after Jewett’s story appeared, abruptly issued a warning letter about surgical staple guns and staples, saying these should be used with caution after the agency had “received over 41,000 individual medical device reports for surgical staplers and staples for internal use, including 366 deaths, over 9,000 serious injuries, and over 32,000 malfunctions.” The FDA promised to issue a further safety guidance on the devices’ use.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them and their loved ones by defective and dangerous products, notably medical devices. It is unacceptable that paper pushing FDA bureaucrats permitted profit-hungry medical device makers so many ways to circumvent important reporting about harms inflicted by products used on or implanted in millions of Americans.

Lawmakers should bring FDA Commissioner Scott Gottlieb before them in public hearings about this matter, though he has resigned and will be departing soon. The appropriate section chiefs at FDA should account for their actions, though.

Further, as patient safety advocates have been warning, Congress needs to step in and figure better the oversight of medical devices in this country, with an estimated market value of a half-trillion dollars by 2020. The field has become a “Wild, Wild West,” critics say, and Gottlieb’s recent efforts that he touted as a tightening of regulations are a sham.

Medical devices mostly were grandfathered in by the FDA, which gives them a light, once-over before clearing them for sale. In contrast with prescription medications, medical devices rarely are required to be tested on humans in rigorous clinical trials. Instead, too many get waved into markets via the agency’s so-called 510k process. Under this approach, makers point to an existing product, say theirs is similar enough, and off it goes to the public. It’s akin to seeing the movie-making tech in an original Mickey Mouse short as being as good as what appeared in the 2019, Oscar-winning “Spider Man: Into the Spider-verse.”

It’s not enough to shorten the time span for 510K product precedents, as Gottlieb suggested. We’ve heard enough from industry cheerleaders who have pushed Congress for awhile now that the FDA needs to lighten up even more on medical device makers to allow innovations, especially those rooted in technology, to race to and benefit the public. It may be past time, however, for lawmakers to heed patient safety advocates and to see the full data on the old-fashioned and painful ways that medical devices injure and kill too many Americans

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