FDA may be letting medical device makers fudge safety reports, study finds

fdanulogo-300x126The federal Food and Drug Administration may be putting patients’ safety at serious risk by allowing medical device makers to self-police their products, notably in making crucial determinations in reporting to the agency the severity of harms the devices inflict.

Using artificial intelligence techniques to scan a sampling of filings made by makers to the FDA over nine years, Christina Lalani, MD, of the University of California San Francisco, and colleagues found that just under a quarter of the documents mis-categorized cases in which medical devices were tied to patient fatalities.

These were not reported as deaths in an important FDA information source known as MAUDE (the Manufacturer and User Facility Device Experience database). Instead, they were “classified as either malfunction, injury, or missing (the report was not put in any category),” reported the medical site MedPage Today.

Investigators detected the misclassifications using “a natural language processing algorithm” and researchers’ subsequent manual review to search in a slice of MAUDE filings, hunting for “at least 1 term that suggested a patient death, such as patient died or patient expired,” they reported in their study, published online on the Journal of the American Medical Association site.

Accuracy of reports is crucial

The researchers reported finding a disturbing number of faulty reports. This is not a bureaucratic abstraction. It can have important consequences for patients. That’s because MAUDE is a way that regulators and the medical community detect and react to serious and even fatal problems with medical devices.

The FDA is supposed to respond aggressively to reports that devices that may be causing deaths, of course, as MedPage Today and the study’s authors emphasized.

“’The classification chosen by the reporter is vital, as the FDA must review all adverse events reported as deaths, which is not the case for other reporting categories,’ the authors wrote. Improving the accuracy of these reports is crucial, since the frequency of patient deaths is what can prompt the FDA to pursue investigations into the device’s safety…”

As MedPage Today also reported:

“The physicians and manufacturers who report adverse events with medical devices must choose whether to classify the event as a malfunction, injury, death, or ‘other.’ Per FDA instructions, the reporter is required to categorize an adverse event as an official death if the cause of death is unknown, or if the device ‘may have caused or contributed to a death.’ In the current analysis, about 56% of reports involving patient deaths were for class III devices — the highest-risk medical devices — and 40.1% were for class II devices, Lalani and team wrote.”

The investigators found that three medical products were most involved in misclassified reporting, including products used in dialysis and devices used in heart bypass and permanent mechanical contraception (transcervical contraceptive tubal occlusion devices).

The researchers said they had not made an exhaustive search of MAUDE filings, checking for problem reporting. But they raised a vital process concern with the FDA allowing makers to classify the severity of issues with their products and classify the concerns as they do, MedPage Today reported, quoting the authors, thusly:

“’It may not be in [makers] interest to facilitate identification of serious problems with their own devices in a timely manner,’ they wrote. ‘There have been multiple instances of delays by manufacturers in reporting serious malfunctions and deaths that were associated with medical devices, as well as complete failures to report. Therefore, it’s likely that a significant number of patients have been unknowingly treated with devices that were later revealed to be dangerous, Lalani and colleagues noted. For example, they referenced the reporting failures that occurred from 2002 to 2013, when 32,000 women reported adverse events associated with the permanent birth control device Essure; the FDA, however, only received 1,023 adverse event reports from the manufacturer during that 11-year period.”

The independent, nonpartisan Kaiser Health News service shocked the FDA itself and the medical device  industry in 2019 by investigating and finding that agency bureaucrats had allowed makers to hide more than 1 million records on problem products in a hidden database beyond MAUDE. KHN also found that regulators let makers disguise the severity of problems with products by scooping up multiple complaints and stashing them in a single reporting file with the FDA.

Lalani and colleagues said the agency needs to reform its procedures to get manufacturers out of their potentially central role now in reporting device issues, concluding:

“[P]hysicians, hospitals, and patients should submit reports directly to the FDA instead of or in addition to reporting through the manufacturer.”

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.

Jeanne Lenzer, a seasoned medical investigative reporter, has found that 32 million Americans — about one in 10 of us — have at least one medical device implanted in our bodies. These include artificial joints, cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices. Most patients — indeed most of the public — may think federal regulators subject all this hardware to rigorous quality and safety testing.

That’s a wrong assumption. And though medical devices may be helping change and save many lives, Lenzer also warns they are harming and even killing too many patients. Under pressure from pro-business, anti-regulatory politicians and lawmakers, federal regulators have allowed a “Wild, Wild West” to flourish in the medical device business, she has argued.

Appointment overdue of an FDA chief

Sure, President Biden has had his hands full since he took office dealing alone with coronavirus pandemic and its major, related harms. But, as he would say, “C’mon, Joe!” it is past time to jump on the big and daily obvious problems with the FDA, notably by appointing a fulltime head of the powerful agency.

It is unacceptable that the agency cozies up with medical device makers and lets them game important systems to protect patients.

It is worrisome that regulators — already having gotten caught for months flat-footed and worse, in the fast-moving mess involving young people and electronic cigarettes and risky vaping — may not be as on top of new social media trends and emerging tobacco products to protect the public from nicotine abuse and novel gateways to a leading and preventable cause of cancer: cigarette smoking.

And, of course, there is a growing, expert outcry over the FDA’s seeming slow-walk of actions now on the coronavirus vaccines. Critics have assailed the agency, asking why the shots — administered to tens of millions around the globe and with rare side-effects — have not been fully approved, instead of allowed on an emergency basis.

We’ve got a lot of work to do to ensure the FDA serves the public as it must do — not profit-hungry Big Pharma and medical device makers.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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