While critics long have ripped the Food and Drug Administration for its weak oversight of medical devices and its too cozy relationships with their makers, the federal agency and a Dutch global conglomerate have given millions of U.S. consumers a big, infuriating, prolonged exposure to just how bungled the oversight of this industry can be.
As 2022 races to its close, the Wall Street Journal has reported on this costly, inconvenient, and unacceptable mess, as has the New York Times. And now, so has Stat, the science and medical news site, which wrote this about the “flaws in device oversight” as so many regular folks have experienced with the FDA, manufacturer Philips, and CPAP (continuous positive airway pressure) and BPAP or BiPAP (bilevel positive airway pressure) devices:
“The ongoing recall of millions of breathing devices made by Philips has been botched and belabored at nearly every turn: It took more than a decade after users first reported the soundproofing foam in their CPAP and BPAP machines breaking down for Philips to issue a recall. Even after the recall notice was issued, it failed to reach many patients, and many are still waiting on their promised replacement devices or refunds, some of which had to be recalled themselves. More than a year after the recall, the FDA has received more than 90,000 reports about problems with the devices, including 260 … deaths reportedly associated with the products. The [FDA] has pulled out all the stops — including regulatory orders not deployed in decades — to force Philips to contact users about the recall and replace the devices in a timely manner.
“But the troubled response, experts said, underscores a critical compromise that’s been made in medical device oversight: The FDA, without enough manpower to fully police the countless medical devices on the market, must rely on companies to self-report any problems that call into question the safety of their own devices. But as the Philips recall makes clear, that collaborative approach to oversight falls apart when companies don’t do their part. And ultimately, experts said, it’s patients who pay the price.”
News organizations have reported, based in part on increasing numbers of lawsuits filed against the company, that Philips got socked with rising numbers of complaints about its machines, commonly used in the treatment of sleep apnea and other night breathing disorders, back in 2015. As Stat reported:
“Philips ultimately recalled 20 different models of CPAP machines, BPAP machines, and ventilators in June 2021. But the recall process, too, has proven a disaster. Philips couldn’t contact people directly, as a car manufacturer would contact customers about recalled parts, because it doesn’t track individual device owners, instead selling most of the machines through third-party vendors. Many consumers instead heard about it from the companies they purchased the devices from, or from media reports. ‘There is a constant information lag when it comes to patient safety,’ said Kushal Kadakia, a medical student at Harvard and co-author of [a] JAMA Internal Medicine editorial [on this issue]. ‘And I think a game of regulatory telephone usually doesn’t have patients on the line.’”
Philips also has been forced to recall machines it tweaked as part of its original recall, Stat reported:
“In late November 2022, the FDA reported that the new foam that Philips used to refurbish recalled machines can detach from its backing and block the machine’s air inlet. ‘FDA has requested additional information from Philips to better understand the cause and scope of the issues, including how many devices are affected,’ the FDA said in a statement to STAT, adding that it will keep the public informed as more information becomes available. The botched refurbishment process has been yet another complication for patients who are still waiting for solutions.”
The New York Times reported that the U.S. Justice Department has stepped into the mess:
“Nearly a year and a half after the recall that involved more than five million devices worldwide, millions of American have endured a long wait for a device. Many have been forced to find alternative methods to ensure they can breathe at night without becoming deprived of oxygen or risking a heart attack. Others have been outraged by unexpected illness, suspicious that a device meant to help them actually caused harm. The U.S. Justice Department is now negotiating the terms of a consent decree with Philips, underscoring the deep concern about what the company knew — or should have known — before millions of people received devices that many believe caused devastating illnesses. A decree would likely require the company to document the steps it would take to prevent such a failure in the future.”
Consumers and the FDA both want more answers about the potential health harms posed by the Philips devices, and what the company knew, and when, Stat reported:
“Between 2011 and April 2021, Philips submitted 30 medical device reports associated with the foam breakdown. By contrast, the FDA documented over 69,000 reports of adverse events and 169 reported deaths between April 2021 and July 2022. Between August and October 2022 alone, there were another 21,000 reports of adverse events and an additional 91 deaths. ‘One could say it’s like the fox guarding the henhouse to have the company in charge of deciding whether an event should be reported to the FDA, and how to categorize it, whether it’s serious, whether it’s a malfunction, an injury,’ said Rita Redberg, a cardiologist at UCSF who also studies medical device regulation. She said it’s estimated that only 10% of events get reported, and her own research shows that deaths reported to companies have sometimes been wrongly recorded to the FDA system as ‘malfunctions’ or ‘injuries.’”
Not good. In my practice, I not only see the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by bankrupting and dangerous drugs as well as defective and dangerous products, notably of the medical kind. Patients also can see clear benefits by staying healthy and far away from the U.S. health care system. It is, according to research conducted in pre-coronavirus pandemic times, fraught with medical error, preventable hospital acquired illnesses and deaths, and misdiagnoses.
Still, when research and experience show that medical devices can be helpful, what choice do regular folks have but to fork over big sums to cover the too-often staggering costs of medical devices? When they do so, they deserve greater protection from their harms. With Philips taking what it estimates as a $1 billion hit to its bottom line and millions of aggrieved consumers clamoring for resolution to this mess — including by seeking justice in lawsuits in the civil system — isn’t it time for Congress to step up and in, too? Where are lawmakers exercising their oversight of the FDA, demanding explanations from the agency’s chief, and determining how to prevent long-running debacles like this from occurring again?
Sleep is a major part of healthful living, and we have much work to do to ensure that even this blessed, natural rest is safe, affordable, accessible, efficient, and excellent.