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 reports of deaths reportedly associated with the products.
The Food and Drug Administration 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.
“You’d hope that if there’s a problem, it wouldn’t take you a decade and 90,000 [adverse event] reports and 200-plus deaths to figure it out,” said Vinay Rathi, chief resident in otolaryngology at Mass Eye and Ear, Brigham and Women’s, Massachusetts General Hospital and co-author of an editorial about the recall in JAMA Internal Medicine.
As problems mounted, the FDA conducted inspections of Philips facilities and investigations into how it responded as problems emerged with its ventilators and CPAP and BPAP machines, which are widely used to help people with sleep apnea keep breathing throughout the night but also are used by people with neuromuscular and degenerative diseases, including children. The agency’s findings describe a company that both refused to admit there was a problem with its devices and failed to swiftly and clearly communicate with consumers once the issues with the foam became impossible to ignore.
Philips did not respond to a request for comment on the recall or the progress of its replacement efforts.
FDA documents show that by 2015, Philips had gotten enough customer complaints to know several of its CPAP and BPAP ventilators had problems with the foam used to soundproof the machines. The foam seemed to be degrading, and patients were inhaling it — and carcinogenic compounds emanating from the foam — as they slept, leading to chest pressure, sinus problems, and deeper concerns about the exposure to potentially cancer-causing chemicals.
According to FDA documents, Philips contacted its foam supplier in 2015 and asked about the potential for the foam to degrade after getting customer complaints about this problem. Philips learned then that high temperatures and humidity could lead the foam to break down “in as little time as a year,” the FDA found — but the agency concluded that there was no evidence Philips acted on this information.
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 the JAMA Internal Medicine editorial. “And I think a game of regulatory telephone usually doesn’t have patients on the line.”
While the Philips recall notice suggested affected users could stop using their device or ask their physician about whether to continue using them, physicians were left to guess how much exposure would make the risks outweigh the benefits. Those challenges were only compounded by the strain they placed on pulmonologists, who were already burned out and short-staffed due to the Covid pandemic and the backlog of cases it created.
“Doctors and nurses were not given information on what to tell patients,” said Indira Gurubhagavatula, an attending physician in sleep medicine at the Hospital of the University of Pennsylvania. “What is the likelihood of someone getting sick? What should you be looking out for, or what is the timeline for a replacement?” The lack of clarity from Philips left physicians and nurses “holding the bag for what happens next.”
“Unfortunately, patients don’t deal with manufacturers. They deal with us,” said Gurubhagavatula.
Many patients, too, either hadn’t heard about the recall or remained unsure of what to do about it. Even after Philips issued its notice, the FDA was still getting a stream of complaints about the machines. “Patients and consumers are frustrated due to the slow progress of the recall, and have resorted to frequently contacting FDA for answers and requesting that the Agency take action,” said a FDA document.
To probe how well Philips had communicated, the FDA contacted 182 suppliers of Philips devices and asked whether they were aware of the recall — and found 28 weren’t.
These results led the FDA in March 2022 to wield what’s known as a section 518(a) order — a harsh mechanism the FDA hasn’t used for over 25 years — that required Philips to notify all health professionals, vendors, and device users of the recall within 45 days. And in May, the agency took the highly unusual step of threatening to also require Philips to replace, repair, or refund users for the recalled machines under a section 518(b) order. Experts said they have rarely, if ever, seen the FDA take such a step, though the agency has not actually issued such an order yet.
George Ball, an associate professor at Indiana University studying medical device recalls, said that the fact that the FDA has used such strong tactics is not just about the product failure — it’s that “Phillips messed up their relationship with the FDA, and they are suffering for it.”
“If I was an executive running a medical device company, and I wasn’t at Phillips, I would see this, and I would kind of meet with my team, and I’d be like, ‘OK. This is what we want to avoid. This is why we work with the FDA. This is why we do what they say, because we don’t want this kind of attention.’”
The FDA, experts said, doesn’t have enough manpower to monitor post-approval device performance of every single product themselves, which is why it must trust companies to keep tabs on emerging issues. But the statistics before and after the recall make clear that Philips policing its own products didn’t cut it: 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.”
Rathi and Kadakia cautioned that because the reports are user-submitted and aren’t verified, it’s not possible to directly attribute the deaths to the machines with the information currently available. But the surge in cases, they said, might also have come from consumers finally being able to connect their symptoms to the machines, which would have happened years earlier if not for Philips delaying the recall announcement.
“There are patients who for years have had this feeling that, ‘This makes me sick, but I know I have to wear it because otherwise I could die,’” said Gurubhagavatula. “They did everything right, yet every time they put the machine on, they would have headaches and congestion and a sense of being unwell. And then those same patients later told me, ‘When I heard about the recall, it finally made sense. So I went off the CPAP for a few days and all of my symptoms cleared up.’”
“I think that had to be distressing, to keep saying that ‘the machine was making me sick,’ but nobody putting two and two together and validating the patient’s concerns,” Gurubhagavatula added.
For patients, the entire process has proved harmful at worst, and a huge headache at best. 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. Richard Benedict, an energy consultant from Rio Rancho, N.M., originally opted to replace his older model Philips CPAP machine, but was later told that because his device was more than five years old — meaning he was eligible for his insurance to pay for a replacement — his only recourse with Philips was a $50 check. Benedict had already gone through the approximately five-month-long process of getting a referral, a new sleep test, a prescription, and a new machine from a Philips competitor once he realized his replacement machine was not coming, but the amount of times he’s called Philips’ 800 number trying to figure out when he’s going to get his $50 check for his returned machine, he said, was “the last straw.”
“I think we’re past the point of figuring out who’s wrong.”
Indira Gurubhagavatula, physician
“I can’t believe that the FDA lets them get away with this where they just string people along,” he said, “Even when I’ve given up and said, ‘OK, I’ll go get my own machine and I’ll return the other one,’ they’re still stringing me along just to, I guess, so they don’t have to pay up to $50 too quick, like they keep the money in the bank or something — I don’t know.”
In response to questions about the threat of a 518(b) order, which would require Philips to speed up its remediation process, the FDA told STAT that it shares frustrations expressed by patients who are awaiting a resolution for this recall. Philips did not request a hearing but instead submitted a written response to the FDA’s notice. “The FDA has been reviewing the company’s response and interacting with the firm,” a spokesperson for the FDA said. “We will continue to take steps until the company adequately mitigates the risk to patients.”
Experts said the time for finger-pointing has passed — the primary concern now is to take care of patients. “I think we’re past the point of figuring out who’s wrong,” said Gurubhagavatula. “It’s just right now, how do we make it right? And I think all of us have a role to play.”