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More than a year after now involving more than 5 million breathing devices, doctors and patients are still feeling the effects as manufacturer Philips continues to remediate machines and weathers scrutiny from federal agencies.

The recall by subsidiary Philips Respironics has affected certain continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines and mechanical ventilators mainly from polyester-based polyurethane (PE-PUR) sound abatement foam that was used in the machines.

Philips said at the time of the recall that the foam could degrade into particles that could enter the device's air pathway and be ingested by the user, and that it could off-gas certain chemicals.

The issues, the company said at the time, could result in serious injury that could be life-threatening, cause permanent impairment, and/or require medical intervention. Potential health risks of particulate or chemical exposure range from irritation to toxic and carcinogenic effects, the company said.

Though the recall , that number has since grown to 5.5 million, according to the company.

Recalling such a mass of critical devices has posed several challenges. Philips still has work to do on a sprawling repair and replacement program, and federal agencies have continued to monitor the company's progress and communications. On top of that, Philips has agreed to pay $24 million to settle that were being investigated by the U.S. Department of Justice (DOJ). Those allegations were unrelated to the recall and were . (See this related story on Philips' run-ins with the DOJ.)

All the while, doctors and patients remain concerned about an ongoing backlog of breathing devices.

"It's had a very wide-ranging set of impacts on sleep medicine practice, and more importantly, for patients," said Shannon Sullivan, MD, a pediatric sleep medicine specialist in California and chair of the American Academy of Sleep Medicine's public safety committee. "There were more than 5 million devices recalled worldwide. Many, many, many of our patients use these types of devices."

"We have patients who are still waiting," Sullivan told MedPage Today. "So, that's a big problem. What do you do with these patients?"

What Went Wrong?

Philips announced the , regarding the PE-PUR foam issues with certain CPAP and BiPAP machines and ventilators. Over the course of the next year-and-a-half, the FDA announced a handful of other recalls of Philips devices due to problems with , , , , and .

In an released by the FDA in November 2021, the agency said it found Philips had been aware of potential issues with the foam used in certain breathing devices prior to the June 2021 recall. The report said executives had been aware of potential foam degradation issues with the machines since at least January 31, 2020. Indeed, field reports and complaints had prompted testing of the foam material as far back as 2016, it concluded.

The FDA told MedPage Today it has received more than 69,000 medical device reports (MDRs) -- including 168 reports of death -- associated with the PE-PUR foam breakdown or suspected foam breakdown since April 2021.

From April 2021 through April 2022, the FDA received more than 21,000 MDRs -- including 124 reports of death -- associated with the PE-PUR foam breakdown or suspected foam breakdown, an agency spokesperson said. And from May 1 through July 31 of this year, the FDA received more than 48,000 MDRs, including 44 reports of death.

"The FDA's in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports during this time," the spokesperson said, noting that the agency received both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients.

The spokesperson said a "wide range of injuries" are reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea, dizziness, nodules, and chest pain.

Philips is continuing to examine the issue that led to the June 2021 recall in the first place. A company spokesperson said in an email to MedPage Today that at the time of that recall, Philips "relied on an initial, limited data set and toxicological risk assessment, and assumed a worst-case scenario for the possible health risks out of an abundance of caution."

Since that time, the company, along with independent testing laboratories and third-party experts, has continued to conduct testing and research on the PE-PUR foam to "better assess and scope the potential patient health risks related to possible emission of particulates from degraded foam and volatile organic compounds (VOCs)," the spokesperson added.

The spokesperson pointed to a , recently published by the company, of a systematic literature review of positive airway pressure device use and cancer risk, that finds no link between the two. It further stated that two studies showed no statistical difference in cancer risk between obstructive sleep apnea patients who used Philips Respironics PAP devices and those who used machines from other brands.

A Waiting Game

In the meantime, Sullivan said the effects of the recall "are still reverberating very much, and it's created a backlog."

The backlog has affected patients with new diagnoses of sleep disorders and those with an old device that has broken down, she said. Either way, a patient may be waiting a long time for a needed machine.

Sullivan also pointed to potential ongoing challenges for sleep labs that require breathing machines to diagnose patients with sleep disorders, as well as hospitals in terms of their ability to discharge patients who require the machines to be safely sent home. Additionally, she said, there are certain sleep disorder patients whose line of work -- for example, long-haul trucking -- makes their reliance on devices inherently important for achieving rest and staying alert while on the job.

During the pandemic, production was indeed ramped up for positive airway pressure devices, including by other established suppliers and those entering the market, Sullivan noted. However, one problem for clinicians is that not all CPAP or BiPAP machines have the same features.

Clinicians want to make sure a device has the expected comfort and data reporting features for a patient adopting a new therapy for a chronic medical condition, she said. When a payer covers a device, the patient will use it for a number of years before they're eligible for another one, she explained. To pay out-of-pocket for a new device can be very expensive and even cost-prohibitive for patients -- potentially $1,000 or more.

The Philips spokesman said the company "regret[s] the concern that the June 2021 recall notification for specific CPAP, BiPAP and mechanical ventilator devices may have caused for patients and care providers, and we apologize for that."

"This is one of the largest field actions in the medical technology industry, and we take the remediation very seriously," he added.

The spokesperson said that a team of more than 1,000 individuals is "working very hard to get a resolution to patients as fast as possible," adding that in an average year the company produces and distributes about 1 million sleep devices. "In the meantime, despite ongoing global supply chain challenges, we have scaled up by a factor of three, but inevitably it still takes time to remediate 5.5 million devices globally."

Specifically, the spokesperson said that Philips Respironics has replacement devices and repair kits, and that 1.65 million units have been shipped to the U.S.

"Philips Respironics expects to complete around 90% of the production and shipments to customers in 2022," the spokesperson said.

But that means resolution is still months away for many doctors and patients.

Sullivan said she and her patients continue to wait for the remaining repair, replacement, and any outstanding backlog issues to be resolved.

In some cases, there may be other treatment options available if patients are waiting for devices, she said. Those could range from positional therapy to surgery.

Sullivan noted that she has one patient who has been waiting on a BiPAP device since April.

"It's been a long haul for some of our patients," she said.

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