More than a year after the start of a recall now involving more than 5 million respirators, doctors and patients are still feeling the effects as manufacturer Philips continues to remedy the machines and stands up to scrutiny federal agencies.
The recall by subsidiary Philips Respironics affected certain mechanical continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) devices and ventilators, primarily due to potential health risks associated with sound-absorbing polyurethane-based foam. of polyester (PE-PUR) which was used. in gear.
Philips said at the time of the recall that the foam could break down into particles that could enter the airway of the device and be ingested by the user, and could off-gas certain chemicals. .
The issues, the company said at the time, could result in serious, life-threatening injuries, permanent impairment and/or requiring medical intervention. Potential health risks from exposure to particles or chemicals range from irritation to toxic and carcinogenic effects, the company said.
Although the recall initially involved between 3 and 4 million machines, that number has since risen to 5.5 million, according to the company.
Recalling such a mass of critical devices posed several challenges. Philips still has work to do on an extensive repair and replacement program, and federal agencies have continued to monitor the company’s progress and communications. On top of that, Philips agreed to pay $24 million to settle the bribery allegations that were being investigated by the US Department of Justice (DOJ). These allegations were unrelated to the recall and were initially made by a whistleblower employee. (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 machines.
“This has had a very broad set of impacts on the practice of sleep medicine and, more importantly, on patients,” said Shannon Sullivan, MD, a pediatric sleep medicine specialist in California and chair of the committee. Public Safety from the American Academy of Sleep Medicine. “There have been over 5 million devices recalled worldwide. Many, many, many of our patients use these types of devices.”
“We have patients who are still waiting,” Sullivan said. MedPage today. “So that’s a big deal. What do you do with these patients?”
What went wrong?
Philips announced the initial recall in June 2021, regarding PE-PUR foam issues with certain CPAP and BiPAP machines and ventilators. Over the next year and a half, the FDA announced a handful of other recalls of Philips devices due to issues with broadband therapy software, expired adhesive, power fluctuations, broken parts, plastic and mask magnets.
In an inspection report released by the FDA in November 2021, the agency said it found that Philips was aware of potential issues with the foam used in certain respirators prior to the June 2021 recall. The report said executives were aware of the 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 early as 2016, he concluded.
The FDA said MedPage today it has received over 69,000 medical device reports (MDRs) – including 168 fatality reports – associated with PE-PUR foam failure or suspected foam failure since April 2021.
From April 2021 to April 2022, the FDA received more than 21,000 MDRs — including 124 death reports — associated with PE-PUR foam failure or suspected foam failure, an FDA spokesperson said. agency. And from May 1 to July 31 of this year, the FDA received more than 48,000 MDRs, including 44 death reports.
“FDA’s thorough review and analysis of these new MDRs will include consideration of possible reasons for the increased number of reports during this time,” the spokesperson said, noting that the agency has received both mandatory reports from Philips and voluntary reports from healthcare 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 investigate 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 this recall, Philips “relyed on a limited initial data set and toxicological risk assessment, and assumed a worst-case scenario for possible health risks out of an abundance of caution”.
Since then, the company, in conjunction with independent testing laboratories and third-party experts, has continued to perform testing and research on PE-PUR foam to “better assess and determine potential health risks to patients.” related to a possible emission of particles from degraded products. foam and volatile organic compounds (VOCs),” the spokesperson added.
The spokesperson pointed to a summary, recently published by the company, of a systematic review of the literature on the use of positive pressure devices and the risk of cancer, which finds no link between the two. He further said that two studies showed no statistical difference in cancer risk between patients with obstructive sleep apnea 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 “still reverberate a lot, and it’s created a backlog.”
The backlog affected patients with new sleep disorder diagnoses and those with an old device that failed, she said. In any case, a patient can wait a long time for a machine that he needs.
Sullivan also pointed to potential ongoing challenges for sleep labs that require breathing devices to diagnose patients with sleep disorders, as well as hospitals in terms of being able to discharge patients who need the devices sent home. safely. Additionally, she says, there are some sleep-disordered patients whose jobs — for example, long-distance trucking — make their reliance on devices inherently important for resting and staying alert at work.
During the pandemic, production has indeed been ramped up for positive airway pressure devices, including by other established vendors and those entering the market, Sullivan noted. However, a problem for clinicians is that not all CPAP or BiPAP machines have the same features.
Clinicians want to be sure a device has the comfort and data-reporting features expected for a patient adopting a new therapy for a chronic condition, she said. When a payer covers a device, the patient will use it for several years before being eligible for another, she explained. Paying out of pocket for a new device can be very expensive and even prohibitive for patients – potentially $1,000 or more.
The Philips spokesperson said the company “regrets[s] the concern that the June 2021 recall notification for specific CPAP, BiPAP and mechanical ventilation devices may have caused patients and healthcare providers, and we apologize for this. »
“This is one of the biggest field actions in the medtech industry, and we take remediation very seriously,” he added.
The spokesperson said a team of more than 1,000 people are “working very hard to get patients resolved as quickly as possible,” adding that in an average year, the company produces and distributes approximately 1 million sleep devices. “Meanwhile, despite the current global supply chain challenges, we have tripled, but inevitably it still takes time to remedy 5.5 million devices globally.”
Specifically, the spokesperson said Philips Respironics has produced more than 3.3 million replacement devices and repair kits, and 1.65 million units have been shipped to the United States.
“Philips Respironics expects to complete approximately 90% of production and customer deliveries 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 repairs, 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. These could range from positional therapy to surgery.
Sullivan noted that she had a patient who had been waiting for a BiPAP device since April.
“It’s been a long journey for some of our patients,” she said.
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