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Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could potentially degrade and get into the airways. Methane Gas Ch4 Detector
Fast forward a year and a half, and Philips is still effectively out of the respiratory devices market as it works to repair the devices. FDA presently has 90,000 reports of problems — including 260 mentioning deaths.
Philips CEO Roy Jakobs has said the Dutch medtech giant is deeply sorry about the recall.
Meanwhile, competitor ResMed has struggled amid supply chain challenges to fill the resulting CPAP shortage. ResMed CEO Mick Farrell said this week that patients in some parts of the world have to wait up to 12 weeks to receive a CPAP after a sleep apnea diagnosis.
“There’s still excess patient demand, and we see that as a humanitarian emergency,” Farrell said.
Philips remains in the midst of consent decree talks with the U.S. Department of Justice and the FDA.
Here is a timeline — pulled from MassDevice archives — of how the Philips Respironics recall has unfolded:
The FDA says Philips during this time period only had 30 medical device reports (MDRs) filed associated with the PE-PUR foam degradation in respiratory devices. Only eight reports were from the U.S., with no reports of injury or death.
Philips’ first recall notification involved specific Philips bi-level positive airway pressure (bi-level PAP), continuous positive airway pressure (CPAP) and mechanical ventilator devices due to potential risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in the devices, according to MassDevice’s reporting.
Philips said the majority of the affected devices within the advised five-year service life were in the first-generation DreamStation product family. The complaint rate registered at 0.03% in 2020, Philips said.
Philips said it determined through testing that there are possible risks to users related to the PE-PUR sound abatement foam component, including the possibility of the foam degrading into particles that may enter the device’s air pathway and be ingested by the user. Additionally, it said the foam might off-gas certain chemicals. Its degradation might be exacerbated by unapproved cleaning methods such as ozone, as well as high heat and humidity environments.
Class I recalls are the most serious kind, defined by FDA as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
“As a consequence of the prioritization of the repair or replace actions, we are currently not taking new orders for sleep therapy systems while masks and other consumables, of course, continue to be sold,” then-CEO Frans van Houten said during an earnings call. He said at the time that it would take 12 months after regulatory approval to address problems with all the devices.
Philips remains out of the market.
FDA announced another serious recall involving Philips respiratory devices. The recall — which Philips Respironics announced in an “Urgent Field Safety Notice” letter on June 18 — involved thousands of V60 Plus ventilators and all V60 ventilators upgraded to enable high flow therapy (software version 3.00 and 3.10). If the oxygen flow was partially blocked for any reason, the system would go on providing the patient with lower oxygen flow rate — issuing a low-priority alarm.
An FDA Form 483, produced after inspections of Philips Respironics’ Murrysville, Pennsylvania facility, says Philips and its foam supplier were aware for years that polyester-based polyurethane (PE-PUR) sound abatement foam could break down and potentially enter a device’s air pathway.
The FDA designated more Philips recalls as Class I. The recalls involved all models of the Philips Respironics V60 ventilator, the V60 Plus ventilator and the V680 ventilator (distributed outside the U.S.). For all three ventilators, the problem involved an internal electrical circuit within the devices, with the potential for ventilators to stop operating.
At this point, the FDA says it had more than 21,000 medical device reports (MDRs) filed that reported sound-abatement-foam-related problems. The agency said 126 of the reports mentioned deaths. (It’s important to note that FDA’s Medical Device Reporting (MDR) system is a passive system with limitations.)
The FDA proposed an order requiring Philips to submit a plan for its recalled respiratory devices.
Philips said only a small portion of returned respiratory devices displayed the sound abatement foam degradation.
During an earnings call, van Houten broke the news that the U.S. Department of Justice, acting on behalf of FDA, had provided a proposed consent decree on July 18. The proposed consent decree came after the inspection of U.S. Philips Respironics facilities in 2021. Van Houten said talks with the DOJ were in the early stages.
The FDA said it had a total 69,000 medical device reports (MDRs) filed related to the sound abatement foam recall, with 168 mentioning deaths.
The U.S. Department of Justice alleged that Philips RS North America (formerly Respironics) misled federal healthcare programs by paying kickbacks to durable medical equipment (DME) suppliers. On top of the $24.8 million settlement, there had been an agreement earlier in the week to pay $4.2 million to resolve claims that Philips substituted the components of its Intellivue MP2 mobile patient monitoring device that it sold to military purchasers without rectifying the device for military airworthiness. Philips remained in separate talks with federal prosecutors over its handling of the respiratory devices recall.
The company’s Respironics subsidiary alerted users of CPAP or BiPAP therapy masks with magnetic headgear clips or straps that could negatively interact with implantable, metallic medical devices. Philips said it had distributed more than 17 million masks containing the magnetic clips. It had 14 reports suggesting that the masks may have impacted implanted devices.
Reuters reported that French prosecutors had opened a preliminary investigation into the recall.
The new recall involved 386 ventilators distributed from Aug. 6, 2020, to Sept. 1, 2021. The BiPAP machines might contain plastic in their motors that could release volatile organic compounds (VOCs). On top of the risk of users inhaling dangerous VOCs, the plastic could also cause device failure.
Roy Jakobs succeeded Frans van Houten, who had been CEO for more than 11 years. Jakobs joined Philips in 2010 and moved up over the years to become the company’s Connected Care chief business leader. He’s been a go-to person in the company to manage crises. He took a lead on Philips’ COVID-19 pandemic response in early 2020. Then, he took over the handling of the Philips Respironics recall in June 2021.
Jakobs said the Dutch medtech giant is taking steps to realign itself with its “people-centered” ideology. “Delivering on this is what matters most, and that will require us to double down on what we do best, continuing to innovate, but also urgently fixing things where we have disappointed patients and customers. This will, of course, also help to restore our financial health.”
Philips said it would cut its workforce by roughly 4,000 roles globally — representing about 5% of the headcount listed in its most recent annual report. Jakobs said the company’s immediate priority was to “improve execution so that we can start rebuilding the trust of patients, consumers and customers, as well as shareholders and our other stakeholders.”
The FDA said Philips had informed it that reworked Philips Respironics Trilogy ventilators had two new potential issues. Philips soon followed up with a news release that said the Trilogy 100/200 ventilators with potential additional problems make up roughly 3% of the 5.5 million respiratory devices in the original recall. (That comes to roughly 165,000 devices.)
The FDA issued an update that reports of sound-abatement-foam-related problems had grown to 90,000, including 260 mentioning deaths.
Philips released results from tests on health risks related to its recalled DreamStation sleep therapy devices. Philips’ testing showed that, among other things, exposure to certain emissions from the recalled devices is “unlikely to result in appreciable harm to health in patients,” according to the company.
Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Respiratory Tagged With: CPAP, Philips, Philips Respironics
Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at firstname.lastname@example.org.
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