WASHINGTON – A massive recall of millions of sleep apnea machines has caused anger and frustration among patients, and US officials are weighing unprecedented legal action to accelerate efforts to replace them. That is expected to last next year.
Manufacturer Philips warned in June 2021 that the silencer foam in pressurized ventilators could break down over time, leaving users potentially inhaling tiny black particles or toxic chemicals while they sleep. , manufacturer Philips warned in June 2021.
Philips initially estimated that the appliances could be repaired or replaced within a year. But with the recall extended to over 5 million devices worldwideThe Dutch company now says the effort will last until 2023.
That leaves many patients with a choice between using a potentially harmful device or trying risky remedies, including removing the foam themselves, buying a second hand machine online, or simply going. no therapy.
These devices are called continuous positive pressure ventilators, or CPAPs. They force air through the mask to keep passageways clear during sleep.
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Untreated sleep apnea can cause people to stop breathing hundreds of times a night, leading to dangerous sleepiness and an increased risk of heart attack. This problem is more common in men than in women, with an estimated 10% to 30% of adults affected.
Most patients are better off using the recalled device, the doctors said, because the risk of untreated sleep apnea still outweighs the potential harm of the decomposing foam. But doctors have had a hard time helping patients find new machines, which often cost between $500 and $1,000, and have been in short supply due to supply chain problems.
“What happened was the company just said, ‘Speak to your doctor.’ But doctors can’t build new machines,” said Dr. John Saito, a respiratory specialist near Los Angeles.
Risks from foam include headaches, asthma, allergic reactions and carcinogenic effects on internal organs, according to the report. Food and Drug Administration. The recalled devices include Dreamstation and SystemOne CPAP models and several other Philips machines, including Trilogy ventilators.
Last March, the FDA took a rare step order Philips to expand its communication efforts, to include “more clear information about the health risks of its products.” Regulators estimate that only half of affected US consumers have signed up with the company.
The agency has not issued such an order in decades.
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In a statement, Philips said continued testing of the recalled devices was “encouraging” and showed low levels of particles and chemical by-products emitted by its flagship brand of machines. . Philips said its initial communication about the dangers posed by foam was “a worst-case scenario for possible health risks”. The company notes that deterioration is exacerbated by unauthorized cleaning methods.
The FDA has received more than 70,000 reports of device-related problems, including pneumonia, infections, headaches, and cancer. Such reports have not been independently verified and cannot prove a cause-and-effect link. They can be filed by manufacturers, patients, doctors or attorneys.
Jeffrey Reed, of Marysville, Ohio, had been using his Philips machine for about a year when he started seeing dark spots in the tube and mask. His equipment supplier said the debris was caused by improper cleaning so he continued to use it.
Over the next seven years, Reed says he developed persistent sinus infections, including two episodes of pneumonia, that didn’t resolve with antibiotics. After hearing about the recall, he suspected the foam particles might be playing a role.
Reed, 62, who got his hands on a competitor’s device after a few months, said: “When I left their machine, it all became clear. Like other users, Reed could not clearly prove his problem was caused by the Philips device.
More than 340 personal injury lawsuits against Philips have been aggregated in a Pennsylvania federal court, and thousands more are expected in the coming months. Reed is not part of the lawsuit.
Like the vast majority of US CPAP users, Reed gets his equipment through a medical device supplier contracted by his insurance company. The company went out of business prior to the recall and he never heard from them about a replacement.
Even under normal circumstances, those companies typically don’t follow up patients long-term.
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“After a few years, you are just forgotten in the system,” said Ismael Cordero, a biomedical engineer and CPAP user. “I stopped listening to my supplier about three years after I received my machine.”
Cordero learned that his Philips device had been recalled through his work at ECRI, a non-profit organization that evaluates the safety of medical devices.
In May, the FDA informed Philips that it was reviewing a second order that will force the company to improve and accelerate its repair and replacement program.
Medical device companies often conduct recalls voluntarily, and former FDA officials say the agency has never actually used its authority to force additional steps.
“FDA shares the frustration of patients awaiting a resolution to this recall,” the agency said in a statement. Philips has yet to provide “all of the information we require to assess the risks from the chemicals released from the foam”.
Earlier this year, Philips revealed that it had received a Justice Department subpoena for the recall. The agency has not commented publicly on the matter, according to federal regulations.
But one FDA inspection of Philips’ Pennsylvania offices discovered a series of red flags last fall, including emails showing the company was alerted to the problem six years before the recall. In an October 2015 email, a customer warned Philips that polyester polyurethane foam could degrade, according to the FDA.
Between 2016 and early 2021, the FDA discovered 14 cases where Philips was aware of the problem or was analyzing it internally. “No design changes, remedial actions, or field modifications were conducted,” FDA inspectors repeatedly noted.
In an email in May 2018, foam supplier William T. Burnett wrote to Philips in an email: “We do not recommend the use of polyester foam in such an environment. … It will eventually break down into a sticky powder,” according to an affidavit filed as part of the foam lawsuit.
Since the recall, Philips has used a new type of silicone foam to refurbish the machines.
But the FDA warned consumers last November that the new material failed a safety test. And regulators have asked the company to do more testing to clarify any health risks with both the new foam and the recalled material. Philips said Independent testing has not identified any safety issues.
The company says it has replaced or repaired about 69% of the recalled devices globally and aims to ship 90% of the requested devices by the end of the year. On average, the company produces about 1 million sleep aids annually.
“We have scaled up by more than a factor of three, but it certainly still takes time to repair 5.5 million devices globally,” the company said. About half in the US
Jeffrey Reed is among those still waiting.
Reed registered the replacement device in June 2021 – within a week of the recall. This month, he received an email from Philips stating that his appliance was discontinued and not available for immediate replacement. Instead, the company offers him $50 to return the machine or the option to provide additional information to get a newer one.
“They had to wait until October to tell me my device was too old, when they had known exactly what my device was from the day I signed up – that was frustrating,” says Reed. “It’s disappointing that a life-saving equipment supplier treats people like this.”
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