Philips CPAP recall for foam particles drags on, angering sleep apnea patients : NPR

Jeffrey Reed, who suffered from persistent sinus infections and two bouts of pneumonia while using a Philips CPAP machine, poses with the device October 20 at his home in Marysville, Ohio.

Jay Laprete/AP

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Jay Laprete/AP

Jeffrey Reed, who suffered from persistent sinus infections and two bouts of pneumonia while using a Philips CPAP machine, poses with the device October 20 at his home in Marysville, Ohio.

Jay Laprete/AP

WASHINGTON — A mass recall of millions of sleep apnea devices has stoked patient anger and frustration, and U.S. officials are considering unprecedented legal action to expedite a replacement effort that is expected to stretch into next year .

Sound-absorbing foam in pressurized breathing apparatus can break down over time, leading users to potentially inhale tiny black particles or dangerous chemicals while they sleep, manufacturer Philips warned in June 2021.

Philips initially estimated that it could repair or replace the units within a year. But with the recall expanding to more than 5 million devices worldwide, the Dutch company now says the effort will stretch through 2023.

This has left many patients to choose between using a potentially harmful device or trying risky remedies, including removing the foam themselves, buying used machines online, or simply going without therapy.

The devices are called Continuous Positive Airway Pressure or CPAP machines. They force air through a mask to keep the passageways open during sleep.

Untreated sleep apnea can cause people to stop breathing hundreds of times a night, leading to dangerous drowsiness and an increased risk of heart attack. The problem is more common in men than women, with estimates ranging from 10% to 30% of adults affected.

Doctors say most patients would be better off using a recalled device because the risks of untreated sleep apnea always outweigh the potential damage from disintegrating foam. But doctors have struggled to help patients find new machines, which typically cost between $500 and $1,000 and were already in short supply due to supply chain issues.

“What happened was the company just said, ‘Talk to your doctor.’ But doctors can’t make new machines on the fly,” said Dr. John Saito, a respiratory specialist near Los Angeles.

Foam-related risks include headaches, asthma, allergic reactions and carcinogenic effects on internal organs, according to the Food and Drug Administration. The recalled devices include Dreamstation and SystemOne CPAP models and several other Philips devices, including Trilogy ventilators.

Last March, the FDA took the rare step of ordering Philips to expand its communication efforts, including “clearer information about the health risks of its products.” Regulators then estimated that only half of affected US consumers had registered with the company.

The agency had not issued such an order in decades.

The FDA has received 70,000 reports of related illnesses

In a statement, Philips said ongoing testing of the recalled devices is “encouraging” and shows low levels of particles and by-product chemicals emitted from its leading brand of machines. Philips said its initial communication about the hazards posed by the foam was “a worst-case scenario for possible health risks”. The deterioration appears to worsen with unauthorized cleaning methods, the company noted.

The FDA has received more than 70,000 reports of problems attributed to the devices, including pneumonia, infections, headaches and cancers. Such reports are not independently confirmed and cannot prove causation. They can be filed by manufacturers, patients, doctors or lawyers.

Jeffrey Reed, from Marysville, Ohio, had been using his Philips machine for about a year when he started seeing black 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 suffered from persistent sinus infections, including two bouts of pneumonia, which didn’t go away with the antibiotics. After hearing about the recall, he suspects foam particles could play a role.

“Once I left their machine, it all cleared up,” said Reed, 62, who obtained the device from a competitor after several months. Like other users, Reed cannot definitively prove that his problems were caused by the device from Philips.

More than 340 personal injury lawsuits against Philips have been consolidated in federal court in Pennsylvania with thousands more expected in the coming months. Reed is not part of the litigation.

Like the vast majority of American CPAP users, Reed obtained his device through a medical equipment supplier under contract with his insurer. The company went out of business before the recall and he never heard of a replacement.

Even under normal circumstances, these companies generally do not follow patients long term.

“After a few years, you’re just forgotten in the system,” said Ismael Cordero, biomedical engineer and CPAP user. “I stopped hearing from my supplier about three years after I received my machine.”

Cordero learned that his Philips machine had been recalled through his work at ECRI, a non-profit organization that reviews the safety of medical devices.

Regulators consider forcing Philips to speed up

In May, the FDA warned Philips that it was considering a second order that would require the company to improve and accelerate its repair and replacement program.

Medical device companies typically conduct voluntary recalls, and former FDA officials say the agency never actually used its authority to impose additional measures.

“The FDA shares the frustrations expressed by patients awaiting a resolution to this recall,” the agency said in a statement. Philips has still not provided “all the information we requested to assess the risks of chemicals released by the foam”.

Philips revealed earlier this year that it had received a subpoena from the Department of Justice regarding the recall. The agency has not publicly commented on the matter, per federal rules.

But an FDA inspection of Philips’ Pennsylvania offices revealed a series of red flags last fall, including emails suggesting the company had been notified of the problem six years before the recall. In an October 2015 email, a customer appeared to warn Philips that polyester polyurethane foam could degrade, according to the FDA.

Between 2016 and early 2021, the FDA found 14 instances where Philips was made aware of the issue or was analyzing the issue internally. “No other design changes, corrective actions, or field corrections were made,” FDA inspectors repeatedly note.

In a May 2018 email, foam supplier William T. Burnett wrote to Philips in an email: “We would 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 in a foam lawsuit.

A bad solution?

Since the recall, Philips has been using a new type of silicone-based foam to refurbish the machines.

But the FDA alerted consumers last November that the new material had failed a safety test. And regulators have asked the company to conduct more tests to clarify the health risks associated with both the new foam and the recalled material. Philips says independent testing has not identified any safety issues.

The company says it has replaced or repaired around 69% of recalled devices worldwide and aims to ship 90% of those requested by the end of the year. On average, the company produces about 1 million sleep devices per year.

“We’ve grown by more than a factor of three, but inevitably it still takes time to address 5.5 million devices globally,” the company said. About half are in the United States

Jeffrey Reed is one of those still waiting.

Reed registered for a replacement device in June 2021 – within a week of the recall. This month he received an email from Philips stating that his device has been discontinued and is not available for immediate replacement. Instead, the company offered him $50 to return the machine or an option to provide additional information to get a newer one.

“Having them wait until October to tell me my machine is too old, when they know exactly what machine I’ve had since the day I checked in, it’s frustrating,” Reed said. “It’s disappointing that a lifesaving equipment supplier treats people like this.”

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