Sleep apnea device recalls are delayed, angering users

Sleep apnea device recalls are delayed, angering users

Sleep apnea device recalls are delayed, angering users

Washington – The mass recall of millions of sleep apnea machines has sparked anger and frustration among patients, and US officials are taking unprecedented legal action to speed up a replacement effort that is set to drag on next year.

Sound-proofing foam in pressurized breathing machines can break down over time, potentially inhaling tiny black particles or dangerous chemicals while users sleep, manufacturer Philips warned in June 2021.

Philips initially estimated that it could repair or replace the units within a year. But with more than 5 million devices being recalled around the world, the Dutch company says the effort will last until 2023.

It is left for many patients to choose between using a potentially harmful device or trying risky measures, including removing the foam themselves, buying a second-hand machine online, or simply going without therapy. .

devices are called continuous positive airway pressure, or CPAP, machines. They let air through the mask to keep the passage open during sleep.

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

Physicians say most patients are better off using a recall device because the risks of untreated sleep apnea still outweigh the potential harm of dissolving foam. But doctors have been hard pressed to help them find the new machines, which typically cost between $500 and $1,000, and were already in short supply due to supply chain problems.

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

According to the Food and Drug Administration, risks from the foam include headaches, asthma, allergies and cancer-causing effects on internal organs.

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

The agency had not issued such an order in decades.

In a statement, Philips said ongoing testing on the recalled equipment is “encouraging” and shows low levels of particulates and chemical byproducts emitted by its flagship brand machine. Phillips said its initial communication about the dangers posed by the foam was “a worst-case scenario for potential health risks.” The company notes that the deterioration is getting worse with unauthorized cleaning methods.

The FDA has received more than 70,000 reports of device-related problems, including pneumonia, infections, headaches and cancer. Such reports are not independently confirmed and cannot prove a causal relationship. They can be filed by manufacturers, patients, physicians or lawyers.

Jeffrey Reid, of Marysville, Ohio, had been using his Philips machine for about a year when he began to see dark spots in the tubing and mask. His equipment supplier said the debris was due to improper cleaning, so he continued to use it.

Over the next seven years, Reid says he experienced frequent sinus infections, including two bouts of pneumonia, which did not resolve with antibiotics. After hearing about the recall, he suspected that foam particles might play a role.

“Once I got off his machine, it was all right,” said 62-year-old Reid, who received a competitor’s device after several months. Like other users, Reed can’t definitively prove that his problems were caused by a Philips device.

More than 340 personal injury lawsuits against Phillips have been consolidated in 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 obtained his equipment through a medical device supplier contracted by his insurer. The company went out of business before the recall and never heard from them about a replacement.

Even under normal circumstances, those companies usually don’t track patients for long.

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

Cordero learned that his Philips machine had been recalled through his work at ECRI, a nonprofit that reviews medical device safety.

In May, the FDA gave Philips notice that it was considering a second order that would force the company to reform and accelerate its repair-and-replacement program.

Medical device companies typically conduct recalls voluntarily, and former FDA officials say the agency has never really exercised its authority to take additional steps.

“The FDA shares the frustrations expressed by patients who await a resolution to this recall,” the agency said in a statement. Philips still hasn’t provided “all the information requested to evaluate risks from chemicals released from the foam.”

Phillips revealed earlier this year that he received a Justice Department subpoena upon his recall. According to federal regulations, the agency has not publicly commented on the matter.

But an FDA inspection of Philips’ Pennsylvania offices revealed red flags last fall, with emails suggesting the company warned of the problem six years before the recall. According to the FDA, in an October 2015 email, a customer warned Philips that polyester polyurethane foam could be rancid.

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

In a May 2018 email, foam supplier William T. Burnett wrote in an email to Philips: “We would not recommend the use of polyester foam in such an environment. … it will eventually decompose as a viscous powder,” according to an affidavit filed as part of a lawsuit over the foam.

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

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

The company says it has replaced or repaired approximately 69% of recalled equipment globally and aims to ship 90% of requested equipment by the end of the year. On average, the company makes about 1 million sleep devices annually.

“We have increased growth by more than a factor of three, but it still takes time to essentially fix 5.5 million devices globally,” the company said. almost half are in the US

Jeffrey Reid is among those still waiting.

Reed registered for the replacement device in June 2021, within a week of replacement. This month, he received an email from Philips indicating that his device had been discontinued and was not available for immediate replacement. Instead, the company offered him $50 to return the machine or the option of providing additional information to obtain a new one.

“It’s frustrating to have to wait until October for me to tell them that my machine is too old, when they know what device I have from the day I registered it,” Reid said. “It’s disappointing that a provider of life-saving equipment treats people like this.”


Follow Matthew Perron on Twitter: @AP_FDAwriter


The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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