CPAP 003

 

Massive medical device recall leaves patients unsure what to do

BOSTON —

Last month, Philips issued a huge recall of ventilators and continuous positive airway pressure machines, leaving millions of people with sleep apnea unsure of how they'll get a good night's sleep.

Philips has not offered a timeline of when repairs will be made, and for many, answers aren't very easy to find.

Like millions of people, Michael Crosta of Abington is facing a conundrum over his Philips CPAP machine, which helps him keep breathing and sleep soundly despite sleep apnea.

"It's a health risk," he said of the machine. "You tell me not to use this machine because Philips is recalling it and it may cause cancer, but this is a script that I'm supposed to use on a daily basis. What am I supposed to do?"

Karen Roberts of Plaistow, New Hampshire, received the same recall notice from Philips over her machine.

"Now I'm worried," she said. "I feel like I really need that medical device to keep me safe."

Philips said foam inside the device may give off dangerous gas or break down into potentially dangerous tiny particles, which can be ingested. The company plans to replace the foam but doesn't yet have the approval to do that, and patients like Crosta and Roberts are only authorized by insurance to buy a new CPAP machine every five years.

Roberts said she called Philips and was told to call her doctor, who told her to call the medical device company she bought the machine from who pointed her to her insurance, which sent her back to Philips.

The company says patients should register the machine to make sure they're on the list for a fix.

"It leaves me at risk of health issues, and I really don't know what to do at this point," Roberts said. "I've called everyone I can think of."

"I don't have anything to use," Crosta said. "What am I supposed to use?"

Dr. Lawrence Epstein is director of the Division of Sleep and Circadian Disorders at Brigham and Women's Hospital. He said patients with severe problems should keep using the machines despite the risks while they assess the situation with their physician and said others have to judge for themselves — or with their doctor's advice — whether the benefits of the machines outweigh the dangers.

"Our best judgment is that the risk of a complication from it is rather low if they're not having specific symptoms. And those have been cough, chest pressure, headache, sinus infection," Epstein said. "If it's a life-threatening condition for which they're using the machine, then they should definitely continue to use it while waiting unless they're having some symptoms."

In a statement, Philips tells us it's moving as quickly as it can, but says there are three to four million machines impacted by this, half of those in this country. And the company needs FDA approval for the fix.

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