Millions of U.S. sleep apnea patients are scrambling to find ways to protect their nightly slumber, following a voluntary recall from one of the nation's leading manufacturers of CPAP breathing machines.
Multiple recalls
Philips Respironics agreed to a voluntary recall of continuous positive airway pressure (CPAP) machines in late June, over concerns that noise-dampening foam inside the devices might degrade and produce toxic particles and gases.
"The potential risks of exposure to chemicals released into the device's air pathway from the PE-PUR foam include headache; dizziness; irritation in the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea/vomiting; and toxic and carcinogenic effects," the U.S. Food and Drug Administration said in its recall notice.
Weeks later, a second recall was issued for its V60 ventilators due to the discovery that the devices may provide the patient with a lower oxygen flow rate. The problem caused 25 injuries at the time of the recall. The recall covers 1,511 devices distributed over a two-week period last summer.
In January, Phillips started its latest recall stating its Respironics V60 and V60 Plus ventilators could cause serious injuries or death after noticing some ventilators were assembled using expired adhesive.
"If the adhesive fails, it could cause a capacitor support bracket to become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may cause an alarm to notify the health care provider, or it may not sound any alarm at all," the agency wrote.
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The difficult choice for sleep apnea patients
Patients with severe sleep apnea now face a difficult choice if they own one of the Philips machines — go without good sleep for months on end, shell out $1,000 for a new device, or keep using a breathing aid that could harm their health.
Philips said in September it could take up to a year to repair or replace all machines affected by the recall.
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Many patients simply won't be able to wait that long, says Dr. Steven Feinsilver, director of the Lenox Hill Hospital Center for Sleep Medicine, in New York City.
"I have lots of patients — I was just talking to an airline pilot — who are in positions where being sleepy is not trivial," Feinsilver adds.
Sleep doctors across the country have been flooded with calls from patients worried that the machine that helps them get a good night's sleep might harm their health, says American Academy of Sleep Medicine President Dr. Raman Malhotra.
"Just me individually, I have hundreds of patients on these machines, and our sleep center alone has several thousand," says Malhotra, an assistant professor of neurology in the sleep medicine section at Washington University School of Medicine in St. Louis. "Personally, I get somewhere in the 10 to 20 range calls a day. Our center gets over 100 a day."
Last month, Phillips said they had shipped a total of more than 650,000 replacement devices to customers in the U.S. They aim to complete the repair and replacement program in the fourth quarter of 2022.
"We are working to address this issue as expeditiously as possible," Philips said in the statement. "Given the number of devices currently in use (estimated at 3 to 4 million units globally based on production and shipment data – about half are in the U.S.)..."
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How sleep apnea affects sleep
As many as 25 million U.S. adults suffer from sleep apnea, according to the American Sleep Association, although many Blacks with sleep apnea go undiagnosed.
The condition occurs when muscles in the back of the throat relax and block the airway, stopping a person's breathing and causing them to wake. This can happen more than 30 times an hour throughout the night, destroying a person's ability to get good rest, the association says.
"There were times where I would literally fall asleep mid-sentence talking to someone because I was so exhausted from not going to sleep the night before," sleep apnea patient James Colbert told CBS News in a report about the Philips recall.
CPAP machines improve sleep by pushing a steady stream of air into the patient's nose and mouth, through a mask strapped onto the face. The constant air pressure keeps the airways open.
"As soon as you see a CPAP machine, you know it must really work, because no one would sleep with this stupid-looking thing if it didn't work," Feinsilver shares. "When I first broached the idea, everybody immediately says there's no way I could sleep with this thing. Then they come back and say they can't sleep without it."
Doctors caught off guard
The recall caught sleep doctors by surprise.
"Unfortunately, Respironics said stop using your machine immediately and call your doctor, which is a big problem because as your doctor, I have no idea what to tell you, and not a whole lot of options," Feinsilver says. "This was done very badly. I think anybody in the field would tell you that."
The CPAP machine market is dominated by Philips Respironics and a San Diego-based medical device firm called ResMed, Feinsilver and Malhotra said.
"I have perhaps 1,000 patients on CPAP, probably a third to a half of whom are on Respironics machines," Feinsilver says.
Plenty of CPAP machines are available from ResMed and other smaller companies, but patients will have to fork over as much as $1,000 if their insurance won't cover the cost of a replacement device.
"You can buy one, with a prescription. But insurance isn't going to pay for a second one unless the first one is at least five years old," Feinsilver shares.
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Are there other strategies available?
Patients with mild to moderate sleep apnea might be able to try other strategies to improve their sleep, Malhotra says. They could raise the head of their bed, sleep on their side, or lose weight.
They also might consider being fitted with an oral device designed to maintain good breath during sleep.
"It moves the lower jaw forward during sleep," Malhotra shares. "By doing that, that does bring the tongue and the soft tissue forward and opens up the airways during sleep."
For his part, Feinsilver tells patients who can't afford a new device to keep using their Philips machine until it is repaired or replaced.
He says the devices filter air upon intake, so he personally can't figure out how particles or gases produced from foam located outside the blower would be inhaled by the patient.
"Everything in medicine is balancing risk and benefit. That's always true," Feinsilver adds. "And as far as I can tell, the risk of whatever the problem is with this machine is smaller than the risk of sleep apnea if you have significant sleep apnea."
Malhotra agrees.
"If we feel the benefits of the machine outweigh the potential risk, then we recommend continuing the machine, which is the case in many cases if not most that we come across," he says. "These patients are on a machine for a reason, and it's really helped their quality of life and their health. It's just not safe to come off of it, even with the risk that Philips is stating."
For a complete list of the recalled devices, click here.
