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.
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.
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.
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