A massive recall of sleep apnea machines stokes frustration. New machines are on the way but the replacement process could drag into next year—depriving millions of safe sleep.
Continuous positive airway pressure (CPAP) machines force air through a mask to keep passageways open during sleep. They help treat sleep apnea, a condition in which sleepers stop breathing, sometimes hundreds of times per night. Untreated, sleep apnea can lead to dangerous drowsiness and increased heart attack risk.
Philips is the world’s largest CPAP manufacturer. Its machines contain sound-dampening polyester foam that can break down over time. When that happens, users could inhale tiny black particles or hazardous chemicals.
After about a year of wearing a CPAP, Jeffrey Reed began seeing specks in his tubing and mask. His equipment supplier said the debris was from improper cleaning, so he kept using it.
Over the next seven years, Reed experienced persistent sinus infections, including two bouts of pneumonia. Now he suspects the foam particles might have caused his difficulties.
“Once I got off their machine, all of that cleared right up,” Reed says. Like other users, Reed can’t prove his problems stemmed from Philips’ device.
In June 2021, Philips warned registered users of the foam disintegration. The company thought it could repair or replace the affected units within a year.
But the recall quickly expanded to more than five million devices worldwide. Now the company says the recall effort will stretch into 2023.
Meanwhile, patients must choose between a potentially harmful device and risky remedies—like removing the foam themselves or snoozing sans CPAP.
The U.S. Food and Drug Administration (FDA) has received more than 70,000 reports of problems blamed on CPAPs: headache, asthma, allergies, cancer.
Inspectors uncovered emails suggesting the company knew of the foam issue six years before the recall. There were 14 instances in which Philips was informed of the matter or analyzed the problem internally—without making changes.
Foam supplier William T. Burnett told Philips in 2018: “We would not recommend use of polyester foam in such an environment” because it could “decompose to a sticky powder.”
Last March, FDA officials ordered Philips to provide “clearer information about the health risks of its products.”
Philips says it has replaced or repaired about 69% of recalled devices globally, and the company has begun using a new type of foam.
Meanwhile, Reed still awaits his replacement.
He says, “It’s disappointing that a provider of life-saving equipment treats people like this.”
Whoever knows the right thing to do and fails to do it, for him it is sin. — James 4:17
Why? Jesus calls us to love our neighbors as ourselves. James 4:17 instructs against willfully ignoring a problem that harms others or failing to inform others of danger.