Maker of sleep apnea machines required to overhaul systems

The company responsible for a global recall of sleep apnea machines will be barred from resuming production at U.S. facilities until it meets a number of safety requirements, under a long-awaited settlement announced Tuesday by federal officials.

Philips will be required to overhaul its manufacturing and quality control systems and hire independent experts to vet the changes, according to a court order announced by the U.S. Department of Justice. The company must also continue to replace, repair or provide refunds to all U.S. customers who got the defective devices, the department said.

The action is a major step toward resolving one of the biggest medical device recalls in history, which has dragged on for nearly three years.

Most of the devices recalled are continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep mouth and nasal passageways open during sleep. Left untreated, sleep apnea can lead to dangerous drowsiness and increased risk of heart attack.

Philips has recalled more than 5 million of the machines since 2021 because their internal foam can break down over time, leading users to inhale tiny particles and fumes while they sleep. Efforts to repair or replace the machines have been plagued by delays that have frustrated regulators and patients in the U.S. and other countries.

Lawyers for the federal government alleged that the company failed to comply with good manufacturing practices needed to ensure device safety. The company did not admit to the allegations, according to the court filing.

“This office, the FDA and our partner agencies are committed to holding manufacturers accountable when they violate the law and put the public at risk,” U.S. Attorney Eric Olshan said in a statement.

Under the legal agreement, Philips must hire independent auditors to create a plan for fixing its manufacturing problems and for monitoring problems with the sleep devices. The plan must then be approved by the Food and Drug Administration. The experts must also certify that new foam selected by the company meets FDA safety standards.

Jeffrey Reed, of Marysville, Ohio, experienced persistent sinus infections and two bouts of pneumonia during the seven years he used a Philips machine.

“I worry about my long-term health,” Reed said.

“I used this machine for years and no matter what money I might get out of this, what’s going to happen?”