Philips Respironics is to halt sales of all of its breathing machines in the United States after reaching a settlement with the Food and Drug Administration (FDA) over continuing problems with the devices.
Millions of the company’s ventilators and CPAP machines, used to ease breathing, at night, have been recalled after reports that they blew bits of foam and potentially toxic gases into consumers’ airways.
In terms of the settlement, Amsterdam-based Philips said it would have to meet a list of standards in a “multi-year” plan before it could resume business in the US, reports The New York Times.
The company said further details would be disclosed when the agreement was finalised in court, but it would continue to repair existing devices and provide service for users.
The company initially began the recall of millions of devices in June 2021 and paused sales of new sleep therapy machines to the United States, said Steve Klink, a spokesman for Philips.
At the time, the company and the FDA cited the potential for serious injury or permanent impairment from the potentially cancer-causing chemicals emitted from the devices.
The company has since released results of additional testing, saying the devices were “not expected to result in appreciable harm to health in patients”, and that it was continuing to conduct tests.
The FDA has pushed back on some of the company’s updated claims, and at one point called them “unpersuasive”. Philips has also faced continuing scrutiny and undertaken more recalls in its attempts to upgrade the devices.
Dr Jeff Shuren, director of the FDA’s device division, said the agency could not comment until the agreement was finalised and filed with the court.
The initial recall affected about 15m breathing machines produced since 2006, though roughly 5m were still in circulation in mid-2021.
With replacements not immediately available, the recall caused confusion and upset for many doctors and patients. Many struggled to weigh the risk of continuing to use a faulty device against the peril of sleeping with impaired breathing.
Millions of people suffer from sleep apnoea, or interrupted breathing, which is associated with elevated rates of strokes, heart attacks and possible cognitive decline.
Recalled machines included CPAP, or continuous positive airway pressure, machines; BiPap devices; and ventilators.
Philips disclosed that it had reached an agreement, or a consent decree, that was brokered with the US Justice Department and the FDA, and that it would continue to sell its products in other countries.
Thousands of patients have since sued Philips, claiming the machines led to a wide range of respiratory and other ailments, including allegations of deaths from lung cancer.
In September, the company reached a $479m settlement with plaintiffs that was meant to cover the financial losses related to repairing or replacing the machines. Litigation over illnesses and medical costs is still pending.
See more from MedicalBrief archives:
FDA still not satisfied with Philips recall
Philips coughs up $479m in apnoea device settlement
New issues with repairs of recalled Philips ventilators