By Christy Santhosh
(Reuters) -A U.S. federal court issued a decree to restrict the production and sale of Philips’ new sleep apnea machines at several facilities in the country, the Food and Drug Administration said on Tuesday.
The U.S. District Court for the Western District of Pennsylvania has entered into what is known as a consent decree against the company’s subsidiary Philips Respironics to curb the sale and production until certain requirements are met.
In January, the Dutch health technology company had said that it will not sell new devices to treat sleep apnea in the United States in the coming years as it works to comply with a settlement with the FDA.
The agreement followed the recall of millions of breathing devices and ventilators used to treat sleep apnea in 2021 because of concerns that foam used to reduce noise from the devices could degrade and become toxic, carrying potential cancer risks.
The decree also requires implementation of a recall remediation plan, agreed to by the FDA and Philips, to help ensure relief is provided to patients impacted by the recall.
The plan outlines remediation options such as a new or reworked device for the patients with the option for partial refund of certain devices.
As part of this plan, Philips is also required to make several attempts to contact a patient or a medical equipment provider regarding actions they must take to help ensure patients receive remediation in a timely manner.
Almost the whole of the company’s actionable registered sleep therapy devices have been remediated globally, Philips told Reuters, adding that it will retain experts to review aspects of the remediation.
The company said it will continue to provide new sleep and respiratory care devices outside the United States as the consent decree allows for exports.
(Reporting by Christy Santhosh; Editing by Maju Samuel)
