By Christy Santhosh
(Reuters) -A U.S. federal court has issued an order to restrict the production and sale of Philips’ new sleep apnea devices 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 a so-called consent decree against Philips subsidiary Respironics to curb sales and production until certain requirements are met.
The Dutch health technology company said in January that it will not sell new devices to treat sleep apnea in the United States in the next few years as it works to comply with an agreement with the FDA.
The settlement followed the recall of millions of breathing devices and ventilators used to treat sleep apnea in 2021 over concerns that the foam used to reduce the noise of the devices could degrade and become toxic, posing potential cancer risks.
The order also requires the implementation of a recall remediation plan, agreed upon between the FDA and Philips, to ensure that relief is provided to patients affected by the recall.
The plan outlines repair options such as a new or reworked device for patients with the option of partial reimbursement of certain devices.
As part of this plan, Philips is also required to make several attempts to contact a patient or medical equipment supplier regarding actions to take to ensure that patients receive remedies in a timely manner.
Nearly all of the company’s registered sleep therapy devices have been remediated globally, Philips told Reuters, adding that it will hire experts to review aspects of the cleanup.
The company said it will continue to supply new sleep and respiratory care devices outside the United States as the consent decree allows exports.