Christy Santosh
(Reuters) – A U.S. federal court has issued an order restricting the production and sale of Philips’ new sleep apnea machines at several plants in the country, the Food and Drug Administration said on Tuesday.
The U.S. District Court for the Western District of Pennsylvania issued a so-called consent order against Philips subsidiary Respironics to restrict sales and production until certain requirements are met.
In January, the Dutch health technology company said it would not sell new sleep apnea devices in the United States for years to come as it works to comply with an agreement with the FDA.
The agreement follows the recall of millions of breathing machines and ventilators used to treat sleep apnea in 2021 over concerns that foam used to reduce noise from the devices could degrade and become toxic, posing a potential risk cancer development.
The order also requires implementation of a recall recovery plan agreed upon by the FDA and Philips to ensure relief is provided to patients affected by the recall.
The plan outlines remedial options, such as purchasing a new or remanufactured device for patients, with the possibility of partial refunds for certain devices.
Under this plan, Philips is also required to make several attempts to contact the patient or medical device provider regarding the actions they must take to ensure that patients receive reimbursement on a timely basis.
Almost all of the company’s registered sleep therapy devices have been refurbished worldwide, Philips told Reuters, adding that it would hire experts to review aspects of refurbishment.
The company said it will continue to supply new sleep and respiratory care devices outside the U.S. as the consent decree allows export.