A U.S. federal court has taken action to limit the production and sale of Philips’ latest sleep apnea machines across several facilities in the nation, as confirmed by the Food and Drug Administration on Tuesday.
The U.S. District Court for the Western District of Pennsylvania has imposed a consent decree against Philips Respironics, a subsidiary of the company, aiming to restrain sales and production until specific conditions are met.
Earlier in January, the Dutch health technology giant announced its decision not to distribute new sleep apnea treatment devices in the U.S. for the foreseeable future, as it endeavors to comply with an agreement reached with the FDA.
This move came in the wake of the recall of millions of breathing devices and ventilators designed for sleep apnea treatment in 2021. The recall was prompted by concerns that the foam utilized to diminish noise from the devices could degrade over time, potentially posing health risks including cancer.
The decree also mandates the implementation of a recall remediation plan, jointly agreed upon by the FDA and Philips, to ensure affected patients receive appropriate assistance.
The remediation plan outlines various options, including the provision of new or refurbished devices to affected patients, with the possibility of partial refunds for certain devices.
As part of this initiative, Philips is obligated to make concerted efforts to communicate with patients or medical equipment providers regarding necessary actions to facilitate prompt remediation for affected individuals.
According to Reuters, Philips has already addressed the majority of its registered sleep therapy devices globally. The company has committed to engaging experts to oversee various aspects of the remediation process.
Philips has clarified that it will continue to offer new sleep and respiratory care devices outside the U.S., as the consent decree permits exports.