In a significant development, Philips, the company responsible for a global recall of sleep apnea machines, has reached a settlement with federal officials that bars them from resuming production at U.S. facilities until they meet strict safety requirements. The settlement, announced on Tuesday by the U.S. Department of Justice, brings hope of resolving one of the largest medical device recalls in history that has stretched on for nearly three years.

Under the court order, Philips is mandated to undertake a comprehensive overhaul of its manufacturing and quality control systems. Additionally, the company will have to hire independent experts to review and validate the proposed changes. The U.S. Department of Justice has further stated that Philips must continue to replace, repair, or provide refunds to all U.S. customers who have received the defective sleep apnea devices.

The majority of the recalled devices are continuous positive airway pressure (CPAP) machines, which help maintain open airways during sleep by delivering air through a mask. If left untreated, sleep apnea can lead to severe drowsiness and an increased risk of heart attack. The recall was initiated due to concerns that the internal foam in the machines could degrade over time, causing users to inhale harmful particles and fumes during sleep.

Efforts to repair or replace the recalled machines have been plagued by frustrating delays, disappointing both regulators and patients in the U.S. and around the world. Federal government lawyers have alleged that Philips failed to comply with necessary good manufacturing practices essential for ensuring device safety. However, the company has not admitted to these allegations per the court filing.

U.S. Attorney Eric Olshan expressed a commitment to holding manufacturers accountable for any violations that put the public at risk. As part of the legal agreement, Philips is required to engage independent auditors who will develop a plan to address the manufacturing issues and oversee any potential future problems with the sleep devices. This plan will need approval from the Food and Drug Administration (FDA), and the selected foam for the machines must meet FDA safety standards, certified by the experts.

The settlement comes after several personal injury lawsuits were filed against Philips by over 750 individuals affected by the defective devices, with these cases now consolidated in a federal court in Pennsylvania. Similar lawsuits are also pending in Canada, Australia, Israel, and Chile, according to the company.

Though a tentative agreement was announced in January between Philips, the FDA, and the Department of Justice, it had not been confirmed by federal judges until now. In response to the settlement, a spokesperson for Philips stated that it provides a roadmap of defined actions, milestones, and deliverables to meet regulatory requirements. The company will still be able to export some machines for sale outside the U.S.

The FDA's website cautions patients about the risks associated with ingesting the faulty foam, including headaches, asthma, allergic reactions, and more serious health complications. An FDA inspection conducted in the fall of 2021 revealed concerning evidence, including emails suggesting that Philips was aware of the foam problem six years prior to the recall. Between 2016 and early 2021, the FDA found 14 instances where Philips had knowledge or was investigating the issue, yet no effective action was taken.

In 2022, the FDA took the extraordinary step of ordering Philips to intensify its outreach efforts to inform customers about the recall and provide clearer information about the health risks associated with the products. At that time, the agency estimated that only about half of the people in the U.S. who owned the affected machines were aware of the recall.

Customers attempting to obtain refunds or replacement devices from Philips have reported enduring long delays, adding to the frustration caused by the ongoing recall. It is hoped that the settlement will now pave the way for a more efficient resolution of the sleep apnea machine recall and ensure the safety of users worldwide.