On April 9th, federal officials announced in a much-anticipated settlement, that Philips, global producer of sleep apnea machines which were a part of a massive recall, is banned from resuming production in the U.S. until they meet certain safety requirements. It’s the latest development in an almost three year saga, when Philips acknowledged using foam inside sleep apnea machines and ventilators for noise reduction that could release toxic, carcinogenic particles as patients used the machines to breathe better while they sleep. CPAP machines are largely used for treating Obstructive Sleep Apnea, OSA, which involves difficulty breathing during sleep.
Last week, a consent decree was filed in federal court, detailing the issue and next steps. The company has been in the spotlight consistently since the initial recall, as they attempted to replace millions of devices that are critically important to people’s health. ProPublica and the Pittsburgh Post-Gazette investigated separately, finding that the massive company had withheld thousands of additional complaints about the foam for more than a decade before warning customers. (1)
Now, Philips is required to change its manufacturing quality control standards and systems, and to hire independent experts to vet those changes, the Associated Press reports. (2) In addition, they have to continue the rest of the recall resolution process, giving refunds, replacements, and repairs to those impacted. Since the recalls began, it’s been a rocky path for the company, whose stock fell substantially in December 2023, and who allocated $1.1 billion to addressing the recalls’ 15 million devices. They’ve also been at the center of multiple additional investigations and legal suits around the issue.
As of February 2024, 561 deaths have been tied to the recalled machines. According to the U.S. Food and Drug Administration’s April 9 press release, Philips can no longer produce or sell new CPAP machines, BiPAP machines, and other devices in several U.S. facilities. (3) The FDA calls it a “significant milestone” in the recall process. Jeff Shuren, M.D., J.D., and director of the FDA’s Center for Devices and Radiological Health says that it’s a step towards getting consumers “relief they have long deserved,” and notes it’s the first time a device company is providing a remediation payment option for a recalled device under a consent decree.
The independent expert who will work with Philips will assess their testing for the foam, including testing that has been completed, to determine that it won’t degrade during use and present similar issues as the noise-abatement foam did in the recalled devices. THey will submit those findings to the FDA, and the company will have to address any gaps in testing to the FDA to comply with the settlement.
For those personally impacted by the recall, the FDA encourages people to still register their device if they haven’t already, and ensure their contact information is up to date.
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Sources
1. Korsh, Michael; Robinson-Johnson, Evan; “After CPAP Recall, Philips Must Institute New Safeguards in Agreement With U.S. Justice Department,” Pittsburgh Post-Gazette; https://www.propublica.org/article/after-recall-philips-must-launch-new-safeguards-in-doj-agreement; April 9, 2024.
2. Perrone, Matthew; “Company that made millions of defective sleep apnea machines ordered to overhaul manufacturing,” Associated Press; https://apnews.com/article/cpap-sleep-apnea-philips-lawsuit-fda-229c8959b4ccbda015b1fad42f7477af; April 9, 2024.
3. FDA News Release; “Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines,” FDA.gov; https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-philips-respironics-following-recall-certain-sleep; April 9, 2024.