Manufacturer of Faulty Sleep Apnea Devices Ordered to Revamp Production
In a significant development, federal officials announced a settlement on Tuesday that mandates the restructuring of manufacturing practices at Philips, the company responsible for a global recall of sleep apnea machines. This settlement prevents the company from resuming production at its U.S. facilities until it fulfills a series of safety prerequisites, as per a court order unveiled by the U.S. Department of Justice.
Philips is obliged to revamp its manufacturing and quality control systems and engage independent experts to assess these changes. Furthermore, the company must continue to offer replacements, repairs, or refunds to all U.S. customers affected by the defective devices, the department emphasized.
This settlement marks a pivotal stride in resolving one of the most significant medical device recalls globally, spanning nearly three years. Predominantly, the recalled devices are continuous positive airway pressure (CPAP) machines, essential for maintaining open airways during sleep to mitigate the risks associated with sleep apnea.
The recall stemmed from the discovery that the internal foam of the machines could degrade over time, potentially exposing users to inhalation of particles and fumes. The remediation process has been beset by delays, vexing regulators and patients alike in the U.S. and other nations.
Allegations by federal government lawyers centered on Philips’ purported failure to adhere to good manufacturing practices necessary for ensuring device safety. However, the company did not concede to these allegations, according to court filings.
Under the terms of the legal agreement, Philips must enlist independent auditors to devise a plan for rectifying manufacturing deficiencies and monitoring issues with the sleep devices. This plan must garner approval from the Food and Drug Administration (FDA). Moreover, the selected experts must certify that the new foam material meets FDA safety standards.
Despite the settlement, concerns linger among affected individuals. Jeffrey Reed from Ohio, who endured health complications due to his use of a Philips machine, remains apprehensive about his long-term well-being. Reed’s story is emblematic of the more than 750 personal injury lawsuits filed against the company in relation to the faulty devices.
While Philips has reached a tentative agreement with the FDA and the Department of Justice, pending judicial review, legal battles persist across multiple jurisdictions worldwide. The FDA has been proactively cautioning patients about the potential health risks associated with the defective foam, including headaches, asthma, and allergic reactions.
In light of the FDA’s inspections uncovering lapses in Philips’ response to the foam issue, the settlement underscores a critical juncture in the ongoing efforts to address the ramifications of the sleep apnea machine recall. Despite the agreement, challenges remain for customers seeking refunds or replacements, with reports of protracted delays in the process.
