Rédaction Africa Links 24 with Associated Press
Published on 2024-04-09 21:14:07
Washington- In a recent settlement announced by federal officials, Philips, the company responsible for a global recall of sleep apnea machines, will be prohibited from resuming production at U.S. facilities until certain safety requirements are met. This long-awaited settlement requires Philips to revamp its manufacturing and quality control systems, as well as bring in independent experts to assess the changes. Additionally, the company must continue to replace, repair, or refund all defective devices for U.S. customers. This action marks a significant step towards resolving one of the largest medical device recalls in history, spanning nearly three years.
The majority of the devices recalled are continuous positive airway pressure (CPAP) machines, which help keep mouth and nasal passageways open during sleep by delivering air through a mask. Sleep apnea, if left untreated, can lead to dangerous drowsiness and an increased risk of a heart attack. Philips initiated the recall of over 5 million machines since 2021 due to the breakdown of internal foam, causing users to inhale small particles and fumes while sleeping. However, efforts to repair or replace the machines faced delays, causing frustration among regulators and patients in various countries.
Allegations from federal government lawyers suggested that the company failed to comply with good manufacturing practices necessary for ensuring device safety. Although the company did not admit to the allegations, U.S. Attorney Eric Olshan emphasized the commitment to holding manufacturers accountable for putting the public at risk. The settlement mandates Philips to hire independent auditors to devise a plan for addressing manufacturing issues and monitoring the devices’ problems, subject to FDA approval. These experts must also confirm that the new foam selected by Philips meets FDA safety standards.
One affected individual, Jeffrey Reed from Ohio, experienced persistent sinus infections and pneumonia during the seven years he used a Philips machine. Concerned about his long-term health, Reed worries about the consequences despite receiving a newer Philips device as a replacement, which he prefers not to use. Reed is among the 750+ people who filed personal injury lawsuits against the company over the defective devices, consolidated in a federal court in Pennsylvania. Similar lawsuits are pending in countries like Canada, Australia, Israel, and Chile.
The FDA’s website highlights the risks of ingesting foam particles, including headaches, asthma, allergic reactions, and, in rare cases, fires caused by machine overheating. An FDA inspection of Philips’ Pennsylvania offices in 2021 revealed several issues, including emails suggesting prior warnings about foam problems. Despite being made aware of the issue, Philips did not take necessary corrective actions over several years. Additionally, the FDA ordered increased outreach to inform customers about the recall, as many were unaware of the affected machines.
Customers seeking refunds or replacements from Philips reported significant delays, further complicating the resolution of this recall issue. Moving forward, Philips is mandated to address these safety concerns and manufacturing defects before resuming production at U.S. facilities. The settlement represents a critical step in ensuring the safety and well-being of individuals relying on sleep apnea machines for their health needs.
