Are Replacements for Recalled CPAP Machines Also Dangerous?

 Posted on December 27,2021 in Recalled Devices

In June of 2021, the medial device manufacturer Philips Respironics recalled more than 15 million CPAP machines and similar devices. This recall was performed because the devices contained a foam that could degrade, causing users to experience health risks because of the inhalation of tiny foam particles or toxic chemicals. While the recall has left many users without the treatments needed to address issues related to sleep apnea, Philips has begun making replacement CPAP devices available. However, some concerns have also been raised about the potential health risks of using the replacement machines.

FDA Asks for Testing to Determine Safety Risks of New CPAP Machines

As part of the recall, the U.S. Food and Drug Administration (FDA) has been investigating Philips’ manufacturing practices, including reviewing records and visiting the company’s facilities. During these investigations, the FDA uncovered potentially troubling information about the plans to replace the noise-abatement foam in the recalled devices.

The recalled CPAP and BiPAP machines and ventilators had used a polyester-polyurethane (PE-PUR) foam that was meant to reduce vibrations and decrease noise when patients were using the devices. The breakdown of this foam over time had put users at risk, since this led to small particles and potentially harmful chemicals entering the devices’ airways. Philips has planned to repair the recalled devices by replacing the PE-PUR foam with a different type of foam that is silicone-based.

Records reviewed by the FDA have raised concerns about the potential risks that the silicone-based foam may present. Other similar medical devices containing this foam that were marketed and sold outside of the United States have failed safety tests. These tests indicated that the silicone foam may release volatile organic compounds (VOCs) that may be inhaled by users, possibly causing injuries or health issues. To address this issue, the FDA has asked Phillips to perform additional testing to determine whether the silicone foam it plans to use in CPAP machines will place users at risk.

Contact Our CPAP Injury Lawyers

Unfortunately, Philips has already begun making CPAP machines with silicone-based foam available to consumers. While the company may perform tests to determine whether there are any risks, it is understandable if consumers do not trust that the company will prioritize their best interests, since investigations have indicated that Philips failed to address health risks after performing these types of tests in the past. Users of CPAP devices who have experienced injuries or health issues will want to determine their best options for holding the manufacturer responsible, and they can do so by working with a CPAP injury attorney. Our team can provide advice and guidance in these matters, and we will help injury victims take legal action to address the damages they have suffered. Contact us today for a free consultation.

Sources:

https://www.fda.gov/news-events/press-announcements/fda-provides-update-recall-certain-philips-respironics-breathing-assistance-machines

https://www.medtechdive.com/news/fda-philips-sleep-apnea-device-recall-resmed/610026/

https://www.medicaldesignandoutsourcing.com/fda-requests-safety-testing-of-replacement-foam-in-philips-sleep-devices-recall/