According to a news story posted on mddionline.com, the U.S. Food and Drug Administration reported that its inspectors have just completed an inspection of a Philips facility in Pennsylvania. The report states that the FDA may not be satisfied with Philip’s replacement foam choice for the recalled Philips Respironics ventilators, continuous positive airway pressure (CPAP) machines, and its bilevel positive airway pressure (BiPAP) machines.
In June of 2021, Philips began a recall of over 15 million CPAP, ventilators, and BiPAP breathing machines because of a serious health concern with the devices’ polyester-based polyurethane sound abatement foam. According to the recall notice, the sound abatement foam can degrade and shed small particles and release a toxic gas that the user may inhale. The FDA reported that the issue could cause serious and “life-threatening injuries, cause permanent impairment, and could require medical intervention to forestall permanent harm to device users.”
After Philips initiated the massive recall, the company worked with the FDA to create a plan to replace the polyurethane foam on the recalled ventilators, BiPAP, and CPAP machines with the new silicone-based foam. The FDA tentatively approved Philips’ plan contingent on the test results of the new foam. Those test results were to be provided by Philips. However, the FDA’s recent inspection of a Philips Respironics manufacturing facility unveiled new information that was not previously made available to the FDA. The information concerned the silicone-based foam Philips’ was using to replace the toxic foam. According to the report, the silicone-based foam Philips’ is using in the recall failed safety tests for the release of volatile organic compounds.
As a consequence, the FDA has demanded Philips hire an independent laboratory to conduct further testing to ascertain what safety risks are associated with the silicone-based foam. The FDA also acknowledged that it understood some patients already received their devices with the replacement silicone-based foam. FDA stated that it does not have enough information to decide if the silicone-based foam poses a risk to U.S. patients affected by the recall. The FDA is not recommending that patients discontinue the use of the devices they received as part of the repair program.
According to the news report, Philips was aware of the foam degradation issue six years ago. The FDA investigator’s report states that Philips was aware of foam degradation issues on its Trilogy ventilator products. The company either failed to perform or document any investigation, risk analysis, health hazard evaluation, or design analysis of the problem.
The FDA stated that it will evaluate Philips’ response to the inspection and recommendations and the agency will determine the appropriate next steps.
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