According to an online news report posted on informa.com, Royal Philips has been struck with several risk management and quality systems observations following a recent FDA facility inspection. The FDA inspection also revealed that Philips failed to open a formal investigation after it received hundreds of thousands of complaints of contaminants and small particles being inhaled when patients used their breathing machines.
In July, the FDA classified the Philips CPAP, BiPAP, and ventilator recalls as Class I recalls July. Class I recalls are the most serious type of recall because it identifies the recalled product as a product that can cause injury or death.
According to the FDA’s most recent inspection, Philips’ management was “aware of potential foam degradation issues since at least 01/31/2020, or earlier.” Moreover, Philips did not conduct a “formal investigation, initiate a risk analysis or corrective and preventive action, perform or document a response to the more than 222,000 complaints potentially related to foam degradation.”
The FDA’s assertions are especially striking since Philips has been sued by customers concerning the company’s recalled breathing machines. The lawsuits allege that Philips knew about the foam problems for a long time and chose not to fix the issue. According to the FDA inspector’s report, Philips’ management was aware of the foam degradation issues concerning, the company¡s BiPAPs CPAPs, and Trilogy ventilators since at least 01/31/2020, or earlier. However, the company failed to implement no any corrective action until April 2021.
As part of its remedy, Philips is removing degraded polyester-based polyurethane foam from all affected BiPAPs, and CPAPs and is using silicone-based foam. However, the FDA obtained additional information that was not provided to the FDA. This information states that the type of silicone-based foam now being used may be as dangerous as the original, recalled foam. The silicone-based foam failed a safety test for the release of volatile organic compounds.
The FDA is now requiring Philips Respironics to engage an independent laboratory to run further testing to determine what safety risks the silicone-based foam may have on its breathing machine customers. The FDA recommends that patients who have machines with the new silicon-based foam continue to use their machines until the independent safety testing is completed.
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