Philips Working With U.S. FDA After Mass Ventilator Recall

(Bloomberg) -- Royal Philips said it is working closely with the U.S. Food and Drug Administration after the agency asked for more tests on a silicone foam the medical equipment company plans to use to repair ventilators that were recalled earlier this year.

The FDA issued a number of initial findings on Friday following an inspection of a U.S. manufacturing facility. The Dutch company’s subsidiary, Philips Respironics, issued a voluntary recall of certain sleep and breathing devices, and ventilators in June because a polyester-based polyurethane foam which, if it degrades, could potentially become toxic. 

“We will work closely with the FDA to clarify and follow up on the inspectional findings and its recent request related to comprehensive testing,” Chief Executive Officer Frans van Houten said in an emailed statement.

Following the recall, Philips Respironics planned to replace the foam in the recalled devices, which are relied on by millions of patients, with a different silicone-based foam. The FDA initially approved this plan, in part because of testing results the company provided to the agency on the new foam. 

But when investigators visited the manufacturing site, the FDA found that the new foam had failed one test on a device marketed for sale outside the U.S. The test was for the release of certain chemicals of concern, called volatile organic compounds. The FDA has asked for an independent laboratory to perform additional examinations.  

Royal Philips said tests it had carried out on the new silicone foam replacement had demonstrated acceptable results. It said it already works with third-party test labs. 

An FDA investigator’s list of inspection observations does not constitute a final determination by the agency of whether any rules and regulations have been violated, the company said.

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