FDA provides update on Philips recall

WASHINGTON – The U.S. Food and Drug Administration obtained additional information during an inspection of a Philips’ manufacturing facility that was not previously available to the agency that showed the silicone-based foam used in a singular, similar device marketed outside the U.S. failed one safety test for the release of volatile organic compounds. 

Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 

“The FDA has requested that Philips retain an independent laboratory to perform additional testing to determinate what, if any, potential safety risks may be posed to patients by silicone-based foam,” the agency stated in a press release. “At this time, the agency does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product.” 

The FDA initially approved Philips’ plan to repair the polyester-based polyurethane foam in recalled CPAP and BiPAP devices with a different, silicone-based foam, in part, on testing the company provided to the agency in June. 

The FDA has provided the results of its inspection to the company in a Form 483, but it noted that the results do not constitute a final determination whether or not any condition is in violation of the Food, Drug and Cosmetic Act or any of its implementing regulations. 

“We will work closely with the FDA to clarify and follow up on the inspectional findings and its recent requests related to comprehensive testing,” said Frans van Houten, CEO of Philips. “Until we have concluded these discussions, we are not able to publicly provide further details on these responses. We remain fully committed to supporting the community of patients who rely on the affected devices, and the physicians and customers who are dedicated to meeting patient needs.”  

Since June, Philips and certified testing laboratories have been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks, with support from appropriately qualified third-party experts. The company plans to make more data available in the fourth quarter. 

Separately, Philips has also conducted testing to support the new silicone replacement foam.