Months after Philips received the FDA’s go-ahead to begin repairing and replacing the ventilators affected by the Class I recall the company initiated in mid-June, the regulator identified a potential safety risk with a replacement component, according to a Nov. 12 statement.
The recall was sparked by an issue Philips identified with the polyester-based polyurethane foam used to muffle sound and vibrations in its continuous and non-continuous ventilators. Over time, the company found, that foam could break down, potentially sending specks of black debris and other dangerous toxins into the air pathway.
By the time the FDA handed down its most serious rating to the recall in July, it had received upwards of 1,200 complaints about the issue, linked to more than 100 injuries.
In September, the agency gave Philips the OK to begin its repair-and-replace program for the about 2.2 million recalled CPAP and BiPAP machines and other respiratory devices. The proposed effort included replacing the polyurethane foam with a silicone-based alternative.
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The FDA’s green light for the program was based in part on the results of tests of the new material that Philips completed in June. Testing for the silicone-based foam in devices authorized for use in the U.S. demonstrated acceptable results, the agency said.
However, while conducting a recent follow-up inspection of a Philips manufacturing facility as part of its efforts to identify the root cause of the initial issue, the FDA was given new information showing less than favorable results for the replacement foam in one device marketed outside of the U.S. In that case, the machine—equipped with the new material—failed a safety test studying the release of volatile organic compounds within the device.
The agency has since asked Philips to select an independent laboratory to test the silicone-based foam to identify any potential safety risks and their scope.
As the additional testing begins, the FDA said it doesn’t yet have enough information to issue a ruling on the safety of Philips ventilators in the U.S. that have already been repaired with the new foam and so “does not recommend that patients who have participated in the repair and replace program discontinue use of their product.”
That advice was based on the FDA’s assessment that the benefits of using the repaired devices still outweigh the risks of stopping the use of the ventilators based on the unconfirmed safety issue.
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After the FDA published its findings from the follow-up inspection, Philips said in a Nov. 14 statement that it will soon submit a response to those findings for review and reiterated that the regulator has yet to change its recommendations regarding the repaired devices.
“We will work closely with the FDA to clarify and follow up on the inspectional findings and its recent requests related to comprehensive testing. Until we have concluded these discussions, we are not able to publicly provide further details on these responses,” CEO Frans van Houten said. “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.”