Until we have concluded these discussions, we are not able to publicly provide further details on these responses,” CEO Frans van Houten said. “We will work closely with the FDA to clarify and follow up on the inspectional findings and its recent requests related to comprehensive testing. 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. RELATED: Philips CPAP recall still chips away at earnings, with nearly 40% drop in Q3 connected care salesĪfter the FDA published its findings from the follow-up inspection, Philips said in a Nov. 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. 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.” 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.Īs 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. In that case, the machine-equipped with the new material-failed a safety test studying the release of volatile organic compounds within the device. 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. demonstrated acceptable results, the agency said. Testing for the silicone-based foam in devices authorized for use in the U.S. 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. RELATED: Philips gets green light to begin repairing millions of recalled sleep apnea machines
The proposed effort included replacing the polyurethane foam with a silicone-based alternative. As you may have heard, PAP manufacturer Philips. 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. Several people use CPAP or BPAP or mechanical ventilators for treatment of sleep apnea and other conditions.
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