In its latest update on Philips Respironics’ June 2021 recall of certain CPAP, BiPAP, and ventilator devices, the US Food and Drug Administration (FDA) highlights ongoing concerns about the potential health risks from the devices’ foam degradation.
The update from Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health says the FDA “remains unsatisfied” with the status of the recall and that Philips’ testing to date is inadequate.
“We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” reads the update. “Although Philips concluded that the exposure to foam particles and VOCs from these devices is ‘unlikely to result in an appreciable harm to health in patients,’ the FDA believes additional testing is necessary.
According to the update, Philips has agreed to conduct the requested additional testing.
Following the initiation of the recall by Philips in June 2021, Philips, at the FDA’s request, began extensive additional testing on the PE-PUR sound abatement foam to better assess potential health risks related to the possible emission of particulates from degraded foam and certain volatile organic compounds (VOCs).
In a notification order issued to Philips under section 518(a) of the Federal Food, Drug, and Cosmetic Act, the FDA ordered the company, in part, to provide a link for health care providers and registrants to access all available testing results and third-party confirmed conclusions on findings from testing PE-PUR foam used in devices manufactured by Philips for particulates and VOCs, regardless of the Philips devices that the foam may have been tested in.
Philips has issued updates about its independent testing program to assess the health risks related to the PE-PUR sound abatement foam found in certain recalled Philips ventilators, BiPAP machines, and CPAP machines. The FDA has reviewed the available information and data provided to FDA by Philips.
Based on the currently available information, the FDA maintains its recommendations regarding the potential health risks associated with the PE-PUR foam breakdown in these recalled devices. The FDA says it will review any additional information provided by Philips and continue to monitor medical device reports to further inform the ongoing analysis of the potential health risks.
Additionally, the FDA issued to Philips a notice of opportunity for an informal hearing on CDRH’s proposal that a section 518(b) order should be issued—an authority that has not been used by the FDA’s Center for Devices and Radiological Health in the past 10 years. This notice proposed that an order should be issued requiring the company to submit a plan for the repair, replacement, and/or refund of the purchase price of devices subject to the recall that were manufactured after November 2015. Philips did not request a hearing but instead submitted a written response relating to, among other things, the recall remediation plan and repair, replacement, and/or refund.
As part of the FDA’s continued efforts to ensure consumers have the latest information on the Philips’ recall, the agency published a new resource section on FDA.gov, including a comprehensive timeline of FDA activities related to the June 2021 recall.
“Patients, consumers, and health care providers have played an integral part in providing feedback to the FDA about the Philips recall, and their feedback is reflected in this new resource to ensure it provides timely and accurate information,” the update notes.
