BIRMINGHAM, Ala. (November 16, 2021)—During a recent plant inspection, the Food & Drug Administration (FDA) found that silicone-based foam Philips Respironics planned to use to repair recalled CPAP and ventilator devices had failed a safety test for volatile organic compounds.
Earlier this year, Philips initiated a recall of certain ventilators, CPAP and BiPAP machines due to potential health risks related to polyester-based polyurethane sound abatement foam used in the devices. This type of foam may break down and can result in serious injury. In September, the company announced the FDA had approved the repair and replace program for the devices.
The facility inspection was in response to the initial recall, but the agency obtained additional documentation while conducting it that showed the silicone-based foam, which is currently used in a device marketed outside the United States had failed a single safety test. The FDA did not identify which device was affected.
Similar testing provided by Philips to the FDA on U.S.-sold devices demonstrated acceptable results. The FDA has asked the company to have an independent laboratory perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam.
“The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program,” the agency wrote in a news 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.
Philips has been conducting its own tests on the foam and “takes this matter very seriously and will fully collaborate with the FDA,” the company wrote in a Q&A released on November 14 in response to the FDA’s report.
“We will work closely with the FDA to clarify and follow up on the inspectional findings and its recent requests related to comprehensive testing,” Philips CEO Frans van Houten said in a statement. “Until we have concluded these discussions, we are not able to publicly provide further details.”
In a press release, the FDA said it did not recommend patients who have already participated in the repair and replace program discontinue using their device because that may be more harmful to the patient’s health and quality of life. For patients using a recalled device that has not yet been repaired, the agency recommends patients consult their health care provider. The FDA will communicate the results of the independent lab testing.
“Ensuring patients and providers have the most up-to-date information regarding the recall of these critical devices is a top priority for the FDA,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “We recognize that patients rely on these devices, and we are closely monitoring the company’s actions to ensure that the issues are resolved in a timely manner given the impact on patients. We are committed to continuing to regularly update the public about the status of this recall, including any new recommendations or actions regarding Philips Respironics’ devices.”