FDA Requests More Device Testing From Philips

WASHINGTON—The Food and Drug Administration (FDA) isn’t satisfied with the recall of CPAP and respiratory devices from Philips Respironics and has urged the company to conduct more testing.

The recall began in June 2021, when the FDA alerted people using some Philips ventilators, CPAP machines and BiPAP machines to potential health risks caused by the breakdown of polyester-based polyurethane (PE-PUR) foam used to dampen sound in the devices, including the possibility of users breathing in particulate matter or volatile organic compounds. An estimated 15 million devices were affected worldwide.

Philips launched a voluntary recall in the United States and began extensive testing on the PE-PUR foam. In its most recent notice, the FDA said it doesn’t think the testing is sufficient.  

“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,” the agency said on a web page posted Oct. 5 and attributed to Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “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.”

The FDA and Philips both said the company has agreed to conduct the additional requested testing. Philips said it is still in discussions with the FDA on details about future testing.

“Philips shares the same objective as the US Food and Drug Administration (FDA) and other regulators to ensure the highest standards of patient safety and quality in the delivery of healthcare,” the company said in a response issued Oct. 6. “Philips remains committed to working closely with regulators across the world, as we continue to dedicate all necessary resources to ensure that patients receive remediated devices, and the test and research program is completed.”

Philips Respironics said it conducted extensive testing with five independent laboratories and concluded that its sleep therapy devices aren’t likely to result in appreciable harm.

Meanwhile, the FDA published a new resource section on its website with information about the Philips recall, saying it reflected feedback from patients and providers about the need for timely information.

“We understand the recalled devices deliver critical care and serve an important public health need for a widespread patient community,” Shuren said. “Ensuring patients and providers have the most accurate and up-to-date information about the Philips recall remains of utmost importance to the FDA, and we are committed to doing everything we can to protect the health and safety of patients affected by this recall. We will continue to keep the public informed as new information becomes available.”