FDA ‘remains unsatisfied’ in Philips Respironics ventilator, sleep apnea device recall

The FDA asked for more testing regarding the recall of certain Philips Respironics ventilators, bilevel positive airway pressure machines and continuous positive airway pressure machines, according to an update from the agency.

“The FDA remains unsatisfied with the status of this recall, and we continue to take steps to protect the health and safety of individuals using these devices,” Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said in a statement.

In June 2021, the FDA issued an alert that Philips Respironics recalled 15 million ventilators, bilevel positive airway pressure (BiPAP) and CPAP machines because of the possibility for a polyester-based polyurethan (PE-PUR) sound abatement foam to break down and enter the device’s air pathway, subsequently to be swallowed or inhaled by the device’s user.

According to the FDA update, Phillips began testing after the recall to understand the health risks of the PE-PUR sound abatement foam and its volatile organic compounds (VOCs). The FDA has reviewed results from this testing but has deemed them unsatisfactory and has called for additional testing.

“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,” Shuren said in the statement. “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.”

Although the original recall of these devices created a shortage for patients who use them, the FDA acknowledged in its update that by working with other manufacturers and government partners, alternatives have become available and the supply of CPAP and BiPAP devices has increased enough to warrant their removal from the FDA’s device shortage list.

FDA encourages anyone with an affected device to register it if they have not done so. More information on all the recalled Philip devices and the FDA’s activities thus far are available online.

“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.”