FDA requests more testing from Philips

WASHINGTON – The U.S. Food and Drug Administration has requested that Philips conduct additional testing on the health risks related to the sound abatement foam in certain recalled Philips ventilators and BiPAP and CPAP devices. 

“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 FDA stated. “Although Philips concluded that the exposure to foam particles and VOCs from these devices is ‘unlikely to result in appreciable harm to health in patients,’ the FDA believes additional testing is necessary. Philips has agreed to conduct the requested additional testing.” 

Philips is still in discussions with the FDA on the details of further testing, according to a statement from the company. 

In the past two years, Philips, together with five independent, certified testing laboratories, has conducted extensive testing and, based on the results to date, the company says that use of its sleep respiratory therapy devices is not expected to result in appreciable harm to health in patients. 

• Most recently, in July, Philips said testing on the impact of ozone cleaning on the Philips System One and DreamStation Go sleep therapy devices shows VOCs and particulate matter emissions related to foam degradation are within the applicable safety limits and are unlikely to result in appreciable harm to health in patients. 

• In May, the company released a completed set of test results for the first-generation DreamStation, System One and DreamStation Go sleep therapy devices that indicate potential patient exposure to foam particulate matter and VOCs from the foam in these devices is unlikely to result in appreciable harm to health in patients. 

• In 2022, the company said a comprehensive testing and research program on the foam in certain CPAP, BiPAP and mechanical ventilator devices has shown very low prevalence of visible degradation.  

“Philips shares the same objective as the FDA and other regulators to ensure the highest standards of patient safety and quality in the delivery of healthcare,” the company stated. “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.” 

The FDA says, based on currently available information, it maintains its recommendations regarding the potential health risks associated with the foam breakdown in recalled devices.