AMSTERDAM—Philips Respironics has released updated results of testing on its recalled PAP and ventilation devices to the Food and Drug Administration, saying that the assessments available show patients exposed to chemicals and particulates by using them were unlikely to have appreciable harm to their health.
The company published a table of the comprehensive third-party assessments that have been completed so far. It said that, for those machines using the Type A version of the sound- and vibration-abating foam—those on first-generation DeamStation, DreamStation Go and System One platforms—the tests found it is unlikely to result in “appreciable harm” if patients are exposed to foam dust and compounds.
“These risk assessments characterized the chemicals present in degraded foam and included conservative exposure assumptions, including that all Type A foam in a device (i.e., 100% of the foam in the device) could become severely degraded, emitted from the device and reach a patient,” Philips wrote in its report issued May 16.
Tests of devices with Type B polyester-based polyurethane (PE-PUR) foam—the Trilogy 100 and 200 and A-Series—are still ongoing and assessments have not yet been provided, Philips said.
Philips said it was releasing the data, which has been gathered from five independent testing labs in the United States and Europe, to help health care providers, users and others determine the risks continuing to use recalled devices.
In June 2021, Philips announced a voluntary recall for 18 CPAP, BiPAP and ventilator devices due to allegations that the PE-PUR foam used inside them to dampen sound and vibrations could degrade and release carcinogenic materials into the breathing passage. At the time, Philips said, it did not have conclusive data that exposure to the particulates or volatile organic compounds released by aging foam would lead to cancer, but it acted out of an abundance of caution.
Almost two years later, the recall is still ongoing as the company works to replace devices. In April, the FDA said that the number of replacement and remediated devices was considerably less than the number Philips said had been shipped—some 2.46 million—and that it was concerned about wait time for consumers.
Philips said in its latest report that it “remains fully committed to addressing all devices … and continues to work with the relvant competent authorities to further optimize the remediation plan.”
The FDA had not yet responded to or reported Philips’ recent testing report. The company warned that the agency “may reach a different conculsion.”
