Philips says recalled CPAP, BiPAP machines show low risk of harm in completed safety tests

Almost two full years into its Class I recall of more than 5 million respiratory devices, Philips has wrapped up safety tests covering nearly all of the affected models—and is reiterating its previous conclusion that the disintegrating foam at the heart of the recall carries a low risk of harm to users’ health.

The June 2021 recall began after users reported that the polyester-based polyurethane (PE-PUR) foam used to muffle sounds and vibrations in many of Philips’ CPAP and BiPAP machines and ventilators may break down over time.

In the original recall notice, the FDA said that the disintegration could send small particles of foam and release untested chemicals into users’ airways, potentially causing health issues ranging from internal and external irritation to asthma, nausea and other “toxic and carcinogenic effects.”

Between April 2021 and the end of 2022, the FDA received more than 98,000 medical device reports (MDRs) stemming from the recall, the agency reported earlier this year. Those complaints include reports of 346 patient deaths, though both the FDA and Philips have noted that MDRs are unaudited, so their details can’t be definitively linked to a recall.

Philips released the latest set of safety test results (PDF) on Tuesday, covering all of the CPAP and BiPAP sleep therapy machines included in the recall—which together make up about 95% of all of the recalled devices. The tests included examinations of new, used and lab-aged devices, including the DreamStation, DreamStation Go and System One models.

Philips conducted the tests with help from five independent testing labs, and it reviewed the results alongside third-party qualified experts and an external medical panel.

In an echo of the partial results Philips published in December, the third-party reviewers once again concluded that exposure to any particles or chemicals released by the disintegrating foam in the sleep therapy devices “is unlikely to result in an appreciable harm to health in patients.” Those results carried over regardless of whether a device had been treated using ozone-based cleaners—which Philips has said can speed up the foam’s breakdown.

The testing also found that there was “low” visible foam degradation among used first-generation DreamStation devices. But even if all of the foam in a machine degraded, according to Philips, “the third-party risk assessment concluded that exposure to particulates from degraded foam in these devices, including potential respirable and non-respirable particulates, is unlikely to result in an appreciable harm to health in patients.”

Philips said it has submitted the latest results to the FDA and other necessary agencies, noting, “The FDA is still considering the data and analyses that Philips Respironics has provided and may reach a different conclusion.”

“We share the same objective to ensure patient safety and quality in the delivery of healthcare, and we remain committed to working closely with these agencies,” Philips CEO Roy Jakobs said in a press release Tuesday. “The completion of testing and remediation of the affected devices remain our highest priorities.”

In the meantime, the company is still in the process of testing the ventilators included in the recall—which contain a different type of PE-PUR foam than the CPAP and BiPAP machines—and is also still examining DreamStation Go and System One machines that underwent ozone cleaning.