Philips Respironics Provides Testing Update

• By Laurie Watanabe
• May 25, 2023

Philips Respironics has provided an update on its test and research program designed to evaluate health risks related to the polyester-based polyurethane (PE-PUR) foam in ventilators and sleep devices involved in the company’s June 2021 voluntary recall.

In a May 16 news announcement, parent company Royal Philips said, “The risk assessments have now been completed for the CPAP/BiPAP sleep therapy devices under the recall notification/field safety notice, i.e., the first-generation DreamStation, System One and DreamStation Go devices, representing approximately 95 percent of the registered devices globally … Additionally, tests and analyses have been completed for first-generation DreamStation devices that have been exposed to ozone cleaning.”

The testing was done with “five independent, certified testing laboratories,” and results were assessed by third-party experts, Philips Respironics, and an external medical panel, the manufacturer added.

The actions involved included testing “performed on multiple used devices with differing amounts of patient usage and observed visual foam degradation, and on lab-aged foam that had been intentionally degraded to different degrees. Very conservative assumptions were included in the risk assessments.”

What the Testing Said

As part of the announcement, Philips Respironics released test results and analysis for sleep devices not exposed to ozone cleaning. “The completed set of test results and analyses for the first-generation DreamStation, System One and DreamStation Go sleep therapy devices indicate that potential patient exposure to foam particulate matter (PM) and volatile organic compounds (VOCs) from the PE-PUR foam within these devices is unlikely to result in an appreciable harm to health in patients,” the manufacturer said. “Expanded testing and toxicological risk assessments on multiple devices with new, used, and lab-aged foam have shown no appreciable harm to health for the VOCs detected based on ISO 18562-3 [2] testing, and a third-party risk assessment concluded that exposure to VOCs for these devices is unlikely to result in an appreciable harm to health in patients.”

Philips Respironics added that tests were done on PM emissions of used devices that had visible degradation, and that those devices’ emissions “were not statistically different than PM emissions of used devices without degradation, suggesting that degradation did not contribute to appreciable elevated levels of respirable particles in the devices tested.

“Even with the very conservative and theoretical assumption that all of the foam could degrade and that a patient is then exposed to all of the degraded PE-PUR foam within the devices, 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.”

Ozone Cleaning Test Results

The announcement also said Philips Respironics had completed testing on first-generation DreamStation devices that had been exposed to ozone cleaning, and concluded that “exposure to VOC emissions from the assessed devices treated with ozone cleaning is unlikely to result in an appreciable harm to health in patients.” The same result was announced for exposure to PM emissions in the devices that had been examined: “Unlikely to result in an appreciable harm to health in patients.”

The company acknowledged that ozone cleaning “exacerbates foam degradation,” but said that degradation is “unlikely to result in an appreciable harm to health in patients.”

“Philips Respironics is in the process of completing various remaining tests and analyses,” the announcement said. “Patients currently using an affected sleep therapy device that has not been remediated and not registered yet are requested to register their devices to facilitate the remediation.

“Philips Respironics continues to advise patients using affected sleep therapy devices that have not been remediated yet to contact their physician or care provider to decide on a suitable treatment for their condition, which may include stopping use of their device, continuing to use their affected device, using another similar device that is not part of the recall, or using alternative treatments for sleep apnea.”

In June 2021, Philips Respironics recalled certain ventilators, BiPAP machines and CPAP machines because the PE-PUR foam in the systems could break down, and the foam or chemicals in the foam could be breathed in or swallowed by users. “The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer,” the U.S. Food & Drug Administration said in an announcement.

Philips recalled devices made between 2009 and April 2021. The PE-PUR foam was meant to reduce sound and vibration when the devices were in operation.