Philips: ‘We have better understanding of the potential health risks’

AMSTERDAM – Exposure to particulate matter emissions from degraded foam in first-generation DreamStation devices is unlikely to result in harm to patients and exposure to volatile organic compounds is not anticipated to result in long-term health consequences for patients, according to the latest test results and assessments from Philips. 

Additionally, presence of visible foam degradation in inspected returned devices was found to be low: Of 36,341 returned devices from the U.S. and Canada, 164 showed significant visible degradation, according to results and assessments. 

“Our first priority is the health and well-being of patients, both in terms of safety and providing replacement devices,” said Roy Jakobs, CEO of Royal Philips. “Over the past 18 months, we have focused on gaining more clarity about the safety of the devices affected by the June 2021 field safety notice and providing replacement devices to patients as fast as we can. Now, have a better understanding of the potential health risks compared to the limited insights that we had in early 2021. I would like to stress that we are very sorry that it has taken this much time, but the testing involved long throughput times, and needed to be done thoroughly. We deeply regret the concern and uncertainty felt by patients, their physicians, and customers, and continue to work hard to address their needs. By year-end we have ramped up our production such that we have produced almost 90% of all devices that are needed for the remediation program.” 

Philips also published results to date for first-generation DreamStation devices exposed to ozone cleaning showing exacerbated foam degradation. However, the company found that exposure to particulates from degraded foam with self-reported ozone use in first-generation DreamStation devices is unlikely to result in appreciable harm to health in patients. It is still assessing the VOC toxicological risk of this ozone-induced foam. 

• Read about the testing results previously published by Philips in June 2022 and December 2021.