Philips completes testing for first-gen DreamStation devices

• Company has spent 18 months testing exposure to particulate matter and VOC emissions from degraded foam in its first-generation DreamStation CPAP devices
• It has shared test results and assessments with the U.S. Food and Drug Administration but does not have a timeline for when it will hear back 
• Right now, there are no changes to guidance for health care providers and patients 

AMSTERDAM – Philips officials say a now completed set of test results and assessments of recalled first-generation DreamStation CPAP devices is “encouraging and reassuring.” 

Results showed exposure to particulate matter emissions from degraded polyester-based polyurethane (PE-PUR) sound abatement foam is unlikely to result in appreciable harm to the health of patients and exposure to volatile organic compound emissions (VOCs) is not anticipated to result in long-term health consequences for patients. 

When asked during a conference call if the results mean that Philips can modify the current field safety notice, CEO Roy Jakobs said the company needs “alignment” with the U.S. Food and Drug Administration and other regulators. 

“We come out with results today that do show use of DS1 is within safety limits,” he said. “In terms of the process we’re in and any potential change to the advice, that, of course, has to happen in alignment with regulators. We have taken 18 months to get through these results because this is a scientific, elaborate process that needs to be done thoroughly, and we have put an ample amount of resources on it. We have shared this data set with the regulator, but they have had only a few weeks. They need time to work through this; they also uphold the right to draw conclusions. We have stayed in very close contact with the regulators. They have even had input on today’s release. After the alignment with the regulator and their assessment, then you can change, for example, the field safety notice that we have out there.”

These latest results follow previous results released in December 2021 and June 2020.

Philips officials also addressed additional VOC testing for its replacement silicone-based foam, saying that, based on final reports that are also subject to FDA review, the company has not identified any safety issues. 

Additionally, Philips published a set of test results for devices exposed to ozone cleaning that show it exacerbates foam degradation but that, even when degradation occurs, it is unlikely to result in appreciable harm to the health of patients. The company is still assessing the VOC toxicological risk of degradation from the devices.

When asked if Philips has the same obligation to patients who have used ozone cleaning on their devices as those who have not, Jakobs said, “We are addressing all machines in the field and replacing them, regardless. In determining any safety risk that has related to the use of it, that’s where we are giving the update today that we have encouraging results.”

Philips emphasized the scope of its test and research program, which not only spanned 18 months but also involved five certified independent testing labs in the United States and Europe, third-party toxicologists and a medical panel.

“We’ve inspected more than 60,000 devices,” Jakobs said. “We’ve conducted hundreds of tests. We have taken a very rigorous approach.”

Philips officials also reiterated plans to complete 90% of its remediation program by the end of this year, despite supply chain and other challenges.

“We've quadrupled our production capacity compared to before the recall and we’ve mobilized more than 1,000 people working on the recall day in and day out,” Jakobs said. “We know how important these devices are to patients and we’re working hard to get them to them as quick as we can.”