The problems with Philips sleep apnea devices are less dangerous for users than the Dutch healthcare technology company previously thought. The company made this announcement based on early research results into the machines. The recall continues unabated, however.

The sound-insulating foam in the devices caused the problems. The foam could crumble and release chemical substances. Because Philips did not know how harmful those chemicals were, the company assumed the worst - that they were carcinogenic. But extensive testing in the lab showed that much smaller amounts of chemicals were released than feared. The tested machines also fell within the safety standards regarding substance emissions. That means that the risk of cancer and other diseases due to using the sleep apnea machines is “very small,” according to Philips.

Philips also looked at the crumbling of the insulation foam. But research showed that it barely happens. When the foam is affected, it turns into a kind of gel-like mass. That makes the possibility of small particles entering users’ lungs less likely. 

Philips relies heavily on tests done on North American devices for the test results. Devices with degraded foam were found in that region and not in Europe and Japan. Philips thinks that cleaning with ozone, which Philips never recommended and the US regulator FDA warned against, played a role. Devices that users said had not been cleaned with ozone were 0.5 percent affected. Devices cleaned with ozone were 7 percent affected.

Philips is complying with FDA requirements in providing this update. But in its own words, the company also wants to give users some clarity. “Right now, we say to patients: ‘Talk to your doctor about whether you should continue to use the device.’ This information can help with that.”

The test results showing that improper cleaning may be behind the sleep apnea device problems are encouraging for Philips, CEO Frans van Houten said to ANP. “That was already our assumption but has now also been proven.” Also, with a view to possible damage claims, Van Houten is “very happy with this result.”

“In the tested devices, there were 422 about which a complaint had been lodged, but only 4 percent’s insulating foam had been affected,” Van Houten said. “So you could conclude that the rest of the complaints have nothing to do with this recall.”

At the same time, Van Houten acknowledged that this is a difficult time for patients. “We were criticized that it all takes a long time, and from the patient’s perspective, that is true,” he said. “A patient should never be the victim of a device, whether it is because of the device itself or because of the way it is cleaned.”

In the Netherlands, Philips has so far replaced about 35,000 devices. That’s about a third of the total. By the end of this year, Philips wants to replace 90 percent of the approximately 5.5 million affected devices with a new one or a wholly revised one with a different type of insulating foam. Philips set aside almost 900 million euros for this. 

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