A year after Philips launched a major recall of sleep apnea machines, the concern interim reported about its own research into the danger of those devices. Philips must provide clarity about this danger from supervisors. It has sold millions of these devices worldwide.
The problem lies in the sound-absorbing foam that Philips used, made of polyester-polyurethane. That foam turned out to be able to ‘degrade’, become loose in the device. The airflow from the machines goes directly into the lungs of users, and possibly the foam as well. Patients with sleep apnea experience prolonged pauses in breathing during their sleep.
Philips has now inspected more than 60,000 replaced or repaired appliances. In addition, it was noted that equipment cleaned by cleaning machines that use ozone was significantly more likely to suffer from crumbling foam. “Significant degradation” of the foam was seen in 7 percent of these devices. Foam degradation also occurred in sleep apnea devices not exposed to such cleaning machines, but less frequently: “significant foam degradation” was seen in half a percent of these devices.
Cleaning with ozone
The company has previously made connections with cleaning machines. Manufacturers such as the American SoClean focus on convenience: they prefer to clean automatically than manually every morning with soapy water. SoClean itself claims that ozone is harmless when cleaning sleep apnea devices and has previously threatened lawsuits against Philips over “false and misleading” accusations.
What is striking about the research results is that much is still unclear. For example, Philips is still investigating to what extent the floating foam is harmful to the body. Different types of machines are also still the subject of research. Previous research by Philips showed that the emissions from foam released remain within the safety standards.
Share falls
The affair with the sleep apnea devices is a drama for Philips. The healthcare group has lost 60 percent of its stock market value since March last year. Investors also reacted negatively to the update on Tuesday, as the share price fell by just under 2 percent.
Investors fear legal fees – claims have already been filed in many countries. The company has allocated almost a billion euros for the operational side of the recall. Philips is also held liable by users in the Netherlands. About fifty thousand Dutch people use the machines.
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