Most Philips sleep apnea devices safe despite risk of crumbling insulation foam
Most of Philips’ troubled sleep apnea devices were safe after all, the medical tech company concluded after extensive research. Last year, Philips also brought out favorable test results for the company regarding the long-dragging and expensive recall. Now Philips has a new update.
The problem with the sleep apnea devices is related to insulation foam in the machines. The foam could crumble or release chemical substances after contact with certain cleaning agents. But according to Phlipls, the research so far has shown that the risks fall within the safety limits.
CEO Roy Jakobs spoke of “good news for the patients who used the devices.” According to him, they can now rest assured that the devices were safe.
The test results relate to approximately 95 percent of the delivered devices. If the machines were not cleaned with ozone, there were no safety risks, according to Philips. And regardless of which cleaning agent was used, the first-generation Dreamstation devices posed no danger to users’ health despite the potential of insulation foam breaking down. That covers about two-thirds of the devices.
In total, Philips has to replace 5.5 million sleep apnea and ventilator devices worldwide. The company has so far replaced 4.3 million of these machines. In the Netherlands, there are almost 100,000 affected devices.
According to Jakobs, the testing will continue in the coming time. Later this year, Philips hopes to also publish results for the ventilators. Jakobs said that the first figures for the ventilators look “encouraging,” but Philips would like to have everything “scientifically substantiated.”
The company already reserved about a billion euros for the entire recall. In April, Philips also set aside 575 million euros for a possible damage claim in the United States connected to the sleep apnea devices’ recall. American patients are busy setting up a mass claim.
More claims at play could increase the costs of the affair even further. According to Philips, ozone is a common cleaning agent in the United States, unlike in the Netherlands. However, the company has already indicated that many reports have also been received about devices in which, after checking, the insulation foam was still intact.