insiderblm
In The Hague: Independent tests on sleep respirators at the center of a massive recall revealed Tuesday that the devices are unlikely to harm patients, according to the Dutch medical technology firm Philips.
In 2021, the medical device manufacturer announced a recall of its DreamStation machines due to sleep apnea, a condition in which breathing stops and starts during sleep.
Users risked inhaling or swallowing toxic soundproofing foam, which could cause irritation or headaches.
The Amsterdam-based company also mentioned a “potential” cancer risk in the long run.
However, Philips stated on Tuesday that tests covering 95 percent of its products globally yielded similar results to a December study that concluded the devices were “within safety limits.”
Additional tests will be performed on first-generation DreamStation units that have been subjected to ozone cleaning.
According to the evaluation, exposure to both foam and ozone cleaning emissions “is unlikely to result in an appreciable harm to health in patients.”
Ozone cleaning, according to Philips, would likely cause further degradation of the foam.
According to Philips, the tests were carried out in collaboration with five independent, certified laboratories, and the results were reviewed by third-party experts.
According to CEO Roy Jacobs, the findings are “positive and reassuring.”
The most recent tests have been submitted to the US Food and Drug Administration, which “may reach a different conclusion,” according to Philips.
Following the recall, Philips cut 10,000 jobs worldwide. Last year, the company lost 1.6 billion euros ($1.7 billion) and set aside 575 million euros for potential lawsuits in the United States.
