Philips says sleep respirators 'unlikely' to harm

THE HAGUE, Netherlands - Dutch medical tech firm Philips said Tuesday that independent tests on sleep respirators at the centre of a massive recall showed the devices are unlikely to harm patients.

The medical device manufacturer had in 2021 announced a recall of its DreamStation machines for sleep apnoea, a disorder in which breathing stops and starts during sleep.

Users were at risk of inhaling or swallowing pieces of toxic soundproofing foam that could cause irritation or headaches.

The Amsterdam-based firm had also mentioned a "potential" cancer risk in the long term.

But Philips said Tuesday that tests covering 95 percent of its products globally showed similar results to another study in December that concluded the devices were "within safety limits".

Additional tests will be done to first-generation DreamStation which have been exposed to ozone cleaning.

Exposure to both emissions from the foam and ozone cleaning, according to the evaluation, "is unlikely to result in an appreciable harm to health in patients." Philips advised against ozone cleaning, which would likely cause further degradation of the foam.

The tests were conducted in collaboration with five independent, certified laboratories and the results were reviewed by third-party experts, Philips said.

The findings "are positive and reassuring", said CEO Roy Jacobs in a statement.

The latest tests were submitted to the US Food and Drug Administration, which "may reach a different conclusion", Philips said.

Philips has cut 10,000 jobs worldwide following the recall. The company posted a loss of 1.6 billion euros ($1.7 billion) last year and set aside 575 million euros for potential lawsuits in the United States. - AFP