Philips says tests clear recalled sleep apnea machines of health risks
(Reuters) — Dutch medical devices maker Philips said Tuesday that independent tests have shown that the use of its respiratory devices involved in a major global recall did not cause health risks for patients.
Philips said “rigorous testing” by external parties on the range of DreamStation machines used to treat sleep apnea showed positive results, confirming preliminary results released last year.
“We are very pleased with these results, it is very important for patients to know that the use of the devices did not lead to a health risk,” Philips CEO Roy Jakobs told Reuters in a phone interview.
“It proves we have worked with a safe product, even though it might degrade.”
Amsterdam-based Philips has been grappling with the fallout of the global recall in June 2021 of millions of respirators used to treat sleep apnea over worries that foam used in the machines could become toxic.
It said exposure to particulate matter emissions and volatile organic compounds from degraded foam in DreamStation devices was “unlikely to result in an appreciable harm to health in patients.”
Philips had already said last year that tests indicated foam degradation was very rare and was linked to the use of unauthorized ozone-based cleaning products.
It now added that foam degradation as a result of such cleaning was also unlikely to result in appreciable harm.
Philips shares were up 3% in early Amsterdam trading.
Philips has lost around 70% of its market value since announcing the recall, as investors feared large litigation bills from a string of lawsuits launched by worried patients.
The DreamStation machines included in the tests cover 95% of all recalled devices, Philips said.
The company expects test results for the remaining 5% to become available in the third quarter of this year.
