Dutch medical device maker Philips said on Wednesday that extensive testing of the recalled ventilators showed they were “within safe limits” for use, but the final verdict is on global regulations. He said it was left to the authorities.
The Amsterdam-based company announced a global recall 18 months ago for devices used to treat people suffering from sleep apnea. This is due to concerns about “potential toxic and carcinogenic effects” if patients inhale or swallow the machine’s degraded sound deadening foam.
The recall has so far cost the company €2.2 billion ($2.3 billion), cut 4,000 jobs and forced one chief executive to step down.
But the company said Wednesday that extensive testing has shown the ventilators “comply with acceptable limits for particulate matter emissions.”
Philips based its results on research conducted by five independent laboratories, third-party experts, and an outside medical panel.
The study found that exposure to particulate matter emissions from degraded foam is “unlikely to cause appreciable harm to patient health.”
Philips CEO Roy Jacobs told AFP: “It’s important because today starts with reassurance that the product we put out was actually within the safety limits.” .
– “FDA still under review” –
“This is a complex issue and we wanted to do a very scientific and thorough job,” he added.
The latest test results have now been submitted to regulatory agencies, including the U.S. Food and Drug Administration, and are still to be evaluated.
“FDA is still reviewing the data and analysis … provided and may reach different conclusions,” Philips said.
Philips also said its advice to patients remains unchanged. Talk to your doctor to consider whether to continue using the affected model or switch to another model or alternative treatment.
The company said it is continuing to test other models, including those with different forms.
We have also investigated the impact of non-regulated and approved cleaning methods on machines, and the data available so far indicates that ozone cleaning exacerbates foam degradation.
Investors responded positively to Philips’ announcement, with the company’s share price jumping more than 4% in intraday trading on the Amsterdam Stock Exchange’s prime AEX index.
Starting as a lighting company over 130 years ago, Philips has undergone a major transformation in recent years, selling assets to focus on manufacturing high-end electronic healthcare products.
https://www.expatica.com/nl/general/embattled-philips-says-respirators-within-safety-limits-456872/ Stumped Phillips says ventilator is ‘within safe limits’