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Testing indicates degraded foam in Philips respirators unlikely to pose substantial harm

by John R. Fischer, Senior Reporter | December 23, 2022
Business Affairs European News
Philips' DreamStation 1 Device
Philips saw its shares rise 3.5% this week after revealing that respiratory devices it recalled over the last year were proven to have limited health risks.

Since June 2021, the company has recalled millions of breathing devices and ventilators for treating sleep apnea after it was discovered that the polyurethane foam used to dampen the machines’ sounds may degrade and release small particles that irritate the airways and become toxic, potentially causing cancer.

The global recall and subsequent concerns of lawsuits have cost the company 70% of its market value, to date, according to Reuters.

But on December 21, the company said that independent testing on its first-generation DreamStation devices showed that the degraded foam was "unlikely to result in an appreciable harm to health in patients", as long as they were not treated with ozone-based cleansing products, as per instructions, reported Reuters.

“Over the past 18 months, we have focused on gaining more clarity about the safety of the devices affected by the June 2021 field safety notice, and providing replacement devices to patients as fast as we can. The comprehensive test and research program has yielded extensive data and results for the first-generation DreamStation devices, and we now have a better understanding of the potential health risks compared to the limited insights that we had in early 2021,” said Philips CEO Roy Jakobs in a statement.

The first-generation solutions represent approximately 68% of the registered recalled devices globally. Jakobs said the company has produced almost 90% of all replacement devices.

The tests also showed that exposure to volatile organic compound emissions were not expected to create long-term health consequences for patients.

The company said earlier this year that testing had shown that foam degradation was very rare and primarily caused by the use of unauthorized ozone-based cleaning products.

Additional tests showed that exposure to these products makes devices 14 times more likely to have significant and visible foam degradation, compared to those cleaned appropriately.

Philips Respironics is currently completing other tests, including for SystemOne sleep therapy devices (approximately 26% of the registered devices globally) and DreamStation Go (approximately 1%), which have the same PE-PUR foam.

Testing for the Trilogy 100/200 (approximately 3%) and OmniLab Advanced Plus ventilator devices (approximately 2%), which have a different type of PE-PUR foam, is also underway.

“The relevant competent authorities globally, including the FDA, are still reviewing the extensive data and assessments that we have provided. We share the same objective: to ensure patient safety and quality in the delivery of healthcare,” said Jakobs.
(1)

Arnav Singh

Philips Return

January 11, 2023 10:25

we really miss the philips product, its should come strongly.

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