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Foam degradation rare in Philips ventilators, mainly caused by cleaning products

by John R. Fischer, Senior Reporter | July 07, 2022
Business Affairs European News Risk Management
Testing shows that foam degradation is rare in Philips' recalled medical devices and linked almost exclusively to unauthorized cleaning products.
Independent testing in Europe and the U.S. has revealed that foam degradation in Philips’ recalled ventilators is very rare and linked almost exclusively to unauthorized cleaning products.

CEO Frans van Houten shared the update June 28, calling the results “very encouraging” and saying use of aggressive ozone-based cleaning products is what mainly caused the issues.

Last summer, Philips recalled 5.5 million bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines after it was discovered that the polyester-based polyurethane (PE-PUR) sound abatement foam within them could break down and release particles that could enter a device’s airway pathway and become toxic. This could cause a range of potential health problems, including possibly cancer.

An inspection of over 60,000 machines in the U.S. showed degradation in less than 0.5% of those not cleaned with ozone products. Using the cleaning solutions increased damage up to 7% or 14 times more, according to Reuters.

The devices tested represent 68% of all those affected worldwide, said van Houten. “While certain prolonged tests across the affected product categories are still to be completed, the results to date for the first-generation DreamStation devices, which represent the majority of the registered affected devices, show a very low prevalence of visible foam degradation."

Concerns about the potential harm caused Philips to withdraw from the sleep therapy market for at least a year and have cost it around €15 billion ($15.9 billion) due to fears over a hundred class action lawsuits filed. Philips orchestrated a recall and repairs operation in September, which is half complete and expected to cost around €900 million (over $916 million).

Testing consisted of visual assessments, volatile organic compound evaluations, particulate matter (PM) testing, and assessments for risks created by contact with the foam.

Philips says it will continue to assess the potential toxicity of the degraded foam parts. "The recall is far from over, but today’s release will provide comfort that potential healthcare risk for patients has been very low," ING analysts wrote in a note.

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