FDA

The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices.

The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam supplier were aware for years that polyester-based polyurethane (PE-PUR) sound abatement foam could break down and potentially enter a device’s air pathway, causing health problems for users.

In the Form 483, FDA alerted management at the Royal Philips (NYSE:PHG) subsidiary of conditions that the inspector considered possible violations of the U.S. Food, Drug and Cosmetic Act or related regulations. The post-inspection report is not a determination of wrongdoing and will be considered by the FDA along with any evidence or documents collected from the facility and responses offered by Philips.

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The FDA said it has requested additional safety testing on the material used to repair Royal Philips (NYSE:PHG) sleep therapy devices recalled for foam that could harm patients using them.

The Class I recall that started in June covers more than 15 million devices, after hundreds of complaints and more than 100 injuries from polyester-based polyurethane (PE-PUR) sound abatement foam that broke down, allowing foam and chemicals to potentially enter the device’s air pathway and cause health problems for users.

On Friday, the FDA said that upon inspection of a Philips Respironics manufacturing facility used to make replacement foam for the recalled devices, it learned that the silicone-based product failed a safety test for the release of volatile organic compounds (VOCs). That test was conducted on a similar device sold outside the U.S.

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