Devices

FDA ‘Unsatisfied’ with Philips Respironics Recall

CDRH director Jeffrey Shuren says FDA remains unsatisfied with the status of the Philips Respironics recall of ventilators, bilevel positive airway pressure machines and continuous positive airway pressure machines due to potential health risks of PE-PUR sound abatement foam. In an online post, Shuren says that although Philips undertook testing on the PE-PUR foam at the request of FDA to better assess the health risks, the agency believes the testing and analysis Philips has shared to date are not adequate to fully evaluate the risks posed to users from the recalled devices.

“Although Philips concluded that the exposure to foam particles and volatile organic compounds from these devices is ‘unlikely to result in an appreciable harm to health in patients,’” Shuren wrote, “FDA believes additional testing is necessary. Philips has agreed to conduct the additional testing. Based on the currently available information, FDA maintains its recommendations regarding the potential health risks associated with the PE-PUR foam breakdown in these recalled devices.”

The post also discusses the FDA recall response team that has been dedicated to this issue; efforts to address device shortages; issuance of the 3/10/22 order requiring the company to notify all device users, durable medical equipment suppliers, distributors, retailers, and healthcare providers about the recall and the health risks posed by the foam used in the recalled products; and Philips’ decision not to take advantage of an opportunity for an informal FDA hearing and instead submitted a written response relating to, among other things, the recall remediation plan and repair, replacement, and refund.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome