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US drug regulator ‘unsatisfied’ by Philips’s progress on ventilator recall

Dutch medical device maker, Philips Respironics, agreed to conduct further tests on its faulty ventilators after the USFDA said it was “unsatisfied” with the status of a recall.

HQ Team

October 6, 2023: Dutch medical device maker, Philips Respironics, agreed to conduct further tests on its faulty ventilators after the USFDA said it was “unsatisfied” with the status of a recall.

The Food and Drug Administration had reviewed the available information and data provided to the FDA by Philips, Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health said.

“We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users of the recalled devices,” Dr Shuren said in a statement.

Though 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,” the FDA believes additional testing is necessary, he said.

PE-PUR foam

The recall impacted 15 million devices worldwide.

The polyester-based polyurethane foam used in these devices to reduce sound and vibration can break down. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device, the FDA stated.

The swelling of the foam pieces could potentially result in serious injury and may require medical intervention to prevent permanent injury.

In June 2021, the FDA alerted people who use certain Philips ventilators, and airway pressure machines, because of potential health risks.

Philips has issued updates about its independent testing program to assess the health risks related to the sound abatement foam found in certain recalled Philips ventilators and airway pressure machines.

‘Still monitoring’

“While this matter is ongoing, the agency continues to monitor the company’s recall progress and share new information with device users, patient care facilities, and other stakeholders,” Dr Shuren said.

“The FDA remains unsatisfied with the status of this recall, and we continue to take steps to protect the health and safety of individuals using these devices.”

Philips has agreed to conduct the requested additional testing, he said.

“Based on the currently available information, the FDA maintains its recommendations regarding the potential health risks associated with the PE-PUR foam breakdown in these recalled devices.”

The FDA will review any additional information provided by Philips and continue to monitor medical device reports to further inform our ongoing analysis of the potential health risks, he said.

Other manufacturers

An FDA Recall Response Team is meeting regularly with Philips to monitor and track its handling of this recall. The team has a wide range of expertise and is dedicated to developing FDA’s safety.

“Recognising the critical need for these devices, the FDA has worked with other manufacturers and government partners to help make more machines available over the course of the recall,” Dr Shuren said.

“The FDA continues to take steps, including regular monitoring of Philips’ reported progress on the remediation and replacement of these critical devices, to ensure patients receive accurate and transparent information about this recall,” he said.

The FDA has removed these products from the device shortage list.

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