![]() Recognizing 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. The team has a wide range of expertise and is dedicated to developing FDA's safety communications, monitoring the status of the recall, reviewing test results and other submissions related to the recall, communicating with patients and health care professionals affected by the recall, and mitigating shortages of these important devices. This team meets regularly with Philips to monitor and track its handling of this recall. Recall Response Teamįrom the start of the recall in 2021, we have mobilized a dedicated response team across the agency to work on the regulatory efforts related to this recall and address questions and concerns raised by patients and health care providers. Patients, consumers, and health care providers have played an integral part in providing feedback to the FDA about the Philips' recall, and their feedback is reflected in this new resource to ensure it provides timely and accurate information. Today, as part of our continued efforts to ensure consumers have the latest information on the Philips' recall, the FDA published a new resource section on FDA.gov, including a comprehensive timeline of FDA activities related to the June 2021 recall. The FDA will review any additional information provided by Philips and continue to monitor medical device reports to further inform our on-going analysis of the potential health risks. 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. Philips has agreed to conduct the requested additional testing. Although Philips concluded that the exposure to foam particles and VOCs from these devices is "unlikely to result in an appreciable harm to health in patients," the FDA believes additional testing is necessary. We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices. The FDA has reviewed the available information and data provided to FDA by Philips. Philips has issued updates about its independent testing program to assess the health risks related to the PE-PUR sound abatement foam found in certain recalled Philips ventilators, BiPAP machines, and CPAP machines. In a notification order issued to Philips under section 518(a) of the Federal Food, Drug, and Cosmetic Act (see further information below), the FDA ordered the company, in part, to provide a link for health care providers and registrants to access all available testing results and third-party confirmed conclusions on findings from testing PE-PUR foam used in devices manufactured by Philips for particulates and VOCs, regardless of the Philips devices that the foam may have been tested in. Independent Testing: PE-PUR Foamįollowing the initiation of the recall by Philips in June 2021, the company, at the FDA's request, began extensive additional testing on the PE-PUR sound abatement foam to better assess potential health risks related to the possible emission of particulates from degraded foam and certain volatile organic compounds (VOCs). ![]() ![]() The alert was based on problems reportedly associated with the PE-PUR foam breakdown that could potentially result in serious injury and may require medical intervention to prevent permanent injury. 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 polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. In June 2021, the FDA alerted people who use certain Philips ventilators, BiPAP machines, and CPAP machines because of potential health risks – impacting 15 million devices worldwide. 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. 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. The FDA remains steadfast in our commitment that patients impacted by the June 2021 recall of certain Philips Respironics ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines deserve relief. The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health
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