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. 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 unsatisfied with the status of this recall, and we continue to take steps to protect the health and safety of individuals using these devices.
In June 2021, the FDA alerted External Link Disclaimer people who use certain Philips ventilators, BiPAP machines, and CPAP machines because of potential health risks – impacting 15 million devices worldwide. The polyester-based polyurethane (PE-PUR) 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 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.
Following 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).
Philips has issued several updates since the start of the recall and the FDA has reviewed the available information and data provided to FDA by Philips.
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. 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. Philips has agreed to conduct the requested additional testing. 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 on-going analysis of the potential health risks.
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. 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.
