FDA Issues Update on the Philips BiPAP and CPAP Recalls

Last week, the United States Food and Drug Administration released a statement updating consumers and industry leaders on the Philips Respironics recalls due to the potential risks associated with polyester-based polyurethane (PE-PUR) foam. The FDA Center for Devices and Radiological Health (CDRH) issued the update and attributed it to the director, Jeff Shuren, MD, JD.

The original recall was issued on June 30, 2021, and applied to bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines manufactured between 2009 and 2021. According to the original statement, multiple devices, such as the E30, DreamStation ASV, DreamStation ST AVAPS, and SystemOnes ASV4, and ventilators, including Trilogy 100 and A-Series BiPAP V30 Auto, were recalled. The FDA estimates that the recall impacted nearly 15 million devices globally.

The organization noted that the PE-PUR foam was incorporated into these devices to minimize the machines' and ventilators' sound and vibrations. However, an investigation into the products found that the foam breaks down and can release black debris or chemicals in the devices’ air pathways. Inhaling the debris or chemicals can result in serious injury, permanent impairment, skin, eye, and respiratory tract irritation, inflammatory responses, headaches, asthma, and carcinogenic effects on organs.

Despite the recall being issued over two years ago, the FDA criticizes the response and status of the recall.

“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,” noted Shuren in the update.

The update criticizes the independent testing of the BiPAP and CPAP machines by Philips, noting that the organization has not provided adequate data and insights. Based on the independent testing, Philips said the exposures are “unlikely to result in an appreciable harm to health in patients.” However, the FDA believes that additional testing is necessary and maintains that the risk necessitated a recall.

The FDA requires Philips to issue recall notifications to all device users, durable medical equipment suppliers, distributors, retailers, and healthcare providers. Additionally, the organization is working with alternative manufacturers to address the device shortages, eventually removing them from the device shortage lists.

“We understand the recalled devices deliver critical care and serve an important public health need for a widespread patient community. Ensuring patients and providers have the most accurate and up-to-date information about the Philips recall remains of utmost importance to the FDA, and we are committed to doing everything we can to protect the health and safety of patients affected by this recall. We will continue to keep the public informed as new information becomes available,” added Shuren.

As the FDA continues to monitor the recall and response, Philips is tasked with adequately addressing the complications in this recall. Additionally, the company has had to navigate multiple other recalls on its BiPAP and CPAP machines, including recalls linked to device interference with other medical devices and mask recalls.