The U.S. Food and Drug Administration (FDA) has ordered Philips Respironics to issue warnings about the company’s recall of numerous ventilation products.
The order, issued March 10, comes after a recall was issued in 2021. The FDA determined there was an “unreasonable risk of substantial harm to the public health” from the degradation of the polyester-based polyurethane foam used in those products to minimize sound. After investigating, the FDA determined that Philips Respironics had not sufficiently warned users of these dangers.
According to the FDA, this particular foam, used in continuous positive airway pressure (CPAP) machines, and bilevel positive airway pressure (BiPAP) machines produced by Philips Respironics, has the potential to break down and cause serious injuries, some of which can be life-threatening or cause permanent damage. Past injuries from inhaling this foam have required medical intervention to prevent permanent injury to its users.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the order, “The FDA has heard the frustration expressed by patients and durable medical equipment suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process.”
In order to make patients and other affected parties more aware, the FDA is ordering Philips Respironics to take several actions. First, the FDA is mandating that Philips Respironics notify all affected parties. These parties include:
- Durable medical equipment suppliers
- Distributors
- Health care providers who prescribe the products
- Retailers
- Users
These affected parties must be notified by Philips Respironics about the 2021 recall and the health risks posed by the foam that is used in the recalled products. Philips must also inform patients about the risk of using ozone cleaners on the recalled devices. This information must be on their main webpage for the recall, and patients must be provided instructions for registering their devices on the Philips website.
As additional measures, the order also includes steps for Philips to better communicate with the public regarding the recall. Though not strictly an order, the FDA recommends that Philips Respironics provide monthly updates to users who register their devices on the Philips website. The FDA also recommends that Philips provide detailed information to all interested parties about the replacement process.
“Taking this action today enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by the foam used in the recalled products with patients and the public and to ensure that individuals who rely on these essential devices are receiving the important information they need from the company,” stated Dr. Shuren.