The U.S. Food and Drug Administration March 10, 2022, issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products. The FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate.
“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,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “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.” Recalled Phillips Respironics Products DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+ SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 REMstar SE Auto E30 (Emergency Use Authorization) Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent ASeries BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto A-Series BiPAP A40 A-Series BiPAP A30 Dorma 50)
The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about the recall and the health risks posed by the foam used in the recalled products. The order also directs Philips to maintain language to patients regarding the risk of using ozone cleaners on the recalled devices on their main webpage for the recall, and to provide instructions for device users to register their devices on the Philips website.
Along with these actions, the FDA recommends additional measures Philips can take to better communicate with the public regarding the recall. Specifically, the FDA recommends that Philips provide monthly updates to device users who register their devices on the Philips website that include information on expected time for replacement and current rate of replacement of recalled devices. The FDA also recommends that Philips provide detailed information to device users, DME suppliers, distributors, retailers, and healthcare providers on the replacement process.
In June 2021, Philips Respironics initiated a recall of certain ventilators, CPAP and BiPAP machines due to potential health risks related to PE-PUR sound abatement foam used in those devices. This particular foam may break down and can result in serious injury, which can be life-threatening, cause permanent impairment and/or require medical intervention to prevent permanent injury to users.
Since the initiation of the recall, the FDA has engaged with Philips on several fronts about the effectiveness of its communications with the public regarding the recall and the risks presented by the recalled products and has expressed concern that it is likely a significant portion of patients and consumers using the recalled products are unaware of the health risks presented by those products.
The FDA is issuing this order under section 518(a) of the Federal Food, Drug, and Cosmetic Act. Under this authority, the FDA may order a manufacturer to provide notification if the FDA determines that a device presents an “unreasonable risk of substantial harm to the public health” and such notification is necessary to “eliminate the unreasonable risk of such harm and no more practical means are available [under the Federal Food, Drug, and Cosmetic Act] to eliminate such risk.” The FDA may order that adequate notification be provided to device users, health care providers who prescribe or use the device, and any other person who should receive notification to eliminate such risk.
The order directs Philips to provide the notification described in the order within 45 days of its issuance.
