For Immediate Release: March 10, 2022
Today, the U.S. Food and Drug Administration 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, as well as the unreasonable risk of significant harm to public health associated with the decomposition of the soundproofing foam based on polyester polyurethane (PE-PUR) used in these products. The Food and Drug Administration has determined that this order is necessary to address the unreasonable risk of harm from the recalled products, as the company’s notification efforts so far have been insufficient.
“The FDA has heard the frustration expressed by patients and durable medical equipment providers who were unaware of the recall and were given insufficient information about their next steps regarding the recall process,” said Jeff Shuren, MD, director of the FDA’s Center for the Study of Devices and Radiological health. “The adoption of this decision today allows the FDA to require Philips Respironics to improve communication to patients and the public about the recall and the serious risk associated with the foam used in recalled products, and to ensure that people who rely on these important devices receive the important information they need. needed from the company.
The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) providers, distributors, retailers and healthcare providers who prescribe products of the recall and the health risks associated with the foam used in the recalled products. The order also requires Philips to inform patients of the risk of using ozone purifiers on recalled devices on its main recall web page and to provide device users with instructions on how their devices on the Philips website.
Along with these actions, the FDA recommends additional steps that Philips can take to better inform the public about the recall. In particular, the FDA recommends that Philips provide monthly updates to device users who have registered their devices on the Philips website, which include information about the expected replacement time and the current replacement rate of recalled devices. The FDA also recommends that Philips provide device users, DME providers, distributors, retailers and healthcare providers with detailed information about the replacement process.
In June 2021, Philips Respironics initiated a recall of certain ventilators, CPAP and BiPAP devices due to potential health risks associated with the PE-PUR noise-absorbing foam used in these devices. This particular foam may break down and cause serious injury which may be life threatening, result in permanent damage and/or require medical attention to prevent permanent injury to users.
Since the recall began, the Food and Drug Administration (FDA) has engaged with Philips on several fronts regarding the effectiveness of its communications with the public regarding the recall and the risks associated with recalled products, and has raised concerns that it is likely that a significant proportion of patients and consumers using recalled products are unaware of the health risks associated with these products.
The FDA issues 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 notice if the FDA determines that a device poses “an unreasonable risk of significant harm to public health” and such notice is necessary to “remove the unreasonable risk of such harm and no more.” practical means available [under the Federal Food, Drug, and Cosmetic Act] to eliminate such risk. The Food and Drug Administration may order appropriate notice to be given to users of the device, health care providers who prescribe or use the device, and any other person who must receive notice to address such risk.
The order requires Philips to provide the notice described in the order within 45 days of its issuance.
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The U.S. Food and Drug Administration, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring that medicines for humans and animals, vaccines and other biological products for humans, and medical devices are safe, effective, and secure. . The agency is also responsible for food safety, cosmetics, dietary supplements, products that emit electronic radiation, and for the regulation of tobacco products.
Content is current as of:
03/10/2022