Additional Communication Requirements Placed on the Company Following June 2021 Device Recall
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
In our last blog post regarding the Philips Recall, "Philips CEO Responds to FDA Update on Philips Breathing Devices Recall", we reported on the Philips Respironics CEO Frans van Houten's commentary on recent claims that the company failed to properly investigate complaints about its ventilators, CPAP, and BiPAP machines. Since this December 2021 blog post, the Food and Drug Administration (FDA) has ordered Philips Respironics to notify all patients and others of the June 14, 2021 recall of certain ventilators, CPAP and BiPAP machines.
As background, based on some observations made during the FDA's inspection of a Philips manufacturing plant, the FDA expressed concerns regarding the new foam replacement part for the defective sound abatement component which patients would receive when they participated in the Philips repair-and-replace program.
According to a March 2022 FDA News Release titled, "FDA Orders Philips Respironics to Notify Patients Regarding the Recall of Certain Breathing Assistance Machines", the FDA is taking complaints filed against Philips seriously:
“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.”
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According to the March 2022 News Release, the order not only requires Philips to notify patients of the potential health risks posed by the breakdown of the foam sound abatement component, but also restricts Philips' actions moving forward:
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.
If you or someone you know used one of the recalled Philips Bi-Level PAP, Philips CPAP, or Philips Mechanical Ventilator devices and, in turn, developed cancer or experienced organ failure, we are providing free case evaluations for possible lawsuits against Philips. You can use our online Philips Breathing Devices Case Evaluation Form or, if you prefer, call us on our toll-free number, 800-426-9535.
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