FDA Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration/Wikipedia)
The US Food and Drug Administration (FD) has ordered Dutch medical equipment maker Philips Respironics to notify patients about the company’s recall of certain respiratory assistance devices, announced in June last year.
The devices include ventilators and continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines.
Also, the order requires the company to notify about the harm posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in the products.
FDA considers its order to be an important step to eliminate the risk of harm posed by the recalled products, as the company’s efforts have been ineffective, to date.
FDA Centre for Devices and Radiological Health director Jeff Shuren said: “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.
“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.”
In June last year, Philips Respironics has recalled certain ventilators, CPAP and BiPAP machines due to potential health risks due to PE-PUR foam used in the devices.
The US agency found that the company’s communications with the public regarding the recall and the risks presented by the recalled products are not effective.
It has issued the order under section 518(a) of the Federal Food, Drug, and Cosmetic Act.
The FDA order requires Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers about the recall.
It also directs the company to inform patients about the risk of using ozone cleaners on the recalled devices and provide instructions for device users, on their webpage.
The US agency recommends Philips take additional measures regarding the recall, including providing monthly updates and providing detailed information about replacement.