The FDA issued a notification order alerting Philips (NYSE:PHG) that its notification efforts on the recall of its ventilators have been inadequate to date.
Philips Respironics last year recalled millions of specific ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines due to polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.
Philips said last summer that it was no longer taking orders of sleep therapy systems as it handled the recall, which knocked it out of the sleep therapy market for at least a year. FDA has classified the recalls as Class I, the most serious kind.
In a news release, the FDA confirmed that it will require Philips to do a better job of notifying patients and others of its recall after what the agency labeled as inadequate efforts so far. That includes notifying 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.
Additionally, the FDA directed Philips to maintain language to patients regarding the risk of using ozone cleaners on the recalled device on their main webpage for the recall and to provide instructions for device users to register their devices through the Philips website.
“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,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the release. “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 addition to the actions recommended, the FDA suggested additional measures for Philips to better communicate with the public on the recall, including monthly updates to device users registered on Philips’ website. Those updates would include information on the expected time for replacement and the current rate of replacement.
The FDA said it has worked with Philips across several fronts regarding the effectiveness of the company’s communications with the public surrounding the recall. The agency said 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 order directs Philips to provide the notification described in the order within 45 days of its issuance.
Philips issued a notification in response, confirming its efforts to monitor recall awareness for affected users.
“Philips Respironics is working cooperatively with the [FDA] to further increase awareness for patients, consumers, and healthcare providers of the recall,” the company wrote in the update. “Based on feedback from the FDA, Philips Respironics will be working with its DME customers to allow the company to directly contact those patients and other end-users that may not yet have received notice of the recall.”
The company said it has shipped a total of more than 650,000 replacement devices to U.S. customers and plans to complete the repair and replacement program in Q4 2022.