March 11, 2022 -- The FDA has issued an order to Philips Respironics Inc., requiring the company to notify patients and distributors about a June 2021 recall of certain ventilators and breathing assistance machines. The FDA said the company’s “notification efforts to date have been inadequate.”
A polyester-based polyurethane sound abatement foam used in the products may cause “serious injury” that can be life-threatening, cause permanent damage, and require medical treatment, the FDA wrote.
“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,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
“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,” he said.
The FDA ordered the company to notify all device users, durable medical equipment suppliers, distributors, retailers, and health care providers who prescribe the products about the recall and health risks. The foam was used in specific Philips continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) devices, and mechanical ventilators.
The foam may break down, the FDA wrote, and black debris or chemicals released into the device’s air pathway may be inhaled or swallowed by patients using the device. This could harm lung tissues, cause organ impairment, and lead to long-lasting respiratory dysfunction.
Philips Respironics notified the FDA about potential health risks related to the foam in April 2021 and said it would investigate the issue. In June, the company issued a voluntary recall of the products due to the serious health risks. Since then, the FDA has been monitoring Philips’ communications and has received “a number of calls” from patients who reported concerns but were unaware of the recall or health risks.
The FDA estimated that, even though the recall has been underway for nine months, about 50% of consumers who have purchased one of the recalled products in the last five years have requested a replacement device. The FDA also contacted 182 consignees — such as suppliers — to determine whether they had been notified of the recall.
In September and October 2021, the FDA sent emails to Philips that listed 28 of the consignees who reported that they weren’t aware of the recall. Philips didn’t respond to either email, the FDA wrote. In November, the FDA and Philips had a call to discuss the recall, and the company stated that 23 of the 28 consignees had received written notification of the recall and presented a spreadsheet that showed “delivery confirmation.”
“FDA notes that delivery confirmation receipts generally do not confirm that a recall notification communication has been effective,” the FDA wrote in its order. “Typically, firms demonstrate the effectiveness of its recall communications through evidence more meaningful than a delivery confirmation receipt, such as returned response form or a documented telephone conversation.”
Throughout the process, the FDA has continued to hear from patients and consumers who were unaware of the recall, as well as consignees who hadn’t received a recall notice, the FDA wrote. During teleconferences on March 8 and 9, the company agreed to adhere to a notification order.
The order, issued on March 10, requires Philips to notify all relevant parties about the recall and health risks in the next 45 days. The company is also directed to:
- inform patients about the risk of using ozone or UV light cleaners on the devices
- provide a link for health care providers to view testing results about the foam
- give clear instructions about how to receive a replacement device.
The FDA has also ordered the company to provide monthly updates to people who have registered their devices and include information on the expected timeframe for replacement.
“Due to their health conditions, many patients and consumers are not able to cease using the Recalled Products they were prescribed, and have expressed to FDA fear about the extensive delay in receiving a replacement device given the health risks associated with use of the Recalled Products,” the FDA wrote in the order.
Patients and providers can visit the Philips medical device recall information link for additional information, register a device, and check the list of affected devices. The FDA also has an update page with additional information about the recall, affected devices and advice for patients.