Philips Hit With Rare 518(a) Order on Ventilators
FDA has issued a rare Section 518(a) notification order to Philips Respironics “requiring the company to notify patients and others of the company’s 6/14/2021 recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products.” The notification order was necessary due to what the agency described as “inadequate” company notification efforts to date.
“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,” CDRH director Jeff Shuren is quoted in a release as saying. “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.”
Last year, FDA inspected Philips and issued a 29-page Form FDA-483 based on a Class 1 recall follow-up involving the continuous and non-continuous ventilators, which are used to provide respiratory support or treatment for sleep disorders. The inspection was initiated to assess compliance with regulatory requirements and to investigate concerns about the devices’ polyester-based polyurethane sound abatement foam, which is used to reduce sound and vibration. An earlier recall notice said the foam may break down and enter the device’s air pathway. “If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device,” the notice says, adding that exposure to debris or chemicals could cause serious adverse events in patients. There have been more than 1,200 complaints and more than 100 injuries reported on the issue.
Under the notification order, Philips Respironics is required to notify all device users, suppliers, distributors, retailers, and health care providers about the recall and the health risks related to the foam used in the recalled products. The order also instructs Philips to include language on its recall Web page for patients about the risk of using ozone cleaners on the recalled devices, and provide instructions for device users to register their devices on the Philips Web site. Additionally, FDA recommends the company provide monthly updates to device users who register their devices that include information on expected time for replacement and current rate of replacement of recalled devices.
In the order, FDA says that it assessed the effectiveness of Philips’ recall communications by contacting a sample of 182 consignees to determine whether they had been notified of the recall. Late last year, the agency said it sent two emails to Philips listing 28 consignees (of the 182 FDA contacted) who had reported they were not aware of the recall, and Philips did not respond to either email. An FDA subsequent phone call with the company took issue with “ineffective recall audit checks,” it says. “Typically, firms demonstrate the effectiveness of its recall communications through evidence more meaningful than a delivery confirmation receipt, such as a returned response form or a documented telephone conversation.”
The order did acknowledge that Philips has begun to undertake some of the agency’s recommended actions in response to a recent teleconference. It further instructed the company to submit within two weeks a plan describing how it will verify completed actions under the order.