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FDA Calls Philips Respironics’ Recall Efforts ‘Inadequate’

Article-FDA Calls Philips Respironics’ Recall Efforts ‘Inadequate’

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The agency has issued a notification order regarding the June 2021 recall of some ventilators and sleep apnea devices. Sound-abating PE-PUR foam used in the devices can degrade into particles, which may be ingested or inhaled by the user.

The US Food and Drug Administration (FDA) issued a notification order to Philips Respironics yesterday requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines. The agency deemed that the company’s notification efforts thus far have been insufficient.

As we reported in June, Philips recalled some of those devices because of degradation of the polyester-based polyurethane (PE-PUR) foam used to dampen sound. The PE-PUR foam may degrade into particles that can enter the device’s air pathway and be ingested or inhaled by the user, and off-gas certain chemicals, the company said in June. This can result in serious injury, which can be life-threatening, cause permanent impairment, and/or require medical intervention to prevent permanent injury to users, according to FDA. Now, the agency has determined that a notification order is needed to “eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate.”

Patients and durable medical equipment suppliers, often unaware of the recall, have received insufficient information on their next steps regarding the recall process, according to Jeff Shuren, Director of FDA’s Center for Devices and Radiological Health. “Taking this action 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,” said Shuren in yesterday's announcement.

FDA is ordering Philips Respironics to notify all device users, durable medical equipment suppliers, distributors, retailers, and healthcare providers who prescribe the products about the recall and the health risks posed by the foam. 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.

FDA also recommended additional measures Philips can take to better communicate with the public regarding the recall, including monthly updates on expected replacement times and the current rate of replacement of recalled devices. 

Since the initiation of the recall in June, FDA said its has engaged with Philips on several fronts about the effectiveness of its communications with the public regarding the recall and the risks presented by the recalled products. During that time, the agency said it has expressed concern that a significant portion of patients and consumers using the recalled products may be 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.

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