The Food and Drug Administration (FDA) has notified Philips Respironics that additional steps need to be taken to alert patients, health care providers and durable medical equipment customers about the June 14, 2021 recall of certain ventilators, continuous positive airway pressure and bilevel positive airway pressure machines.
The Agency issued the notification order as it deemed the Company’s notification efforts to be inadequate. Use of the recalled machines may pose health risks related to the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in these products. Serious injury may result from the breakdown of this foam. The degradation of PE-PUR foam may also be accelerated by repeated exposure to ozone cleaning, which the Company warned is not an approved cleaning agent.
Since the recall was initiated in June, the FDA has engaged with Philips about this issue and the need for timely and effective communication regarding this risk. Based on the Company’s response thus far, the Agency believes that a significant number of patients are still continuing to use the recalled products and are unaware of the potential for harm.
“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,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “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 response to the FDA’s action, Philips Respironics issued a statement confirming that work is being done to increase awareness of the recall. According to the Company, approximately 2.6 million devices have been registered following multiple rounds of patient and customer outreach. The Company is also using a mobile app called DeamMapper to send notifications about the recall to patients and consumers.
So far, more than 650,000 replacement devices have been shipped to US customers, said the Company, with a goal of full repair and replacement by the fourth quarter of 2022.
Detailed information on the recall can be found here.
- FDA orders Philips Respironics to notify patients regarding the recall of certain breathing assistance machines. March 10, 2022. News release. Accessed March 11, 2022. https://www.prnewswire.com/news-releases/fda-orders-philips-respironics-to-notify-patients-regarding-the-recall-of-certain-breathing-assistance-machines-301500633.html
- Philips Respironics provides update for the US on ongoing CPAP, BiPAP and Mechanical Ventilator field action. News release. Philips Respironics. Accessed March 10, 2022. https://www.globenewswire.com/news-release/2022/03/11/2401495/0/en/Philips-Respironics-provides-update-for-the-US-on-ongoing-CPAP-BiPAP-and-Mechanical-Ventilator-field-action.html