The U.S. Food and Drug Administration (FDA) has updated its safety communication regarding recalled Philips Respironics ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines. The Feb. 9 announcement stated that medical device reports received by the agency at the end of 2022 have now been added for public examination.
The focus of these medical reports and the recall of Philips devices is the breakdown of polyester-based polyurethane (PE-PUR) foam. This material is used in order to reduce the intensity of sounds and vibrations created by the machine during use. However, it has been discovered that PE-PUR can break down during use, releasing pieces of foam into the device’s air tubes.
Due to the nature of ventilators, BiPAP, and CPAP machines, this has led to patients inhaling or swallowing the foam while using the device, leading to serious and potentially permanent injury. According to the safety communication, this breakdown is particularly prevalent in hot and humid conditions and in devices cleaned by ozone cleaners, which Philips does not recommend for use on the devices.
According to the FDA, long-term damage potentially caused by inhaling or swallowing PE-PUR foam or chemicals contained in the foam includes:
- Chronic headache
- Chronic irritation to the skin, eyes, nose, and respiratory tract
- Inflammatory responses
- Toxic or carcinogenic damage to the kidneys and liver
Additionally, the agency noted that there are short-term effects to inhaling PE-PUR foam including allergic reactions, dizziness, headaches, immune responses, nausea or vomiting.
The updated statistics released by the FDA cover a two-month period from Nov. 1, 2022 to Dec. 31, 2022. During that time, the FDA received over 8,000 injury reports related to PE-PUR foam breakdown or suspected foam breakdown and 82 deaths. This brings the total number of reported injuries since April 1, 2021 to over 98,000, and the total number of deaths to 346.
The agency notes that while medical device reports are a valuable tool for detecting trends in medical device injuries, it is also a passive and imperfect system. The FDA announcement notes that several factors lead to inaccuracies, including underreporting of incidents, inaccuracies within the reports, lack of verification of reports, and lack of detail within the reports. The FDA recognizes that information such as incidence of symptoms, prevalence of symptoms, and cause of symptoms cannot be independently verified through medical device reports alone. However, the FDA considers these reports to be one of several vital sources of postmarket surveillance data.
A number of lawsuits have been filed against Philips over its recalled devices alleging economic and health injuries. Philips moved to dismiss the CPAP lawsuits against it in early Dec. 2022.