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The medical device manufacturer Philips has issued a recall that impacts millions of sleep-apnea devices and mechanical ventilators, which contain sound abatement foam that may degrade over time and release toxic gases, potentially exposing users to a risk of cancer.
The Philips Bi-PAP, C-PAP and ventilator recall was announced by the manufacturer on June 14, after identifying a potential health risk associated with the device’s polyester-based polyurethane (PE-PUR) sound abatement foam, which the company warns can degrade and release particulate matter into patients’ airways.
Approximately 3.5 million Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices were equipped with PE-PUR sound abatement foam, which are being withdrawn from the market due to evolving health concerns.
Philips announced this week that internal testing revealed the PE-PUR sound abatement foam has the potential to “degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.” Philips indicated the particulate matter and gases may be toxic to patients and could potentially cause cancer.
To date, Philips has received several complaints of the devices causing patients headache, irritation, inflammation and respiratory issues after inhaling the polyester-based polyurethane foam, representing approximately 0.03 percent of devices sold in 2020.
An investigation by the manufacturer determined unapproved cleaning methods of the devices such as ozone and high heat and high humidity environments may be a contributing factor to the accelerated deteriorating of the PE-PUR sound abatement foam. However, an investigation is still ongoing.
Owners of the Philips C-PAP and Bi-Level PAP machines, representing about 80% of the devices recalled, have been instructed to stop using the devices immediately, and to consult with their healthcare professional for an alternative.
The remaining 20% of the recalled devices are mechanical ventilators. Philips recommended doctors and patients using life-sustaining ventilators should first consider whether the potential danger from the foam outweighs other risks.
The recall notice claims the company is working closely with regulatory agencies to provide customers a resolution which will include the deployment of updated instructions for use and a comprehensive repair and replacement program for the affected devices.