WASHINGTON (Agencies): This week, the Food and Drug Administration (FDA) disclosed that 561 deaths have been linked to previously recalled sleep apnea machines. The agency initiated a recall in June 2021 for Philips Respironics BiPAP and CPAP machines, along with ventilators, citing concerns over the breakdown of the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices to reduce sound and vibration.

Following the initial recall, the FDA has received reports of 561 deaths associated with the breakdown of the PE-PUR foam or suspected foam breakdown. The agency highlighted the potential risks, explaining that black debris or certain chemicals released from the foam could be inhaled or swallowed by individuals using the affected devices.

BiPap and CPAP machines, designed to assist those with sleep apnea, a disorder causing breathing interruptions during sleep, have become central to managing the condition. The Cleveland Clinic describes sleep apnea as a condition prompting the brain to awaken individuals to resume breathing, disrupting restful and healthy sleep. Both machines function by delivering pressurized air through a mask worn over the face during sleep.

Since the recall, the FDA has received over 116,000 reports of actual or suspected incidents involving foam breakdown in these machines, affecting more than 5 million devices. The ongoing developments underscore the critical need for continued vigilance and awareness surrounding the safety of sleep apnea equipment.