READ THIS NEXT: If You Got These Meds at CVS, Rite Aid, or Walgreens, Don’t Take Them, FDA Warns. The FDA publishes “Safety Communications” every year to alert the public about ongoing issues with medical devices, and what the agency recommends to keep consumers safe. The agency has issued a number of these communications already in 2022. From January through March, the FDA sent out several alerts urging consumers to stop using certain at-home COVID tests, largely due to a high risk of false results. More recently, the agency cautioned parents, caregivers, and healthcare providers not to use baby neck floats due to the risk of death or injury. “The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients,” the agency says. Now, an updated FDA safety communication is alerting the public about one kind of popular device that has been linked to over 150 deaths. On Aug. 16, the FDA updated a safety communication it issued last year about several Philips Respironics breathing devices in order to “provide the latest information” to the public. In June 2021, the agency alerted people who use Philips ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines that the company had recalled multiple versions of these devices due to potential health risks. These products are all used to help breathing, with BiPAP and CPAP machines being primarily used by those who have sleep apnea. “This update provides additional information on the recall for people who use repaired and replaced devices,” the FDA said in its new alert. Last year, the agency said there had been no reports of death as a result of issues related to these devices. Now, that’s no longer the case. According to the FDA, manufacturers like Philips are required to submit medical device reports (MDRs) when “information reasonably suggests that their device may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device they manufacture would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” In its Aug. 2022 update, the FDA said it has now received more than 69,000 MDRs that include 168 reports of death associated with the recalled devices. RELATED: For more up-to-date information, sign up for our daily newsletter. The FDA said the 168 reports of death are linked to polyester-based polyurethane (PE-PUR) foam breakdown or suspected foam breakdown. According to the agency, Philips uses this foam in its devices to “lessen sound and vibration in these devices and other medical equipment,” but in the recalled devices, the foam has the potential to break down.ae0fcc31ae342fd3a1346ebb1f342fcb “If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device,” the FDA said. “The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer.” Exposure to pieces of foam or chemicals as PE-PUR breaks down “could potentially result in serious injury and require medical intervention to prevent permanent injury,” the FDA warned. The agency said a “wide range of injuries” have been reported in the 69,000 MDRs it has received so far, “including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.” According to the FDA, the potential risks from inhaling or swallowing pieces of the black foam include irritation to the skin, eyes, nose, and respiratory tract, inflammatory response, headache, asthma, and toxic or cancer-causing effects to the organs like the kidneys and liver. Similarly, potential risks of inhaling chemicals released into the device’s air tubes from the foam include headache, dizziness, irritation in the eyes, nose, respiratory tract, and skin, a hypersensitivity reaction, nausea or vomiting, and toxic or cancer-causing effects.
