Philips Says Faulty Cleaning Increased Foam Problem With Apnea Device

Patients with sleep apnea, who use recalled CPAP and BiPAP machines, are struggling to navigate a difficult year with varying degrees of information after a massive sleeper recall.

Five million people were affected by a voluntary recall 2021, usually for first-generation DreamStation products made by Philips. Since then, many patients have experienced delays in obtaining replacement devices, and others have turned to alternative methods for the treatment of sleep apnea and snoring and still others are using their devices despite the recall.

On June 28, Philips released a additional statement explaining that on further investigation and additional testing, the foam central to the recall rarely dissolves, and they found “a very low prevalence of visible foam degradation.” the Wall Street Journal reported† Philips added that the new and used versions of the recalled machines have passed emissions tests for volatile organic compounds (VOCs) and respirable particulates, which analyze how harmful the foam’s inhaled chemicals could be. Philips also pointed to improper cleaning methods, such as “ozone cleaning” in cases of greater foam breakdown. Ozone gas cleaningor UV light cleaning devices are not FDA-approved and should not be used as a reliable source of cleaning for CPAP machines.

Multiple lawsuits against the company are pending, and in a statement to: BloombergPhilips hinted that this unauthorized use of ozone purifiers could be an important defense tactic in upcoming

The US Food and Drug Administration statement explains that between April 2021 and April 2022, they had received more than 21,000 medical device reports, including 124 reported deaths “related to PO-PUR foam degradation or suspected foam degradation”. These include reports from Philips and voluntary reports from patients, healthcare professionals and consumers. Some of the main concerns included dizziness, pneumonia, cancer, difficulty breathing, coughing, headaches and other symptoms.

dr. Po-Chang Hsu, Medical Content Expert at sleeping ocean explains that VOCs are being considered carcinogens† “They can seriously affect a person’s health,” he says, urging patients to see their doctor while they wait for a replacement machine. †As a consumer, always contact your doctor if you experience any discomfort or symptoms related to your breathing machines. The sooner you let your healthcare providers know about these issues, the sooner your healthcare providers can identify the causes and provide solutions to your issues related to your machines and treatments.”

In a June statement from Philips to Sleepopolis via email, Steve Klink, Head of Global Press Office and Industry Relations at Philips, explained that “We regret the concern and inconvenience that the June 2021 recall for specific CPAP, BiPAP – and mechanical ventilator devices may have caused patients and caregivers, for which we apologize.”

Alexandra Frost

Alexandra Frost is a Cincinnati-based freelance journalist, content marketing writer, copywriter, and editor who focuses on health and wellness, parenting, real estate, business, education, and lifestyle. Outside of the keyboard, Alex is also mother to her four sons under the age of 7, who keep things chaotic, fun and interesting. For more than a decade, she has been helping publications and companies connect with readers and bring them high-quality information and research in a recognizable voice. She has been published in the Washington Post, Huffington Post, Glamour, Shape, Today’s Parent, Reader’s Digest, Parents, Women’s Health and Insider.

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