(RepublicanDaily.org) – The Food and Drug Administration has released information recently that shows that previously recalled sleep apnea treatment devices manufactured by Philips were responsible for 561 deaths.
In an update issued January 31, the FDA said that more than 116,000 reports regarding malfunctions and defects in a slew of devices such as the Philips Respironics BiPAP, and the Dreamstation and Dorma series of machines have been sent to the agency since April 2021. The malfunctions and defects include inside parts and components breaking down and getting accidentally inhaled by users, which cause choking and can also increase the likelihood of them contracting cancer.
According to the agency, the recalled sleep apnea devices used foam made out of polyester-based polyurethane (PE-PUR), which apparently breaks down and breaks up over time and repeated use of the machines, causing them to enter the airways of the people using them. PE-PUR was used in the machines as a means to reduce vibration and sound, but when the foam degrades, it, along with “certain chemicals that are not visible” can be “breathed in or swallowed” by users, according to the FDA.
The said devices were used as ventilators and / or part of sleep apnea treatments, with many users wearing the devices repeatedly overnight – which meant prolonged exposure and inhalation of the dangerous chemicals and particles in the defective machines.
According to the FDA, inhaling or swallowing pieces of PE-PUR can cause a number of adverse conditions, ranging from eye, nose, skin, and respiratory tract irritation, headaches, asthma, nausea, vomiting, and inflammatory responses, to toxic and cancer-causing effects to users’ liver and kidneys.
The FDA said that it also found out that while the devices marketed in the U.S. previously underwent safety tests with “acceptable results”, the PE-PUR used in a similar machine sold outside the U.S. failed one safety test for the release of volatile organic compounds (VOCs).
Philips has agreed to stop selling the machines in the U.S. and faces a hefty fine that could reach as high as $400 million. The company will continue to service devices with PE-PUR that have already been sold.
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