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Manufacturers of devices used to clean CPAP machines are trying to put distance between themselves and a massive recall of Philips’ DreamStation devices, after the manufacturer suggested problems with sound abatement foam may be linked to ozone cleaning devices, like SoClean.
Earlier this month, a massive Philips CPAP machine recall was issued for millions of devices used by individuals with sleep apnea, as well as Bi-PAP and ventilator devices, due to foam degradation issues where particles from the polyester-based polyurethane (PE-PUR) sound abatement foam may cause respiratory and other health problems.
Philips has indicated problems with the CPAP foam breaking down could be exacerbated by unapproved cleaning products, which use ozone and high heat.
The recall also came just a few months after the FDA issued a warning to CPAP users and healthcare professionals not to use illegally marketed ozone gas or ultraviolet (UV) light cleaning products to disinfect or sanitize CPAP machines.
These two events have raised questions as to whether there was a connection between the CPAP and ventilator recall and CPAP cleaning devices.
“The risks include that the PE-PUR foam may 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. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation,” Philips’ recall notice warned.
In a report published last week by HME News, which covers the medical equipment industry, interviews with multiple CPAP cleaning device manufacturers indicated they had no indication the recall was connected to any of their products.
Executives from SoClean, VirtuOx, Sleep8, Sunset Healthcare Solutions and others all said in the report that a connection to their devices is unlikely for a variety of reasons, or indicated they are still investigating the issue, but have not been informed there’s a problem.
CPAP devices provide steady air pressure through a mask or nosepiece, granting continuous positive airway pressure to prevent the user’s airway from collapsing, thus preventing constant broken sleep.
The devices are often used by those diagnosed with obstructive sleep apnea, which is a condition which causes a person’s airway to collapse during sleep, resulting in short periods of time where the individual stops breathing. Individuals suffering from sleep apnea have a greater risk of experiencing adverse health and heart problems. Typically, these individuals have a higher risk of suffering hypertension, stroke, heart disease and daytime sleepiness.
The FDA indicates it has received at least 11 reports of CPAP cleaning problems involving use of ozone or UV light products from 2017 through 2019, involving individuals who experienced coughing, difficult breathing, nasal irritation, headaches, asthma attacks and other breathing problems after using the unapproved products.
Meanwhile, Philips has received several complaints involving the recalled devices, 80% of which were DreamStation CPAP machines, 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.
Philips cited the FDA warning about cleaning methods in its recall notice. The company indicates it is working closely with regulatory agencies to determine the extent of the problems, and 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.