SoClean, a company specializing in CPAP cleaning machines, recently initiated a voluntary field action to address user complaints regarding improper set-up and unauthorized modifications. The Food and Drug Administration (FDA) has responded with additional information, highlighting safety concerns related to the use of ozone cleaners, such as SoClean, for continuous positive airway pressure (CPAP) machines. Philips, a competitor, has asserted that ozone cleaners contributed to issues leading to a massive recall of its respiratory devices.
SoClean’s voluntary action follows 7,417 complaints, representing 0.33% of its sold units, with 334 FDA-reportable adverse events. Complaints range from difficulties setting up the device to issues like a mildew smell, excessive ozone odor, coughing, and exacerbation of preexisting conditions. Although no deaths were reported, SoClean is addressing these concerns by updating warnings and contraindications in its manual and providing users with a hose and mask adapter to enable cleaning without introducing ozone into the CPAP machine.
In response, the FDA issued a safety communication, offering six recommendations to consumers. These include using the provided hose and mask adapter, refraining from connecting SoClean to an in-use CPAP device, and carefully reading the updated manual. This development comes two years after SoClean filed a $200 million lawsuit against Philips, accusing the latter of making false statements about ozone cleaners that allegedly harmed SoClean’s business. Philips has sought dismissal of the case