Continuous positive airway pressure (CPAP) devices are often prescribed for home use to patients with obstructive sleep apnea, a condition where an individual’s airway becomes blocked during sleep causing breathing to intermittently stop and start. CPAP devices use air pressure to keep airways open during sleep.

Since 2017, the U.S Food and Drug Administration has received 11 reports of patients experiencing cough, difficult breathing, nasal irritation, headaches, asthma attacks and other breathing complaints when ozone gas-based products were used to clean, sanitize or disinfect CPAP devices and accessories.

No devices claiming to clean, disinfect or sanitize continuous positive airway pressure (CPAP) devices or accessories (such as masks, tubing, headgear) using ozone gas or ultraviolet (UV) light can legally be marketed. Their safety and effectiveness for use with CPAP devices and accessories is unknown.

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Ozone is a gas that can be used to kill harmful bacteria but it needs to be used at a concentration far greater than what is considered safe for humans. If a leak occurs, ozone gas in the room where the devices are used may temporarily rise to unsafe levels especially if the room is small or not well ventilated. If the device is used, without remaining ozone gas being eliminated, this could lead to someone inhaling ozone gas and result in breathing problems.

UV light may not be able to penetrate all components of CPAP devices and accessories, like the plastic tubing, masks and connectors, which could lead to inadequately disinfected components that may be unsafe for people to reuse. If it is at the right wavelength, intensity and exposure time to work, direct exposure could result in damage to users.

To ensure the safe and effective cleaning of CPAP devices and accessories, the FDA is recommending that consumers and health care providers follow the cleaning instructions provided by the manufacturers.