FDA warns against disinfection of CPAP machines with Ozone or UV Light

The U.S. Food and Drug Administration (FDA) has warned consumers and health care providers that it has not authorized for market any products using ozone gas or ultraviolet (UV) light to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices and accessories.

FDA has cautioned consumers that they should not use unapproved methods of cleaning their continuous positive airway pressure (CPAP) machines and accessories. These include using ozone gas or ultraviolet light.CPAP machines are devices prescribed to patients with obstructive sleep apnea to keep their airways open during sleep.

Most often, CPAP manufacturers recommend regular cleaning of CPAP device accessories with mild soap and water. The FDA recommends consumers to-Follow the CPAP manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. If you cannot find the owner's manual or instructions, or have questions, contact the CPAP device or accessory manufacturer.  You also can contact your health care provider with any questions. 

Be aware that the FDA has not evaluated the safety and effectiveness of ozone gas or UV light products claiming to clean, sanitize or disinfect CPAP machines and accessories in the home or healthcare setting. Understand the potential risks from exposure to excessive amounts of ozone gas or UV light as described below include irritation to breathing passages (that is nose, throat, and lungs), particularly for those who have respiratory sensitivity such as asthma or allergies.

Seek medical attention if you suspect you have experienced injuries or irritation from using products claiming to clean your CPAP machine or accessories. The concentration of ozone that is required to kill bacteria is considered unsafe for humans, and leaks can occur when cleaning CPAP machines. When done in an enclosed area, like a bathroom, users could be exposed to unsafe ozone levels.

Additionally, the FDA says that if consumers use the CPAP machine without allowing fresh air to circulate through it, the ozone could irritate a person's airway or worsen chronic respiratory diseases. Cough, difficulty breathing, nasal irritation, headaches, and asthma attacks have been reported among people using ozone to clean their machines. Ultraviolet light — another method being marketed for CPAP cleaning — may not adequately disinfect the device if the light doesn't penetrate all areas. In addition, users could be at risk for eye injury, skin burns, or skin cancer.

The FDA has received no reports of injury from UV light. Although FDA has not received any problem reports associated with using UV light products that claim to clean CPAP devices and accessories, unintentional or excessive exposure to UV light during cleaning may put a user at risk of eye injury, skin burns or even an increased risk of skin cancer.  

FDA MedWatch safety alert