The most common ways CPAP cleaners work are through the use of ozone or ultraviolet (UV) light. Data on the safety and efficacy of devices that claim to clean, disinfect, or sanitize CPAP devices and accessories using either of these two methods is sparse. Thus, controversy exists surrounding the use of these products.
What do we know about ozone?
Ozone, also known as activated oxygen, is a gas that can kill bacteria upon exposure. For ozone to effectively kill bacteria, it must be present at a concentration much greater than what is considered safe for humans.
Exposure to unsafe levels of ozone can cause:
- Worsening lung function
- Shortness of breath
- Lung tissue inflammation
- Worsening of asthma
- Throat irritation and cough
- Chest pain
- Increased susceptibility to respiratory infection
With CPAP cleaners that use ozone, the ozone can leak from tubing connections, filters, or the storage bin out into the surrounding room. This can cause ozone levels in the room to temporarily rise to unsafe levels, particularly if the room is small or has poor ventilation.
Ozone can also remain temporarily within the CPAP equipment itself after cleaning (eg, within tubing), creating a risk for exposure if not allowed time to air out after cleaning cycles.
What do we know about UV light?
A primary risk of UV light is that it can be harmful depending on its wavelength, intensity, and exposure time.
Furthermore, UV light may not be capable of penetrating CPAP equipment to clean the inner surfaces of tubing, masks, connectors, etc. This increases risk of exposure to harmful bacteria that was not effectively eradicated during the cleaning cycle.
What does the Food & Drug Administration (FDA) say?
In a press release made on February 27, 2020, the Food & Drug Administration (FDA) stated that devices that claim to clean, disinfect, or sanitize CPAP devices or accessories using ozone gas or UV light are not legally marketed for this use in the United States. Given this, the safety and efficacy of these devices is unknown.
The FDA has asked manufacturers to submit data demonstrating the safety and efficacy of their products that make the above claims.
Adverse events have only been reported for devices that use ozone gas. The FDA received 11 reports from 2017-2019 from patients experiencing cough, difficulty breathing, nasal irritation, headaches, asthma attacks, and other breathing complaints after using ozone gas devices. The FDA has not received any adverse event reports for products that use UV light.
Preliminary lab testing by the FDA has found the following:
- Ozone devices produce ambient levels of ozone above the safety limit for humans
- After running a cleaning cycle with an ozone device and waiting the amount of time recommended by the manufacturer, ozone levels were still found to be high in CPAP machines and tubing
- There was considerable variation in the power of UV light and the recommended time of exposure to UV light by manufacturers of UV light devices
- More data must be provided to demonstrate the safety and efficacy of devices that claim to clean, disinfect, or sanitize CPAP devices and accessories
- Remember to follow the cleaning instructions provided by your CPAP manufacturer
- Clean your CPAP devices and accessories by hand with soap and water
- Food & Drug Administration. FDA Reminds Patients that Devices Claiming to Clean, Disinfect or Sanitize CPAP Machines Using Ozone Gas or UV Light Have Not Been FDA Authorized. https://www.fda.gov/news-events/press-announcements/fda-reminds-patients-devices-claiming-clean-disinfect-or-sanitize-cpap-machines-using-ozone-gas-or. Accessed May 2020.
- U.S. Environmental Protection Agency. Ozone generators that are sold as air cleaners. www.epa.gov/indoor-air-quality-iaq/ozone-generators-are-sold-air-cleaners. Accessed May 2020.