Are Ozone CPAP Cleaners Approved by FDA?

Are Ozone CPAP Cleaners Approved by FDA?

If you use a CPAP device at night to help you breathe during sleep, you know it can be challenging to keep up a regular cleaning schedule. A dirty CPAP machine contaminated with germs such as viruses and bacteria can make you sick. So automated devices advertised on TV that claim to clean or disinfect your CPAP might look like the right choice. But it would be best if you think twice before purchasing a device that claims to clean or disinfect a CPAP. These machines are not legally marketed for this use by the FDA in America. Machines are not compulsory to clean your CPAP. Most CPAPs can be cleaned with mild soap and water, as described in the owner’s guide for your device. Some manufacturers recommend utilizing diluted vinegar.

What is a Continuous Positive Airway Pressure (CPAP) Machine?

A CPAP machine is a form of a ventilator that helps individuals with obstructive sleep apnea, a health condition that causes brief pauses in breathing during sleep. When you have sleep apnea, your airway becomes totally or partially blocked by your tongue, tonsils, or other parts of your mouth or throat. When your airway is briefly blocked, your brain and organs do not get enough oxygen, causing health complications. A CPAP machine keeps your airway open by providing a continuous stream of air over a mask. A long, flexible hose links the CPAP machine to the mask so that you can move around or turn over in bed.

Why Does My CPAP Machine Require Cleaning?

Germs from your lungs, throat, or mouth can get into the CPAP mask or tube as you breathe in and out during sleep, or germs on your skin may get transmitted to the CPAP mask or hose. Dust, mold, or other allergens can also get into the CPAP mask or tube. All kinds of CPAP machines must be cleaned frequently so that these germs and contaminants do not grow inside of your equipment and make you sick. Dust and dirt can also cause problems with the device, making it more likely to break or require replacement.

Types of CPAP Cleaners That Are Sold

There are two major types of machines that clean CPAPs. One type uses ozone gas, which can be hazardous and toxic above certain levels. The second type employs ultraviolet (UV) light. To date, the FDA has not approved or cleared any equipment to clean a CPAP. This means the FDA has not made a judgment concerning the safety or effectiveness of these machines for this use.

Why is the FDA Concerned About Machines That Cleans CPAPs?

The FDA has received reports from persons who use CPAPs that they experienced unexpected asthma attacks, headaches, and breathlessness after using devices that use ozone gas to clean their CPAP. Not only can ozone leak out of the CPAP machine into your home during the cleaning, but ozone levels inside of the CPAP equipment can be above safe limits even several hours after cleaning is done. Ozone gas and UV light equipment that clean CPAPs do not have FDA clearance or approval, indicating that the FDA has not found that ozone gas and UV light cleaners work to destroy germs on CPAPs and are safe. The FDA has not received data or evidence from manufacturers that say UV light can clean the inside surface of CPAP hoses or prove that UV light does not damage CPAP machines. The FDA does not have evidence that devices utilizing UV light protect you from unsafe levels of UV radiation exposure.

Does the FDA approve home CPAP Cleaners?

No home CPAP cleaning machines that use ozone gas or UV light have been approved or cleared by the FDA. The FDA has not established whether CPAP cleaning devices are safe. The FDA does not have evidence of whether CPAP cleaning devices work to clean or disinfect CPAP machines of germs or allergens.

References and Resources

• How CPAP Machines Work