Are Ozone CPAP Cleaners Safe?

By Angela Giudice, RPSGT

Are ozone CPAP cleaners safe?

I have been a clinician in the sleep business for a long time. Sometimes I see a product on the market that raises an eyebrow, and sometimes I see a product that raises genuine concern.

Patients with obstructive sleep apnea (OSA) run the gamut from healthy and athletic to those faced with other comorbidities such as asthma, COPA, and pulmonary fibrosis.

It is that overlap of the patient population that concerns me most when I see ozone-based CPAP cleaners heavily marketed.

Out in California, the California Air Resources Board (CARB) was sufficiently alarmed to adopt legislation to protect public health. Why? Because ozone is not what other manufacturers advertise it to be (i.e. “activated oxygen”). Rather, ozone is a toxic gas. FDA regulations are pretty clear on this:

Sec. 801.415 Maximum acceptable level of ozone.
(a) Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals.
(b) Although undesirable physiological effects on the central nervous system, heart, and vision have been reported, the predominant physiological effect of ozone is primary irritation of the mucous membranes. Inhalation of ozone can cause sufficient irritation to the lungs to result in pulmonary edema. The onset of pulmonary edema is usually delayed for some hours after exposure; thus, symptomatic response is not a reliable warning of exposure to toxic concentrations of ozone. Since olfactory fatigue develops readily, the odor of ozone is not a reliable index of atmospheric ozone concentration. (emphasis added).

The two products I see in the marketplace that rely on ozone for disinfection are SoClean and VirtuClean.

One has a warning not to use the CPAP equipment for several hours. The other has no warning at all for a waiting period.

A safe waiting period is probably several hours.

But, how much ozone is being vented in the room? Is it safe for pets, children and the elderly? Does the product
label even indicate how much ozone is released?

Probably not.

If a patient wants to use an ozone product, at least some awareness as to the risks needs to be raised to ensure that the product is used safely and as directed.

The worst thing that can happen is that the patient does not wait several hours to use and inhales a full column of ozone in the CPAP hose into their lungs, or the device vents enough ozone to raise the room concentration above 0.05 ppm.

So are ozone CPAP cleaners safe?

If you can smell ozone, you are breathing it.

And that is never a safe thing.

September 18, 2018 51

A. Giudice

A Sleep Professional with over 20 years of industry experience, a healthy respect for research and a slightly sarcastic writing style.