SoClean and Other Ozone Cleaners - FDA Warning

[ChicagoGranny]

Ozone and ultraviolet cleaners are included in the notice.

Date Issued: February 27, 2020

The U.S. Food and Drug Administration (FDA) wants to make consumers and health care providers aware that, to date, the FDA 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 (for example: hoses, masks, tubing and headgear).

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.

...

Ozone (O3), sometimes called “activated oxygen”, is a gas that can be used to kill harmful bacteria. However, for ozone to be effective in destroying harmful bacteria, it must be present at a concentration above levels considered safe for humans.

Although products that claim to use ozone gas to clean CPAP machine equipment are designed to keep the ozone generated inside the machine and its accessories, leaks can occur at tubing connections, filters or through fabric containers used to house CPAP accessories. When leaks occur, ozone gas in the nearby space may temporarily rise to unsafe levels, especially if the space is not well ventilated. Ozone gas concentrations within the CPAP machine and tubing can also remain above safe levels even after the recommended waiting periods for ozone gas products that claim to clean. If the CPAP accessories are used without first allowing fresh air to circulate through the entire CPAP machine to remove any remaining ozone gas, this could lead to nasal, lung or any other type of irritation to the user’s breathing passages. Exposure to high levels of ozone gas also may worsen chronic respiratory diseases, such as asthma, or increase vulnerability to respiratory infection.

The FDA has received reports from patients experiencing cough, difficulty 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.

Using UV Light Products that claim to Clean CPAP Machine Equipment and Accessories

UV light may be used to disinfect surfaces in a setting where UV light does not escape to the surroundings. If products generating UV light do not shield the user from exposure, they pose a potential health hazard depending on the wavelength, intensity, and exposure time.

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. Additionally, when UV light is used with the purpose of disinfecting CPAP machine equipment and accessories, UV light may be unable to penetrate all areas of the CPAP accessories such as the hoses, masks and connectors. This may result in inadequately disinfected CPAP devices and accessories that may not be safe for reuse.

Full notice: https://www.fda.gov/medical-devices/saf ... chines-and

[clownbell]

Wow - that tells the tale. And it's not just some random person's opinion, it's an official FDA warning. I think this should be a sticky so that all PAP users can see it. Good work, Granny.

[ups4]

I'm glad to see this brought up again.
I have had this information bookmarked since it was published, for factual information to present to the SoClean fanboys.

It's somewhat shocking to me when I present this info to the ozone fanatics and their response is "I don't believe in anything the FDA says. It's a government agency and shouldn't be trusted". When I ask them exactly what information they DO trust....no answer.

I'm not trying to turn this thread into a ridiculous discussion about ozone devices, It's just amazing to me to hear these types of responses.

[chunkyfrog]

Kool-Aid is a powerful truth-repellent.
Cult behavior cannot be fixed.
Logic does not work--only a 2x4, swung in a horizontal arc, and connecting with a hard object.

[tlohse]

Hmm. This article is over a year old its 2021 now. I would think they would of stopped making them if it was so unsafe and was proven by more than a few people or on a forum like this. I believe that the SoClean2 is FDA approved as of now.

[Dog Slobber]

Hmm. This article is over a year old its 2021 now. I would think they would of stopped making them if it was so unsafe and was proven by more than a few people or on a forum like this. I believe that the SoClean2 is FDA approved as of now.

You'd be wrong.

[ChicagoGranny]

I believe that the SoClean2 is FDA approved as of now.

No.

[ups4]

Hmm. This article is over a year old its 2021 now. I would think they would of stopped making them if it was so unsafe and was proven by more than a few people or on a forum like this. I believe that the SoClean2 is FDA approved as of now.

Please cite your source.

Would you stop making something that gullible people think they need? People are still so easily conned with a scam.

[ChicagoGranny]

Please cite your source.

Note, he says "would think" and "believe". These terms are used by people who have no evidence.

[zonker]

I believe that the SoClean2 is FDA approved as of now.

No.

are you refuting the notion that he believes it?

[ChicagoGranny]

are you refuting the notion that he believes it?

I believe I am.

[chunkyfrog]

DO NOT DRINK THE KOOLAID.
Is that clear enough?
Also, avoid consuming applesauce or bull droppings.

[Goofproof]

are you refuting the notion that he believes it?

I believe I am.

I believe for every drop of rain that falls, a flower grows, and we need to smell them before the Ozone damages us so bad we can't smell them anymore. Jim

[palerider]

Hmm. This article is over a year old its 2021 now. I would think they would of stopped making them if it was so unsafe and was proven by more than a few people or on a forum like this. I believe that the SoClean2 is FDA approved as of now.

Since the FDA says that nobody should use an ozone machine, your belief is wrong.

There are lots of ineffective and potentially dangerous products that are made.

"patent medicine" scams separating gullible people from their money has been a thing for ever.

[zonker]

guys, tloshe came in at 5:25 am forum time. he's read the replies up to that point.

he either still believes what he believes or isn't going to admit to a change of mind....