Hey guys, how many of you have been doing OZONE and how long? any of you take precautions and use a respiratory mask? the cheap ones like the spray painters wear? or just the mask that's provided in the clinic? Anyone had any health effects? Inputs appreciated

We use ozone for disinfection of our bicarb loop. We have very good ventilation in the room which also has a ozone monitor. We do not use a mask however if you were looking at getting one I would get one that is impregnated with charcoal since charcoal will nuetralize ozone. It must also be fitted to ensure a good seal. Anyone with respitory issues should not be involved in the ozone disinfection process.

I use Ozone for the bicarb loop once a week for 20-30 minutes. I don't use a mask and I do have an ambient air monitor.

here is my question ~ how are you getting by with using ozone? no one has a ozone unit with a FDA 510k clearance ( excecpt for use with the SDS system from MarCor). Plus the FDA says that ozone is NOT approved for biofilm removal. With all the new CMS guidelines i would be very wary of having an ozone unit in a clinic.

AAMI RD52:2004 5.3.4.2 Ozone may be used to control bacterial proliferation in water storage and distribution systems. Ozone may also degrade endotoxins.......

We ozone the bicarb system once a week. We also have an ambient air monitor. Contact time is 20-30 minutes. After that it starts to dissipate anyway. CMS requires 10 min. or mfr. guidlines

State was just here and left without a peep. No issues with our backroom.

As far as CMS and ozone goes, check V216 in the regs.
You can also check AAMI 62:2006

Yes AAMI says that but the unit supplying the ozone would still have to meet FDA standards to be approved for use. AAMI doesn't set the medical device standards, the FDA does. Because ozone would be considered a medical device it can only be used if there is an FDA 510k approval, which no one has on an ozone unit. Recently the FDA cited one of the water treatment company's because they were selling an ozone unit. The company had to pull it. And when it comes to getting paid CMS wants EVERYTHING to meet FDA guidlines. Just trying to let everyone know that this could be an issue when you get an inspection.

During ozone, if you stick your head in the tank and get teary eyed for 15 minutes, you need more. If your throat gets scratchy for half an hour, you're good to go.

We looked into a bicarb preparation system a number of years ago that used ozone as the disinfectant. Occupational health evaluated and as a result almost $100,000 (3 systems) worth of ventilation and monitoring upgrades and validation where required before use.

If you want to find out more google "occupational effects of ozone"

Exposure (even a 1 time accidental exposure) to ozone even in low concentrations can cause immediate, severe, and permanent damage to your lungs.
I would recommend that you talk to occupation health and safety experts and not try to gain "knowledge" about ozone from a forum such as this. You don't want to risk your health and safety by following peoples thoughts and opinions that "may" be wrong.
One wrong move with ozone can affect you for the rest of your life.

The quote below is taken directly from the link below.
"Even very low concentrations of ozone can be harmful to the upper respiratory tract and the lungs. The severity of injury depends on both by the concentration of ozone and the duration of exposure. Severe and permanent lung injury or death could result from even a very short-term exposure to relatively low concentrations."

Hope this gives some food for thought.

Ozone Link

Very Serious Consequences,

Your detailed analysis has no conclusion.

The webpage you provided said that this was only tested on animals, not humans. Not to mention the quote: "A 30-minute exposure to 50 ppm is considered potentially lethal. "
Our clinic is not ventilated very well at all. We get a >1.3 ppm solution and rapid loop this for 12 minutes. The exposure measure with a draeger pump, shoed that our average ambient air quality sample was 0.0375.

Conclusion

Be informed and be careful.
Be aware of all your workplace/occupational risks and take appropriate precautions.

As far as testing only being done on animals. I'm ok with that.
Human testing of hazardous and toxic substances should not be done on humans.

What about the fact that these units DO NOT have a FDA 510k clearance? They are not approved for use by the FDA. Also OSHA will EAT YOU UP on this if you do not have the proper ventilation systems.

Ozone is approved for use with bicarb systems and bicarb loops. It however, IS NOT approved for use with dialysis water systems and loops.

I may be going out on a limb here but, I like ozone. And, just because it is not approved by FDA does not mean it can't be used. We know ozone is safe to use...if properly used. And, if it is approved to be used on the bicarb system, it should not cause harm to use it on the water loop. For a bicarb loop, if you have a system that is not approved by FDA, you can still use it but you can't take credit for it. AAMI RD52 recommends disinfecting the bicarb loop weekly. You can use an approved disinfectant weekly to meet the requirement, but ozone more often (daily). You need to disinfected the water loop monthly with an approve disinfectant, but you can ozone it more often.

Disclaimer - some times you need to look at reality and not just the regulations. And, you should not be penalized for doing more.

Florian - i agree with you except for the fact that we do have to follow regulations even if they don't make since. it is better to change them than break them....