ETO Handling BI concern

[MGonzalez]

Hello, good friends of our prestige organization. I have a concern that I will need people with the same expertise or knowledgeable to tell me something about ETO processing sterilization. I work for a hospital which is has the big tanks on the back of the sterilizer and it uses 80% ETO. Whenever we remove the cart to be put into the aeration room, I have a dilemma with handeling the BI and touching any paper records before the total areation is complete. Am I exagerating or this is the correct protocol, to wait until all items are completely aerated. Please let me know, what the protocol is. I have approach management about it , and they say not to worry about because the levels of ETO are very minimum if there is any. So it is ok by them to do what we do!! Incubate the BI as soon as is comming out from the sterilizer.

Gonzalez, CRCST
NY

Please if you have any documentation that states the contrary protocol please send me a link or a copy so I can share with others techs.

[HRJohn]

AAMI does make a provision for handling the BI prior to aeration in ST41 6.10.6:.

"When it is necessary for an operator to handle items that have not been aerated such as a BI test pack, personnel should be monitored to verify the safety of the practices followed"

AAMI also recommends in ST41 7.8 that you contact the manufacturer of the sterilizer (and I would add, the manufacturer of the BI) to determine the need to aerate or not aerate the BI. One issue is that the BI will be further exposed to EO during the aeration process, possibly skewing the results

However, your manager's comment "not to worry about because the levels of ETO are very minimum if there is any." is not an appropriate answer.

You should be following very strict guidelines with regard to ventilation and protective equipment, etc. any time you handle an unaerated item straight out of the chamber. Especially one like you described which contains absorbent material.

I would get your BI manufacturer involved in this discussion. Most of them have technical support people that can help you formulate a safe handling policy, and they can probably help you with regulatory data as well.

[MGonzalez]

Yes, there is no doubt about the importance of handeling the BI, and I thank You for give a lead to find the rigth answer. I appreciate the time you have taken to reply my concern..

I will follow your advice and will input the result when I find out more about it.
MGonzalez, CRCST
NY

[HRJohn]

M Gonzalez,

Are you by chance using the 3M Attest biological indicator?

I looked up a procedure that I have on file from 3M, and they do appear to recommend aerating the BI.

Let me know if this procedure would be any help to you. I'd be happy to email it to you.

-John

[MGonzalez]

HR Jhon.
Thank you very much for finding out valuable information regarding this issue! Yes we use the 3M Attes biological indicator the GREEN CAP in the pack (one per pack). I read something about this long time ago and I can find the paper work. That is why I challenged management about it. I remembered it said the BI or anything other than metal shoulbe be aerated before making any contact with it. Please feel free to send me the manufacture's recommendations at my email or you can post the link if there is any!

MGonzalez
melvin.gonzalez@gmail.com

I do really appreciate this info HR John...
By the way I used to lived at LA, California, I kinda miss the weather a lot!!!
Thank You, again.

[HRJohn]

Mel,

I'm going to try to upload the procedure here, as a Word file.

If this doesn't work, I'll email it to you.

This was a procedure that 3M emailed to me as a suggested procedure when I asked them for help writing my policies.

We don't have an EtO sterilizer any more, but I still had this one on file.

PS- Coincidentally, I used to live in Mamaroneck, NY, and I DONT miss the weather;)

[MGonzalez]

HRJhon, It worked well. Thank You very much!

MGonzalez, NY