Manufacturers Guidlines

[has]

We all now that we are to following Mfg guidlines for sterilization, but what if the Mfg guidelines fall below AAMI standards? I have a device the is to be run at gravity 250 20/20. My internal indicators and biologicals fail....... HELP!!! I have called the company to make sure they haven't updated. They haven't. I have told them that this does not meet FDA approval and they say that any longer will ruin their product. They offer no alternative method of sterilization. ARGHHHHH:(

[klammon]

Will the company provide options for a sterilization modality other than steam? (Like ETO, hydrogen peroxide plasma, Ozone?)

[has]

No they only offer the gravity 250 20/20, nothing else. Our service tech for our autoclaves tell us that we could do it at 30 minutes and it should (I hate the word should) not effect it and that they say that we have to follow FDA/AAMI guidlines.

[jtruitt]

Could the item be placed in a flash gravity cycle for just in time use using a BI for that cycle? I know we are trying to cut down on flash just like everybody else but you may not have a choice. If you can get your infection control department involved they can help with this problem. The physician that uses the device should be made aware that this company provides sterilization instructions that cannot be followed iby your department. Your director and your infection control department should back you up on this. Hope this helps.

[has]

That would be an alternitive, however, this is something that goes to another department (lab). The feeling of IC is that the instructions are more for a table top sterilizer which comes to temp quicker and that is the reason for the 20 minutes. I am at a loss.....

[fkrizman]

We also have one of these items. It is used for lab as a dispenser of solution. It is ran for decontamination and it is cultured weekly by lab to be sure it is not growing anything. The manufactures instructions recommend periodic steam sterilization at gravity 250degrees for 20 minutes. Because the it is not a critical use item and the sterility is confirmed by lab we continue to do this. Our BI does come up negative and our chemical indicator passes but does not completely turn.



Not sure what the FDA and AAMI say about the end use. Would these meet the requirements for high level disinfection?

[has]

Ours used to do the same thing. We have been following the mfg for years for this item. The problem really only came to light when we switched to a higher class intergrator (4 to 5) and BI. I just can't seem to figure out the hit and miss of the BI.

[chipmoore]

Check with your BI Mfg and ask them how long their BI's (how resistant) will survive at 250F (121C). I think BI are mfg and design to live/show growth up to 12 minutes. If this is true, your 20 minute cycle lacks overkill assurances.
Chip Moore
Rochester, NY
Retire, but involved