Sterilization Parameters & Manufacturer Guidelines

[Francisco]

As manufacturer guidelines become more and more diverse, I am interested in hearing what other processing departments are doing about this issue. Is there a "standard" for sterilization cycles anymore? Should we sort loads based upon manufacturer guidelines? If a tray undergoes a sterilization cycle that exceeds its suggested exposer time, are we in breach of the manufacturer guidelines? Any response would be greatly appreciated.

[sonny1388]

The answers as I know them are: yes, we still use 4/20 as a standard, yes loads do need to be sorted, yes, exposing sets to times greater than suggested are in breach of the guidelines (unless you are lucky enough to have one that says "at least 6 mins" or similar). Unfortunately, because of the complexity of new instrumentation, there are many different methods being validated for sterilization. We had a new alligator forcep from Medtronic come in the other day that didn't have recommendations for a 270 cycle, but 4 different ones for 250. It is becoming a big issue at our hospital because quite frankly, I am out of cycles on both of our sterilizers. I have taken to changing a cylce for a particular item, and then changing it back when the cycle is finished.

As for your last question, I would like to elaborate just a bit. The reason that you would risk breaching guidelines by sterilizing a set for longer than suggested is that the sets and the instrumentation therein have only been validated for the cycle in the guidelines. If one of the instruments were to malfunction, the company would ask how it was sterilized, and if it was not what they had recommended, they would relinquish all liability to the hospital for using the item "off label". It's a pain, but not much we can do about it right at the moment.