IProof of sterility.

[Guest]

We have a case with 15 orthopedic trays , we follow our procedures to clean them, and before we wrapp them we place and indicator on every tray.
With each load we run a Biological test, we have a print out from the sterilizer and every thing went perfect until they open in OR three trays without inside indicators. This cause a caos , they stripped down the room and brought every thing back to be resterilized again.
My question is , if all the other parameters were correct and we have a biological test done and negative why a chemical integrator missing case such a caos.
Is any AAMI regulation that will help me?

[eshep]

It causes a problem because you do not have proof that the inside of these trays reach the parameters of time, temperature and steam penetration. AAMI does reccomend a internal indicator be placed in every package, tray , and container and they reccomend a class 4 or 5 indicator be used.