Hi,
At my hospital we use 3 spores per load once a week for our steam steriliser, one spore per shelf. In addition we also use a spore for any load that has implants. I have been told that if the steriliser meets all requirements of validation and parametric release that there is no need to spore implants.
I have looked at all questions and answers and see that only 1 spore is needed per week and it is advised to spore implants. I was wondering where I can find documentation on this recommendation.

Thanks Debbie

Dear Debbie,

The answer to your question depends on where in the world you are because legal requirements are different in different places.

The procedures that you are using meet the requirements for Biological Testing in the U.S.A. In the U.S.A., every steam load containing implants must be monitored with a Biological Test, and all the steam sterilizers must be monitored at least once per week using Biological Monitors. It is suggested that Steam Sterilizers be monitored at least once per day with a Biological Monitor even if no implants are sterilized. One reason for this suggestion is that in the event of a positive Biological test, every item run in the sterilizer since the last good Biological test must be recalled and reprocessed. The shorter the periods between Biological monitoring, the fewer items need to be subject to recall.

The place to find these standards is The Association for the Advancement of Medical Instrumentation (AAMI - www.aami.org) "Good Hospital Practice: Steam Sterilization and Sterility Assurance" standards, which are pricey - $565/$795. These are typically purchased by hospital departments in the U.S.A.

Parametric release is commonly used in Europe. A Sterility Assurance Level of 10 -6 (SAL 10 -6) is reached in 1.25 minutes with Steam sterilization at 270 F or 136 C. Typically, steam sterilizers are run for 3.5 - 4 minutes, or three times longer than is required to reach a SAL of 10 -6 which is what is measured by the Biological Tests. Biological tests never show growth when all the parameters of the sterilization cycle are met because of the huge overkill built into the normal steam sterilization cycles. The reasoning is that these Biological tests in steam cycles are a waste of hospital resources when they never show a failure when all the parameters of the steam sterilization cycle are met.

You can find more information about the CEN Standards on this EFHSS website, a couple buttons below the Questions and Answers button.

Warm Regards,
Pete Bobb