EFHSS Questions and Answers - Question Q00176

Hi everyone!

I am currently in the process of implementing E.R.S, (Event Related Sterility) within the hospital. What could I do as an on-going quality assurance testing protocol? Would it be having a 'dummy' tray set up with instruments and randomly testing it by Microbiologists?....or is there a a better/different way?
Look forward to some answers.

Thank you.

Lynne Cleary
CNC/CSSD
Launceston
Tasmania
Australia

Hi Lynne,

If you have all required standards for the storage of sterile items (packaging material, storage condition and very important, proper training of all staff handling sterile items) I don't think it is necessary to do any Test.
But in the process of implementing E.R.S. I understand very well that you wish or have to present a quality protocol for your "revolutionary" change.
On our last EFHSS Congress 2001 in Gent, Jay R. Sommers, Ph.D (Kimberly-Clark Corp) suggested the following Event-Related Testing:

Packages are

1. Sterilized
2. Transported to storage
3. Placed on a storage shelf
4. Taken off the storage shelf
5. Put in a transportation cart
6. Rolled into the elevator (exposure to vibration)
7. Taken to O.R.
8. Rolled back to elevator
9. Return to Central Service Storage
10. Placed on a storage shelf
11. Repeat Steps 4 - 7
12. Put in a sterile bag and send it to Microlab

To make it easier for the Lab I suggest placing some 4 x 4 compresses as test object on the outside of the product, top, bottom and sides. Then wrap and sterilize it and follow the above steps.
Dear Lynne it would be great to read the "result" of your action on our Web page!

All the best
Josy Holdener

Dear Lynne,

May I turn your attention to an article by Kevin J Sherlock: "Event Related Sterility Testing"? It appeared in "Sterilization in Australia" 2000, 19(4), 16-20 and in Central Service 2/01.

Kind regards,
Wim Renders