EFHSS Questions and Answers - Question Q00642

Greetings! I would like to know if Test Packs for Steam Sterilization considered as Process Challenge Device? Thanks...

Beatriz,

All test packs inculdeing the Bowie Dick test are classified as PCDs

Regards
Bill Davis

Hi
Bill has a mistake.

BD (Test pack) verify effectiveness of air removal, or, in other words effective steam penetration. Nothing else. The Indicator is Class 2 classified.
Routine, dayly BD test confirm the properity of the Autoclave.

PCD shall assure that sterilization conditions were transfared from the sterilizer to the load. PCD is multiparameter Indicator. It is classified as Class 4,5 or 6
miki

Hi Beatriz

I agree with Bill - all tests that form a challange to the sterilization process are classified as Process Challenge Devices and therefore represent a specific test.

However the Bowie and Dick test as mentioned by Miki is not done to prove the effectiveness of the sterilization process but to determine rapid and even penetration into a small porous load thereby testing the mechanical function of your sterilizer. This is why it is conducted at the beginning of each day in an empty chamber.

The other PCD's, as refered to by Miki, are placed in the load as a load control - however I disagree with Miki on this as we believe these indicators are classified as class 2 as they are indicators for use in a specific test and not for general use. We also believe that these load controls do offer the CSSD manager confirmation of conditions inside the sterilizer however they do not confirm what is actually happening within the trays or items being sterilized.

Kind regards
Peter Newson

Dear Peter

Firstly: You are the responsible person, so the final decision is yours!
2nd: Sterilization is not an issue of belief. It is an issue of assurance.
3dr: You conduct it in the morning because it simulate the "worst case"
4th: Did you discussed this issue with an AP?

miki

To all concerned;

Thank you very much for the informations you gave me... I hope you'll help me again when I have other questions....

Best regards,
Beatriz