Peelpacks

[Rod Brueggeman]

I am looking for some input regarding the processing of items in peelpacks and question some of the written guidelines.

Why is it bad practice to place a peelpouch inside of a wrapped sterilization tray or sterilization container? I have run several studies where I have placed a challenge pack inside a double and triple peel pack;I have folded the peelpacks over and then placed these packs inside of trays. Every instance has demonstrated 100% lethality of the BI challenge. Never a wet pack!

I have also done this same study (without placing the pack inside of a tray)with double and triple peelpacks folded and with a hole punch have punched holes in the internal peelpack (and have also run it without holes)to allow air removal and steam penetration and have achieved 100% lethality. Never a wet pack!

So, I question not being able to place a peelpack inside a tray and I question not being able to fold a peelpack and place it inside of another peelpack!

[jrc]

I think is has to do with the fact that since the peel pack manufacturers did not test the packs inside containers they were not approved by the FDA to be used in that manner. It may be safe; it's just that it has not been proven to be safe and approved by the FDA.

[chipmoore]

Hi Rod,
My comments are not meant to say the practice is right or wrong, merely to point out some things.
From a JCAHO point of view, they will want to see your P & P's and the source documents to back them up. There are few if any out there supporting the practice. In ST79-2006, paragraph 8.3.4, the rationale states the "pouches can not be positioned to ensure adequate air removal...." This comment is endorsed by the users on the ST79 commitee (Klacik, Strickland, S Lee, L. Slone) to name a few. I also doubt the pouch Mfg supply written instructions for the practice.
In Europe, they practice parmetric release, meaning they validate their loads. The studies you have done probably mirror their daily practice. Unfortunately, user load validation isn't practice in the US, we just don't have the talent or guidelines in place.
I have no doubts of the process lethality you have measured using BI's. It is possible to perform chamber temperature mapping using thermocouples inside the load/pouch and recording devices to document time at temperature. In the US, our sterilization time at temperature is the "over kill" method, assuming the air is adequately removed. No sterilizer gets 100% of the air out and BI's die even if there is some air present inside the chamber/load. BI's will die even if the B-D Test fails. It's also true that the quality of the steam varies from facility to facility and can change without notice.
You should be congratulated for using science to question practices. If your studies can support cycle to cycle repeatibilty and you feel that strong about the practice and the benefits, work through your IC committee to see if it would be acceptable to your institution to implement.
Regards,
Chip Moore
Getinge
Rochester, NY