Challenge Pack

[Kristopher]

I am wondering if anyone is using the Sixcess Challenge Pack from St**is.
Their claim is that this product can replace the use of biologicals in implant loads. I find this to be a hard pill to swallow since AAMI standards states that "Biological indicators provide the only direct measure of the lethality of the sterilization process".
I can understand the use of this product for the release of nonimplant loads since it is a process challenge device and provides an immediate easy to read result of sterilization parameters.
Anyone have any thoughts?

[chipmoore]

Class 6 Indicators, called emulators, are Class 2 medical devices and thus require FDA clearance prior to commercial distribution. Check the Mfg for cleared claims. Class 6 indicators are specific to an exposure time and temperature. AAMI standards will eventually catch up with new technologies.
Chip Moore
Rochester, NY
Retired but involved

[Chuck Hughes]

Kristopher,

Here are my thoughts....

You are hesitant to use the new product to release implants, but ok to release routine loads? This statement assumes that you have accepted the premise that there is a need for a Class 6 to measure the full cycle "internally". I do not agree! Our gold standard (here in the US) as promoted by AAMI, AORN, and the CDC, has never been to measure the inside of packages for full cycle parameters with a CI or BI, but rather something significantly less (yet above) the death curve of Geobacillus stearothermophilus spores. By demonstrating BI kill or Class 5 (that correlate BI kill) passing, we know all pathogenic organisms would have been killed much, much earlier and can release the processed items with a high level of confidence. Of course, this assumes that best practices for the entire process, i.e. cleaning, packaging, etc... have been followed. Remember, sterilization requires a "systems approach".

Chip's response seems to encourage the release of all loads as this is the label claim the FDA cleared for this new product. When I say "new" product, I do not mean "new technology" as making a CI harder to pass has always been possible, just not advisable since we do not want to have a failed CI and a passed (negative) BI in the same package. This can lead to user confustion, unnecessary sterilizer repairs, unnecessary reprocessing of items, unnecessary patient communication, etc...

I was always taught that measuring the full cycle is the purpose and fuction of physical indicators via guages and print outs. To require the most challenging locations "within packages" to reach full cycle parameters is not necessary to achieve sterility of the items. That is why we practice the "overkill" philosophy here in the US, unlike some countries. The parameters needed to change C5 integrators or kill the BI, are significantly less than what the sterilizer is set for. And remember, the purpose of sterilization is to sterilize items, not to pass the most resistant CI. The indicators we choose to use, should reflect that purpose plus an acceptable safety factor, as defined by standards. I submit that the current Class 5 integrators and BIs provide just that. To measure beyond this safety factor has always been possible, yet not needed (with the exception of a prion situation where 18 minutes of direct steam contact is desired at 134C in a pre-vacuum cycle).

So, think about why you need to measure more of the sterilizer cycle? If you feel that you do, then the use of a C6 is exactly the way to do it. And be sure to reference the mfg's label claims and instuctions in your Policy and Procedures, not AAMI standards or AORN Recommended Practices.

Good luck and feel free to contact me offline for more discussion!

Chuck Hughes, GM
SPSmedical - Sterilization Products & Services
1-800-722-1529