Many factors can affect the heat sterilization process. If
the process is not routinely monitored, a problem that can jeopardize
patient protection can go undetected. Physical monitoring alone,
such as observing dials, gauges and printouts, is not sufficient.
Sterilizing failures involving overloading, improper packaging,
or air pockets will not show up on the dials. Chemical and biological
monitoring must be used in addition to physical monitoring to
adequately verify the process. Sterilization monitoring falls
into three major categories:
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Mechanical and Electronic Indicators, which
are the dials, gauges and printouts on your sterilizer. These
do not indicate sterility, only gross equipment malfunction.
-
Chemical Indicators in the form of
color-changing ink are used to show that one or more conditions
of sterilization were met, but usually cannot be used to show that
the conditions necessary for sterilization were achieved. Use of the patent-pending Crosstex Sure-Check sterilization pouch with Class 4 multi-variable chemical indicators does provide confirmation that the 3 variables for sterilization were met. As most facilities utilize sterilization pouches it is important to know that nearly all of these pouches are manufactured with a Class 1 Process Indicator, internal, external or a combinaion of both, that simply measures temperature. The Process Indicator will change color if exposed to bright sunlight, left sitting on top of a sterilizer or when placed in the sterilizer itself. It does not provide any indication/validation that the 3 variables for sterilization were met. Advanced technology, such as the patent-pending Sure-Check sterilization pouch with Class 4 internal and external indicators is an effective Chemical Indicator in that it will only change color when all three variables required for sterilization are met - temperature, for a specified period of time and the presence of steam. Without any one of these variables being met, the indicator will NOT change. When used in conjunction with daily/weekly biological monitoring it provides you with the optimal sterility assurance program.
-
Biological Indicators (BIs) which are a standardized,
viable population of bacterial spores known to be resistant
to the mode of sterilization being monitored and are inoculated
into a liquid or onto a paper carrier. Biological indicators
are intended to demonstrate whether the conditions were adequate
to achieve sterilization through actual organism kill.
Is weekly spore testing adequate? Additional
testing may be necessary when:
- A new type of packaging or tray material is used.
- Following training or retraining of personnel.
- A new sterilizer is used initially or after repair.
- Implantable devices are in the load.
- Following any changes in sterilization procedures.
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