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ConFirm | The Sterilization Process
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:
  1. Mechanical and Electronic Indicators, which are the dials, gauges and printouts on your sterilizer. These do not indicate sterility, only gross equipment malfunction.
  2. 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.
  3. 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:

  1. A new type of packaging or tray material is used.
  2. Following training or retraining of personnel.
  3. A new sterilizer is used initially or after repair.
  4. Implantable devices are in the load.
  5. Following any changes in sterilization procedures.
ConFirm | Educational Topics
The Sterilization Process
Learn what types of indicators there are and how often you should use them.
Sterilization Guidelines - U.S.
What organizations require sterilization monitoring and when.
Sterilization Guidelines - Canada
What organizations require sterilization monitoring and when.
Loading Sterilizers Properly
Get directions on how to correctly prepare your sterilizer for testing.
Why Tests Fail
Have you failed a test? Find out why.
Related Links
Find links to related companies and organizations.
 
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