The sterilization process is standardized and the process monitoring consists of five methods:
- Operator observation and interaction.
- Parametric monitoring
- Chemical monitoring
- Biological monitoring
- Diagnostic cycle
The sterilant cup is examined and the expiration date noted prior to placement in the sterilizing unit. The buffers in the bottom of the cup should not be hard. After placing the sterilant cup in the system, the aspirator probe must be properly positioned and the tubing inspected for kinks that would prevent aspiration of the PA.
At the end of the cycle, the sterilant cup is checked to note the complete aspiration of the active ingredient. If fluid is noted in the cup, appropriate disposal methods must be employed according to the manufacturer's instructions.
Chemical indicators monitor the presence of the minimum necessary concentration of the active ingredient during the sterilization cycle. A chemical indicator does not guarantee sterility of the load but merely shows that the active ingredient was present for sterilization to be achieved. The manufacturer recommends that a chemical indicator be included with each sterile processing cycle to verify the presence of the active ingredient.
Biological monitoring consists of a test challenge compared to a control culture obtained from a live spore strip of Bacillus stearothermophilus. The frequency to the testing will be determined by the health care facility's internal policy. A chemical indicator should be run with all biological testing. After appropriate incubation, the test challenge is compared with the control and the results are recorded.
The diagnostic cycle should be run daily when the processor is in use. The first phase of this cycle tests the electrical, mechanical, pneumatic and hydraulic systems. The second phase verifies the integrity of the sterile water filter membrane.
A failed diagnostic cycle will lock out any attempts to use the sterilizer until the fault has been corrected, and a successful diagnostic cycle is completed. The cup of sterilant is not used when running a diagnostic cycle.
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