Whenever this happens, it is advisable to check the sterilization process. There are certain variables such as time, temperature, pressure, etc. which might need to be re-adjusted. In case problems continue, the equipment will have to be examined. There might be some problems with the packaging material before approving its performance.
In case of a positive biological test, the sterilizer should be removed from service. All records of physical and chemical monitoring since the last negative BI test should be reviewed. If the physical (e.g., time, temperature, and pressure) and chemical (i.e., internal or external) indicators demonstrate the sterilizer is functioning correctly, a single positive spore test probably does not indicate sterilizer malfunction, consider the possibility of operator error.
Review cleaning, packaging, loading, and biological testing procedures with all staff who work with the sterilizer. In the absence of mechanical failure of the sterilizer unit, overloading, failure to provide adequate package separation and incorrect or excessive packaging material are all common reasons for a positive BI. Using the same cycle that produced the failure, repeat the biological test immediately after correctly loading the sterilizer.
But when improper sterilization does occur, common factors are:
- Chamber overload
- Excessive packaging material
- Inadequate exposure time
- Incorrect temperature/pressure settings
- Failure to preheat the sterilizer (if indicated)
- Interruption of the cycle
- Expired chemical solution (chemiclaves only)
So what should you do if a indicator turns positive?
Follow these steps:
- Ensure the indicator hasn’t expired.
- Ensure testing protocol was met.
- Check the sterilizer for obvious inconsistencies.
- Retest with the process indicator immediately.
- Contact your monitoring service immediately for assistance.
Content source:
June 1, 2016|Categories: Compliance, Risk Management|Tags: OSHA Review, spore testing, sterilization
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Steam Chemical Indicator class 6 (RRS 14-11610)
Steam Biological Indicator 10^5 (RRS 14-21110)
Steam Biological Indicator 10^6 (RRS 14-21120)
