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Biological sterilizer monitoring (i.e., spore testing)
Biological indicators (BIs) are the only definitive method of demonstrating sterilization as they show if actual microbial life has been destroyed. Biological indicators are either strips or ampoules that contain a large, known quantity of the highly resistant spore Geobacillus stearothermophilus for steam and chemical vapor sterilization or Bacillus atrophaeus for dry heat and ethylene oxide sterilization. Biological monitoring of sterilizer should be performed at least weekly. The BIs should be placed in the center of the largest, most difficult pack to sterilize. The pack is placed horizontally in the lower front portion of the sterilizer chamber to create the greatest challenge.
After being subjected to the sterilization process, BIs must be incubated or processed according to the BI manufacturer’s instructions. If a processed BI shows a positive result, the sterilizer should be retested and products should be recalled if possible. The sterilizer in question should not be used until the cause of the sterilization failure is determined, corrected, and testing has been performed to validate the sterilizer efficacy.
Chemical sterilizer monitoring
Chemical indicators show that the package has been exposed to the physical conditions within a sterilizer; they do not prove that sterilization has taken place. There are several types of chemical indicators available. Each type is meant to monitor specific parameters such as time, temperature, and/or the presence of steam or gas. There are external chemical indicators which are placed on the outside of the package and should be checked after the sterilization process.
There are internal chemical indicators which are placed within the package in an area that is least accessible to the sterilant and should be checked at point-of-use. If parameters are not met, the product should NOT be considered sterile and should be reprocessed before use. A special type of chemical indicator, called a chemical integrator measures time, steam, and temperature. Chemical indicators are best when used with every load or at least once daily. Follow the chemical indicator manufacturer’s instructions for interpretation of results.
Mechanical monitoring includes temperature gauges, pressure gauges, and recording charts (i.e., round charts and computer driven printouts found on larger and newer sterilizing units). Checking temperature and pressure will help determine if the proper cycle parameters are being met and will alert the operator if a malfunction occurs. Mechanical monitoring measures specific parameters at certain points in the sterilizer chamber and does not indicate that actual sterilization has taken place.
It is vital to the safety of your employees and patients that you properly monitor the sterilization process in your practice. It is imperative to monitor your sterilizer to reduce the risk of cross contamination. It is important to mechanically monitor your sterilizer during every cycle, paying close attention to all gauges and printouts and following the manufacturer’s recommendations.
At least once daily (preferably with every sterilizer cycle), it is recommended that chemical indicators/integrators are used to monitor the main parameters of the sterilization cycle including time, steam, and temperature. Biological monitoring should also be performed to determine sterilization. Biological indicators are the only method of demonstrating sterilization, as the results show if actual microbial life has been destroyed.
Biological monitoring is recommended on a weekly basis by the CDC (Centers for Disease Control), ADA, OSAP, and AAMI (Advancement of Medical Instrumentation). A majority of state dental boards require weekly biological monitoring (see regulations map). Chemical and mechanical monitoring should be done with each load.
The most frequent reason for sterilization failure is operator error. It is critical that specific procedures and techniques be clearly defined and followed to aid the overall quality assurance program. The proper training of employees in sterilizer operation and sterilization procedures can result in more effective sterilization.
It is recommended to review all sterilization protocol and follow procedures recommended by the CDC. Please send us another test immediately.
Another necessary step to reduce your exposure to liability is accurate record keeping. It is important to keep accurate records regarding the phases of sterilizer monitoring. Inspectors may request to see your records to see that mechanical, chemical and biological monitoring is being properly performed and recorded. Should a situation arise and litigation become necessary, accurate records will protect you and your practice.
Maintenance recording should include:
- Date of service
- Reason for maintenance
- Model and serial number of sterilizer
- Name of person requesting service
- Description of service
- Types and parts replaced
- Signature of service technician
- Date for retesting
- Retesting results