| FAQ - Sterilization - Archived Through 2012
Our practice uses a sterilizer monitoring system. We test our autoclave weekly. We recently received a card from the company introducing a "chemical integrator” to be placed in every package of each cycle. Is this a mandatory procedure? Is this another over-kill sales gimmick?
Weekly biological/live spore testing and chemical integrators, in each package, should be performed.
OSAP would like to refer you to the Centers for Disease Control and Prevention's (CDC) Infection Control Guidelines for a detailed explanation of both procedures. Although the CDC guidelines are only recommendations, State Boards of Dental Examiners/Licensing Agencies often mandate, through the dental practice act and/or other state legislation, compliance with the CDC guidelines.
Additionally, CDC guidelines are considered the standard of due care. There may be other state laws/regulations that OSAP is not aware of, therefore, you should also consult with your state agencies.
In part, the guidelines state the following:
Monitoring of sterilization procedures should include a combination of process parameters, including mechanical, chemical, and biological. These parameters evaluate both the sterilizing conditions and the procedure's effectiveness. (1)
Mechanical techniques for monitoring sterilization include assessing cycle time, temperature, and pressure by observing the gauges or displays on the sterilizer and noting these parameters for each load. Some tabletop sterilizers have recording devices that print out these parameters. Correct readings do not ensure sterilization, but incorrect readings can be the first indication of a problem with the sterilization cycle. (1)
Chemical indicators, internal and external, use sensitive chemicals to assess physical conditions (e.g., time and temperature) during the sterilization process. Although chemical indicators do not prove sterilization has been achieved, they allow detection of certain equipment malfunctions, and they can help identify procedural errors. External indicators applied to the outside of a package (e.g., chemical indicator tape or special markings) change color rapidly when a specific parameter is reached, and they verify that the package has been exposed to the sterilization process. Internal chemical indicators should be used inside each package to ensure the sterilizing agent has penetrated the packaging material and actually reached the instruments inside. A single-parameter internal chemical indicator provides information regarding only one sterilization parameter (e.g., time or temperature). Multi-parameter internal chemical indicators are designed to react to >2 parameters (e.g., time and temperature; or time, temperature, and the presence of steam) and can provide a more reliable indication that sterilization conditions have been met. Multi-parameter internal indicators are available only for steam sterilizers (i.e., autoclaves). (1)
Because chemical indicator test results are received when the sterilization cycle is complete, they can provide an early indication of a problem and where in the process the problem might exist. If either mechanical indicators or internal or external chemical indicators indicate inadequate processing, items in the load should not be used until reprocessed. (1)
Biological indicators (BIs) (i.e., spore tests) are the most accepted method for monitoring the sterilization process because they assess it directly by killing known highly resistant microorganisms (e.g., Geobacillus or Bacillus species), rather than merely testing the physical and chemical conditions necessary for sterilization (243). Because spores used in BIs are more resistant and present in greater numbers than the common microbial contaminants found on patient-care equipment, an inactivated BI indicates other potential pathogens in the load have been killed. (1)
Correct functioning of sterilization cycles should be verified for each sterilizer by the periodic use (at least weekly) of BIs. Every load containing implantable devices should be monitored with such indicators, and the items quarantined until BI results are known. However, in an emergency, placing implantable items in quarantine until spore tests are known to be negative might be impossible. (1)
Manufacturer's directions should determine the placement and location of BI in the sterilizer. A control BI, from the same lot as the test indicator and not processed through the sterilizer, should be incubated with the test BI; the control BI should yield positive results for bacterial growth. (1)