Govoni's tips for quality assurance

March 23, 2011
Even if the sterilizer passes the weekly monitoring test, that does not mean that each instrument pack in each load that is processed daily has been sterilized.

by Mary Govoni, CDA, RDA, RDH, MBA

No one would argue the importance of the sterilizer in the instrument reprocessing cycle in dental practice. Most dental teams follow the Centers for Disease Control (CDC) recommendation to monitor sterilizers at least weekly with a biological monitor (spore test).

But even if the sterilizer passes the weekly monitoring test, that does not mean that each instrument pack in each load that is processed daily has been sterilized. That may sound contradictory, since the spore test is the most appropriate evaluation of sterilizer effectiveness. But unless a spore test is run with each load (which would not be cost-effective), we can only assume that the sterilizer is working properly between the weekly spore tests.

Is it likely that the sterilizer malfunctions frequently? Probably not. But operating the sterilizer incorrectly, such as improper loading, is relatively common. Improper loading can cause problems (lack of sterilization) for individual instrument packs, which can go undetected without additional quality assurance measures.

These quality assurance measures are chemical indicators that measure whether or not the instruments in each pack or cassette were exposed to the necessary conditions for sterilization. The indicators come in two forms: indicator strips that can be placed in sterilization pouches or cassettes, or those that are incorporated into sterilization pouches.

Older style sterilization pouches have color change indicators on the outside border of the pouch while the newer style pouches have the indicator on the inside of the package. In other words, the indicator is underneath the “plastic” layer of the sterilization pouch.

Again, the indicators inside the packs validate that the instruments inside have been exposed to the right parameters for sterilization, and that the steam in the autoclave has contacted the instruments in the pack.
Indicators on the outside of an instrument pack are temperature-only indicators, and do not validate whether the steam has penetrated the packaging material and contacted the instruments.

These indicators include those on the outside of packages, and packaging or autoclave tape. These types of indicators only validate that instrument packs have been processed through the sterilizer.
So the first step in enhancing quality assurance for instrument sterilization is to use these chemical indicators for all instrument packs. The next step is taking appropriate action if the indicator strip indicates a “fail” or the color does not change on a sterilization pouch.

For that instrument pack, the instruments should be repackaged in a new pouch or wrap (for cassettes) and reprocessed through the sterilizer. The last step is to review the appropriate protocol for loading the packs in the sterilizer to avoid overloading, and to maximize the circulation of steam (or unsaturated chemical vapor) to enable appropriate penetration into the instrument packs.

Spore tests or biological indicators for monitoring sterilizer effectiveness can be accomplished with in-office monitoring systems or outside, third-party services. In both cases, either the manufacturer of the in-house testing system or the monitoring service has extensive technical support to assist the dental team in the case of a sterilizer failure. Remember that if a failure is indicated, that sterilizer must be taken out of service until the problem is fixed.
Monitoring services indicate that the most common cause of sterilizer failure is operator error. A good plan to avoid this scenario is to find the sterilizer instruction manual and review the proper procedures for operation and loading of instrument packs. This should also include following the manufacturer’s instructions for cleaning and maintenance of the sterilizer, which will keep it operating properly and extend its use life.

Sterilization of instruments is a critical step in infection prevention. Review your quality assurance program and take steps to enhance it if necessary. 

Mary Govoni, CDA, RDA, RDH, MBA, is the owner of Clinical Dynamics, a consulting company based in Michigan. She is a member of the Organization for Safety, Asepsis and Prevention. She can be contacted at [email protected].