Many factors can affect the heat sterilization process. If
the process is not routinely monitored, a problem that can jeopardize
patient protection can go undetected. Physical monitoring alone,
such as observing dials, gauges and printouts, is not sufficient.
Sterilizing failures involving overloading, improper packaging,
or air pockets will not show up on the dials. Chemical and biological
monitoring must be used in addition to physical monitoring to
adequately verify the process. Sterilization monitoring falls
into three major categories:
Mechanical and Electronic Indicators, which
are the dials, gauges and printouts on your sterilizer. These
do not indicate sterility, only gross equipment malfunction.
Chemical Indicators usually in the form of
color-changing ink are used to show that one or more conditions
of sterilization were met, but cannot be used to show that
the conditions necessary for sterilization were achieved.
Biological Indicators (BIs) which are a standardized,
viable population of bacterial spores known to be resistant
to the mode of sterilization being monitored and are inoculated
into a liquid or onto a paper carrier. Biological indicators
are intended to demonstrate whether the conditions were adequate
to achieve sterilization through actual organism kill.
How often should sterilizers be biologically monitored?
CDC - "Proper functioning of sterilization
cycles should be verified by the periodic use (at
least weekly) of biologic indicators (i.e., spore
tests)." - Recommended Infection-Control
Practices for Dentistry, 1993
ADA - "Biological monitors should be used
routinely to verify the adequacy of sterilization cycles.
Weekly verification should be adequate for most dental practices."
- Council on Scientific Affairs and
Council of Dental Practice, JADA, May 1996
OSHA - "Autoclave efficiency can be verified
by means of biological ...indicators. ...documentation kept
for the sterilizer...should include results of routine spore
testing."- OSHA Instruction CPL 2-2.44C,
March 6, 1992
Is weekly spore testing adequate? Additional
testing may be necessary when:
- A new type of packaging or tray material is used.
- Following training or retraining of personnel.
- A new sterilizer is used initially or after repair.
- Implantable devices are in the load.
- Following any changes in sterilization procedures.
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