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9. Biological Monitoring
9.1 Selecting Biological Indicator
Healthcare personnel should select Biological Indicators
consisting of spores of Bacillus Stearothermophilus that comply
with the American National Standard, Biological Indicators for
saturated steam sterilization processes in healthcare facilities
(AAMI, 1986). In addition, data should be obtained from
manufacturers on the reliability, safety and performance
characteristics of their products. Manufacturers of Biological
Indicators should also be required to provide written instructions
on the storage, handling, use and microbiological testing of their
products.
9.2 Frequency of Use of Biological Indicators
Table top sterilizers should be biologically monitored during
installation and after any major repairs. In addition, sterilization
loads should be biologically monitored at least once a week, but
preferably daily. Each load containing implantable devices should
be monitored and, whenever possible, the implantable devices
should be quarantined until the results of the Biological Indicator
testing are available. Biological Indicator should also be used for
periodic monitoring of all types of packages and trays processed.
9.3 Biological Indicators
This sterilizer is designed for surface sterilization, therefore, a
spore strip or self-contained Biological Indicator offers an
appropriate challenge to measure delivery of an adequate dose to
kill spores. Placement of Biological Indicators should be near the
centre of the instrument load in the basket or in one of the
cassettes. For small loads, the indicator should be placed amongst
the instruments which are being processed.
9.4 Routine Biological Monitoring
For routine biological monitoring, the sterility of the load is
evidenced by the killing (failure to recover) of all spores on the test
Biological Indicators (spore strips). All Biological Indicator results,
including results from controls, must be interpreted by a qualified
individual and must be included in the sterilizer records.
Biological Monitoring
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