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S T E R I L I Z A T I O N
A S S U R A N C E
For example, a Class 6 indicator might be designed for pre-vacuum
cycles run for 4 minutes at 270°F. Another could be intended for gravity cycles run for 30 minutes at 250°F. Class 6 indicators are likely a
good option if you're running just a few cycles of the same instrument
types. But if you're running multiple cycles filled with various instruments and devices that demand different exposure times and temperatures, the Class 6 indicators present an opportunity for user error
and might not be the best option.
AAMI is working on recommendations for biological and chemical
indicators intended for extended cycles. This is a big issue to address
because of the growing number of sophisticated surgical devices —
especially orthopedic tools and instruments — that must be run for 8,
10 or 12 minutes instead of standard 4-minute cycles. My facility
recently had a urology transducer in for a trial that required a 1-hour
pre-vacuum cycle run at 270°F. I called the device's manufacturer, figuring it was a misprint, but representatives say the FDA told them to
recommend such a long exposure time because of the device's intricate design.
3. Report reading
Many central sterile staffers still don't know how to interpret sterilizer
printouts and often sign off on records that indicate failed loads. They
believe the temperatures and cycle times printed at the top of reports —
4 minutes at 270°F, for example — reflect loads that reached intended
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O U T PAT I E N T S U R G E R Y M A G A Z I N E O N L I N E | J A N U A R Y 2013
