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Infection prevention and control guidelines
10. Reprocessing reusable medical devices
In addition to monitoring every cycle, daily checks of steriliser function are required in accordance with the manufacturer’s instructions for use.
For a steriliser that uses a vacuum in any part of its operation, a leak-rate test is required on each day of its use (or weekly, if there is an air detector) to check the leak rate does not exceed the maximum specified in the current relevant standard.
Refer to the steriliser operating instructions for information on whether an air detector is fitted and how to perform the leak-rate test.
If the practice uses Class B sterilisation cycles and reprocessed narrow-lumen (hollow A) items, a steam penetration/air removal test must be performed daily in accordance with steriliser instructions for use and process challenge device instructions for use.
Various commercially manufactured process challenge devices are available. These mimic particular challenges or worst-case scenarios. For example, the helix device for air removal/steam penetration consists of a coil of thin tubing with one open end and the other attached to a thin sealable cylinder containing a strip. The strip changes colour if the right conditions are met during the steriliser cycle (ie that the steriliser has successfully removed all the air from the cylinder via the narrow tubing).
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