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The pouch should not be used and the item inside should be reprocessed. Chemical indicators printed directly on pouches assist users to visually see processed versus unprocessed items. No colour change on a processed pouch can be caused by overloading, improper cycle selection or running the sterilizer from a cold start.

Be sure to review proper sterilizer parameters and loading procedures before processing. It should be noted that chemical indicators do not reproduce the exact same change every time.

A discernible change from the starting colour indicates that the sterilization process has been completed. In order to avoid a “false positive” indicator colour change i.e. A change when the sterilization process has not been completed, occasionally run a cycle shorter than the ISO 11140-1 recommended guideline for Class 1 process indicators. Traditionally, hospitals have used “expiration dating” as the standard sterility maintenance policy for in-hospital sterilized supplies. However, organizations such as AORN, JCAHO and others now recognize that sterility is “event-related”, not time-related. In other words, sterile supplies are not contaminated by time, but by events, such as exposure to moisture, dropping, excessive handling.

As a result, many hospitals are moving from an expiration dating system to an “event-related” sterility maintenance policy for in-hospital sterilized supplies. With this system, expiration dates are not required; packages are considered sterile unless damaged or opened. GS Medical’s pouches, and rolls have been tested to determine their ability to provide protection from contamination. Shelf-life studies confirm that our pouches and rolls provide effective protection for at least twelve months with 100% maintenance of sterility.

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