Introduction:Event-related sterility assurance is, simply put, any event that compromises the integrity of the barrier enclosing the sterilized material. Such events may occur just subsequent to sterilization, during transport, and during storage (including repeated handling of the packaged material), leading to breaches, punctures, holes, rips, tears, dampness, crushing, etc. This includes materials that are sterilized in-house, or those that are purchased pre-packaged and pre-sterilized.The scope of this article includes materials that have been subjected to a sterilization process, followed by their transport and storage. Many factors should be considered when determining how long these materials remain sterile (e.g., time limit, hold time, expiration, etc.). For example, the following factors should be considered: the type and configuration of material packaging; how frequently a sterilized material is handled before use; storage conditions, such as an open shelf or a closed cabinet; the method and environmental control of the transportation; the environment of the storage area, such as an International Organization for Standardization (ISO) area classification, temperature, humidity,disinfection regimen, etc.Thisarticle introduces the concept of eve nt-based sterility assurance and provides guidance for implementing an event-based sterility assurance program.
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