AAMI Publishes Standard for Sterilization Containment Devices - AAMI ST77
April 4, 2007 // Published as a news service by IHS
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The Association for the Advancement of Medical Instrumentation (AAMI) released the first-ever standard that specifies requirements for container systems and containment devices that hold sterilized surgical instruments building on a record number of new and revised sterilization standards and guidance documents that have been released or published over the last year.
The new standard, American National Standards Institute (ANSI)/ AAMI ST77:2006 -Containment devices for reusable medical device sterilization, provides requirements to help ensure that containment devices allow sterilization and sterility maintenance of their contents as well as (where applicable) adequate drying and sterilant removal.
Nancy Chobin, RN, and a member of the AAMI Reusable Sterilization Container Working Group, calls ANSI/AAMI ST77 "a long-awaited and sorely needed document," because there was previously "no regulation or guidance on the manufacture, cleaning or sterilization of rigid containers or organizing cases … Both the materials and the construction of the containers and organizing cases has an impact on sterility maintenance because the design often would cause damage to the packaging system being used."
ANSI/AAMI ST77 addresses these important concerns about materials of construction by setting requirements for a number of key parameters, including:
- Durability - materials shall not deteriorate (crack, flake, peel, fracture, become brittle or deform) within the manufacturer's recommended useful life at the maximum conditions of use.
- Compatibility with the sterilization process - materials shall not inhibit or interfere with the sterilization and drying process for which the containment device is recommended.
- Biocompatibility - materials shall not adversely affect the biocompatibility of the devices being processed.
Source: Association for the Advancement of Medical Instrumentation (AAMI).