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A fter reusable medical instruments have been decontaminated they arrive in Prep and Pack to be inspected, assembled into sets and trays, and packaged for subsequent terminal sterilization. Most facilities use a variety of packaging materials including peel pouches, sterilization wraps, and rigid containers. Packaging must allow sterilant penetration during the sterilization process, prevent rnicrobial penetration during storage and transport to maintain the sterility of processed items, and facilitate aseptic presentation of the contents. Rigid sterilization containers are an attractive option because they protect the packaged items, facilitate organization of instrument sets, and help reduce the volume of waste at the end of a surgical case. This self -shady article, based on information contained in standards and recommended practices published by the Association for the Advancement of Medical Instrumentation (AAMI) and the Association for periOperative Registered Nurses (AORN), will briefly review container performance requirements and discuss considerations for use of rigid sterilization containers in healthcare facilities.
Container performance requirements
Manufacturers of rigid containers turn to ANSI/ AAMI ST77, Containment devices for reusable medical device sterilization, for guidance on labeling and performance requirements. As a user of these products, it? s helpful to be aware of some of these requirements. For example, ST77 states that the combined weight of the containment device and the instruments to be sterilized should not exceed 25 pounds (Section 4.3.5).' This weight limit was set both in consideration of the attainment of sterilization and drying, and also in recognition of ergonomie concerns of technicians repeatedly handling these containers. Container manufacturers must conduct sterilization validation studies demonstrating that the contents of the container can be sterilized to a sterility assurance level of 10* in the sterilization cycles for which the container is labeled. ST77 encourages manufacturers to validate sterilization cycles commonly available in healthcare facilities (Section 4.4.1.1). For steam sterilization (other than "flash"), manufacturers also need to design containers such that they are dry after typical hospital cycles. For ethylene oxide sterilization, manufacturers need to validate the container and its contents can be adequately aerated.
A comprehensive list of the information container manufacturers should provide to users in their Instructions for Use (IFU) is also included in ST77. As with any medical device, the IFU is a thorough document that addresses common...