Sterilization Container Systems

CHAPTER 2


Sterilization Container Systems*



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Sterilization packaging systems are required to secure instrument sets, provide for sterilant penetration of contents, and withstand multiple handling events during a prolonged period of storage and handling. There are two types of containment devices: rigid reusable sealed containers and case trays, which are designed to be wrapped. Rigid, reusable container systems provide an efficient, cost-effective way to package and protect surgical devices for sterilization, transport, storage, and aseptic presentation of contents. They are sealed systems and serve as an alternative to disposable and reusable sterilization wrap. A sterilization container’s rigid sides protect fragile devices within and eliminate the tears associated with sterilization wrap. Some containers are cleared for steam sterilization only, others for low-temperature sterilization. Only one is universal and corrosion resistant, cleared by the FDA for all current sterilization methods from steam to various low-temperature methods.


Containers are most typically constructed from anodized aluminum and have a boxlike structure with removable lids, including a gasket to secure a tight seal. Sealed containers include tamper-proof locking mechanisms and handles for ease of transport. All sterilization containers have a filter mechanism designed to permit the sterilant to enter and exit as well as to act as a microbial barrier. Most sealed container systems are designed for terminal sterilization and extended storage, utilizing a disposable filter secured by a gasketed filter retention plate. Some containers have a filterless system equipped with a pressure-sensitive or thermostatic valve that opens and closes within the sterilizer. Such devices are cleared for prevacuum steam sterilization only, and few for sealed flash sterilization, including gravity displacement steam.


All sealed container systems require an inner basket or tray to secure the contents of the load. The basket may contain accessories, including instrument brackets, partitions, and posts, to secure and to organize and protect contents. Some may include stackable trays to separate contents into levels and protect contents from damage during transport. Peel pouches may not be used within sealed or wrapped container systems as they are not able to stand on their sides for sterilization. Small perforated trays or insert boxes are recommended in lieu of pouches.


Rigid sterilization systems should be cleaned and inspected after each use. The disposable filter should be discarded and the components disassembled for cleaning. Valve-type closures must be decontaminated following the manufacturer’s written instructions. Particular attention should be given to the type of detergent used as alkaline cleaners and those followed by acid neutralizers can damage the passive layer of sealed systems. Inspection procedures should include verification that gaskets are intact and latches are properly functioning. If the hardware is riveted to the container, such devices may become compromised over time as rivets loosen and create pathways for entry of microorganisms.


Aseptic presentation is important with all sterilization packaging systems. To properly remove the inner basket or tray from the container, the sides of the basket must not touch the edge of the container or the contents will be considered contaminated. Furthermore, the contents of the container system must be dry. Wet packs are considered nonsterile, the only exception being for flashed items, properly cleaned, decontaminated, and sterilized for immediate use only. To manage wet packs, be sure that the contents are dry prior to sterilization. Preheat the load to reduce the formation of condensation during the cycle, evaluate the weight and density of the set, and review manufacturer’s recommendations for processing, including proper cool-down prior to transport to sterile storage. Plastic containers may require additional drying time as they do not have the thermal conductivity properties of aluminum and other metals. Metal materials used to construct containment devices must be corrosion resistant or treated to improve their corrosion resistance. Furthermore, these materials must not affect the biocompatibility of the device.


All containment devices, whether sealed containers or wrapped trays, are considered Class II medical devices and must be cleared by the FDA for their intended use. According to AORN Recommended Practices, “Packaging systems should be evaluated before purchase and use to ensure that items to be packaged can be sterilized by the specific sterilizers and/or sterilization methods to be used and should be compatible with the specific sterilization process for which it is designed.” AAMI ST 77 provides guidelines for manufacturers of containment devices for reusable medical devices. Many international standards have been adopted in the U.S. document with the goal of providing minimal labeling, safety, performance, and validation requirements. Manufacturers are required to validate their containment devices and provide the data to the FDA for clearance. However, health care personnel bear the ultimate responsibility for ensuring that the containment device or sterilization packaging is compatible with or can be effectively sterilized within the health care facility.


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Mar 16, 2017 | Posted by in NURSING | Comments Off on Sterilization Container Systems

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