The selection of proper sterilization packaging has an impact on surgical instruments, medical devices, infection control, patient safety and the bottom line. Sterilization packaging, including wraps, containers and pouches, is available in varying sizes, materials and configurations for different methods of sterilization. However, all packaging is not suitable for all devices or all sterilization methods.
Health care professionals involved in selecting sterilization packaging should be knowledgeable about the suitability, reliability and costs of various sterilization packaging and have an understanding of the selection process to help ensure the selection of safe, efficient and cost-effective products. The purpose of sterilization packaging is to provide a safe, effective method to package and protect reusable devices for sterilization, transportation, storage and aseptic presentation, ensuring the integrity of the sterilized contents until the package is opened for use. Single-use (disposable), flat sterilization wrappers, composed of paper or synthetics, must be compatible for the method of sterilization and the size and strength of the wrap must be appropriate for the instruments/sets. The wrapper provides an adequate barrier to microorganisms, but can tear or puncture, which compromises the sterility of the contents.
To reprocess them incurs increased costs in time, labor and material. Protective plastic can be applied to wrapped packages after sterilization to protect the pack from environmental contaminants. Single-use wrap requires continual purchase, inventory of a variety of sizes and strengths and cost for disposal. Protective plastic over-wraps increase costs.
Reusable containers, constructed of rigid materials, such as metal, plastic or a composite are the most durable sterilization packaging and can withstand the impacts of handling and storage without tearing or puncturing.
Containers differ in materials, design and intended use. Some containers can be used in multiple methods of sterilization and one universal, sealed container can be used in all methods of sterilization commonly used in the health care setting. Containers can accommodate a wide range of instrument sets, from small delicate sets to large complex sets. They provide maximum protection to instruments from damage and an optimum barrier to protect the sterilized contents from microorganisms and environmental contaminants. Containers should be disassembled and cleaned after use, using a neutral pH detergent to avoid damage to the containers’ construction material. Containers require an initial one-time purchase and disassembly and cleaning after use.
Single-use (disposable) peel pouches are designed to contain individual lightweight items or groups of small components and are often used when content visibility is important. They should not be used for heavy or bulky items because the seals can become stressed and break open.
Pouches must be compatible with the sterilization method and device, and appropriately positioned during sterilization. They are not recommended for use within wrapped sets or containers because they cannot be properly positioned to ensure adequate air removal, sterilant contact and drying. Peel pouches require continual purchase, inventory of a variety of types and sizes, and cost for disposal.
Selection process
The FDA regulates sterilization packaging as a Class II medical device and requires 510(k) premarket clearance. Health care professionals involved in selecting sterilization packaging should carefully review manufacturers’ written validation test results—including shelf-life studies, intended use, labeling, instructions for use, and care and handling—for any packaging being considered. A value-cost analysis is a useful tool and is recommended as part of the process. Applicable standard and recommended practices for sterilization packaging also should be reviewed. Both AORN (www.aorn.org) and AAMI (www.aami.org) have sterilization packaging guidelines. A written evaluation based on pre-established objective criteria can help ensure that the sterilization packaging chosen will best meet a facility’s needs. Health care professionals have a choice of sterilization packaging systems. The challenge is to make the right choice to protect your instruments, your patients and your bottom line.
Arlene Carlo, R.N., is a consultant and clinical specialist and educator for Case Medical Inc., Ridgefield, N.J.
This article first appeared in the July 2007 issue of Materials Management in Health Care.
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