Today you have three choices for packaging reusable medical devices: CSR wrap (reusable and disposable), peel pouches (paper/plastic and all-plastic), and rigid container systems. Rigid containers offer some advantages over the other options, but they also require special care and handling. In this article I will outline the key issues to consider if you plan to use rigid containers to package, sterilize, store, and transport your medical instrumentation and devices.

Are containers right for you?
Sterilization containers are available in a wide assortment of sizes and in aluminum, stainless steel, and plastic varieties. All containers have filters or valves for allowing air and sterilant to pass through.

First, you need to decide whether sterilization containers are the right choice for your facility. Some pros and cons to consider:

PROS:

• Containers protect instruments from damage better than CSR wrap or peel pouches.
• They help facilities bypass the environmental hazards involved with washing or disposing of wrappers. Once you clean and dry them, they're ready to go.
• You can use the same container to protect clean instruments from contamination on the way to the OR and protect the environment and your staff from contamination when you are transporting dirty instruments to decontam.
• Containers can help you standardize your instrument sets. They limit the number and size of instruments you can place in them, which forces you to standardize.

CONS:

• Storing large quantities of wrappers can be a problem, but containers take up just as much room empty as they do when they are full. To ensure space efficiency, you should always be using rigid containers. They are very costly and inefficient places to store instrument sets. Even if you do switch, realize that you'll still need to keep some CSR wrap around for basin sets and large ortho and linen packs.
• Containers' filters and valves may provide an entry for contamination.

The most important factor when choosing between containers and other options is undoubtedly cost. If you're considering switching from CSR wrap or plastic peel pouches to rigid containers, carefully analyze your current annual costs and consult with your present supplier and a container manufacturer to determine the best way to compare the cost of all options. Ask each company to point out all the costs associated with the competitive product.

Selecting the right containers
When evaluating sterilization containers, consider the following questions:

• Will the container system be compatible with your sterilization system? Manufacturers should indicate what sterilization systems their containers are meant for, but you should also run your own tests.
• Does the manufacturer's documentation include how the system was challenged? Did they test the system with the types of instruments you will be using?
• Can you get a list of users in your area that you can visit? It's best to visit more than one.
• Will the manufacturer provide qualified technical service during the evaluation and implementation period, as well as adequate maintenance and follow up?
• Is the labeling and external sterilization indicator convenient and easy to use?
• Are the sizes that are available compatible with the products you intend to use with the system?

Prepping and assembling containers
Just as there's an art to wrapping a package properly, there's a right way and a wrong way to load containers. Some tips:

Before loading: Make sure all mating surfaces are clean and free of dents and chips. Gaskets should be free of any breaks or cuts, pliable, and properly seated. Also check valves and filters for proper function and integrity.

Loading the container: The weight and distribution of instruments in containers is even more critical than with wraps because aluminum and stainless steel containers add metal mass and weight (refer to last month's column on wet packs). If the quality of your steam is less than optimal, you may have to use absorbent materials within the container or the basket to absorb excess moisture.

Effective sterilization depends upon the sterilizing agent making contact with all surfaces to be sterilized. To ensure this, keep in mind the following while loading the container:

• Use dividers, stringers, and sorting pins to contain and separate items.
• Open jointed instruments and disassemble complex instruments unless testing in your systems proves this to be unnecessary.
• Lumened items should have moisture in the lumens. The moisture will turn to steam and push out the air.
• Place items that have surfaces that will pool water on edge and secure them so that they do not fall over during the sterilization cycle. You should also place paper/plastic pouches on edge. Always place containers flat on the sterilizer cart. This makes it easier to predict the action of the steam on the instruments inside the container.
• Place internal chemical indicators in a corner at the bottom of the container or anywhere else it is difficult for the sterilant to reach. Do not just simply toss the indicator into the basket along with the instruments. Your facility's policies may or may not mandate using an indicator in every container.
• Don't use adhesive external indicators-they tend to be difficult to remove from hot containers. Use a non-adhesive external indicator appropriate for the sterilization process. The indicators, which you should use on every container so you can tell which containers have completed the sterilization cycle, should be bold and easy to see.
• Similarly, don't use adhesive labels; use metal or plastic labels that stay with the container during all processing steps if the container is always used for the same set. If you don't use labels, make sure you have an easy and effective way of displaying the contents to the end user.

Sterilization
When using containers in loads with wrapped items, always place the containers on the bottom shelves, because they will develop condensate that could drip onto the lower shelves, potentially compromising the sterile integrity of the wrapped items. Do not stack containers unless the manufacturer specifically permits it. Stacking could interfere with air evacuation, steam penetration, and drying.

It's critical to test containers before you buy them to ensure that the system is compatible with the sterilization process. Beware of the following issues with particular types of sterilizers:

Gravity-displacement sterilizers: Containers with non-breathable surfaces will trap air that will impede steam contact with those surfaces and with the items within the containers. Therefore, you may need to lengthen both the sterilization cycle and drying times in order to use containers in this type of sterilizer. You also have to take special care to ensure that the filters and/or valves in the bottom of the containers are intact to allow steam, air, and moisture to penetrate and drain from the container.

Flash sterilizers: Most of these are gravity type sterilizers and run fast cycles; they're designed to be used with no packaging. Use particular caution and skepticism when evaluating containers for these sterilizers-perform thorough and comprehensive testing using sterilizers and instruments that would be most commonly used in practice.

Pre-vacuum and steam-flush, pressure-pulse sterilizers: These sterilizers have less of a penetration problem, but because they run faster and at higher temperatures, drying can be a problem. They generate much more condensate than other types of sterilizers, so it is critical that the containers' valves that open during the vacuum and steam cycles also open during drying. You can use containers with solid bottoms in these sterilizers, which adds to the overall sterile integrity of the package.

EtO sterilization: Although some container manufacturers claim their products can be used for EtO sterilization, my personal opinion is that a better package is a single non-woven wrap and an all-plastic bag. I am a strong believer that containers should be circulating constantly-used-cleaned-used again. They are designed to be used in steam, where they can make several trips in a day. Containers were never designed for gas sterilization, and I wouldn't use them. If you do, make certain you carefully evaluate EtO and moisture penetration as well as effective aeration.

Plasma sterilizers: You cannot use metal containers in plasma sterilizers. At least one manufacturer has a plastic container system specifically designed for plasma. Test it before you buy.

Storing instruments between cases
Don't use containers to store items that you aren't going to use in the very near future-they are very expensive storage bins. Carefully match your supplies to procedures, so you don't have to use containers to store "just-in-case" sets. Use normal sterile storage protection to keep instruments between sterilization and use.

Transporting containers to the OR
As with all other sterile supplies, transport your containers to protect the contents from being compromised. Carts used for moving containers should be large enough to prevent them from extending beyond the sides of the cart and allow for the containers to be transported flat. Most manufacturers have dedicated transport systems that you might consider, if your budget allows.

Aseptic presentation
The protocols for aseptic presentation are exactly the same as for wrapped items. Place the container on a table close to the sterile field. The scrub nurse should examine the container's external indicator and identification and look for damage to the filters and/or valves, and then carefully remove the lid.

The scrub nurse should then examine the internal indicator (if used) and carefully remove the basket to the sterile field, being careful not to touch any non-sterile surfaces. He or she should examine the condition of the instruments looking for any sign of damage or lack of proper positioning that might indicate a sterilization failure.

Transporting containers to decontam
You can use solid bottom containers to transport contaminated supplies back to decontam as long as the materials used in the container are compatible with any enzyme solutions used to help pre-clean the instruments. I have seen aluminum containers that have been seriously discolored by active enzyme solutions, so be careful. During transport, always cover containers bearing contaminated instruments.

Cleaning and decontamination
Once the container is in decontam, remove and dispose of or thoroughly clean the filter, depending on what type of filter the container has. If you use the container to transport the soiled instruments back to decontam, all you have to do is remove the basket and place it, along with the contents, into a washer. This process has the advantage of not requiring the decontam personnel to touch contaminated sharps.

For this process to work, make sure a container with a basket and an enzyme solution is available at the end of the procedure (this applies whether you use sterilization containers or not). Have OR personnel open and/or disassemble complex instruments before placing them in the basket; if time or other constraints prevent this from happening, station a decontam person in the OR to perform this task. Fasten the container lid securely for transport. When it gets to decontam, the staff can put the basket into the washer without ever having to touch a contaminated sharp instrument. Every OR should have such a system in place.

Clean the container itself either by hand or in a mechanical washer in accordance with the manufacturer's recommendations. Never use cleaning agents or equipment that might prove to be incompatible with the container.

Maintenance
Like any piece of equipment, sterilization containers wear out. Repeated sterilization cycles and openings and closings cause hinges to fail, locks to bend, screws to loosen, and valves and gaskets to fail. Therefore, ask your manufacturer to help you design a preventive maintenance program. The manufacturer should tell you how many cycles the average container can safely be expected to satisfactorily perform and help you devise a method of counting cycles, or you can simply go to a calendar aging process to determine when a container should go back to the manufacturer for inspection and reconditioning. Don't wait for it to fall apart before replacing it.

Dan Mayworm is the former publisher of the Journal of Healthcare Resource Management and Infection Control