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Thinking Outside the Box:
Sterilization Containers and Packaging
By John Roark
The nuts and bolts of sterilization containers and packaging are fundamental to infection control. What are the hot spots on the minds of the pros? What are the salient points that you should know?
Dust covers are a part of the packaging scenario in helping maintain sterility for those products that are not widely used or improve the sterile barrier. “AORN recommends that dust covers be used on items that you will not be using often, say six months or more before you need it,” says Blanchard. “Having a dust cover is appropriate for those types of instrumentation that are not used routinely. Otherwise, you are wasting a lot of money dust-covering things that are used often.”
“Applying the dust cover needs to be done at the appropriate time,” adds Broder. “It can’t be applied directly when the product comes out of the sterilization cycle. The product must be cooled down, and then the dust cover applied. Not three hours later or the next day. It should be applied directly after the product has been cooled down.”
With a variety of fabrics on the market that are superior to the traditional 240-pound muslin wrap, why are sterile processing managers reluctant to try something new? “Muslin is one of the sacred cows that’s been around for a long time,” says Broder. “But there have been a ton of new fabrics than have come out, both synthetic and microdenier fabrics that have been developed over the last 30 years. What comes to mind is the Kimberly-Clark polyolefin wrapper, which provides a double layer in one fold. The thread count on these new fabrics are significantly greater than the old 240 count doublewrap muslin that we used to use.”
“The old muslin doesn’t have as tight a weave,” adds Blanchard. “For that reason it’s probably not as appropriate to use as the newer products. People think that if a package has been sterilized, it’s okay to reuse the wrapper or the product, and not have to wash it between sterilizations. You have to rewash it because it’s been in a patient room and may have been contaminated, it may have dust on it.”
“We have enough data to show that the muslin or the cotton wrappers are not effective microbial barriers,” says Jay Sommers, PhD, director of clinical and scientific documentation for Kimberly-Clark. “If you’re going to wrap the kit or cassette, you want to have an effective barrier so that when you put it on the shelf you can be assured that the container is going to have its sterility maintained.”
Many people believe that if a package is dropped onto the floor, it is automatically not sterile, says Blanchard. “That is not necessarily true. If your package is intact and has no abrasions or openings, it should be fine if the package is prepared appropriately to use. You need to do a visual inspection. According to AORN standards, “Whether to use a sterile item from a package that has been dropped on the floor depends on the type of packaging and the condition of the surface on which the package lands. Sterile items from packages that were dropped on the floor may be used if they were packaged in an impervious wrapper and the area of contact remained dry. The dropped item should be used immediately, as some contamination of the outside wrapper may have occurred. Sterile packages that have been dropped should not be placed on the shelf for future use.”
“If an item is packaged in a pervious woven wrapper and dropped on the floor, the sterility of the item is questionable. When dropped, the impact of the package landing on a hard surface forces the sterile air out of the package with an implosion of ambient air into the package. If the sterility of an item is in doubt, the item should be considered unsterile and not used.”1
By Becki Harter, CST, RCST, CRCST, FEL
1. MYTH: Sterilization Containers are not FDA regulated devices and do not require a 510(k).
FACT: False. Every container must be cleared by the FDA and have its 510(k) to be used as a sterilization container. Sterilization containers are Class II medical devices and require clearance. Request this information from the device manufacturer and follow up with the FDA on the information provided. Make sure the 510(k) information is for the device upon which the information was requested.
2. MYTH: Sterilization containers do not require validation for sterilization process because they are Class I devices. Healthcare facilities validate the sterilization process.
FACT: False. All containers must be validated for intended purpose. If the FDA and the Association for the Advancement of Medical Instrumentation (AAMI) guidelines and for each sterilization process intended (steam, plasma, Parecetic acid, etc.). Request a validation summary for each sterilization container type you are considering for purchase.
3. MYTH: Because sterilization cycles can be changed, it is not necessary to validate in published healthcare sterilization cycles.
FACT: False. Sterilization containers must be validated in a published standard healthcare cycle(s) in order for results to be achievable and repeatable for all healthcare facilities using the container. In addition, sterilizer manufacturers will not stand behind any cycle outside of its prescribed parameters for your sterilizer and healthcare then, is responsible for validating a cycle outside of the manufacturer’s recommendation for use using AAMI ST8. The issue with this is that healthcare cannot validate new cycles. Manufacturers and testing facilities can but not healthcare. Thus, do not purchase sterilization containers that cannot support the sterilizer manufacturer’s recommended cycles for your sterilization units.
4. MYTH: There is no magic number for instrument set(s) weight.
FACT: False. Sterilization containers must be able to support the 16 to 20 pound weight limit designated by sterilizer manufacturers.
5. MYTH: The numbers of layers in a sterilization container do not matter as long as sterilant can reach all areas of the container.
FACT: False. Sterilization trays with greater than two layers create undue challenge for the sterilization process and often cannot achieve and or maintain the 16 to 20 pound weight limit.
6. MYTH: The size, configuration and weight of a sterilization container do not matter.
FACT: False. Sterilization trays need to be ergonomic in that they should not create undue stress for staff, cleaning/disinfection, sterilization, storage or distribution.
7. MYTH: The design of the sterilization container does not hinder sterilization practices. Distribution and configuration of instrument(s) does.
FACT: False. Sterilization containers should not have hidden compartments or dead spaces that cannot be reached that may prevent proper decontamination or sterilization.
8. MYTH: The use of hybrids and/or polymer sterilization containers does not create any more moisture issues than do metallic ones.
FACT: False. Avoid hybrids or polymer trays that create moisture retention or reformation of moisture during or after the sterilization process or in the preparation prior to sterilization.
9. MYTH: Hole configuration in a sterilization container does not play an integral role in the overall efficacy of the sterilization container.
FACT: False. Sterilization containers with large volumes of holes and drainage accessibility will fair better in the total process than those that do not have a large ratio of holes-to-container space.
10. MYTH: Modularity of a sterilization container is not needed.
FACT: False. Modularity of the sterilization tray is a purchase indicator. The ability to change the internal configurations of the sterilization container to meet device/instrumentation needs and at the same time maintain the integrity/ efficacy and the sterilization parameters for a published standard healthcare sterilization cycle(s) is a good purchase indicator. Make sure, however, that the container has been approved for modularity devices.