Infection Control Today - 11/2003: Thinking Outside the Box

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?

Containers

• The ideal container should be compartmentalized to facilitate instrument protection, says Bryant Broder, ACSP, past president of the American Society for Healthcare Central Service Professionals (ASHCSP) and sterilization and disinfection product manager for Skytron US. “That doesn’t mean that all containers have to be compartmentized, but they should be developed to facilitate instrument protection with either a matting or connectors to help manage and protect the instruments.”
• “People think if they just put on a lid and lock it lid down, they’re providing a sterile barrier. You need to inspect the lid, make sure the gasket is in good condition and make sure the lip of the container fits securely together, or you’re not going to provide a good sterile barrier. That’s a key factor in sterility assurance — to make sure your gaskets and your container are in good working condition, along with the locks and the filter mechanism, the filter retainer clips and things of that nature.”
• Use the right container for the job, says Broder. “Don’t put your product in a larger container than necessary, or try and shove it in a smaller container than necessary.”

• “A key factor in packaging is the seal and the temperature at which you seal the packages,” says Broder. “You have to have a good seal and a good sealer. The sealer should be tested on a daily basis to make sure it is providing adequate purchase, and providing a uniform seal across the package. Seals should always be tested after the product is sealed and after the product has been sterilized.”
• “Another key factor in placing anything in a peel pouch is to make sure you have a large enough pouch to hold the item that you’re putting in there, allowing the packaging to expand and contract without damaging the instrument or packaging, to provide a sterile barrier,” says Broder.

• “People are still using the old thinking,” says Joan Blanchard, RN, MSS, CNOR, CIC, perioperative nurse specialist in the center for practice, Association for periOperative Registered Nurses (AORN). “Unless there is a manufacturer’s date for outdating, you use event-related established guidelines.”

• Make sure packaging has an indicator or labeling on it. “Many people label the wrong side of a peel pack,” says Broder. “They should not be writing on the paper or the Tyvek side of it, they should write on the plastic or polypropylene side, or have a label made up that is placed on the package. Inks tend to bleed through that type of packaging, thus creating a portal for bacteria.”

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