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What do the Holy Grail, the Fountain of Youth, and the perfect sterilization wrap have in common? They are each an item that eludes discovery. Modern science and technology have gone a long way to provide helpmates to sterilization, and although they may not fulfill every desire of the sterile processing department (SPD), these solutions do assist in maintaining sterility. They include rigid containers, peel pouches of plastic and/or paper, and sterilization wraps (woven and nonwoven).
How, then, do an SPD manager and an infection control practitioner (ICP) team up to find the wrap that best suits their facility? Nonwovens, disposables, reusables, and rigid containers all have a place in central sterile (CS).
In “Choosing a Sterilization Wrap for Surgical Packs,” an article by William A. Rutala, PhD, MPH, and David J. Weber, MD, MPH, featured in a previous issue of ICT, the authors describe the elements to look for when assessing the ideal wrap. These include an effective barrier, penetrability for steam or ethylene oxide, aeration, ease of use, draping ability, flexibility, puncture resistance, tear strength, toxicity, odor, waste disposal, linting, cost, and transparency. But finding all of these elements in one wrapping product is a tall order.
“Is there a perfect wrap? No. The ideal wrap would be made of cement to be able to go through all the processing,” quips Nancy Chobin, RN, CSPDM, SPD/CS educator for Saint Barnabas Health Care System in New Jersey.
“There has to be a cognitive decision about what type of packaging we are going to use,” she adds. “It’s not for my convenience, but for the safety and integrity of the device we’re trying to maintain sterility of.”
When choosing the right wrap for your facility, and even for specific instruments or sets, Chobin says, consider how the device itself is going to be used, where it is going to be used, and where it will be stored. A tracheotomy tray, for example, is an emergency tray, and will, therefore, stay out on the floor so it’s readily accessible. Sterile packaging should be chosen that is appropriate for that setting.
“Sterilization wrap is ideal for packaging large items, such as a basins or trays,” suggests Laurie Clark, product technical manager for Kimberly-Clark Health Care. “Because the wrapper is opened by unfolding it away from the contents on all sides, there is little risk of contaminating the contents in the opening process.”
One size does not fit all. “When wrapping items that are large, heavy, or unusually shaped, it is important to choose the appropriate grade of sterilization wrap to support the weight of the item to be packaged,” she adds.
It is crucial that when selecting a sterile wrap, the sterile processing department and infection control should cooperate to find the solution that best fits the needs of both departments — an item that can be used quickly and easily, but that still provides good sterility preservation.
“Infection control and CS staff should understand the demands that are placed on a packaging material during all stages of the package cycle, then communicate those requirements to product manufacturers, who can provide guidance about the optimal packaging system for their facility,” Clark recommends.
Problems With Sterile Wrap
“Low lint generation is important during several stages of the package cycle,” adds Clark. “Lint can be a particular nuisance to Central Service/ SPD staff during the wrapping process and can lead to housekeeping problems. Low lint generation is especially important in the operating room (OR) where cellulose (wood pulp and cotton) fibers have been associated with post-operative complications including granulomas and adhesions. Dry particles can also serve as vehicles for microorganisms, increasing the risk of infection for surgical patients. A low-lint packaging material should be used to ensure that freed fibers do not come in contact with surgical instruments and the surgical wound.”
Another issue associated with sterile wrap can be the wetness persisting when using transport trays in the sterilizer. “The solution is to put some absorbent material (e.g., a towel or a tray liner) between the package and the transport tray prior to sterilization. Alternatively, you can allow the package to completely cool post-sterilization and then place it in a transport tray,” Clark says.
“In my opinion, the most abused, misused packaging is paper/plastic pouches,” observes Chobin. Often, she explains, some employees don’t bother labeling packages because they can see what’s inside. And, she jokes, “If we could find one big enough to put a car in, we’ll put a car in it. This is really not the intended use. If you look at standards from the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of periOperative Registered Nurses (AORN), the peel pack was intended for single, lightweight items. When you start putting multiple items or heavy items inside, there can be damage to the packaging or to the seals, and the damage may not be visible.”
It is essential, she points out, to use the wrap only in the way recommended by the manufacturer. “You don’t do anything without getting something in writing stating how to use it,” she stresses. “For years, we put a paper/ plastic pouch inside a wrapped tray or rigid container. Who said we could do it? Nobody. Did we do it? Sure. Should we have done it? No. Why? The container manufacturer never tested for you to use another packaging inside their container. So people say, ‘Then I won’t seal it.’ It doesn’t work that way! You should only place single lightweight items in there. You may be able to put a few really light items in there but it’s not recommended. You should read the technical data from the manufacturer and see what their recommendations are. That is what AAMI recommends.
“With peel packs, there is the issue of using them inside trays, which is bad. Another issue is using the wrong size. We have two or three sizes and we make do, which is not good, because if the package is too large, the item can move around and can damage the seals. But if it’s too small, it’s like a balloon that breaks or there’s too much pressure,” Chobin says.
There are proponents for and against the concept of double wrapping. “Sometimes, of course, a very small breach may go unnoticed and the fact that a second layer is present does provide some ‘insurance policy’ [against contamination],” Clark points out. “But if the breach is noticed, it is prudent practice to reprocess the package. Studies have found that wrapping sterile items using KIMGUARD ONE-STEP™ Simultaneous Wrap carries no greater risk of bacterial contamination than double-wrap methods and may lead to significant cost savings in both time spent in wrapping and recycling costs.”
“In central processing, double wrapping can be done sequentially or non-sequentially (simultaneous wrapping). The sequential wrap uses two sheets of the standard sterilization wrap, one wrapped after the other, creating a package within a package. The non-sequential process uses two sheets wrapped at the same time so that the wrapping needs to be performed only once. This latter method provides multiple layers of protection of surgical instruments from contamination and saves time since wrapping is done only once. Multiple layers are still common practice due to the rigors of handling within the facility even though the barrier efficacy of a single sheet of wrap has improved over the years,” write Rutala and Weber.
“Most people today are using nonwoven wrappers, and as good as it is, we still want to put an extra measure of protection there, because once it leaves my department, I can’t control what they’re doing to it,” Chobin explains.
“I’d want to put that in a hermetically sealed dust cover. I would allow it to cool, I’d put the dust cover on, and now I’ve provided additional protection, so if somebody forgets and puts it on a damp counter or drops it on the floor, it’s being protected. That’s where you have to make your decision about what type of packaging to use. If I’m sending something to the operating room, if I’m wrapping basin sets, and I know we run out of them every day, I don’t need a heavy-duty wrapper on that or need to worry about maintaining sterility because they’re using it in less than 24 hours.
“There is no problem with double packaging, but why would we go through that added labor and expense if it’s not necessary?” she asks. “Operating rooms will say, ‘If they single-package the peel pouch, there’s a hole in it.’ Well, that’s a handling issue. There’s excessive handling, or maybe we need to put tip protectors on it. That paper side is glorified medical-grade craft, so we have to use a little common sense. If it’s sharp, it’s going to poke through. If they do have to double package, the inside package has to lie flat. You can’t bend over the edges, because that could interfere with air removal and steam penetration, and I still see this in virtually 95 percent of hospitals I go to today. I still see that the inside package is folded over, and I still see people double packaging.
They say, ‘We’d have to change our practice in the OR.’ I say, ‘Didn’t you change your practice when you went to one-step?’ If we’re looking to save money in hospitals without impacting on patient care, it seems like that’s a pretty easy solution.”
Sterilizers were initially designed and tested for linen, Chobin points out. And, she says, “It’s not the sterilizer manufacturer’s responsibility to go back and test their sterilizers with all these crazy packaging materials we want to use — it’s our responsibility. AAMI says any time you make a major change in packaging (going from cloth to nonwovens, or to rigid containers), you have to do some biological testing to ensure that you are able to sterilize under the conditions in your department using your sterilization equipment. Furthermore, AAMI recommends that once a year, you go back and retest your containers.”
One must always remember that just because a wrapping material is disposable, that doesn’t mean it cannot be damaged. When opening a new box of sterile wrap, inspect one or two sheets for defects to ensure the batch is suitable. “It is in the paper family, so it is subject to tears and holes, so you have to be careful how you handle it,” Chobin says. “The downside is that it increases disposal costs because now you have garbage, but they say it’s more cost effective. It does have good moisture barrier, it does have good bacterial barrier, but it has to be handled carefully. We have to protect the sterility by proper handling, by proper storage, by proper transportation, and if we don’t do that with everybody in the supply chain, then we’re going to have a problem.”
It is also critical to remember that the package cannot notify staff members when it becomes compromised. “If it has a big hole, we can see it, but it may not be compromised due to a hole,” Chobin observes. “It may have been compromised because somebody dropped it and forgot to send it back to decontam, or they put it under their armpit when they were taking it to the department and then they didn’t need it and brought it back. They might have taken it off the autoclave cart while it was still hot, because the OR was screaming they needed it, but then didn’t use it, so it was sent back and put back on the shelf. Did we compress bacteria into it when the packaging was still warm? That’s the issue with sterility — if you’re not sure, you should not be using it.”
Chobin recalls that she once heard a package should not be handled more than four times — but she points out that it may be handled that number of times before it even leaves central sterile.
With the advent of event-related sterility, replacing the former concept of “expiration dating,” packages are considered sterile unless damaged or opened. This type of system acknowledges both the actual cause of contamination, and the hospital’s expertise in maintaining and delivering sterile products.
Clark observes, “KIMBERLY-CLARK* Sterilization Wrap and KIMBERLY-CLARK* Sterilization Pouches and Tubing products have been tested to determine their ability to provide protection from contamination, regardless of which system a hospital uses (event-related or expiration dating). Shelf-life studies confirm that K-C wraps provide effective protection for at least 12 months under an expiration dating system.”
Rigid containers, Chobin notes, do have some advantages over other wrap options. “They’re cost effective because they’re reusable, and they provide ultimate protection to instruments — you can stack them without worrying about crushing the instrument or the packaging. You get a good return on your investment for them. But containers present another set of issues. They do present challenges for drying because you’re adding significant weight to the sets, and sets are already much heavier than they should be. You can’t just put anything inside a rigid container. Some manufacturers didn’t test them for power equipment or lumens, and yet, we were putting them in there.”
Cleaning of the containers is another issue. “It is a packaging material and it must be cleaned after each use, and that doesn’t mean wiping it out with a wipe. It means washing it out. I’d say only fifty percent of facilities are doing that. It becomes an issue of volume, because when we go with containers, people don’t realize the impact on sterile processing. Now I have a top, bottom, basket, and a filter retention plate to wash, and that is going to impact on capacity in my washers,” she says.
Another problem with rigid containers is drying. To test this, run a full cycle with a heavy set. After allowing it to cool, Chobin suggests opening the package and checking for condensate. “I just saw information from a manufacturer today that silicone mats — which people put inside the tray to separate instruments and prevent damage — can actually trap moisture and create wet packs,” she adds.
Instruments with rings for fingers can be put on a stringer, which keeps them open, Chobin says. “But with things like forceps that don’t have handles to string, to get around that, a couple of companies are now developing products that are compatible for inside containers to keep instruments separated.”