The various packs, trays, and cases that move through the operating rooms (ORs) and central sterile department of a healthcare facility come in contact with many opportunities to become compromised. Maintaining the integrity of the packaging and meeting the ultimate goal of maintaining sterility is a challenge, but one that can be met by adhering to best practices.
Ultimately, maintaining sterility is the most important aspect to consider when handling packs, trays, and cases. Maintaining sterility means protecting the package from any insult that would jeopardize its integrity. Such events as dropping an item on the floor, having it in close proximity to water, the removal or partial removal of its outside wrapper, or simply leaving it lying around unwatched and unguarded can all result in an item becoming compromised.
Terri Goodman, RN, PhD, consultant, Terri Goodman and Associates, says the principles of sterility have never changed. Any newness in relation to this topic would be a function of technology, she says. Sterile is sterile. Different approaches are generally the result of new technologies such as when rigid containers were implemented you had to come up with a whole new handling and delivering system because they dont work the same way as the packages weve always used. So, changes in behavior usually result from something different that you need to deal with.
One thing that will never change is the need for good hand hygiene before handling sterile items and before donning gloves to handle the sterile items. Handwashing before any sterile supplies are handled is an area Goodman says still needs stricter adherence. Normally when you are handling sterile supplies, you are in an operating room or in a treatment room and you have gloves on. Handwashing before putting on gloves is frequently omitted.
Other common mistakes when handling sterile supplies includes dropping items or presenting them in such a way that it jeopardizes the sterile field.
One of the things I see is dropping it on the floor, looking around the room to see if anyone has seen you, picking it up, and then using it, Goodman shares. It is very difficult to throw things away or start over and that is probably one of the most common things that I see done by people who know differently. You cant see bugs and it is just very easy to delude yourself that something has not been contaminated because you cant see the contamination unless its wet, in which case it leaves a stain.
Goodman also shares that while not as common, she has seen people handling sterile supplies in the opening process that do not adhere to the protocol that is required to fully protect the sterile field. Presentation is important and not opening items correctly or not protecting the sterile field in the process of adding things to it can have serious repercussions.
Goodman says the opening procedure often is done correctly opening toward you or begin peeling toward you instead of away from you however, she says the problems often occur once its open. Its delivered carelessly, she asserts. Its delivered by leaning over the field, by letting the edges of the wrapping be uncontained or by flipping things over which you have little control once they leave your hands. Those are the things I teach as no-nos. There is a way to deliver everything or every type of object thats contained in a sterile package. You never have to throw it and you never have to jeopardize the sterile field by leaning over the sterile field to deliver an object. You can open it in such a way that the top of the sterile wrapper faces the sterile field and separates your hand from the field so it is protected, and its not difficult to do that. When you learn to open packages that way, you have a great deal of control over where they land when you open them.
According to the 2006 the Association of peri- Operative Registered Nurses (AORN) Proposed Recommended Practices for Selection and Use of Packaging Systems, the method of packaging should be performed in a manner that facilitates the aseptic presentation of the contents. In addition, AORN recommends the appropriate size wrapping material be used to provide adequate coverage of the item being packaged, and the item also must be wrapped securely and in such a way that prevents gapping, billowing, or air pockets from forming.
Assessing the items as soon as they are received is critical. The AORN document advises end users to visually inspect the package or container before opening for package integrity. The inspection should include ensuring the items covering is free of holes and that an effective seal has remained.
You inspect it for any indication of a broken integrity, Goodman explains. Wrapper rips, tears, or holes in the wrapper itself; a broken integrity of the sealing; any indication that the item has become wet and then dried (e.g. water stains); any indication that it has been rewrapped and you can tell the difference in autoclave tape after its been taken off and put back. It doesnt adhere the second time the same way it did when it came out of the autoclave. It is loose and sloppy.
She says this occurs with those who have less knowledge. Theyll open something and realize its not something they want. And you dont know how far down they got. You dont know if they just peeled the corner and then went Oh, this isnt what I wanted, and just put it right back on without ever opening the package or whether they opened it further. Once jeopardized, its contaminated whether it is or it isnt.
Events that may compromise the sterility of a package include:
- Multiple handling that leads to seal breakage or loss of package integrity
- Compression during storage
- Moisture penetration
- Exposure to airborne and other environmental contaminants
- Poor storage conditions
- Type and configuration of packaging materials used
- Use of dust covers and method of sealing
Randy Corn, materials manager for Ariz.-based Carondelet Health Network, spent nearly 30 years working in and managing CS departments, and he says one of the most important things OR personnel should always do is to look at the internal indicator to ensure the pack they are using has been fully sterilized.
It is important that the person in the OR is looking at the chemical indicator inside the pack when they open it because the SPD personnel cannot look at those internal-most indicators, he points out. They are the only ones that can catch the error if one exists.
AORN recommends a chemical indicator be placed both inside and outside each package processed, and the internal indicator should be visible to the user when the package is opened so the user can see that the indicator has changed before touching the contents.
When something is done the same way every day, over and over and over again, and if you are not really keeping in mind how important it really is to do that one check, then it is very easy to stop doing it unconsciously, Corn explains. You just stop really paying attention. If something like that gets by, now youve got the possibility of something that is not sterile affecting the patient. Its really a matter of paying attention to detail at all times; you can not forget to do that. It has to become the norm.
Transportation and storage are also key aspects in integrity protection. Usually, if there is no dedicated lift to the OR from CS/SPD, then case carts are used to transport the supplies.
Transporting sterile supplies should be done in a fashion that protects their sterility, Goodman asserts. Normally, when supplies are transferred from a clean area through an area that isnt like from CS to some other place in the hospital they are transported in covered case carts. Goodman says the fitted covers that zip are generally the more sophisticated kind.
She adds that carrying something sterile through the hospital also is not unusual. And it is in your possession so it is less likely to be jeopardized than it would be if it were on a cart that somebody wasnt watching carefully, she adds.
Appropriate storage for sterile products can be a challenge. This is due mostly to space constraints or environmental factors. AORN suggests that the sterile storage area temperature should be controlled and should not exceed 75 degrees F. Humidity should not exceed 70 percent; a minimum of four air exchanges per hour is recommended, and air flow should be under positive pressure.
In 2002, the Centers for Disease Control and Prevention (CDC) recommended that sterilized instruments be stored in a manner that preserves the integrity of the package. Points offered by CDC include:
- Sterilized items should remain wrapped until they are needed for use
- Sterile items should be stored in enclosed cabinets or drawers free from moisture and dust
- The storage area should be cleaned and disinfected weekly
- Sterile items should not be stored on the floor, under sinks, on window sills, or adjacent to air vents
- A rotational policy should be developed (i.e. a first in/first out system)
Goodman says personnel need to be careful not to mix sterile supplies with dirty supplies, and points out that dirty and clean should not be housed in the same area. Sterile and unsterile but clean supplies often are and in that case the sterile supplies are stored above, she shares. If there is any liquid stored in that area it would be stored on the lowest of shelves kind of logical as if something spills it spills on nothing.
Corn says sterile packs, trays, and cases should be stored on wire shelving to ensure it does not harbor dust, or at least helps to reduce the likelihood of retaining dust. For the top of the shelves, it is best to have some kind of a dust cover to provide further protection, he says.
The bottom shelving should have a solid shelf or a splash guard of some sort so that when the floors are cleaned no splashing will affect the sterile supplies. The shelving also must be a minimum of two inches away from any outside walls because outside walls can hold different temperatures and can create condensation.
It is best not to stack trays on top of each other because the heavier tray can affect the sterility by pushing air in and out. At the same time, if you have a heavier tray, you have to be careful that it is not dragged, Corn adds. It needs to be set at a height that makes it easy to reach across and get a hold of the tray rather than dragging it across the shelf because that will damage the wrapping.
Corn also recommends that the sterile storage area be kept in a way that things arent jammed into spaces. Sterile packaging shouldnt be crammed into a space like a drawer, he says. Rule of thumb in handling sterile packaging is that if the packaging is getting creased, what can happen is if you crease paper over and over again, eventually it will work a hole into that. The more handling that occurs can certainly compromise the packaging. If you can protect the package in a way that doesnt allow them to be handled constantly, then the packaging will last. If its being handled, then there is always that possibility for it to get damaged or possibly even opened.
Corn says that the most important aspect of sterile processing and protecting the integrity of sterile packaging is to adhere to the evidence-based practices that have been established over the years. He says it is very easy to become tempted and look for ways to speed the process, however, any shortcut implemented may result in dire effects, he warns. That shortcut could be cutting out one of the safeguards that is in place for a reason, he adds.
Goodman agrees, and says this is why strong leadership and continual teaching is imperative in this environment. You can not legislate integrity. I firmly believe that. You can teach, you can emphasize outcomes, you can encourage adherence; my answer for the best way to approach it is to have a system in place where everybody does it the right way. There are lots and lots of right ways of doing things, but if in an environment it can be agreed upon which right way were using here and we approach it that way, there is less room and less encouragement for individual interpretation and since everybody does things in the same manner, somebody doing it differently is very obvious. It is less comfortable to break the rules in the company of your peers when it is very obvious they know what you are doing.
People should know the basics, she continues. People should know the principles upon which they practice so that what they are doing makes sense to them. It is very difficult to get somebody to do things when they have no idea why they are doing it. Skipping steps is easy when you dont know that the step is important.
Managing the Burden
Maximum weight and tray configurations should be identified in each institutions policies, according to the 2006 the Association of peri- Operative Registered Nurses (AORN) Proposed Recommended Practices for Selection and Use of Packaging Systems, however many do not or if they do, they are not always adhered to.
It is commonly recommended that the total weight of instrument containment devices not exceed 25 pounds. To my knowledge, there is no standard weight limit, asserts Terri Goodman, RN, PhD, consultant, Terri Goodman and Associates. Since hip replacement instrumentation came into being in four million pound packages, they have been working on a weight limit.
My recommendation is pure and simple common sense. In an environment where you are wrapping things, human beings are wrapping them. If the human beings wrapping them find them uncomfortably heavy, then they are too heavy. Its that simple. If one pack jeopardizes the health and wellbeing of an employee, then it ought to be two packs or possibly three. That one workers comp case is going to wipe out any savings you thought you had by having a single container.
A weight limit makes sense, however, not everybody will be comfortable with a weight that the majority might be. A 10-pound pack may be manageable by most people but how many very heavy OR (operating room) nurses do we have who just dont handle things well and how many tiny little things do we have running around? It seems like the OR is populated by people outside the bell curve either tiny or heavy we have very few normal people in the OR, Goodman points out.
Truly, I think a weight limit is a very good idea, but I dont think a weight limit should be interpreted as acceptable in all cases. If anybody were asking me to manage a 25-pound anything, they would find me noncompliant. I am five feet tall. I dont do well with 25-pound packs. I truly find a 10-pound pack a challenge to deal with.