Clean tools, skin, and hands can prevent infections resulting from surgery. Its as simple as that. However, not everyone properly observes the principles of sterile cleaning and storage. Keeping sterile inventory sterile may sometimes be a challenge. However, sterile storage has come a long way. And having the opportunity to build a facility from the ground up can help create proper storage areas, rather than jury-rigging an older room to function in a way it was never intended, observes Robert Cederberg, MA, DDS, the associate dean for clinical activities and clinic director for the Arizona School of Dentistry and Oral Health Dental Clinic.
You have to have a dirty and a clean side separated by law, he points out. When we built our clinic, we had a specific side where students and faculty would turn in dirty instruments. They run through high speed washers, in cassettes, so theyre not loose or in pieces. Theyre then packaged and inserted into a sterilizer that is built into the wall. When theyre pulled out on the other side of the sterilizer, its in a separate room, so theres no way to mix dirty and clean, because theyre in two separate rooms.
For items that are clean but dont need to be kept sterile, they are stored in a locked cabinet near to each care unit.
Item transportation is simple. The sterile package is collected by the dental student. Students are taught specific procedures on how to clean up after they are done. They use utility gloves, wipe down the instruments and put them back into the cassettes, and those are put into a transfer cart carts with boxes on top that have doors, so dirtied items can be placed inside and transported into the dirty area.
Students undergo a detailed and fairly rigorous orientation session, Cederberg says. During their clinic orientation, they are taught infection control, how to transfer cassettes to the transfer cart, and sterile storage, and all of these things are practiced for months on end, he adds. They also, by law, have to have Health Insurance Portability and Accountability Act (HIPAA) training, and Occupational Safety and Health Administration (OSHA) training, which talks about different OSHA regulations. There is also infection control training. There are elements of the protocols that we use that change yearly, so they are required to have a yearly update of anything that has changed from their initial training. Thats managed annually, during our risk management workshop, where different things are presented in a lecture format that explains things that have changed in protocols or procedures from one year to the next.
Sterile storage is not an issue for most surgical technologists, says Kevin Frey, CST, MA, director of continuing education for the Association of Surgical Technologists. Because everybody is aware of super-bugs and infection rates, especially these days, theyre still pretty careful about meeting Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and OSHA standards, he observes. I have been with a couple of hospitals that remodeled, and we had to not so much jury-rig [an alternate sterile storage room], but still make sure the room is acceptable. Weve had to use an alternate room that meets standards until the remodeling is done.
In Freys experience, storing sterile items that are new from a manufacturer is a long-established process. Boxes of new inventory are brought up, but the boxes themselves are not taken in the sterile storage area. Well open the boxes and put the packs on a cart, because the packs are enclosed in plastic covering to keep everything sterile inside, so we dont take the dirty boxes past what we call the red line, he explains. If you go past the red line, you have to have at least a scrub outfi t on and a hair covering and shoe covers, and you dont want anything real dirty to go past that line. However, he adds, other healthcare facilities may have a different process. In those cases, he says, the shipping and receiving department at the hospital will unpack the boxes and deliver them to the sterile storage area themselves, so the operating room (OR) staff does not have to do it.
A major source of contamination of the sterile storage environment is shipping containers and transportation vehicles, agrees Lisa James, RN, MA, CNOR, clinical resource for VHA Supply Chain Services. Clean or sterile disposable items may come from the receiving area. These items must be removed from their outer shipping cartons and placed in the clean transportation containers or vehicles for transfer into the sterile storage area.
Shipping cartons must never be allowed in either a clean storage area or a sterile storage area, and these containers should never be used as storage containers within these areas. In particular, corrugated cardboard boxes harbor dust and bacteria in their grooves and are frequent sources of fungal contamination and bacterial spores, she says.
Frey points out that instruments generally come directly from the central supply department, and most central sterile (CS) departments are kept in close proximity to the OR. These items, too, are kept inside sterile cases. Also in these instances, the items are kept in enclosed cases, after which the CS staff or surgical technologists will be able to take the entire case back to the sterile storage room.
For shipping and receiving staff, who need to know how to properly handle and store these sterile supplies, the hospital will provide training, or the OR staff will demonstrate how to handle and store the inventory. They can see the name of the item up on the shelf, if its say, a lap pack, theyll see a label on the shelf that says laparotomy pack and know thats where it goes, Frey explains.
For surgical technologists, training is very specific most of these staff members complete an accredited program that is one to two years in length, and they will get all their didactics, lab training, and clinical training during that program. As for the specific topic of asepsis and sterile supply, most programs have either incorporated it into a course or offer it as a separate course, but somewhere in there is all the training about central supply, proper storage, proper wrapping, etc., says Frey.
Inservicing intervals specifically focused on sterile supply are set by the hospital. Most of the time, the techs that they hire have gone through a program, so they know whats to be done, he adds. When theyre first hired, as with any new job, they go through an orientation period. But as far as storage of things, its pretty standardized, how its done, as far as the steps to take. Theyve received that training in school, and thats why theyre hired, so they shouldnt have to be told, This is why you put the nonsterile items in this room and the sterile items here in this room."
As the national professional membership group for surgical technologists and surgical assistants, the Association of Surgical Technologists does not put out specific requirements for continuing education topics. We dont say they you have to take fi re safety every year or learn this certain procedure every year, Frey adds. But one thing we do set is the number of contact hours. Im a certified surgical technologist, and I hold the certification for four years. At the end of my certification, I have to have earned 60 continuing education credits to renew my accreditation through our sister company, the Liaison Council on Certification for the Surgical Technologist (LCC-ST). (It is a separate company with its own board of directors, but we work with them on a lot of things.) Im going to earn those credits in a variety of ways attending medical lectures, those types of things, he continues. But we dont dictate the type of continuing education they have to complete, as long as its relevant to the practice of surgical technology.
The Sterile Environment
It is also important that the air in the sterile storage area be as clean and dust-free as possible; consequently, air entering the area via the ventilation system is usually filtered, says James.
Moisture, too, is a major cause of contamination. Too much or too little environmental humidity can adversely affect package seals and the adherence of sterilization indicator tape and other labels, causing packages to become unsealed or making it impossible to verify that packages have been in the sterilizer, she adds. For these reasons, sterile storage areas should have controlled temperature and humidity. The common practice is to maintain the room temperature in the range of 65 degrees to 72 degrees F, and the relative humidity in range of 35 percent to 75 percent.
People pose another source of contamination. All people carry microorganisms on their bodies and clothing; for this reason, sterile storage areas should be located away from general traffic. There are two basic systems for storing sterile items open and closed shelving. Open shelving, the most common method for storing sterile items, is economical and easy to keep clean, allows ready access to supplies, and conserves floor space, James continues. However, open shelving provides little protection. It must be designed so that the sterile items can be placed at least eight inches from the floor, at least two inches from the outside walls, and at least 18 inches from the ceiling fixtures (sprinklers). It is particularly important that sterile items be stored away from outside walls to avoid temperature changes that can result in moisture/condensation. Inside walls should be avoided because rigid containers can bump up against and damage walls, thus allowing potential contamination from wall surfaces.
Transported sterile items must always be covered. Plastic wrap that is two to three millimeters thick or fitted cart covers are often used.
Sterile items on open shelving or in open containers should always be stored away from sinks, windows, doors, exposed pipes, and vents. A barrier between the items on the bottom shelf and the floor is necessary.
This barrier may be a solid bottom shelf, covered tote boxes, a sheet of heavy-gauge plastic, or other means, James points out. Items on the top shelves of open shelving units must be protected from the contaminants falling from the ceiling, ceiling fixtures, or the vent systems.
Requirements by Accrediting Bodies
Various accrediting bodies make their own recommendations for sterile inventory storage. The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), for example, believes sterility is critical to patient safety, and therefore, has made it part of its Gold Standards in accreditation. The goal of the AAAASF is to develop and implement standards of excellence to ensure the highest quality of patient care through an accreditation program that serves both the medical community and the public interest by establishing a means for measuring medical competence and providing an external source for evaluating patient safety in the ambulatory surgery setting, according to the official Web site of the association.1
A key safety standard to prevent infection begins with the autoclave, says Jaime Trevino, public relations representative for the association. Every facility must have at least one autoclave that utilizes high pressure steam and heat. In addition, other methods used can be chemical autoclave (chemclave) or gas (ethylene oxide) sterilizer. Gas sterilizers must be vented if appropriate for the specific sterilizer.
Not only that, but also, Trevino notes, High level disinfection is used only for non-autoclavable endoscopic equipment and in areas that are categorized as semi-critical in which contact will be made with mucus membrane or other body surfaces that are not normally to be considered sterile. At all times, the manufacturers recommendation for usage should be followed. A weekly spore test must be performed and the results fi led for each autoclave. If a spore test is positive, there is a protocol for appropriate remedial action.
Each load in the autoclave must be checked with indicator tape, chemical monitors, or other effective means both on the outside and inside of the pack, Trevino adds. If a sterilizer produces monitoring records, they must be reviewed by appropriate personnel and stored for a minimum of three years. All sterilized instruments used in patient care must be properly stored away from potential contamination hazards and where applicable, heavy traffi c areas. Sterile supplies must be appropriately labeled indicating sterility and must be appropriately packaged to prevent accidental opening. Supplies must be sealed with autoclave tape. Each sterilized pack should be marked with the date of sterilization and, when applicable, with the expiration date, so as to determine which supplies are to be re-sterilized in case of a spore test failure and to identify supplies that were sterilized first and are therefore to be used first. When more than one autoclave is available, each pack must additionally be labeled so as to identify in which autoclave it was sterilized.
The concept of first in, first out is also recommended. Use supplies that are oldest, then gradually move into newer supplies.
Recommendations have also been made by the International Association of Healthcare Central Service Materiel Management (IAHCSMM) and the American Society for Healthcare Central Service Personnel (ASHCSP). In their joint Position Paper No. 3, dated December 1996, the associations were very clear about what was required for adequate sterile storage.2
Shelf life, when used with respect to a sterilized product, is defined as the period of time during which sterility is assumed to be maintained. A shelf life system must provide for sterility assurance in order to ensure quality patient care, the paper offers. Traditionally, most healthcare facilities have used an expiration dating system to determine shelf life for items sterilized in-house. In recent years, studies have been published that support an event-related shelf-life concept that specific events, not time, are responsible for sterile products becoming compromised.
Current standards and recommended practices from JCAHO, AORN (Association of periOperative Registered Nurses), AAMI (Association for the Advancement of Medical Instrumentation) and the CDC (Centers for Disease Control and Prevention) recognize event-related shelf life as an alternative to timed outdating. Today, many healthcare facilities are considering changing their current time-related shelf life system to an event-related shelf life system.
Since that time, many facilities have transitioned to a system that was based on that event-related shelf life, rather than a time-related shelf life with a specific expiration date. It is made clear, however, that events must be specifically defined, so staff will know if it is safe to continue to use an item, or when it needs to be re-sterilized. An effective event-related sterility assurance system is an integral part of quality patient care and is a cost-effective practice, the paper continues.
Before plans are made to establish an event-related system in a healthcare facility, it is necessary to have essential information in order to make a sound decision as to whether or not this concept will work effectively in the facility. If a recommendation is made to change from a time-related shelf life system to an event-related system, information on how to develop a proposal and plan and implement the system is essential.
Because numerous staff members from central sterile had requested additional information to help them in determining whether the switch from a time-related dating system to an event-related sterility assurance system, ASHCSP and the IAHCSMM joined forces and adopted the following position:
- The focus of any sterility assurance system should be on quality patient care.
- Event-related shelf life is based on the principle that specific events, not time, are responsible for sterile products becoming compromised.
- An item that is correctly packaged, sterilized, stored, and handled after sterilization will maintain the sterility of the product until used, for an indefi nite period of time.
- There should be written policies and procedures in place for an effective event-related sterility assurance program.
- All healthcare facility staff who handle and use sterile products, must be educated to the concept of an event-related sterility assurance system.
When the associations developed their joint guideline, they determined that it must include the following factors:
- Rationale/requirements for change
- Proposal to infection control
- Plan for implementation
- Ongoing monitoring
Central service departments that anticipate using an event-related shelf life system need to have essential information to evaluate the feasibility of the concept for their individual healthcare facility, plan for implementation and monitoring, and have policies and procedures in place for effectiveness of the event-related sterility assurance system. The following guidelines provide essential information that will assist CS professionals to change their current expiration dating shelf life system to an event-related shelf life system, if appropriate for their facility, the paper concludes.
ASHCSP and IAHCSMM Guidelines
I. Investigate possibility to change
A. Review current standards and recommended practices
1. National (JCAHO, AAMI, CDC, AORN)
B. Review relevant literature
1. Shelf life studies
2. Case studies of hospitals that have made the change
C. Review requirements (needs assessment)
1. Wrap/containers, peel pouches (manufacturers recommendation)
2. Plastic sterility maintenance covers (dust cover)
3. Labels (i.e., indefinite shelf life contents sterile unless damged or opened)
4. Storage conditions 5. Handling/transport D. Perform own sterility testing if recommended by hospital E. Consider forming task force representing all concerned departments to provide input/ support F. Make recommendation based on above documented information II. Develop and present proposal to infection control committee A. Define event-related shelf life concept vs. expiration dating B. Prepare summary of current standards and recommended practices
C. Prepare cost/benefit analysis
4. Anticipated annual savings
D. Draft policies/procedures for proposed system
1. Preparation of sterile supplies and labeling
2. Storage and handling
3. Supply rotation
4. Package integrity
E. Present above information to infection control committee for consideration to approve a change to an event-related shelf life system
III. Implementation of event-related shelf life system
1. Assess educational level of staff
2. Inservice CS staff and staff in all departments using sterilized items
a. Explain event-related shelf life concepts vs. expiration dating
b. Identify events that could compromise package sterility c. Handling and transport
You may visit these organizations to view their recommendations as well: JCAHO, AORN, AAMI and the CDC.
JCAHO -- www.jcaho.org
AORN -- www.aorn.org
AAMI -- www.aami.org
CDC -- www.cdc.gov