Eliminating Sterile Outdates
The need to control costs has driven positive change in many areas of surgical services management. For example, event-related sterility is gaining acceptance while producing cost savings and measurable results. Here's how your hospital can implement change.
Here's a good question for people who appreciate the game 'Trivial Pursuit'. Ask any health care professional if any of the flasks that Louis Pasteur sterilized in 1863 are still sterile. Surprisingly the answer is 'yes'. The flasks are in the Smithsonian Institution, still sterile after more than 130 years. Beyond the scientific nostalgia, there is a lesson to be learned about the truth of 'shelf life' as the criterion for sterility. It's already been proven that sterile items protected from the environment can remain sterile indefinitely-so it's easier to believe that Pasteur's sterile flasks could still pass muster in a review by the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) or the Association for the Advancement of Medical Instrumentation (AAMI).
So why do many hospitals continue to honor the old-fashioned idea that sterility is time related and not event related? Let's quickly review the situation.
Pasteur's use of flasks filled with various fermentable liquids proved beyond a doubt that bacteria do not generate spontaneously, nor do they come from air; instead, they are carried on particles of dust in the air. Thus, any medical device that is properly sterilized and protected from the environment is considered sterile unless damaged or opened.
Many hospitals continue to date packages for a specific period of time; this was probably prudent at a time when sterility assurance resources were less precise. However, by following this arbitrary deadline in today's environment of managed health care means a real drain on hospital resources as all the outdated packages in sterile storage are pulled, reprocessed and returned to storage. This misuse of time, personnel, and materials (e.g. wrap, pouches, tape, labels, load cards, charts, indicators) is preventable-but you must be willing to follow new procedures.
Before we offer some suggestions on how to bring about a significant change in sterilization procedures, let's look at some policy statements on event-related sterility in surgical services management.
WHAT DO REGULATIONS SPECIFY?
The Association of Operating Room Nurses, Inc., AAMI and JCAHO support event-related sterility assurance policies. Carole H. Patterson, RN, MN, associate director for interpretation of the JCAHO Department of Standards, wrote the following in 1988: "It is my understanding form the literature that sterility is an event-related function, not time-related, and that if sterilized items are protected properly by wrap and storage procedures (and the sterilizer's function is monitored), items can be given 'indefinite shelf-life'".
Moreover, in the same year, the AAMI "Good Hospital Practice" guidelines stated:"Plastic dust covers may be used to protect and extend the shelf life of properly sterilized items. The shelf life of a packaged sterile item is event-related and depends on the quality of the wrapper". If extended shelf life is used, AAMI says it must be clearly marked with a legend-for example, "Sterile Unless Opened or Damaged". Therefore, if you are a manager needing to ensure the barrier integrity of the hospital's current packaging system, incorporate dust covers over the packs or use peel pouches. These are two acceptable methods of protecting items for event-related sterility assurance.
Bottom-line endorsement for event-related sterility also comes from the Department of Veterans Affairs, which published a circular in 1990 that said: "In the past, expiration dates forced us to frequently pull back and reprocess items prematurely, causing excess labor and unnecessary waste. This circular extends the shelf life of SPD reprocessed items which should save the VA money by redirecting labor and materials to more useful work".
The AORN recommended practices state: Shelf life of a packaged sterile item is event related.
Savvy hospital managers can thus eliminate sterile outdates by properly selecting sterile packaging, monitoring their sterilization processes, and controlling the events surrounding the handling and storage of sterile items until they are used. The only instance for which event-related sterility is not advisable is when using medication or materials within the package that can deteriorate with time, such as balloon catheters. If event-related sterility can improve bottom line performance and still maintain the highest quality standards, why aren't hospitals moving more quickly to change procedures?
PROCEDURES AND CHANGE
Hospitals, because they are highly regulated and sophisticated providers of multiple services, are traditionally slow to incorporate new procedures that might disrupt and challenge the authority and expertise of staff. Louis Pasteur, I'm sure, would have recognized the resistance to new ideas about sterility assurance. However, many hospitals that have successfully incorporated event-related sterility procedures have done so by observing the following guidelines:
• Begin with a written event-related sterility assurance policy that clearly outlines the subject, objective, policy statement, and procedures.
• Consider all labor and materials involved and conduct a cost/benefit study to help educate those involved about the immediate payback if they incorporate this change.
• Present the written policy and cost/benefit analysis to your Infection Control committee for approval. Some monitoring suggestions to include are 'first in/first out' stock rotation, periodic culturing of packs to verify sterility, and ongoing review of the hospital's infection rates.
• Following approval, document all related details in a memo to staff members and related personnel to begin their training. Meet with anyone expressing concerns about the new procedures immediately, and be responsive to what they say. Make yourself accessible and keep meeting and talking to staff members until the objections and concerns are resolved.
• Implement the new procedures with all personnel, including volunteers, who use or handle sterile items. Impress upon each person their responsibility of carrying out effective quality control procedures by inspecting each package carefully for damage or signs of tampering prior to the point of use.
• Give timely, positive oral and written feedback to each individual who has been trained in event-related sterility assurance to emphasize the cost and time savings achieved.
Hospitals that have made a commitment to the event-related sterility assurance policy also report that it works best when there is a total commitment at all levels of the organization-when everyone follows the newly established sterilization standards and practices. The more time spent on educating all those involved, the better the results.
Managing the care of sterile packages has never been more important, particularly in todays' managed care and environmentally aware environment. Event-related sterility assurance is the procedural bridge to the twenty-first century. In fact, if Louis Pasteur were alive today, it would be nice to think that he would be part of a team that represented many different hospital departments' all with their own agendas, but all working together for the benefit of their patients' care. By controlling costs, we can all add to the quality of that care.
 C.H. Patterson, Letter to Broward General Medical Center, Ft. Lauderdale, FL, March 29, 1988.
 Association for the Advancement of Medical Instrumentation, Good Hospital Practice: Steam Sterilization and Sterility Assurance. ANSI/AAMI St 46 (Arlington, VA, 1991).
 Technical Bulletin (Washington, DC: Department of Veteran Affairs, Dec 19, 1990).
 "Recommended practices for sterilization in the practice setting" in 1996 Standards and Recommended Practices (Denver, CO: Association of Operating Room Nurses, Inc., 1996) 277.
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