Infection Control Today - 07/2000: Event-Related Sterility: Then and Now

July 1, 2000

Event-Related Sterility: Then and Now

by Connie Cutler, RN, MS, CIC

Did you ever hear the one about sterile items discovered 50 years after World War II?The story goes that a nurse found gauze and bandages wrapped in muslin in the basement ofa hospital in British Columbia, Canada. The finder surmised that they were probablyprepared for shipment to Europe. She took them to the laboratory for testing, and culturesshowed no growth.1

Ever since I started in Infection Control almost 20 years ago, I wanted to use event-related sterilization as the method to determine the conditions under which an item isconsidered to be no longer sterile. It never made clinical sense to pick a magical dateafter which items would no longer be considered sterile. Illinois finally got the legalability to change to event- related sterilization. However, this change did not comeeasily. Many articles were written supporting this procedure, but the Illinois HospitalLicensing Act only allowed date-related sterilization. When it was time for biannual (atthat time) Joint Commission on the Accreditation of Healthcare Organizations surveys, thenurse surveyor would asked why we weren't using event-related sterilization. I had torespond that state law did not allow it. She advised that we try to change the law. Thatis easier said than done.

Then, in 1994, I was selected to be on a task force of Infection Control Professionalswhose facilities were members of the Metropolitan Chicago Healthcare Council. Thisinfluential group collects data on hospitals and presents programs on health topics. Ourcharge was to make infection control recommendations to the state for incorporation intothe Hospital Licensing Act. This panel's members reviewed the literature on the topic andproposed the change to include event-related sterilization as an additional option. In1995, the state changed the Hospital Licensing Act to allow hospitals the choice to usetraditional time-dated or event-related sterilization. The new wording is as follows:

Designation of shelf-life may be event related if policies and procedures, approvedby the Infection Control Committee, address at least the following:

  • Requirements for wrapping, storage, and rotation of sterile supplies.

  • Definition of an event that may cause a sterile item to be suspected of being compromised, such as the package being wet or torn, or the seal being broken or tampered with.

  • Clear direction that final inspection of the package and the ultimate decision to use the contents of the package rest with the clinician.

  • Orientation, in-service, and other follow-up to assure that all necessary staff understand and implement the policies and procedures.2

Many articles promote the safety of event-related sterility. In 1984, one author statedthat time-related sterility was archaic.3 An article published in March 1991described the institution of successful, documented indefinite shelf-life at twohospitals. The first was successful in implementing the change by performing cultures ofpreviously overlooked outdated items from earlier years. These items were cultured and theresults indicated no growth. The second facility also used culturing of expiration dateditems to convince their Infection Control Committee to change its policy. Both facilitiesclearly defined the events that could cause loss of sterility and educated the users onthese. Those conditions included that the package is not "torn, wet or damaged orsuspected of being compromised."4 In other articles, cultures of itemsalso showed no growth.5-6

A hospital in Milwaukee reported using event-related sterilization as a continuousquality assurance process. This reference concluded that "event-related sterilityassurance improves the quality and efficiency of the sterilization process, utilizes fewerresources, assists in inventory control and related costs, increases staff time forpatient care, and raises employee morale."7 Another author pointed outthat removing items for sterilization after the expiration date had been passed tooksterile instruments out of circulation when they could have been used for patient care.8In this day of decreasing healthcare reimbursement, purchasing extra instruments to allowfor resterilization of sterile instruments just doesn't make sense.

What type of wrapper is best for event-related sterilization? In an article aboutlong-term storage effects, Klapes addressed the type of wrapper that would have the lowestcontamination rate. The differences between four types (peel pouches, two two-ply newreusable non-barriers, two nonwoven barriers, and two two-ply used reusable non-barriers)was not statistically significant in a storage period of 50 weeks.9 In anotherarticle, Belkin concluded that "a perfect wrapper would be one that is impervious toextraneous microbes, liquid-proof, free of holes, free of lint, free of memory, strongenough to resist punctures and tears, and economical to use."10 Unfortunately,such a product would not allow steam to penetrate for sterilization.

In this era of managed care contracts, any opportunity for cost-savings is appreciatedby administration. The estimated savings from using event-related sterility proceduresranged from $2,000 per year in 1990 to $10,000 per year in 1992. Savings derive fromdecreases in labor costs in Central Processing and Operating Room, decreased laundrycosts, fewer sterilization loads, and fewer supplies such as pouches.1 Othercost analyses have shown similar results.5 Another facility estimated a $10,000savings in 1995 in a hospital performing 600 cases/month without including costs of stafftime in "gathering, re-wrapping, reprocessing and reshelving the items."6Another article quoted savings up to $25,000.11

Obstacles to Implementing Event-Related Sterilization

What obstacles have facilities faced when proposing the change to event-relatedsterilization? One author lists the following 10 challenges:

1. Overcoming resistance to change.

2. It takes too much time and effort to change.

3. How to work with state or local laws that still require expiration dates on hospitalpackages.

4. The hospital isn't comfortable with its storage practices.

5. Gaining control over transportation and handling procedures.

6. Uncertainty about whether packaging material will hold up in event-related sterilityenvironments.

7. Fear of problems with the Joint Commission.

8. Writing a policy takes time and knowledge about the new system.

9. Establishing an effective labeling system.

10. Uncertainty about how long it will take to convert to an event- related sterilitymaintenance program.11

In conclusion, Advocate Health Care (Oak Brook, Ill) faced many of the above issues andcame out with a workable event-related sterility program. With a little time, a littlepatience, and a little science thrown in for good measure, other facilities can createsimilar programs. Be a champion for cost savings at your institution by implementingevent-related sterilization.

Connie Cutler, RN, MS, CIC, is the Coordinator of Infection Control at AdvocateHealth Care (Oak Brook, Ill) and Manager of Epidemiology and Infection Control atAdvocate Lutheran General Hospital (Park Ridge, Ill).

1 Small D. A timeless tale: converting from date-related to event-related resterilization of supplies. Leadership in Health Services. 1995;4(2):40-41.

2 Illinois Administrative Code. Hospital Licensing Requirements. 1995;Section 250.1090.

3 Mayworm D. Sterile shelf life and expiration dating. J Hosp Supply, Processing, Distribution. 1984;Nov/Dec:32-35.

4 Donovan A, Turner DW, Smith A. Successful, documented studies favoring indefinite shelf life. Mater Manag Health Care. 1991;9(2):34-40.

5 Schroeter K. Two studies of event-related sterility. Materials Manage. 1995;4(2):44,46.

6 Lamb J, Foster S, Henderson E. Significant savings achieved by implementing event related outdating. 1996;14(3):12-14.

7 O'Connor LM. Event-related sterility assurance. Surg Technologist. 1994;26(1):8-11.

8 Bell MA. Hospital uses team approach to improve processes, reduce costs. AORN J. 68(1):68-72.

9 Klapes NA, Greene VW, Langholz AC, Hunstiger, C. Effect of long-term storage on sterile status of devices in surgical packs. 1987;8(7):289-293.

10 Belkin NL. Should shelf-life policy be determined by events or time? Today's Surg Nurse. 1996;18(2):15-18.

11 Morrall K. Ten challenges to event-related sterility programs. Materials Manage. 1995;4(9):60,62.



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