Shelf life designated as event-related
[Editor’s note: To help our readers, Same-Day Surgery is printing advice in the top 10 areas that receive the most questions at the Center for Nursing Practice, Research, and Health Policy at the Association of Operating Room Nurses (AORN) in Denver. The seventh topic, addressed in this month’s issue, focuses on shelf life.]
Shelf life is defined as the duration of sterility of a packaged sterile item. Shelf life is designated as either time-related or event-related.
AORN believes that loss of sterility of a packaged sterile item is event-related. That is, the length of time the item remains sterile depends on the occurrence of a contaminating event. Naturally, the opportunity for a contaminating event increases over time. However, studies have shown the shelf life of some packaged items to extend up to and beyond 50 weeks with no contaminating event.
Factors that affect the shelf life of an item include:
• the type of materials used for packaging and the methods of wrapping;
• whether dust covers are used and the methods for sealing the dust covers;
• the number of times the package is handled and the number of different people handling the package;
• storage conditions, such as open or closed shelves, cleanliness of the storage area, and the temperature and humidity of the storage area.
The Joint Commission on Accreditation on Healthcare Organizations requires facilities to have policies and procedures designating either time-related or event-related shelf life for hos-pital sterilized items and for commercially prepared sterile items that do not contain an expiration date. The Joint Commission further requires that the policies established be consistent in intent and application throughout the facility.
Many facilities have adopted an event-related shelf life policy. When such a policy is adopted, it is advisable to develop a protocol to ensure that the oldest items are used first. Sterilized items should be marked with the date of sterilization. At regular periodical intervals, stock should be rotated so items with the oldest sterilization dates are at the front of the shelf or bin. These items should be used first to avoid prolonged opportunity for a contaminating event to occur.
Sterile items that remain on shelves and are unused for a period of more than one year should be evaluated as to the continued need for maintaining the item in a sterile state. Items remaining on shelves for extended periods represent poorly managed inventory dollars. Slow inventory turnover should be carefully evaluated to determine the necessity of stocking such items.
The following sources provide additional information related to shelf life:
• Association of Operating Room Nurses. AORN Standards and Recommended Practices. Denver: AORN; 1996, pp. 277-278.
• Donovan A, Turner D, Smith A. Successful, documented studies favoring indefinite shelf life. Journal of Healthcare Materiel Management 9:34, 36, 38.
• Huntsinger C, Greene V. Maintaining sterile integrity of hospital produced packs. Journal of Sterile Service Management 5:21-24.
• Jevitt D. Indefinite shelf life...amen! Journal of Hospital Supply, Processing, and Distribution 2: 36-37.
• Klapes N, et al. Effect of long-term storage on sterile status of devices in surgical packs. Infection Control 8:289-293.
Reprinted with permission from AORN Online (http://www.aorn.org/), 1997. AORN Inc., 2170 S. Parker Road, Suite 300, Denver, CO 80231.
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