Event-Related Sterility

Introduction
Event-Related Sterility Maintenance Policy denes procedures intended to maintain the sterility of packages until they are used. This
document focuses on event-related sterility maintenance of hospital-prepared packages containing sterile supplies wrapped in single-
use or reusable materials. Since some supplies have expiration dates and degrade over time, this document covers only those supplies
for which the manufacturer or the distributor does not provide expiration dating in the form of labeling, instructions of use, or other
statements.

For years, the subject of expiration dating has generated considerable debate. Many hospitals have considered 30 days to be the
standard time period for dating hospital wrapped sterile supplies, principally because of 1971 (1) and 1973 (2) shelf-life studies
conducted by the Center for Disease Control . Those results indicated that items double-wrapped in muslin had a shelf life of three
weeks, and that packs stored in dust covers were considered sterile for at least nine months. Recent studies suggest that current
standards for sterility testing can be improved by the addition of event-related testing, and that contamination of wrapped trays may
occur within days, instead of weeks(3).New and improved packaging materials, along with greater understanding of the factors
aecting sterility, have fueled the debate over expiration dating. Changes in JCAHO Accreditation Standardsreect the premise that
contamination is "event-related" and not "time-related", and recognize the hospital's expertise in maintaining and delivering sterile
products.

While the new standard provides new freedom, it also puts new responsibility on the hospital professional. The major dierence in the
new standard is that a specic date is no longer required. Hospitals must now establish written policies based on their unique internal
practices. The impact of this can be substantial, representing savings in both reprocessing and labor costs. The timely and costly
practice of reprocessing is greatly reduced and sta is free to spend time in more productive job functions (i.e., pack preparation, not
pack reprocessing).
With the change in accreditation standards, hospitals are now able to develop procedures that more accurately reect their sterile
containment needs.

Justication
Rationale for changing to an Event-Related Sterility Maintenance Policy

Patient-care items purchased from manufacturers as sterile typically use "event-related" labels (4) such as "Sterile unless the
package is opened or damaged".

The following professional organizations recommend practices that do not require time-related expiration dating:

AAMI Draft, 1993 (5)

Shelf-Life:"The shelf-life of a packaged sterile item is event-related and depends on the quality of the wrapper material,
the storage conditions, the conditions during transport, and the amount of handling. There should be written policies and
procedures for how shelf-life is determined and for how it is indicated on the product."
Expiration Dating:"Each item intended for use as a sterile product must be labeled with a lot control number, a control
date for stock rotation, and the following statement: 'Product is not sterile if packaging is open, damaged, or wet. Please
check before using.'"

JCAHO(6) "There are written policies for the shelf-life of all stored items." IC.5.1.2
AORN, Recommended Practice VIII (7) "Shelf-life of a packaged sterile item is event-related,..."

Cost of reprocessing items due to Expiration dates vs. Actual compromise of package sterility.

Implementation
Dene goals for the policy.

Develop proposal for Infection Control Committee

Develop a cost benet analysis

Cost of sterilization materials

Time spent repackaging
 Sta salary costs
Anticipated annual savings

Review technical documentation on barrier quality of packaging materials.

Review current practices to establish compliance with:

Local and state laws - consult your hospitals Infection Control and Risk Management departments.
AAMI
AORN
JCAHO
CDC

Develop and implement initial and on-going quality assurance testing protocol.

Develop a policy:

Dene labeling policy

Dene events that would require reprocessing of packages
Determine which items need to be dated
Determine rotation policy
Dene how to monitor compliance

Develop and implement training programs.

Monitor infection rates before and after implementation of new policy. Document other changes in hospital practices that could
impact infection rates to be able to identify the potential cause of a change in infection rates.

Factors Aecting Sterility

Barrier Eciency of Packaging MaterialVisual Evidence of Compromise Packages

Tears
 Holes

Rupture of Seals and Closures

Wetness

Crushed Packages

Storage conditions

Microbial Contamination of the environment

Air Movement

Trac

Location

Temperature

Humidity

Handling, and Transport

Dropping

Compression

Opening the package

Standard Requirements
OLD STANDARD REQUIRED: "Designation of the shelf-life for each hospital-wrapped and hospital-sterilized medical item, and to the
maximum degree possible for each commercially prepared item by a specic expiration date that sets a limit on the number of days an
item will be considered safe for use." (JCAHO Accreditation Manual, IC.5.1.4, 1989)
NEW STANDARD REQUIRES: "Written policies for addressing the shelf-life of all stored sterile items." (JCAHO Accreditation Manual,
Standard 5:5.1.2, 1990.)

References
Standard, P. G., Mackel, D. C., Mallison, G. F., "Microbial Penetration Of Muslin- and Paper-Wrapped Sterile Packs Stored on Open
Shelves and in Closed Cabinets." Applied Microbiology, Vol. 22, No. 3, pp. 432-437, 1971.
Standard, P. G., Mackel, D. C., Mallison, G. F., "Microbial Penetration Through Three Types of Doublewrappers of Sterile Packs."
Applied Microbiology, Vol. 26, No. 1, pp. 59-62, 1973.
Widmer, A. F., Houston, A., Bollinger, E., Wenzel, R., "A New Standard for Sterility Testing for Autoclaved Surgical Trays." Journal of
Hospital Infection, Vol. 21, pp. 253-260, 1992.
Mayworm, D., "Sterile Shelf-Life and Expiration Dating.", Journal of Hospital Supply, Processing and Distribution, Vol. 2, No. 6., pp.
32-35, 1984.
Association for the Advancement of Medical Instrumentation, "Draft: Good Hospital Practice: Steam sterilization and sterility
assurance.", ANSI/AAMI ST46, 1993.
Joint Commission on Accreditation of Healthcare Organizations, Accreditation Manual For Hospitals, Chicago: JCAHO, 1993.
Association of Operating Room Nurses, "Recommended Practices for Selection and Use of Packaging Systems." AORN Journal,
Vol. 56, No. 6, pp. 1096-1100, 1992.