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EVENT RELATED STERILITY REFERENCES

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(1) 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.

(2) 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.

(3) 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.

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(4) Factors Affecting Sterility

  • Barrier Efficiency of Packaging Material
    1. Visual Evidence of Compromise Packages
      • Tears
      • Holes
      • Rupture of Seals and Closures
      • Wetness
      • Crushed Packages
  • Storage conditions
    1. Microbial Contamination of the environment
    2. Air Movement
    3. Traffic
    4. Location
    5. Temperature
    6. Humidity
  • Handling, and Transport
    1. Dropping
    2. Compression
  • Opening the package

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(5) 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 specific 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.)

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(6) Mayworm, D., "Sterile Shelf-Life and Expiration Dating.", Journal of Hospital Supply, Processing and Distribution, Vol. 2, No. 6., pp. 32-35, 1984.

(7) Association for the Advancement of Medical Instrumentation, "Draft: Good Hospital Practice: Steam sterilization and sterility assurance.", ANSI/AAMI ST46, 1993.

(8) Joint Commission on Accreditation of Healthcare Organizations, Accreditation Manual For Hospitals, Chicago: JCAHO, 1993.

(9) Association of Operating Room Nurses, "Recommended Practices for Selection and Use of Packaging Systems." AORN Journal, Vol. 56, No. 6, pp. 1096-1100, 1992.

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