Event Related Sterility References

  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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  1. 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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  1. 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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  1. Mayworm, D., "Sterile Shelf-Life and Expiration Dating.", Journal of Hospital Supply, Processing and Distribution, Vol. 2, No. 6., pp. 32-35, 1984.
  2. Association for the Advancement of Medical Instrumentation, "Draft: Good Hospital Practice: Steam sterilization and sterility assurance.", ANSI/AAMI ST46, 1993.
  3. Joint Commission on Accreditation of Healthcare Organizations, Accreditation Manual For Hospitals, Chicago: JCAHO, 1993.
  4. (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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