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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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(4) Factors Affecting Sterility
- Barrier Efficiency of Packaging Material
- Visual Evidence of Compromise Packages
- Tears
- Holes
- Rupture of Seals and Closures
- Wetness
- Crushed Packages
- Storage conditions
- Microbial Contamination of the environment
- Air Movement
- Traffic
- Location
- Temperature
- Humidity
- Handling, and Transport
- Dropping
- 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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Sterility
- (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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Sterility
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