Background
Sterilized packaging systems are designed to maintain the sterility of surgical instruments
and devices from the time of sterilization until use. This study evaluated the effectiveness
of rigid containers versus wrapped instrument trays, sterilized using North American
sterilization protocols, to maintain a sterile internal environment poststerilization
when challenged with aerosolized bacteria under dynamic environmental conditions.
Methods
Using a custom aerosol chamber, 111 rigid containers of various durations of use (unused,
used <5 years, used 5-9 years) and 161 wrapped trays using 3 grades of sterilization
wrap were challenged with ∼102 colony-forming units per liter of air containing aerosolized Micrococcus luteus with a count median particle size of 1 μm, while simultaneously experiencing air
volume exchanges due to vacuum cycles–two 1-psi cycles, three 0.7-psi cycles, and
three 0.4-psi cycles–to simulate air exchange events occurring during the sterilization,
transportation, and storage of sterilized instrument trays in health care facilities.
Results
Of 111 rigid containers tested, 97 (87%) demonstrated bacterial ingress into the container.
Of 161 wrapped trays, 0 (0%) demonstrated bacterial ingress into the tray. Contamination
rates of rigid containers increased significantly with increasing duration of use.
Conclusions
In this study using a dynamic bacterial aerosol challenge, sterilized wrapped trays
demonstrated significantly greater protection than sterilized rigid containers against
the ingress of airborne bacteria.
Key Words
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Article Info
Publication History
Published online: August 31, 2015
Footnotes
This work was created in the performance of a Cooperative Research and Development Agreement with the Department of the Air Force. The Government of the United States has certain rights to use this work.
This research was funded by Halyard Health (formerly Kimberly-Clark Healthcare).
Conflicts of interest: None to report.
Identification
Copyright
© 2015 Published by Elsevier Inc.
