Authors (including presenting author) :
Law TH(1)(2), Lee CK(2), KO SM(2), Yeung WC(2), Mok NL(2), Yip SY(2), Cheung KW(2), Tang CT(2), Chu YM(2), Ng WS(2)
Affiliation :
(1) Ex-Cluster Operations Manager, (2) SSD, NTWC
Introduction :
Rigid sterilization container is one of the best sterile barrier systems to maintain the sterility of surgical instruments and medical devices after steam sterilization. It typically relies a filter mechanism and a gasket to prevent the entry of microorganisms and dirt, until the container is opened at the point of use. Recommended guidelines were provided by the manufacturer to examine the integrity of sterilization containers via visual inspection on a regular basis; however, whether visual checks of sterilization containers are sufficient to evaluate their functionality remains questioned.
Objectives :
This study aims at exploring different approaches and methodologies to validate the sealing capability of sterilization container from a clinical user perspective.
Methodology :
30 new containers were served as control while 1826 in use containers of different sizes and years of usage in the Sterile Services Departments of Tuen Mun Hospital and Pok Oi Hospital were subjected for evaluation. Three test methods were employed in this study to examine the sealing capability of these containers, including the smoke test, water test and paper test. Pass/fail criteria for each test method was defined and the results were analyzed.
Result & Outcome :
The results depicted that three test methods generated different pass and fail levels, with failure rates ranging from 1.94% to 59.69%. It showed the importance to establish a reliable test method to measure the sealing capability of sterilization container. Nonetheless, containers with over 11 years of usage generated a higher fail rate as compare to those within 7 years of usage regardless of which test method was used. The study showed that there are a variety of techniques that a SSD can use to evaluate the sealing capability of sterilization container during a reprocessing cycle. In addition to visual inspection, smoke test was found optimum in this work to serve as a supplement for evaluation as it can simulate airborne transmission and the result is not affected by the external force and gravity.
