Evaluation of the Physical Performance of Chemical Indicators in the Sterilization Process under the Operation of the Pre-Vacuum Pump System of the Steam Sterilizer

Abstract

Quality and safety in medical services are crucial for healthcare. This study aims to evaluate the physical performance of chemical indicators in the sterilization process under pre-vacuum pump systems in steam sterilizers at central supply units that inspect and maintain medical equipment quality. The study involved testing steam sterilizers at six hospitals across Thailand, representing different regions of the country. The testing method utilized the Bowie-Dick Test (BDT) sheets, CHAMBER brand, model BDS122, following the Hallow load test principle, with 360 sheets tested. The performance of chemical indicators in the sterilization process was assessed under vacuum pump operation in nine steam sterilizers, with 40 test sheets per machine. Post-experiment, the physical change of chemical indicators from blue to dark black was observed. This result indicates that the chemical indicators met all parameters, including pressure, time, and temperature, with 100% compliance. Therefore, the study concludes that the tested steam sterilizers from all brands effectively eliminate microorganisms, as designed according to ISO 11140-4 standards. The study also confirms the design compliance with ANSI/AAMI ST79 and EN285 standards based on the Hallow load test principle. These findings prove the effectiveness of steam sterilizers, ensuring quality assurance and occupational safety in hospitals.