Construction of validation system and clinical application for aseptic technique based on media fill test

OBJECTIVE  To establish an aseptic technique evaluation method based on the media fill test to reduce the risk of hospital-associated infections caused by operational contamination.

METHODS  Simulating clinical intravenous drug preparation scenarios, double-strength tryptic soy broth was used as a substitute for actual medication. Five non-compliant operation scenarios were designed to validate the sensitivity and reliability of the method by intentionally reducing aseptic technique procedures. Eight preparation personnel were evaluated the established MFT method for aseptic operation skills, with each completing three test sets. Their performance was scored for aseptic technique, and environmental hygiene indicators were monitored during the media fill process. The evaluation pass criteria included no microbial growth in samples, a score ≥90, and compliance with environmental monitoring standards.

RESULTS  In sensitivity validation, the highest contamination rate （86.67%） occurred in samples subjected to non-compliant operations, demonstrating the test's sensitivity to aseptic technique flaws. Among the 24 samples prepared by personnel during aseptic technique validation, only one showed contamination, with five individuals passing the evaluation （62.50%） and two failing due to scores below 90.

CONCLUSIONS  The MFT-based aseptic technique validation system developed in this study effectively identifies microbial contamination risks, quantitatively assesses personnel competency in aseptic techniques, and holds significant value in reducing hospital-associated infection risks.