부산대학교 도서관

This study applies Failure Modes, Effects, and Criticality Analysis (FMECA) to evaluate and enhance the reliability of the Neusoft NeuViz Scanner, a critical medical imaging device. Collaborating across disciplines, a specialized working group comprising seasoned radiology experts and engineers undertook a rigorous two-year investigation into the intricate dynamics of gantry and console components. The discernment of critical elements such as the F102 fuse holder, left control panel card, Ucom card, DMS system, and RDC card revealed pivotal nodes requiring strategic intervention. Identifying critical components within the gantry (F102 fuse holder, DMS system, and left control panel card) and console (RDC card and database), the study calculates criticality indices based on Frequency, Severity, and Detectability. Results guide a three-tiered approach, proposing preventive, corrective, and improvement actions. Preventive measures include thorough inspections, cable evaluations, lubrication planning for the gantry, and cleaning procedures for the console. Corrective actions involve card and cable replacements. Innovative improvements encompass incorporating Uninterruptible Power Supplies, adding a second console, and implementing a voltage regulator. In the context of stringent medical device standards, this study stands as a trailblazer, aligning meticulously with ISO 14971 and navigating the intricate landscape of European Union Medical Devices Regulation standards. This unwavering commitment not only fortifies the study's credibility but positions it as a vanguard in the realm of medical imaging. In conclusion, this research provides valuable insights into systematically evaluating and mitigating risks, offering practical strategies for improving reliability, patient safety, and adherence to medical device regulations. To the best of our knowledge, this paper is the first of its kind to employ the FMECA method for the analysis and management of failures in CT scanners. [ABSTRACT FROM AUTHOR]