| Abstrakt: |
This comprehensive article explores strategic risk management in the realm of medical imaging devices, focusing on diagnostic X-ray equipment. While the field is crucial for diagnosing multiple diseases, complete guidelines for risk management and failure analysis covering radiological equipment have been inhibited by rare findings and methodological flaws. This narrative review carefully looks through indexed, peer-reviewed research on failure analysis, risk management and prevention for diagnostic X-ray equipment. Forty-seven studies were found that met the inclusion criteria, which directed the search across databases such as PubMed, Scopus, and Web of Science. To extract significant findings, quality evaluations and qualitative data analysis were used. The review dives into the strategic approaches outlined in the international standard ISO/TR 24971:2020. The Failure Mode, Effects, and Criticality Analysis (FMECA) is applied in the risk management area, with a focus on adhering to pertinent requirements like European Union Medical Devices Regulation (EU MDR). The document outlines the steps involved in risk management, particularly the use of the Failure Modes and Effects Analysis (FMEA)/FMECA, and provides standards for identifying important variables. Failure analysis is presented to rank issues linked to system elements using the Pareto tool. It is then combined with FMECA to establish the risk acceptability threshold. The article concludes with novel recommendations for preventive, corrective, and improvement actions, encompassing routine maintenance protocols, comprehensive component assessments, database and software management, risk reduction strategies, and investments in backup systems. The provided guidelines offer a framework for a preventive approach to maintenance and safety in radiological imaging devices, suitable for various imaging modalities. This review serves as a comprehensive guide to reduce critical hazards in CT systems, which can result in issues like excessive radiation exposure, equipment damage due to mechanical failures, and heightened radiation doses from malfunctioning components. [ABSTRACT FROM AUTHOR] |
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