超高场7.0 T磁共振成像系统双模态应用安全管理体系的构建  

Construction of the Application and Security Management System in Ultra-High Field 7.0 T Magnetic Resonance Imaging Double-Modality

作　　者：程伊莲 谌磊 王健 陈伟 刘晨 陈辉 程琳 CHENG Yilian;CHEN Lei;WANG Jian;CHEN Wei;LIU Chen;CHEN Hui;CHENG Lin(Department of Radiology,The First Affiliated Hospital of Army Military Medical University,Chongqing 400038,China)

机构地区：[1]陆军军医大学第一附属医院放射科,重庆400038

出　　处：《中国医疗设备》2022年第9期112-117,133,共7页China Medical Devices

基　　金：国家重点研发计划(2016YFC0107101);重庆市临床重点专科(精品项目)(CQZDZK007);重庆市技术创新与应用发展专项(cstc2019jscx-msxmX0200)。

摘　　要：目的针对7.0 T磁共振成像(Magnetic Resonance Imaging,MRI)系统在科研临床双模态运行下安全管理的实际需求,构建保障其应用过程中设备、人员、信息等安全的管理体系。方法以西门子7.0 T MRI系统和机房建设为基础,分析整理7.0 T MRI系统双模态应用中存在的安全影响因素,采用失效模式与效应分析法和故障树分析法对以上风险进行评估和分级,组建安全管理团队,建立针对超高强度磁场的安全管理方案,并以此为基准设计7.0 T MRI双模态应用安全管理流程。结果安全管理培训后,工作人员对7.0 T MRI的理论和操作技能显著提高(P<0.001);实施安全管理方案及流程后,7.0 T MRI系统已顺利完成182例检查,多步骤安全筛查流程排除不适合7.0 T MRI检查38人次,发现并去除金属异物26例,保障磁场安全的同时满意率达到98.9%。结论7.0 T MRI系统从纯科研走向临床的转变,为未来无创精准医学奠定了基础,也带来了新的风险和挑战。本研究构建了国内第一个7.0 T MRI双模态应用安全管理体系并实施全面规范的安全管理,期望能为未来7.0 T MRI在国内的进一步推广应用提供安全管理的依据。Objective To construct a management system for equipment,staff and information,according to the actual requirements of safety management in 7.0 T magnetic resonance imaging(MRI)containing double-modality in research and clinic.Methods Based on Siemens 7.0 T MRI system and computer room construction,this research analyzed and sorted out the safety influencing factors in the double-modality application of 7.0 T MRI system,exploited failure mode and effects analysis and fault tree analysis methods to rate and classify the risky and probability of risks,established a safety management team,and established a safety management scheme for ultra-high magnetic field.Based on this,the safety management flow of 7.0 T MRI double-modality application was designed.Results After safety management training,the theoretical and operational skills of staff on 7.0 T MRI were significantly improved(P<0.001).After the implementation of the safety management scheme and process,the 7.0 T MRI system had successfully completed 182 cases of examination.The multi-step safety screening process excluded 38 cases of people who were not suitable for 7.0 T MRI examination,and found and removed 26 cases of metal foreign bodies,ensuring the safety of magnetic field and achieving a satisfaction rate of 98.9%.Conclusion The transformation of 7.0 T MRI system from pure scientific research to clinical practice has laid a foundation for the future of non-invasive precision medicine,but also brought new risks and challenges.This study constructed the first 7.0 T MRI double-modality application safety management system in China and implemented comprehensive and standardized safety management,which is expected to provide a basis for safety management for further promotion and application of 7.0 T MRI in China in the future.

关 键 词：超高场强 7.0 T 磁共振成像系统 双模态 安全管理体系 

分 类 号：R197.32[医药卫生—卫生事业管理]