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。
Abstract：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.
程伊莲，谌磊，王健，陈伟，刘晨，陈辉，程琳. 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[J]. 中国医疗设备, 2022, 37(9): 112-117.
CHENG Yilian, CHEN Lei, WANG Jian, CHEN Wei, LIU Chen, CHEN Hui, CHENG Lin. Construction of the Application and Security Management System in
Ultra-High Field 7.0 T Magnetic Resonance Imaging Double-Modality. China Medical Devices, 2022, 37(9): 112-117.
