Department of Radiology, Faculty of Medicine, University of Miyazaki.
Department of Radiology, Graduate School of Medicine, Juntendo University.
Magn Reson Med Sci. 2021 Dec 1;20(4):347-358. doi: 10.2463/mrms.mp.2020-0084. Epub 2020 Nov 26.
To investigate safety management at Japanese facilities performing human MRI studies.
All Japanese facilities performing human MRI studies were invited to participate in a comprehensive survey that evaluated their MRI safety management. The survey used a questionnaire prepared with the cooperation of the Safety Committee of the Japanese Society for Magnetic Resonance in Medicine. The survey addressed items pertaining to the overall MRI safety management, questions on the occurrence of incidents, and questions specific to facility and MRI scanner or examination. The survey covered the period from October 2017 to September 2018. Automated machine learning was used to identify factors associated with major incidents.
Of 5914 facilities, 2015 (34%) responded to the questionnaire. There was a wide variation in the rate of compliance with MRI safety management items among the participating facilities. Among the facilities responding to this questionnaire, 5% reported major incidents and 27% reported minor incidents related to MRI studies. Most major incidents involved the administration of contrast agents. The most influential factor in major incidents was the total number of MRI studies performed at the facility; this number was significantly correlated with the risk of major incidents (P < 0.0001).
There were large variations in the safety standards applied at Japanese facilities performing clinical MRI studies. The total number of MRI studies performed at a facility affected the number of major incidents.
调查日本进行人体 MRI 研究的机构的安全管理情况。
邀请所有进行人体 MRI 研究的日本机构参与一项综合调查,评估其 MRI 安全管理情况。该调查使用了一份由日本磁共振医学学会安全委员会合作编写的问卷。调查涉及整体 MRI 安全管理、事件发生情况的问题,以及与设施和 MRI 扫描仪或检查相关的具体问题。调查涵盖了 2017 年 10 月至 2018 年 9 月期间。采用自动化机器学习来识别与重大事件相关的因素。
在 5914 家机构中,有 2015 家(34%)对问卷做出了回应。参与调查的机构在 MRI 安全管理项目的合规率方面存在很大差异。在对这份问卷做出回应的机构中,有 5%报告了与 MRI 研究相关的重大事件,27%报告了轻微事件。大多数重大事件涉及造影剂的给药。重大事件的最主要影响因素是该机构进行的 MRI 研究总数;该数量与重大事件的风险显著相关(P<0.0001)。
日本进行临床 MRI 研究的机构的安全标准存在很大差异。机构进行的 MRI 研究总数影响重大事件的数量。