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摘要: 随着信息技术在医疗领域的深入应用, 信息技术相关的医疗不良事件也不断增加。本文对国内外信息技术相关医疗不良事件的术语、概念和研究现状进行梳理, 从事件表现形式、系统组成要素、事件根本原因3方面进行分类, 并给出相应界定和案例说明; 同时结合国内外相关研究, 进一步探讨信息技术相关医疗不良事件的应对策略, 提出提高重视程度、鼓励上报以及建立规范化防范体系等解决方案, 以期提高医疗行业对此类不良事件的认识和关注。Abstract: With the deep application of information technology in the medical field, the number of information technology-related medical adverse events has been increasing. In this paper, the terms, concepts, and research status of medical adverse events related to information technology were reviewed and classified from three aspects:manifestation, system composition, and error causes. And the corresponding definitions and case descriptions were discussed. Based on relevant research in China and abroad, this paper further explored the counter measures for information technology-related medical adverse events, and proposes solutions to enhance attention, encourage reporting, and establish a standardized prevention system. Hopefully, this review will get more attention of medical industry to information technology-related medical adverse events and provide knowledge and reference for relevant research.利益冲突 无
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表 1 2014至2019年美国ECRI“十大医疗技术危害”中与信息技术相关的危害[19]
时间(年) HIT相关危害 2014 电子病历和其他医疗信息系统数据不完整或不可靠；忽视联网设备与系统的变更管理 2015 电子病历和其他医疗信息系统数据不正确或不完整；联网医疗设备和系统保护不规范 2016 HIT的配置和工作流程不匹配 2017 医疗设备软件管理设置缺陷影响患者数据安全 2018 医疗服务中的勒索软件和其他信息安全威胁可能会危及患者安全；未严格使用条码扫描给药系统而使其安全优势难以发挥 2019 黑客可利用远程访问医院信息系统，破坏医疗保健服务 
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表 2 美国MAUDE数据库近10年HIT相关患者死亡事件
时间(年/月/日) 事件描述 发生原因 2008/12/18 患者主动脉内球囊导管破裂，血液在气动驱动线以上，但系统无报警 系统报警消息故障 2009/8/11 患者进行X线检查期间，系统磁盘空间不足，无法运行Windows系统，系统多次重启期间，患者心肌梗死死亡 电脑故障 2009/12/5 软件程序错误设置为以1 ml/h的速率输入1 mg/ml吗啡，导致患者超剂量接受药物，大约1 h后，设备发出警报, 此时患者已死亡 软件编程错误 2010/1/24 患者进行心脏监测和血氧饱和度监测，其床边监测器的危险警报音量被关闭，医护人员未及时发现患者心脏病发作，最终患者死亡 软件故障 2014/12/6 在手术过程中，患者的血流动力学信息显示失真，最终患者死于手术台上 应用程序异常退出 2015/3/23 患者室颤，监护仪报警，护士未发现，调查发现监护仪上的音调设置了5 s延迟(默认值为0 s) 软件控制设置错误 2015/7/1 1例急诊病例因心肌梗死送达医院，在检查室准备进行干预时系统自行关闭，重启系统两次但未成功，患者在转移至其他医院期间死亡 操作系统问题 HIT：同表 1
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表 3 信息技术相关医疗不良事件按表现形式分类
类型 描述 举例 选择错误 从下拉菜单中错误选择了药物/配方/途径/频率等 错误选择了硬膜外注射0.9%氯化钠，而非静脉注射 使用错误 错误使用了药物/配方/给药途径/频率等；处方和药品说明相互矛盾 将硝酸甘油处方开为10 mg/24 h，1贴片，但药品说明是50 mg / 24 h 书写错误 内容出现书写错误 将150 μg斯达力沃的日剂量写成了37.5片 系统错误 系统发生提示错误、默认时间/日期错误、与辅助信息相关的错误等 患者入院后医生开具急查血化验，当天已经打印急查血条码并抽血化验，但系统中急查血化验默认时间为次日凌晨，次日护士重新打印条码并重复抽血
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表 4 信息技术相关医疗不良事件按系统组成要素分类
类型 描述 举例 信息输入 系统：数据采集故障用户：数据录入或记录问题 窗口人员在患者建档时，将姓名字段录入错误，影响医保报销 信息传递 系统：网络瘫痪或延迟、软件接口问题 医嘱系统中患者的口服药医嘱未及时传入包药机系统，导致药品漏发 信息输出 系统：输入设备关闭、记录不可用、输出/显示误差用户：数据查询、记录错误 患者到放射科取头部MRI报告单时，自助机错误印制了其他患者的CT报告单 通用技术 计算机系统故障、访问问题、软件问题、数据缺失等 计算机故障，导致检验结果的危急值接收失败 用户影响 人员培训、认知负荷、不履行职责、职业倦怠 用户对系统的功能和操作不熟悉，导致使用问题
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表 5 信息技术相关医疗不良事件按事件根本原因分类
类型 描述 举例 计算机问题 硬件、操作系统、软件、系统安全问题 系统受到恶意入侵和攻击，导致药品和耗材的供应链破坏 数据问题 数据备份问题、数据完整性问题 纸质和电子形式的数据共用，导致患者部分数据缺失 报警问题 报警系统故障、错误或警告消息无法生成 系统未设置每天药物最大剂量警示，导致患者超量用药 通讯问题 无线通讯问题、网络问题 网络故障造成远程操作失效、数据丢失 应用系统问题 程序异常退出、计算错误、参数设置错误、功率计算错误、版本或升级问题、软件安装问题等 门诊高值系统和住院病房高值耗材系统未关联，部分耗材未记账 人机交互问题 人为因素、人机界面问题、使用问题等 用户同时打开多个医院信息系统界面，无意中在错误的界面进行了操作 HIT：同表 1
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