PDCA在我院医疗器械安全(不良)事件管理中的应用

Application of PDCA in the Management of Safety(Adverse) Events of Medical Devices in Hospital

医疗器械安全(不良)事件管理是医疗器械临床使用安全管理的重要组成部分,其中不良事件报告是发现医疗器械安全性隐患和采取风险管理措施的前提。本文针对我院医疗器械安全(不良)事件的管理现状,借助PDCA质量管理工具,通过查找管理漏洞产生原因、制定整改措施、建立与执行监测管理制度对我院的医疗器械安全(不良)事件管理工作进行规范和有效管理。经过3年的执行与追踪,我院在不良事件管理工作中取得了明显的管理成效,不良事件的上报例数和上报质量均有大幅度的提升,不良事件造成后果和带来伤害的机率得到降低,不仅促进和完善了医疗器械临床使用安全管理体系,进一步增强了我院医疗器械风险管理能力。

Medical device safety （adverse） event management plays an important role in security management of clinical use of medical devices, and medical device adverse event report is the precondition of fnding latent danger and making risk management practices. For a preferable and effective management of medical device adverse event, we searched for the root of management default, established countermeasures, and made monitoring management system via PDCA tool aiming at current situations. In three consecutive years’ execution and tracking, the reports increased greatly in quantity and quality, meanwhile the probability of adverse consequences and harm decreased a lot, and therefore the management of medical device adverse event was obvious to all, which contributed to security management system of clinical use of medical devices promotion and perfection and enhanced our risk management ability.