CAJ | 학술논문

本文介绍了JCI体系下医疗设备风险管理的过程，首先采用特定风险分析工具完成医疗器械的风险等级划分及风险等级分析。然后，根据风险分析结果进行风险管理计划的制定并进行实施。由医疗器械管理部门采集数据、实施监控，必要时实施医疗器械报废甚至召回。以实施的结果和经验来进一步完善该管理计划，促使风险管理计划的持续改进，逐步实现医疗器械“安全、有效”的管理目标。
본문개소료JCI체계하의료설비풍험관리적과정，수선채용특정풍험분석공구완성의료기계적풍험등급화분급풍험등급분석。연후，근거풍험분석결과진행풍험관리계화적제정병진행실시。유의료기계관리부문채집수거、실시감공，필요시실시의료기계보폐심지소회。이실시적결과화경험래진일보완선해관리계화，촉사풍험관리계화적지속개진，축보실현의료기계“안전、유효”적관리목표。
The process of risk management of medical equipment in JCI system is introduced in this paper. Firstly, the risk level of medical equipment was classified and analyzed by risk analysis tool. Secondly, the plan of risk management was formulated and implemented according to the results of risk analysis. Data was collected and monitoring was implemented by medical equipment management department. When necessary, medical equipment could be scrapped or recalled. This management plans should be further improved based on the results and experience of implement, which can promote continuous improvement of risk management plan and realize safe and effective management of medical equipment.