CAJ | 학술논문

目的：探讨完善医用耗材全程质量控制体系，保障临床安全，降低不良事件发生率的有效措施。方法回顾分析2011-2012年医院53例医用耗材质量不良事件的产品类别、产生原因、危害及潜在风险等级。结果不同类别医用耗材的质量不良事件产生的原因、造成的危害及潜在风险等级均有显著性差异。结论管理部门应强化环节质量管理制度，建立产品规范化使用的长效培训机制，注重质量安全信息反馈机制，保障临床安全。
목적：탐토완선의용모재전정질량공제체계，보장림상안전，강저불량사건발생솔적유효조시。방법회고분석2011-2012년의원53례의용모재질량불량사건적산품유별、산생원인、위해급잠재풍험등급。결과불동유별의용모재적질량불량사건산생적원인、조성적위해급잠재풍험등급균유현저성차이。결론관리부문응강화배절질량관리제도，건립산품규범화사용적장효배훈궤제，주중질량안전신식반궤궤제，보장림상안전。
Objective To find effective measures to perfect quality control system of medical consumables , ensure the clinical safety , and reduce the rate of adverse events of consumables .Methods 53 cases of medical consumable quality adverse events in the hospital were analyzed retrospectively from 2011 to 2012 , in accordance with the product categories , causes of adverse event , the damage and potential risk grade .Results Cause of ad-verse event , the damage and potential risk grade were significant difference among different categories of medical consumables .Conclusion We should strengthen the link of the quality management system , establish the long-term training mechanism of the use of product specification , pay attention to the quality and safety information feed-back mechanism to ensure clinical safety .