CAJ | 학술논문

目的以某三甲医院为例，分析可疑医疗器械不良事件上报工作的情况及影响因素。方法研究采用横断面现况调查设计。采取分阶段按比例抽样方法抽取各科室的医生、护士、技师共75人参与问卷调查，调查内容包括知识、行为等。结果调查对可疑医疗器械不良事件的知识知晓程度和态度，对本院不良事件管理和执行的知晓程度均处于较低水平，主动上报很少。结论医院应采取加强组织管理体系和扩大对医务人员宣传教育等措施，提升可疑医疗器械不良事件上报工作的完成情况。
목적이모삼갑의원위례，분석가의의료기계불량사건상보공작적정황급영향인소。방법연구채용횡단면현황조사설계。채취분계단안비례추양방법추취각과실적의생、호사、기사공75인삼여문권조사，조사내용포괄지식、행위등。결과조사대가의의료기계불량사건적지식지효정도화태도，대본원불량사건관리화집행적지효정도균처우교저수평，주동상보흔소。결론의원응채취가강조직관리체계화확대대의무인원선전교육등조시，제승가의의료기계불량사건상보공작적완성정황。
Objectives To analyze Adverse Medical Device Events (AMDE) reporting in a tertiary hospital and its determinants. Methods A cross-sectional study was designed and multi-stage proportional sampling was used to conduct the survey. In total, 75 doctors, nurses and technicians participated in the survey. The survey content included knowledge and behaviors related with AMDE. Results Knowledge of AMDE and attitude towards AMDE reporting were not good enough. So did the knowledge about administration system and regulations. Besides, AMDE was seldom initiatively reported. Conclusion Hospitals should encourage initiative cases reporting by improving administration system and enhance the publicity and education among medical personnel on AMDE.