等离子手术刀头临床使用风险分析及控制  

Risk analysis and control of plasma scalpel head in clinical use

作　　者：石辉 党琳琳 鲁曼君 刘伟军[4] 罗竫娜[5] 张恩科[5] 李宁[6] 王雅军 张智 李童 SHI Hui;DANG Lin-lin;LU Man-jun;LIU Wei-jun;LUO Jing-na;ZHANG En-ke;LI Ning;WANG Ya-jun;ZHANG Zhi;LI Tong(Shaanxi ADR Monitoring Center,Xi′an 710065,China;Shaanxi Provincial Drug and Vaccine Inspection Center,Xi′an 710065,China;Medical Equipment Measurement Center,Shaanxi Institute of Metrology Science,Xi′an 710065,China;Department of Consumables and Reagents,Shaanxi Provincial People's Hospital,Xi′an 710068,China;Department of Medical Equipment Management,Shaanxi Provincial People's Hospital,Xi′an 710068,China;Office of Bidding,Procurement and Supply,the First Affiliated Hospital of Xi′an Jiaotong University,Xi′an 710061,China;Shaanxi Provincial Tumor Hospital,Xi'an 712000,China)

机构地区：[1]陕西省药品不良反应监测中心,西安710065 [2]陕西省药品和疫苗检查中心,西安710065 [3]陕西省计量科学研究院医疗设备计量中心,西安710065 [4]陕西省人民医院耗材试剂部,西安710068 [5]陕西省人民医院医学装备部,西安710068 [6]西安交通大学第一附属医院招标采供办公室,西安710061 [7]陕西省肿瘤医院,西安712000

出　　处：《医疗卫生装备》2023年第6期80-83,共4页Chinese Medical Equipment Journal

基　　金：陕西省创新能力支撑计划项目——重点科技创新团队计划项目(2017KCT-36);陕西省创新能力支撑计划项目——软科学一般项目(2020KRM194)。

摘　　要：简要介绍了等离子手术刀头的使用方法,阐述了等离子手术刀头临床使用风险的主要表现和特点,分析了导致或可能导致等离子手术刀头使用风险的原因,提出了应从医疗器械注册人(生产厂家)、使用单位(医疗机构)、政府及社会3个层面对等离子手术刀头使用风险进行控制。The use of the plasma scalpel head was introduced briefly.The main manifestations and characteristics of the risks of the plasma surgical head in clinical use were described,and the causes that lead to or might lead to the risks were analyzed.It's pointed out the use risk of the plasma scalpel head should be controlled from three levels of the registrant of the medical device(manufacturer),the user(medical institutions)and the government and the society.

关 键 词：等离子手术刀头 临床使用风险 风险分析 风险控制 医疗器械不良事件 

分 类 号：R318[医药卫生—生物医学工程] R197.39[医药卫生—基础医学]