某区医疗器械生产企业现状分析  

Evaluation of Current Medical Device Manufacturers in Xuhui District,Shanghai

作　　者：吴洪[1] 章宝根 朱珍妮[3] 曹广文[1] 

机构地区：[1]第二军医大学卫勤系流行病学教研室,上海200433 [2]上海市食品药品监督管理局徐汇分局,上海200031 [3]复旦大学公共卫生学院流行病学教研室,上海200032

出　　处：《解放军医院管理杂志》2007年第4期302-304,共3页Hospital Administration Journal of Chinese People's Liberation Army

基　　金：国家自然科学基金(70340015)

摘　　要：目的:分析上海市徐汇区医疗器械生产企业的现况及存在的问题,为完善监督体系提供依据。方法:采用横断面调查的方法,对徐汇区医疗器械生产企业的整体情况、人员专业能力、硬件设施及管理制度进行调查,并根据评价指标进行系统评分。结果:企业管理人员具有较好的专业学历背景,以本科学历及工程师职称为主;专业人员能力评分较高;被调查企业的总评分得分率均数在90%以上,达到优良等级。但在管理制度方面的评分较低,且Ⅱ类与Ⅲ类医疗器械生产企业的总评分存在差异。结论:徐汇区医疗器械生产企业具有较好的技术力量,但需进一步严格执行和完善现有的管理规章制度。Ⅱ类医疗器械生产企业需提高自身的要求;相关监督部门应加强监督力度。Objective ： To er existing problems, and grasp the status of the medical device manufacturers in Xuhui District, Shanghai, discovprovide evidences to perfect supervision system. Methods： Cross- sectional study was employed to investigate the general situation of the medical device manufacturers, professional capacities, hardware facilities and administrative mechanism. Indexes concerning those manufacturers were evaluated by systemic scoring. Results： Educational background of the personnel at administrative levels were qualified. Majority of them held Bachelor degree and were appointed as engineers. Professionals got high score. Average comprehensive score of those manufacturers investigated was above 90%, reaching the level of ＂fine＂. But relatively low score was obtained in the administrative mechanism. Significant difference in the comprehensive scores was also determined between manufacturers for class Ⅱ medical device and class Ⅲ medical device. Conclusion： The medical device manufacturers in Xuhui District have good technical potency, but current administrative regulations need to be strictly followed and improved. The manufacturers for class Ⅱ medical devices need to improve own requirement. Strict supervision should be enforced.

关 键 词：医疗器械生产企业 横断面调查 人员 硬件 管理制度 

分 类 号：R197.32[医药卫生—卫生事业管理]