摘要
目的构建医疗器械标准化技术委员会评估体系,为其考核评估提供科学依据。方法梳理《医疗器械标准化技术委员会考核评估细则》中的各项指标,依据各指标的重要性评分,运用层次分析法确定其权重。结果构建了一个包括年度标准制修订情况,年度标准立项情况,标准体系建设和维护情况,标准宣贯、实施评价及复审情况,日常管理工作情况5个一级指标,制修订项目完成情况、制修订程序合规性等19个二级指标的医疗器械标准化技术委员会考核评估体系,其中一级指标的权重分别为0.4992,0.0624,0.0419,0.1517,0.2447,一级指标权重系数判断的一致性指数(CI)为0.096,一致性比率(CR)为0.090;二级指标权重系数判断的CI为0~0.096,CR为0~0.090。结论构建的评估体系为公正、客观、全面地考核评估医疗器械标准化技术委员会的工作提供了量化工具。
Objective To construct the evaluation system of the medical device standardization technical committee(MDSTC),and to provide a scientific basis for its assessment and evaluation.Methods The various indicators in the Detailed Rules for the Assessment and Evaluation of the Medical Device Standardization Technical Committee were sorted out,and based on the importance of the indicators,their weights were determined by the analytic hierarchy process(AHP)method.Results A evaluation system of the MDSTC including five primary indicators and 19 secondary indicators had been constructed.The five primary indicators included the formulation and revision of annual standards,the project approval of annual standards,the construction and maintenance of standard systems,the publicity,implementation,evaluation,review of standards and the daily management.The 19 secondary indicators included the completion of the formulation and revision of projects,the compliance of the formulation and revision procedures and so on.The weights of primary indicators were 0.4992,0.0624,0.0419,0.1517 and 0.2447 respectively,the consistency index(CI)was 0.096 and the consistent ratio(CR)was 0.090 for the primary indicators,and the CI was in the range of 0-0.096 and CR was in the range of 0-0.090 for the secondary indicators.Conclusion The constructed evaluation system provides a quantitative tool for the fair,objective and comprehensive assessment and evaluation of the MDSTC.
作者
毛歆
韩倩倩
MAO Xin;HAN Qianqian(National Institutes for Food and Drug Control,Beijing,China 102629)
出处
《中国药业》
CAS
2023年第3期12-16,共5页
China Pharmaceuticals
基金
中国药品监管科学行动计划第二批重点项目医疗器械项目[药监械注函〔2021〕123号]。
关键词
医疗器械标准化技术委员会
评估体系
构建
medical device standardization technical committee
evaluation system
construction
