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目的研究近七年北京市医疗器械抽检不合格产品的问题原因及其与医疗器械生产环节管理的关系。方法通过对近七年北京市医疗器械抽验不合格产品品种特点、类型特点的梳理汇总,利用统计学手段,找出规律性特点和不合格的潜在原因。结果与结论 2005年1月至2011年12月,抽验产品类型涉及有源医疗器械、卫生材料和无菌医疗器械、避孕套、齿科材料4类,产品不合格项目共290项,与生产环节管理直接相关。
Objective To study the causes of unqualified medical products sampling in Beijing in the recent seven years and its relationship with the management of medical device production processes. Methods By reviewing the characteristics and types of substandard products of medical devices in Beijing in the recent seven years, the statistical methods were used to find out the regular characteristics and the potential causes of unqualified products. RESULTS AND CONCLUSIONS From January 2005 to December 2011, the types of products tested included 4 types of active medical devices, sanitary materials and sterile medical devices, condoms and dental materials, 290 items of unqualified products, Management is directly related.