【摘要】 目的通过质量管理体系在医疗设备质量管理中的应用,探讨其在医疗领域应用的价值。方法将本院重症医学科和神外重症监护室在2012年1~12月的数据作为质量管理体系实施前组(对照组),2013年1~12月的数据作为质量管理体系实施后组(观察组),将两组数据进行统计分析。结果质量管理体系实施后强检器具、非强检器具等漏检率,以及植入性材料质量问题出现率低于及植入性材料质量管理体系实施前,且比较差异均有统计学意义(P<0.05);质量管理体系实施后各项目执行率高于质量管理体系实施前,且比较差异均有统计学意义(P<0.05)。结论质量管理体系是一项重要的质量管理工具,可有效提高医疗设备质量控制的执行率。更多还原

【Abstract】 Objective Through the application of quality management system in the medical device quality management,to explore the value of their applications in the medical field. Methods The hospital critical care medicine and respiratory ICU section from January to February 2012 data as a group before the implementation of the quality management system(control group),from January to December 2013 data as a group after the implementation of the quality management system(observation group),the two sets of data for statistical analysis. Results After the implementation of the quality management system strong inspection equipment,inspection equipment and other non-mandatory undetected rate,and implanted material quality problems were significantly lower than the implanted material and implementation of quality management system before,and the differences were statistically significance(P < 0.05),after the implementation of the quality management system implementation of the projects was significantly higher than before the implementation of the quality management system,and the differences were statistically significant(P < 0.05). Conclusion The quality management system is an important quality management tools,can effectively improve the rate of implementation of quality control of medical equipment.更多还原