医疗器械不良事件统计分析系统开发的探讨

摘要

Objective： To develop a system for statistical analysis of medical device adverse events （MD AEs） so as to monitor the MD AEs effectively and improve quality management of medical device. Methods： Powerbuilder software and Access database were used to design the software of the whole system. Results： The data of twenty-one MD AEs cases were tested by using the system, accurately accomplishing the statistical analysis. Conclusion： The system for statistical analysis of MD AEs can bring great convenience for monitoring MD AEs and has good prospects for application.%目的：医疗器械不良事件监测是医院在医疗器械质控管理中的重要环节。因此,需要设计出针对医院不良事件进行统计分析的系统,用来更好的对医疗器械不良事件进行监管,提高医疗器械质控管理水平。方法：通过Powerbuilder软件和Access数据库进行软件设计,完成整个系统的搭建工作。结果：使用医疗器械不良事件统计分析系统对医院21例医疗器械不良事件数据进行测试,能够准确的完成相应的统计分析工作。结论：医疗器械不良事件统计分析系统为医院的医疗器械不良事件监测工作带来了不少便利,有较好的应用前景。