摘要
目的建立透析器使用全过程质量控制管理体系，并通过金字塔模型对质量问题进行管控分析，以监测不良反应，为透析器质量管理打下坚实的基础。方法使用透析器条码和透析管理软件对每个透析器进行编码。收集上海市2家血液净化中一~2012年6月～2013年2月透析器使用情况数据，建立单次治疗中单个病人透析器使用过程的点对点的关联体系，从而实现透析器的可追溯管理。结果利用金字塔型数据模型，通过多维度分析，对质量问题进行归类。结论透析器质量管理体系的实施，实现了透析器的可追溯管理。
Objective To establish the quality control management system for the whole using process of dialyzer, and analyze quality control issues with pyramid model to monitor adverse actions to lay a solid foundation for quality management of dialyzer. Methods Each dialyzer is encoded with bar code by using dialysis management software. Usage data of dialyzer from June 2012 to February 2013 is collected from two blood purification centers, and the point-to-point connection system during dialyser using process of single patient in single treatment is establised to implement the traceable management of dialyzer. Results Quality control issues are classified with pyramid model by using multi-dimension analysis. Conclusion The traceable management of dialyzer has been implemented with the application of the quality control management system.
出处
《中国医疗设备》
2013年第11期56-58,共3页
China Medical Devices
基金
上海理工大学
上海医疗器械职教集团2012年医学工程学与医学装备管理课题(SZJ12003Y)
关键词
透析器
可追溯性
质量控制
不良反应监测
dialyzer
traceability
quality control
monitoring of adverse actions
