在用血液透析类医疗器械存在的问题及原因分析

摘要

Objective To study the problems and causes of hemodialysis medical devices in the course of use. Methods Statistical analysis based on the National Quality sampling data from CFDA, and to conduct research in the medical insti-tutions. Results The results indicated a mixed quality in the use of hemodialysis devices. Some of the major technical indi-cators failed to meet the standards. Conclusion In the development of technical specifications for medical devices, strength-en the communications between the health sector and medical devices quality management to effectively solve the problems.%目的 探讨血液透析类医疗器械在使用过程中存在的问题及原因分析. 方法 对国家质量监督抽验数据进行统计分析,对医疗机构进行走访调研. 结果 在用血液透析器械质量良莠不齐,某些重要技术指标不合格. 结论 对在用医疗器械制定技术规范,加强卫生部门与医疗器械质量管理部门交流沟通才能有效解决问题.