血液透析类医疗器械的监管现状及使用中存在的问题与原因分析

Monitoring Status, Existing Problems in Use and Cause Analysis of Hemodialysis Medical Device

伴随临床医疗技术的发展,血液透析类医疗器械在各大医院得到较为广泛的应用,对于很多慢性肾衰竭患者具有重要意义。但临床使用过程中,血液透析设备并非完全安全,存在一定的风险性,有的血液透析设备质量不达标,有的重要技术指标未符合标准等现象出现。在对血液透析类医疗器械进行监管过程中,存在检验标准及技术规范的缺失、血液透析器械检测参数指标标准缺失的情况,通过《医疗机构血液透析室管理规范》的实施,虽然解决了一部分临床应用中的问题,但医疗器械管理的内容并无健全性,需进一步的规范研究。在血液透析器械使用过程中,其安全隐患、器械自身问题均需予以关注,了解血液透析器械故障原因,并建立对应解决策略具有重要意义。针对上述问题,应制定有效的医疗器械使用技术规范,提高监管力度,该文研究了血液透析设备安全性管理系统的开发应用,便于逐步避免恶性医疗事件的发生。

With the development of clinical medical technique, the hemodialysis medical device has been widely applied in each big hospital, which is of major significance to many patients with chronic renal failure. The hemodialysis device is not totally safe in the clinical use with a certain risk, the quality of some hemodialysis devices is nonstandard and some major technical indexes fail to meet the standards. The lack of test standards and technical specification and test parameter index standard of hemodialysis device exists in the course of monitoring the hemodialysis medical device, part of clinical applica-tion problems are solved by the implementation of management specification of medical institution hemodialysis room, but the medical device management content is not perfect, which needs further standard research. The hidden danger and device problems need to be paid attention to in the course of using hemodialysis medical device, knowing hemodialysis medical device disorder causes and building countermeasures are of major significance. We should make an effective medical device use technical specification and improve monitoring force aiming at the above problems. The paper researches the develop-ment and application of hemodialysis device safety management system in order to gradually avoid the occurrence of malig-nant medical accidents.