血液透析设备急需加强安全性评估与管理

Emphasizing safety assessment and management of hemodialysis equipment

随着人民生活水平的提高和医疗技术的快速发展,血液透析设备已在各大医院广泛使用,延续了许多慢性肾衰竭患者的生命。但在实际应用中,血液透析设备不是绝对安全或者零风险的,在我国,血液透析设备属于政府重点监管目录中的第三类高风险设备。这几年,因血液透析设备失效或故障造成的不良事件频频发生,给患者带来许多痛苦。因此,血液透析设备在使用中的安全性评估及管理是一个十分值得研究的课题。如果能够科学地分析血液透析设备在使用中潜在失效模式和已发生的故障,找出影响使用中安全的主要问题和隐患,并提出相应的控制措施,就能很好的预防或降低使用中的风险,提高血液透析设备使用中的安全性。

With the improvement of living conditions of people and thedevelopment of medical technology, hemodialysis devices have been used considerably in hospitals to help patients survive chronic renal failure. Since the risk exists in operation of hemodialysis devices, the hemodialysis devices belongs to class, high-risk equipment in our country. Some undesirable incidents have been arisen frequently in these years due to the invalidation or failure of hemodialysis devices. Accordingly, the evaluation and administration for security in the hemodialysis device usage is an absolute significant subject. If the potential invalid pattern and emergent failure in the hemodialysis device usage could be analyzed scientifically, the main problems and potential risks which affect security could be found and the relevant control measure could be advanced. In this way, the risk would be prevented or reduced effectively to enhance the usage of safety.