摘要
目的:对医疗设备质量管理技术的研究是当前医院医学工程部门重点发展的技术之一,是医院长期稳定发展的重要保证。方法:从医疗设备管理技术的基本定义、原理、内涵和外延出发,阐述了医院质量控制技术的程序和总体要求,医疗设备质量控制体系建立和实施的方法,医疗器械不良事件报告制度建立的远景和近期目标。结果:指出医疗器械质量管理的法制性、系统性和医学工程行业人员所应扮演的角色及承担的责任。结论:医疗设备质量管理技术规范的制定将有效地提高医院整体质量水平。
Objective To research the quality management technique of medical device that as an important technique of medical engineering department in hospital is a guarantee of the hospital＇s development. Methods The definition, elements, signification and extension of management technique, elaborated the technique process and requirement of the quality control in hospital were introduced. Results Following an analysis of the quality control system and actualizing methods, perspective and current objective of the accident report system, legal and systemic quality management, as well as the role and responsibility of medical engineering practitioner were discussed. Conclusion The quality level of hospital will be fully improved depending on establishment of the quality management technique for medical device.
出处
《医疗卫生装备》
CAS
2009年第4期88-90,共3页
Chinese Medical Equipment Journal
关键词
医疗器械
医疗设备
质量管理技术
质量控制
质量保证
medical apparatus
medical equipment
quality managing technology
quality control
quality assurance
作者简介
汤黎明（1957-），男，江苏南通人．博士，高级工程师，博士生导师．本刊编委．全军生物工程与卫生装备学专业委员会副主任委员，中华医学会医学工程分会委员，中华医学会影像技术学会江苏省分会主任委员，Email：tandm@163．com。
