摘要
以不同品牌的多参数监护仪为例,依据医疗器械的生命周期,拟定医疗器械应用评价的多维度因素(技术要求、质量控制、临床使用、维修和不良事件)。通过德尔菲法评估每种因素的重要性,设计了医疗器械临床应用评价方案,对多参数监护仪进行综合评价,旨在评估医疗器械的安全性、有效性,促进医疗器械功能完善,提高医疗器械的采购质量。
Taking different brands of multi-parameter monitors as an example,according to the life cycle of medical equipment,multi-dimensional factors(technical requirements,quality control,clinical use,maintenance and adverse events)of medical equipment application evaluation are formulated.The importance of each factor is evaluated by Delphi method.The clinical application evaluation scheme of medical equipment is designed.The multi-parameter monitor is comprehensively evaluated,aiming to evaluate the safety and effectiveness of medical equipment,promote the improvement of medical equipment functions,and improve the procurement quality of medical equipment.
作者
杨利
黄靖
张本兴
魏安海
张和华
YANG Li;HUANG Jing;ZHANG Benxing;WEI Anhai;ZHANG Hehua
出处
《中国医院建筑与装备》
2022年第12期15-18,共4页
Chinese Hospital Architecture & Equipment
基金
重庆市社会事业与民生保障科技创新专项(cstc2017shmsA130074)
陆军军医大学临床医学科研人才资助项目(2019XLC3055)。
关键词
医疗器械评价
多参数监护仪
质量控制
德尔菲法
Evaluation of medical equipment
Multi-parameter monitors
Quality control
The Delphi method
