摘要
目的基于真实世界数据建立婴儿培养箱的临床应用评价方案,提高婴儿培养箱的安全性和有效性。方法以某大型三甲儿童医院使用率排名前3位的品牌(A、B、C)婴儿培养箱为例,收集A、B、C品牌婴儿培养箱的真实世界数据,通过统计、分析、评估数据完成对三品牌婴儿培养箱的技术要求对比、质量控制评价、临床使用评价、维修和不良事件评价,再采用调查问卷计算婴儿培养箱的综合评分。结果A、B、C品牌婴儿培养箱的综合评分分别为84.81、88.84、93.31分。结论基于真实世界数据的婴儿培养箱临床应用评价方案可实现科学、多维度地评估设备的安全性、有效性,促进设备功能完善,提高设备采购质量,为其他医疗设备的临床应用评价提供参考。
Objective To establish a clinical application evaluation plan for infant incubators based on real-world data to improve the safety and effectiveness of infant incubators.Methods With the use of the infant incubators from the top 3 brands in terms of usage rate in A large tertiary grade A children's hospital as an example,real world data of baby incubators from brands A,B and C were collected.Through statistics,analysis and evaluation of the data obtained,the comparison of technical requirements,quality control evaluation,clinical use evaluation,maintenance and adverse event evaluation of various brands of infant incubators were completed,and then the Delphi method was used to obtain the comprehensive score of infant incubators.Results The comprehensive scores of A,B,and C brand infant incubators were 84.81,88.84,and 93.31 points,respectively.Conclusion The clinical application evaluation scheme for infant incubators based on real-world data can achieve scientific and multidimensional evaluation of equipment safety and effectiveness,promote equipment functionality improvement,enhance equipment procurement quality,and provide reference for clinical application evaluation of other medical equipment.
作者
陈沉
李鑫
刘玮
Chen Chen;Li Xin;Liu Wei(Children's Hospital of Chongqing Medical University,Chongqing 400014,China;School of Biomedical Engineering,Chongqing Medical University,Chongqing 400016,China)
出处
《医疗装备》
2024年第15期1-5,14,共6页
Medical Equipment
基金
国家市场监督管理总局科技计划项目(2021MK089)。
关键词
婴儿培养箱
真实世界数据
临床评价
医疗设备行业
Infant incubator
Real-world data
Clinical evaluation
Medical device industry
