新生儿护理设备的目标产品概况:NEST360和联合国儿童基金会的系统开发和结果
Rebecca P Kirby1, Elizabeth M Molyneux2, Queen Dube3
1Kellogg School of Management, Northwestern University, Illinois, USA. Becca.kirby@kellogg.northwestern.edu.
BMC pediatrics
|November 16, 2023
概括
针对低收入和中等收入国家 (LMIC) 的15种新生儿必需医疗器械,制定了目标产品概况 (TPP). 这些TPP成功指导了设备的选择和调整,改善了LMIC环境中的新生儿护理.
科学领域:
- 全球健康 全球健康
- 生物医学工程 生物医学工程
- 医疗器械开发 医疗器械开发
背景情况:
- 医疗器械对于新生儿护理至关重要,但在低收入和中等收入国家 (LMIC) 往往无法获得或不适合.
- 目标产品配置文件 (TPP) 用于在特定环境中定义医疗器械的以用户为中心的性能特征.
- 此外,TPP还可以评估现有设备是否适合特定环境.
研究的目的:
- 为15个类别的基本新生儿医疗器械开发目标产品配置文件 (TPP),以适应LMIC环境.
- 建立一个选择和调整医疗技术的框架,以便在资源有限的环境中改善新生儿护理.
主要方法:
- 采用了类似Delphi的过程,包括在线调查和面对面的共识会议.
- 180名专家被邀请对拟议的性能特征进行评分,分歧通过投票解决.
- 在15个TPP的绝大多数性能特征上达成共识.
主要成果:
- 在180名受邀专家中,有103人回复了在线调查 (57%的回复率).
- 在协商一致会议后,对97%的绩效特征达成共识.
- 开发的TPP已经在四个非洲国家的65家医院安装了2400多种医疗设备.
结论:
- 15个TPP为开发者和实施者提供了宝贵的资源,以选择和适应LMIC的新生儿护理产品.
- TPP进程成功地促进了适合医疗器械的部署,并影响了技术的适应.
- 在全球卫生倡议中,TPP方法表明了超出新生儿护理范围的更广泛应用的潜力.
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