医疗器械的生命周期评估:支持或危及患者的结果? 对评估模型的比较分析
Kathleen R Harkin1, Jan Sorensen2, Steve Thomas1
1Centre for Health Policy and Management, Trinity College Dublin (TCD), Dublin, Ireland.
International journal of technology assessment in health care
|January 5, 2024
概括
了解医疗器械的"生命周期评估"至关重要. 本研究阐明了其在不同领域的不同含义,以确保患者安全和强有力的证据生成.
科学领域:
- 医疗器械评估 医疗器械评估
- 卫生技术评估 卫生技术评估
- 监管科学是一种监管科学.
背景情况:
- 由于缺乏关于医疗器械安全性和有效性的市场前证据,因此需要使用生命周期方法.
- "生命周期评估"在医疗器械评估中的确切含义和应用仍然不清楚.
- 现有的评估模型在范围,目的和时间方面表现出显著的异质性.
研究的目的:
- 在医疗器械评估框架内探索"生命周期"和"生命周期评估"的隐含含义.
- 综合各种各样的角度对生命周期评估在医疗保健,政策制定,行业和监管.
主要方法:
- 使用诱导方法进行定性证据综合.
- 开发用于识别,评估,分析和合成生命周期评估模型的新方法.
- 从52个已识别的模型中提取和比较分析数据,包括模型目的,受众,输出,时间和类型.
主要成果:
- "生命周期"包括多种概念:单个/多个阶段,创新周期或系统.
- "生命周期评估"是利益相关者目标驱动的,为医疗保健,政策制定,行业和监管中的决策提供了信息.
- 对生命周期方法的监管采用导致推销后证据的推迟.
结论:
- 在偿还决策中,生命周期评估不应影响证据生成或患者安全.
- 对安全性和有效性的不充分证据不能被接受作为补偿决定.
- 需要对生命周期评估有明确,标准化的理解,以确保患者安全和监管监督.
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