Medical devices are introduced in the market with an ever-increasing rate, with important benefits for the whole society's health. In the greatest majority of cases, although representing the entry point for devices, healthcare local institutions/hospitals do not receive any macro-level guidance from (inter)national authorities for their assessment. Hence, in the absence of a methodological support, local institutions/hospitals started to assess devices autonomously, building on Health Technology Assessment (HTA) tools based on Multi-Criteria Decision Analysis (MCDA), in order to take into-account the multifaceted aspects connected with devices. However, the strategies described so far in the scientific literature for implementing MCDA in local-based HTA of medical devices suffer from a harsh methodological weaknesses – that is, the use of bespoke criteria for the specific device to be assessed - that severely affect the evaluation of medical devices. Within this scenario, this work proposes a new tool based on peer-to-peer IF-TOPSIS, intended for micro-level assessment of medical devices with the main objective of overcoming the above-mentioned critical issues and provide local institutions/hospitals with a general tool. An example of application of this tool in the choice between three neurological devices is shown. Contributions are both theoretical and practical. Theoretically, while proposing a general MCDA tool for micro-level HTA, we answer the call for the identification of key methodological principles for the local assessment of medical devices. At the practical level, this tool is readily implementable and can be adapted to consider the local idiosyncratic characteristics of the context where decisions have to be made.

中文翻译：

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医疗器械的卫生技术评估。克服当前评估的关键问题

医疗器械进入市场的速度越来越快，对全社会的健康有着重要的好处。在大多数情况下，虽然代表了设备的切入点，但当地医疗机构/医院并未收到来自（国际）国家当局的任何宏观层面的评估指导。因此，在缺乏方法支持的情况下，当地机构/医院开始自主评估设备，以基于多标准决策分析 (MCDA) 的卫生技术评估 (HTA) 工具为基础，以考虑多方面的因素与设备连接。然而，迄今为止在科学文献中描述的在基于本地的医疗器械 HTA 中实施 MCDA 的策略存在严重的方法缺陷——即，对要评估的特定设备使用定制标准——这会严重影响医疗设备的评估。在这种情况下，这项工作提出了一种基于点对点 IF-TOPSIS 的新工具，旨在对医疗器械进行微观层面的评估，其主要目标是克服上述关键问题，并为当地机构/医院提供通用工具。显示了该工具在三种神经设备之间的选择中的应用示例。贡献既有理论性的，也有实践性的。从理论上讲，在为微观 HTA 提出通用 MCDA 工具的同时，我们回应了为医疗器械本地评估确定关键方法原则的呼吁。在实践层面，