[利用模拟工具构建医疗器械临床评估方法并通过三项研究加以说明]。

IF 1 Q4 PHARMACOLOGY & PHARMACY
Cordélia Salomez-Ihl, Claire Chapuis, Pierre Albaladejo, Marielle Picard, Aline Baron, Paz Pardo Garcia, Jean-Noël Evain, Joris Giai, Maud Barbado, Alexandre Moreau-Gaudry, Jean-Luc Bosson, Julien Picard, Pierrick Bedouch
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引用次数: 0

摘要

导言:欧洲法规最近对医疗设备(MD)的安全性和性能提出了更严格的要求:目的:采用一种创新的测试方法,利用医学模拟对三种医疗器械在其生命周期的不同阶段进行评估:方法:使用模拟评估 DM 的方法基于七个阶段:定义背景、培训、构建测试 DM 的情景、验证情景、实现情景、参与者评估情景以及验证和利用结果:我们的评估方法使我们能够评估处于不同开发阶段的三种 DM:初始阶段的呼吸保护装置(原型定义)、呼吸保护面罩(原型优化)和瓶子适配器(上市后):结论:模拟是评估 DM 的重要工具。结论:模拟是评估 DM 的重要工具,建议的方法使其能够在不同情况下使用和调整。它符合这类产品临床评估的特殊性,有助于更好地预测某些风险。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Construction of a methodology for clinical evaluation of medical devices using simulation tools and illustration through three studies].

Introduction: European regulations have recently moved towards more stringent requirements for demonstrating the safety and performance of medical devices (MDs).

Objective: To apply an innovative testing method using medical simulation to the evaluation of three medical devices at different stages of their life cycle.

Method: The methodology for evaluating DMs using simulation is based on seven stages: definition of the context, training, construction of a scenario to test the DM, validation of the scenario, realization of the scenario, evaluation of the scenario by the players and validation and exploitation of the results.

Results: Our evaluation methodology enabled us to assess three DMs at different stages of their development: a respiratory protection device at the initial stage (prototype definition), a respiratory protection mask (prototype optimization) and bottle adapters (post-marketing).

Conclusion: Simulation is a valuable tool for evaluating DM. The proposed methodology enables it to be used and adapted to different contexts. It responds to the specificities of clinical evaluation of this class of products, and helps to better anticipate certain risks.

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来源期刊
Annales pharmaceutiques francaises
Annales pharmaceutiques francaises PHARMACOLOGY & PHARMACY-
CiteScore
1.70
自引率
7.70%
发文量
98
期刊介绍: This journal proposes a scientific information validated and indexed to be informed about the last research works in all the domains interesting the pharmacy. The original works, general reviews, the focusing, the brief notes, subjected by the best academics and the professionals, propose a synthetic approach of the last progress accomplished in the concerned sectors. The thematic Sessions and the – life of the Academy – resume the communications which, presented in front of the national Academy of pharmacy, are in the heart of the current events.
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