{"title":"[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]。","authors":"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","doi":"10.1016/j.pharma.2024.09.003","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>European regulations have recently moved towards more stringent requirements for demonstrating the safety and performance of medical devices (MDs).</p><p><strong>Objective: </strong>To apply an innovative testing method using medical simulation to the evaluation of three medical devices at different stages of their life cycle.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":null,"pages":null},"PeriodicalIF":1.0000,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Construction of a methodology for clinical evaluation of medical devices using simulation tools and illustration through three studies].\",\"authors\":\"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\",\"doi\":\"10.1016/j.pharma.2024.09.003\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>European regulations have recently moved towards more stringent requirements for demonstrating the safety and performance of medical devices (MDs).</p><p><strong>Objective: </strong>To apply an innovative testing method using medical simulation to the evaluation of three medical devices at different stages of their life cycle.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":8332,\"journal\":{\"name\":\"Annales pharmaceutiques francaises\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.0000,\"publicationDate\":\"2024-09-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annales pharmaceutiques francaises\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1016/j.pharma.2024.09.003\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annales pharmaceutiques francaises","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.pharma.2024.09.003","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
[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.
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.