Development and implementation of a system for medical devices monitoring in Morocco

Given the importance of medical devices in improving health, a system of monitoring their use is necessary to ensure an acceptable benefit/risk ratio. The present study focuses on the post-marketing monitoring system, of which the aimis to develop, a national strategy for the establishment of a mult...

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Autores principales:	Qouhafa Meryem, Benaji Brahim, Lebbar Souad, Soulaymani Abdelmajid, Moukhtari Abdelrhani
Formato:	article
Lenguaje:	EN FR
Publicado:	EDP Sciences 2021
Materias:	materiovigilance medical devices post-market surveillance udi regulation Environmental sciences GE1-350
Acceso en línea:	https://doaj.org/article/69ad09e1f79f46158c4c398d842c96d8
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spelling	oai:doaj.org-article:69ad09e1f79f46158c4c398d842c96d82021-11-12T11:44:08ZDevelopment and implementation of a system for medical devices monitoring in Morocco2267-124210.1051/e3sconf/202131901086https://doaj.org/article/69ad09e1f79f46158c4c398d842c96d82021-01-01T00:00:00Zhttps://www.e3s-conferences.org/articles/e3sconf/pdf/2021/95/e3sconf_vigisan_01086.pdfhttps://doaj.org/toc/2267-1242Given the importance of medical devices in improving health, a system of monitoring their use is necessary to ensure an acceptable benefit/risk ratio. The present study focuses on the post-marketing monitoring system, of which the aimis to develop, a national strategy for the establishment of a multidimensional vigilance system to monitor medical devices in Morocco. Methods : The study is based on a systemic review selected by the PRISMA method for the period between [2011-2021] and on the Scopus, Pubmed, Science direct and Web of science databases. Results: A preliminary analysis of the data identified some challenges such as under-reporting and lack of standardization of adverse reaction coding, standard nomenclature problem for international trade, lack of clarity of requirements for manufacturers, and insufficient regulation and significant incentives for the use of unique device identifiers. Recommendations for a more effective national system are put for ward which address the regulation and computerization of the system for the development of medical devices monitoring mechanisms.Qouhafa MeryemBenaji BrahimLebbar SouadSoulaymani AbdelmajidMoukhtari AbdelrhaniEDP Sciencesarticlemateriovigilancemedical devicespost-market surveillanceudiregulationEnvironmental sciencesGE1-350ENFRE3S Web of Conferences, Vol 319, p 01086 (2021)
institution	DOAJ
collection	DOAJ
language	EN FR
topic	materiovigilance medical devices post-market surveillance udi regulation Environmental sciences GE1-350
spellingShingle	materiovigilance medical devices post-market surveillance udi regulation Environmental sciences GE1-350 Qouhafa Meryem Benaji Brahim Lebbar Souad Soulaymani Abdelmajid Moukhtari Abdelrhani Development and implementation of a system for medical devices monitoring in Morocco
description	Given the importance of medical devices in improving health, a system of monitoring their use is necessary to ensure an acceptable benefit/risk ratio. The present study focuses on the post-marketing monitoring system, of which the aimis to develop, a national strategy for the establishment of a multidimensional vigilance system to monitor medical devices in Morocco. Methods : The study is based on a systemic review selected by the PRISMA method for the period between [2011-2021] and on the Scopus, Pubmed, Science direct and Web of science databases. Results: A preliminary analysis of the data identified some challenges such as under-reporting and lack of standardization of adverse reaction coding, standard nomenclature problem for international trade, lack of clarity of requirements for manufacturers, and insufficient regulation and significant incentives for the use of unique device identifiers. Recommendations for a more effective national system are put for ward which address the regulation and computerization of the system for the development of medical devices monitoring mechanisms.
format	article
author	Qouhafa Meryem Benaji Brahim Lebbar Souad Soulaymani Abdelmajid Moukhtari Abdelrhani
author_facet	Qouhafa Meryem Benaji Brahim Lebbar Souad Soulaymani Abdelmajid Moukhtari Abdelrhani
author_sort	Qouhafa Meryem
title	Development and implementation of a system for medical devices monitoring in Morocco
title_short	Development and implementation of a system for medical devices monitoring in Morocco
title_full	Development and implementation of a system for medical devices monitoring in Morocco
title_fullStr	Development and implementation of a system for medical devices monitoring in Morocco
title_full_unstemmed	Development and implementation of a system for medical devices monitoring in Morocco
title_sort	development and implementation of a system for medical devices monitoring in morocco
publisher	EDP Sciences
publishDate	2021
url	https://doaj.org/article/69ad09e1f79f46158c4c398d842c96d8
work_keys_str_mv	AT qouhafameryem developmentandimplementationofasystemformedicaldevicesmonitoringinmorocco AT benajibrahim developmentandimplementationofasystemformedicaldevicesmonitoringinmorocco AT lebbarsouad developmentandimplementationofasystemformedicaldevicesmonitoringinmorocco AT soulaymaniabdelmajid developmentandimplementationofasystemformedicaldevicesmonitoringinmorocco AT moukhtariabdelrhani developmentandimplementationofasystemformedicaldevicesmonitoringinmorocco
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Development and implementation of a system for medical devices monitoring in Morocco

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