首页    期刊浏览 2025年02月18日 星期二
登录注册

文章基本信息

  • 标题:Development and implementation of a system for medical devices monitoring in Morocco
  • 本地全文:下载
  • 作者:Meryem Qouhafa ; Brahim Benaji ; Souad Lebbar
  • 期刊名称:E3S Web of Conferences
  • 印刷版ISSN:2267-1242
  • 电子版ISSN:2267-1242
  • 出版年度:2021
  • 卷号:319
  • 页码:1-8
  • DOI:10.1051/e3sconf/202131901086
  • 语种:English
  • 出版社:EDP Sciences
  • 摘要: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.
  • 关键词:Materiovigilance;medical devices;post-market surveillance;UDI;regulation
国家哲学社会科学文献中心版权所有