Abstract
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.
Highlights
The medical devices (MD) market is increasing thanks to the expansion of care offer in Morocco
Face to the increasing demand for the use of such devices, it is necessary to get ready for and conform to international requirements, in the area of materiovigilance (MV),which aims at monitoring incidents resulting from the use of MDs after they have been brought to the marketing order to improve patients’ safety and improve the quality and efficiency of their use[1].Morocco, faces certain challenges relating to the establishment of a structured information system,including a centralized database such as medicines,a coherent and standardized MD coding system allowing the assessment and monitoring of the safety of these devices, with MV guides
The number for each step is presented according to the PRISMA method (Figure 1) The frequency of words in these 51 documents is presented (Figure 2) .The objective of this collection is to assess the implementation of MD safety monitoring strategies at the international level while exploiting the constraints associated with these different strategies
Summary
The medical devices (MD) market is increasing thanks to the expansion of care offer in Morocco. The marketing of MDs requires prior approval of FDA The latter evaluates whether the MD meets the health requirements and approves its quality and reliability for use.[3]In terms of vigilance, the FDA has post-marketing mechanisms which help identify emerging adverse reactions. These mechanisms include Medical Device Reporting programs that notify of any device-related ARs, a public
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