Navigating the Landscape of Medical Device Failures: Challenges, Regulations, and Materiovigilance
Abstract
Introduction: In the realm of healthcare, the significance of materiovigilance cannot be overstated. Materiovigilance, a term often overshadowed by pharmacovigilance, focuses on the surveillance and control of medical devices' safety and performance post-marketing. Its components include the systematic collection, analysis, and interpretation of data related to medical devices, aiming to enhance patient safety by decreasing adverse events associated and optimize device efficacy
Methodology: This literature review utilized databases like PUBMED, EMBASE, SCOPUS, and COCHRANE, employing keywords such as "materiovigilance"; "pharmacovigilance" ;"materiovigilance history"; and "awareness about materiovigilance"
Results: Critical components like vigilance reporting systems, risk assessment, and regulatory interventions play a pivotal role in ensuring medical device safety. It is evident that a significant lack of awareness, posing risks to patient safety. This research serves as a tool to bridge the awareness gap, emphasizing the need for understanding and active participation in Materiovigilance
Conclusion: Collaborative efforts among regulatory bodies, healthcare providers, and manufacturers can enhance understanding and awareness in Materiovigilance. This clarity and collaboration contribute to fostering Materiovigilance awareness, ensuring improved patient safety. By creating awareness, we aim to establish a safer healthcare environment, guaranteeing the efficacy and safety of medical devices globally.
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