CURRENT STATUS OF MATERIOVIGILANCE GLOBALLY-AN UTTER OVERVIEW WITH CLINICAL CASE PERUSAL

Pratibha Chauhan,Aalia Zarreen,Mohammad Kashif Iqubal

doi:10.22159/ijpps.2019v11i10.34716

Pratibha Chauhan, Aalia Zarreen + Show 1 more

Open Access

https://doi.org/10.22159/ijpps.2019v11i10.34716

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Abstract

Today’s medical devices are the lifesaving tool and these tools are very frequently used globally since long ago. With the increase in the number of medical devices and their uses, there is an increase in the number of adverse events related to such devices. That is why Materiovigilance is an important tool for the identification, collection, reporting, and analysis of any aversive catastrophe related to the use of medical devices and protection of a patient’s life by fending its reiteration. Post marketing surveillance of medical devices has been initiated in many countries, like the United States of America has started a program under the name Medical Device Reporting (MDR), France, Australia and the United Kingdom have also come up with their own programs. Apart from this India has also initiated the Materiovigilance program by Drug Controller General of India (DCGI) at the Indian Pharmacopoeia Commission (IPC) in Ghaziabad in 2015. In this article we have discussed about the risks associated with the use of different classes of medical devices and the need of Materiovigilance program. This article also discusses the adverse events associated with the medical devices, the reporting criteria of those adverse events and the different clinical events of the medical devices.

Highlights

The term “vigilance” means close monitoring of the possible adverse effects [1,2,3,4]
The publications, events related to medical devices and their adverse effects on Google, Google Scholar, PubMed, and Science Direct were searched with the search keywords such as “medical devices,” “adverse effects associated with medical devices,” “materiovigilance”, “case study related to medical devices” and in combination with each other with no particular time restriction in order to get a holistic and comprehensive view of the research done on this topic so far
In a few recent years, the use of medical devices is found to be very frequent by medical practitioners all over the world

Summary

INTRODUCTION

The term “vigilance” means close monitoring of the possible adverse effects [1,2,3,4]. Materiovigilance is the study of adverse events associated with the use of medical devices It deals with the close monitoring of medical devices after post-marketing phase [1, 5]. The risks can include falsifications, technical defects and reduced efficacy [2, 6, 9,10,11,12,13] This makes it essential to have a regulatory program to monitor these associated adverse effects. Importers, distributors of medical devices, including all healthcare stakeholders for better understanding of medical device standards for promotion of patient safety and strengthening of materiovigilance system. To aware stakeholders about the need and significance of medical devices adverse events (MDAE) reporting [15, 16]

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CONCLUSION