CURRENT STATUS OF MATERIOVIGILANCE GLOBALLY-AN UTTE R OVERVIEW WITH CLINICAL CASE PERUSAL
- Vol.11(10)
- M P Innovare Academic Sciences Pvt Ltd 2019
- 1-8p.
Today’s medical devices are the lifesaving tool and these tools are very frequently used globally sinc e long ago. With the increase in the number of medical devices and their uses, there is an increas e in the number of adverse events related to such d evices. 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 reite ration. Post marketing surveillance of medical devi ces has been initiated in many countries, like the United States of America has started a program unde r the name Medical Device Reporting (MDR), France, Australia and the United Kingdom have also come up with their own programs. Apart from th is India has also initiated the Materiovigilance pr ogram by Drug Controller General of India (DCGI) at the Indian Pharmacopoeia Commission (IPC) in Ghaziabad in 2015. In this article we have disc ussed about the risks associated with the use of different classes of medical devices and the need of Materiovigilance program. This article als o discusses the adverse events associated with the medical devices, the reporting criteria of thos e adverse events and the different clinical events of the medical devices.