Chauhan, Pratibha
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.
PHARMACEUTICS
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.
PHARMACEUTICS