Abstract

ASSESSMENT OF ADVERSE EVENTS RELATED TO MEDICAL DEVICES IN INTENSIVE CARE UNIT OF A TERTIARY CARE HOSPITAL AN OVERVIEW

Dileep B. L.*, Mahendrakumar B. J., Rajesh Venkataraman, Hafis A. and Pavan Kumar V.

ABSTRACT

Materiovigilance is the study and follow up of incidents resulting from the use of medical devices. Ministry of Health & Family Welfare, Govt. of India approved and commenced Materiovigilance Programme of India (MvPI) in the country in order to monitor the safety of Medical Devices Associated Adverse Events (MDAEs) in Indian Population. The MvPI launched on 06th July 2015 at Indian pharmacopoeia Commission (IPC), Ghaziabad by the Drugs Controller general India (DCG(I)). Materiovigilance Programme of India enables all health care professionals, patients/consumers to reports MDAEs. There were several challenges and drawbacks over reporting and data collection due to lack of awareness among health care professionals. The collected and generated safety data will help to give recommendations to Central Drugs Standard Control Organisation (CDSCO) for taking regulatory decisions on safe use of medical devices in Indian Population.

Keywords: Materiovigilance, Medical Devices, MvPI (Materiovigilance Programme of India), Patient Safety, Adverse Events, Healthcare Innovation.