Materiovigilance Programme of India: A scheme to assure cardiovascular devices safety surveillance

The Materiovigilance Programme of India (MvPI) has been implemented to ensure the safety of medical devices including cardiovascular devices (MD-CVD). This article describes the role of MvPI surveillance system that comprehensively collects, collates and analyses the adverse events associated with M...

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Main Authors: V. Kalaiselvan, Santanu Kumar Tripathi, Jai Prakash
Format: Article
Language:English
Published: Elsevier 2020-07-01
Series:Indian Heart Journal
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S0019483220301371
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author V. Kalaiselvan
Santanu Kumar Tripathi
Jai Prakash
author_facet V. Kalaiselvan
Santanu Kumar Tripathi
Jai Prakash
author_sort V. Kalaiselvan
collection DOAJ
description The Materiovigilance Programme of India (MvPI) has been implemented to ensure the safety of medical devices including cardiovascular devices (MD-CVD). This article describes the role of MvPI surveillance system that comprehensively collects, collates and analyses the adverse events associated with MD-CVD and also its supplementing role to the Central Drugs Standard Control Organization for taking regulatory decision to reduce the health burden on account of adverse events due to medical devices to the patients based on the evidence based data. This article is expected to stimulate ethical reporting of adverse events due to MD-CVD at MvPI.
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spelling doaj.art-3bdb8a276bf742b5a11d7c504141fce62022-12-21T18:13:53ZengElsevierIndian Heart Journal0019-48322020-07-01724316318Materiovigilance Programme of India: A scheme to assure cardiovascular devices safety surveillanceV. Kalaiselvan0Santanu Kumar Tripathi1Jai Prakash2Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India, Sector 23, Raj Nagar, Ghaziabad, UP, 201002, India; Corresponding author. Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India, Sector 23, Raj Nagar, Ghaziabad, UP, 201002, India.Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, 700073, IndiaIndian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India, Sector 23, Raj Nagar, Ghaziabad, UP, 201002, IndiaThe Materiovigilance Programme of India (MvPI) has been implemented to ensure the safety of medical devices including cardiovascular devices (MD-CVD). This article describes the role of MvPI surveillance system that comprehensively collects, collates and analyses the adverse events associated with MD-CVD and also its supplementing role to the Central Drugs Standard Control Organization for taking regulatory decision to reduce the health burden on account of adverse events due to medical devices to the patients based on the evidence based data. This article is expected to stimulate ethical reporting of adverse events due to MD-CVD at MvPI.http://www.sciencedirect.com/science/article/pii/S0019483220301371MateriovigilanceMedical devicesAdverse eventsCardiovascular devices
spellingShingle V. Kalaiselvan
Santanu Kumar Tripathi
Jai Prakash
Materiovigilance Programme of India: A scheme to assure cardiovascular devices safety surveillance
Indian Heart Journal
Materiovigilance
Medical devices
Adverse events
Cardiovascular devices
title Materiovigilance Programme of India: A scheme to assure cardiovascular devices safety surveillance
title_full Materiovigilance Programme of India: A scheme to assure cardiovascular devices safety surveillance
title_fullStr Materiovigilance Programme of India: A scheme to assure cardiovascular devices safety surveillance
title_full_unstemmed Materiovigilance Programme of India: A scheme to assure cardiovascular devices safety surveillance
title_short Materiovigilance Programme of India: A scheme to assure cardiovascular devices safety surveillance
title_sort materiovigilance programme of india a scheme to assure cardiovascular devices safety surveillance
topic Materiovigilance
Medical devices
Adverse events
Cardiovascular devices
url http://www.sciencedirect.com/science/article/pii/S0019483220301371
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AT santanukumartripathi materiovigilanceprogrammeofindiaaschemetoassurecardiovasculardevicessafetysurveillance
AT jaiprakash materiovigilanceprogrammeofindiaaschemetoassurecardiovasculardevicessafetysurveillance