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Materiovigilance- Monitor all Adverse Reaction to Medical Devices, CDSCO directs State Drug Controllers

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New Delhi: Through a recent notification, the Central Drugs Standard Control Organisation (CDSCO) has informed all the State Drug Controllers about its move to step up Materiovigilance Programme of India (MvPI) in the country and direct them to encourage all clinicians and healthcare professionals to mandatorily adopt reporting of medical devices adverse event to MvPI-Indian Pharmacopoeia Commission (IPC).

The public notice dated November 26 2019, duly signed by Dr V G Somani, Drugs Controller General of India (DCGI) wrote to all the authorities regarding the strengthening of MvPI.

“The Indian Pharmacopoeia Commission (IPC), an autonomous institution of Ministry of Health and Family Welfare, Government of India has been entrusted with the responsibility relating to Materiovigilance Program of India (MvPI) since July 6, 2015. The objective of MvPI is to improve patient safety and welfare of the Indian population by monitoring medical devices safety and thereby reducing the risks associated with the use of medical devices,”  the letter to all state controllers noted

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The issue of adverse events of medical devices has been indeed gaining momentum in the country and so is the authority’s response. Earlier this year, pacemakers sold by one of the largest medical device makers, Medtronic was red-flagged by the apex drug regulator Central Drugs Standard Control Organisation (CDSCO) for battery-related malfunction.

Also Read: Red Flag: CDSCO warns against Medtronic pacemaker for battery-related malfunction

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In the light of such adverse events, the recently rolled out notification by CDSCO regarding Materiovigilance Program is likely to keep track and minimize the adverse impacts of medical devices.

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Materiovigilance (MV) is based on sound scientific principle and is an integral part of effective clinical practices. The discipline needs to develop further to meet the demands of public health for which continuous monitoring of medical devices is essential. Such monitoring will help in assessing, monitoring and detecting adverse effects of medical devices, their malfunctions etc. that can result in higher morbidity and mortality. The measure will help to maximize benefits and minimize the risk associated with medical devices.

“The Materiovigilance and medical device adverse event reporting among healthcare professionals needs to be scaled up. It can be done by developing educational and promotional interventions like continuous medical education, awareness program, workshops, conferences on Materiovigilance etc,” Somani noted

The authority then directed the state controllers  to ensure the stepping up to MvPi In their respective areas

“In view of the above, you are requested to initiate the steps for strengthening public health by sensitizing and advising all clinicians and other healthcare professional under your jurisdiction to mandatorily -adopt reporting of medical devices adverse event to MvPI-IPC,” DCGI stated

Also Read: Certain Medtronic pacemaker batteries fail without warning; USFDA flags issue                                

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