The National Medical Commission has advised all Medical Institutions to set up a committee to monitor adverse events related to medical devices.
Each medical institution should register this Committee with the Indian Pharmacopoeia Commission. Further, the country’s apex medical education regulatory body also mandated that the website of all medical institutions shall also indicate the name of the coordinator or convenor of the committee and additional members, if any.
The Medical Superintendent will ordinarily be the Chair of this Committee. The website shall also indicate the date of registration of MDAEC.
This comes in the wake of an increasing reliance on medical devices for advancing medical studies. “Medical devices have become an indispensable part of modern healthcare, contributing significantly to the diagnosis, treatment, and management of diseases. Various incidents involving medical devices causing harm to the patients have created the need of a system to monitor these events and take necessary actions to prevent these from happening again,” the commission said in a statement.
Additionally, the NMC explained, “In response to this the Ministry of Health and Family Welfare (MoHFW), launched the Materiovigilance Programme of India (MvPI) in 2015 at Indian Pharmacopoeia Commission, to monitor adverse events and risks associated with medical devices used across the country. This national initiative is designed to systematically collect, analyse, and respond to adverse events associated with medical devices, ensuring better patient safety and quality healthcare delivery.
“The program is coordinated by the IPC and operates through a growing network of Medical Device Adverse Events Monitoring Centres (MDMCs) in hospitals and medical colleges. The Medical Devices Rules, 2017 regulate the import, manufacturing, sale and distribution of medical devices in India including post market surveillance of a medical device.”
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