NMC asks medical colleges to set up committee to monitor, assess adverse events related to medical devices

NEW DELHI: The National Medical Commission (NMC) has directed all medical institutions to set up a committee to monitor adverse events related to medical devices, with the aim of monitoring, assessing, and preventing such harmful occurrences. In a public notice, NMC Secretary Dr Raghav Langer stated that each medical institution must register its committee with the Indian Pharmacopoeia Commission (IPC), mention the name of the coordinator or convenor and any additional members on its website, and update the Pharmacovigilance Committee members' details by July 31. The notice, dated July 13, said that the medical superintendent should be the chair of the committee. Dr Langer said the advantages of becoming a Medical Device Adverse Events Monitoring Centre (MDMC) is that the medical colleges will serve as an ideal hub for materiovigilance due to their diverse patient populations and access to advanced healthcare technologies. He said MDMC offers multiple strategic advantages like academic recognition. Participation enhances the institutions stature as a contributor to national public health and regulatory science, he said. Also, he said, it will provide faculty and students hands-on exposure to post-market surveillance, risk assessment, and patient safety. It will also help the institution to access Materiovigilance Programme of India (MvPI) resources, training modules, and national-level collaboration. This will also help provide them opportunities to contribute to evidence-based recommendations and medical device regulations. Moreover, it will ensure early detection and response to device malfunctions, directly improving clinical outcomes, the notice added. Medical devices have become an indispensable part of modern healthcare, contributing significantly to the diagnosis, treatment, and management of diseases. However, there have been various incidents involving medical devices causing harm to the patients, the notice said. This has led to the need of a system to monitor these events and take necessary actions to prevent these from happening again. The top official said that in response to these adverse events, the Union Health Ministry 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. The MvPI programme is a national initiative aimed at ensuring the safety of medical devices across their lifecycle. MvPI enhances device safety through systematic reporting and analysis of adverse events, providing data to Central Drugs Standard Control Organisation (CDSCO) to support regulatory action and guide improvements in clinical practice. 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, he said. 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. The registration form is available on the website of Indian Pharmacopoeia Commission, he added.