The Materiovigilance Programme of India (MvPI) is meant to enable safety data collection in a systematic manner, so that regulatory decisions and recommendations on safe use of medical devices for India could be based on data generated here. The programme is meant to monitor medical device associated adverse events (MDAE), create awareness among health care professionals about the importance of MDAE reporting in India and to monitor the benefit-risk profile of medical devices. Based on these reports, a decision will be taken on whether any change is required in the labelling of the devices, or whether a recall or a ban. To begin with, medical device monitoring centre (MDMC) has been established in 12 medical colleges all over India and PGIMER, Chandigarh is one of them. The Sree Chitra Thirunal Institute of Medical Sciences and Technology in Thiruvananthapuram is to be the national collaborating centre for the programme, which will run in collaboration with the Central Drug Standard Control Organisation (CDSCO). Technical support for the programme is to be provided by the Division of Healthcare Technology, a proposed World Health Organisation collaborating centre for priority medical devices and health technology policy in the National Health Systems Resources Centre. And, Indian Pharmacopoeia Commission (IPC), Ghaziabad will be working as National Coordination Centre to collect the reports on adverse events.

Now, we are on the way to confine to detect medical device adverse event that were previously either unknown or poorly understood. Today many materiovigilance centers have initiated medical device safety monitoring at global pitch, however, at the turn of the millennium it faces major challenges in aspect of better safety, monitoring of devices and several practical issues.

Materiovigilance, as defined by the World Health Organization, is the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other possible drug-related problems. Recent inclusions to this definition are: herbals, traditional and complementary medicines, blood products, biological, medical devices and vaccines.

Working of Materiovigilance

If there is any suspicion that an adverse event or adverse reaction has occurred, the healthcare professional attending to the patient, can fill up the suspected adverse event former patient suspects that he has experienced an adverse event can report to the nearest Medical Devices Monitoring Centers (MDMCs) under Materiovigilance Programme of India (MvPI). There is a prescribed form that can be used in making reports to AMCs which can be downloaded from the website of IPC http://ipc.nic.in/writereaddata/mainlinkFile/File735.pdf. The details of IPC are given in the website of IPC i.e.http://ipc.nic.in/index1.asp?EncHid=&lang=1&linkid=82&lid=548. Simultaneously adverse events are evaluated at NCC and the inferences are used to recommend regulatory body i.e. CDSCO to take necessary regulatory interventions, besides communicating risks to healthcare professionals and the public.

PGIMER Chandigarh was identified as Medical Devices Monitoring Centers (MDMCs) in January 2017. Dr. Bikash Medhi (Department of Pharmacology) and Er. Sanjeev Sharma (Biomedical Division) were appointed as Coordinator right from the first phase of Materiovigilance Program of India. PGIMER Chandigarh. MDMC has been actively involved in creating awareness amongst the health care professionals by means of organizing different CMEs and seminar throughout the Northern India.

Working of MDMC-PGIMER

• Collection of medical device event reports from hospital of PGIMER, Chandigarh
• Checking the completeness of reports for quality followed by causality assessment of medical device adverse event cases, Follow up with the reporter for any incomplete information.
• Delivering lecture on trending news and issues on medical devices safety, importance of reporting the medical devices adverse event; for sensitization of healthcare professionals (Doctors, Nurses).
• Preparing the monthly report of the medical devices adverse event monitoring center.
• Documentation and archival of the reports in both soft and hard copies.
• Providing training to the personnel under materiovigilance program of India in north India on reporting form, SOPs.