Having generated 500 serious adverse events (SAE) due to medical devices during the past three months, the MaterioVigilance Programme of India (MvPI) has put 10 exclusive centres under it to collect and disseminate reporting of adverse events due to medical devices at the point of care besides the 250 adverse drug reaction monitoring centres (AMCs) across the country.

MvPI was launched by Drugs Controller General of India (DCGI) on July 6, 2015 at Indian Pharmacopoeia Commission (IPC) Ghaziabad. IPC functions as a National Coordination Centre (NCC) for MvPI.

The programme is currently operational along the lines of the existing Pharmacovigilance Programme of India (PvPI) and Haemovigilance Programme of India (HvPI) in co-ordination with 10 medical colleges of the country. The medical colleges are equipped to collect and disseminate reporting of SAE due to medical devices.

The Union health ministry had earlier directed the AMCs across the country to also report SAE during the course of usage of a medical devices as part of the MvPI.

The 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 in India.

The programme requires inputs in biomedical engineering unlike in medicines where the mechanism is different for reporting of adverse drug reaction (ADR) reporting.

IPC has also launched a reporting form for MvPI. The reporting form called as Medical Device Adverse Event (MDAE) reporting form will help generate independent, evidence-based recommendations on the safety of medical devices and to communicate the findings to all key stakeholders.

The reporting form which has undergone series of scientific consultations, stakeholder meetings with industry and inputs from scientists across the country will ensure safety of medical devices through reporting of adverse events due to medical devices in India.

The reporting form includes adverse event details, severity of the event, date, location, device category, model of the device available with the organisation, its use after the event, name of medical device, manufacturer, brand name, model number, serial number, batch number, catalogue number for instruments, date of installation/implantation/explanation and list of accessories among other relevant details like actions taken immediately after the incident/event.

IPC which is the national coordination centre (NCC) for PvPI also serves as the nodal agency for the AMCs across the country.

Aimed at monitoring the benefit-risk profile of medical devices, MvPI besides reporting MDAE will start creating awareness among healthcare professionals about the importance of MDAE reporting in India. This will help generate independent, evidence-based recommendations on the safety of medical devices and communicate the findings to all key stakeholders.