Against the backdrop of cases of malfunctioning of medical devices as in the case of hip replacement implants of a leading MNC a couple of years ago among other such cases not reported timely, the government has constituted a national level committee to formulate a system of reporting of adverse events due to medical devices under Materio-Vigilance Programme of India (MvPI) to ensure safety in medical devices.
Envisaged to start with setting up of MvPI cells in 10 medical colleges of the country, the programme will be along the lines of the existing pharmacovigilance programme and haemovigilance programme.
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 is meant to monitor medical device associated adverse events (MDAE), create awareness among healthcare professionals about the importance of MDAE reporting in India and to monitor the benefit-risk profile of medical devices. It is also meant to generate independent, evidence-based recommendations on the safety of medical devices and to communicate the findings to all key stakeholders.
According to an expert, the medical colleges are equipped to collect and disseminate reporting of adverse events due to medical devices. Apart from designing of forms required for effective reporting of adverse events of medical devices, the recently constituted national-level committee is currently, therefore, also looking into aspects related to doing causality assessment which is difficult in medical devices as it requires inputs in biomedical engineering unlike in medicines where the mechanism is different for reporting of Adverse Drug Reaction (ADR) reporting.
Despite being a USD 3.1 billion market for medical devices, India has no system for registering adverse events caused by medical devices or for tracking the safety record of medical devices and is dependent on data from the developed countries. The proposed plan, to be coordinated by the Indian Pharmacopoeia Commission in Ghaziabad, envisages a nation-wide programme, involving district hospitals, medical colleges and corporate hospitals.
The biotechnology wing of the Sree Chitra Thirunal Institute of Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram is to be the national collaborating centre for the programme which will be run in collaboration with the Central Drug Standard Control Organisation (CDSCO).
The institute will coordinate scientific activities with the 10 medical colleges in the country. Technical support for the programme is to be provided by the Division of Healthcare Technology, a proposed WHO collaborating centre for priority medical devices and health technology policy in the National Health Systems Resources Centre.