The Union health ministry is in the process of recruiting technical manpower for its recently launched Materio-Vigilance Programme of India (MvPI) to detect serious adverse events (SAEs) and ensure safety of medical devices when being used in and by the patients.
MvPI would ensure safety data collection in a systematic manner during the usage of medical devices in healthcare settings. This would also help in taking regulatory decisions on safe use of medical devices for India based on the data generated in India.
"A total number of 15 technical staff would be recruited, of which 5 would be attached to Sree Chitra Thirunal Institute of Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram which is also the national coordinating centre (NCC) for the programme. Around 10 would be recruited for medical device monitoring centres identified in the country," an official associated with the development said.
The biotechnology wing of the SCTIMST in Thiruvananthapuram will be running MvPI in collaboration with the Central Drug Standard Control Organisation (CDSCO). Initiated in the backdrop of cases of malfunctioning of medical devices which led to SAEs in the past, the ministry has constituted a national level committee to formulate a system of reporting of adverse events of medical devices under MvPI.
Aimed at monitoring the benefit-risk profile of medical devices, MvPI besides reporting medical device associated adverse events (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.
The programme which will be conducted along the lines of the existing pharmacovigilance programme and haemovigilance programme in the country will run in co-ordination with 10 medical colleges of the country. According to an official, the medical colleges are equipped to collect and disseminate reporting of adverse events due to medical devices.
The health ministry formed committee which is meant to look into the aspects related to doing causality assessment as a part of the programme is also designing a format required for effective reporting of adverse events of medical devices. Devices unlike drugs require inputs in biomedical engineering. In medicines, the mechanism is very different for reporting of adverse drug reaction (ADR) reporting.
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. India has no system for registering adverse events caused by medical devices or for tracking the safety record of medical devices. It is dependent on data from the developed countries.