Following the launch of Materiovigilance Programme of India (MvPI) to report and monitor medical device associated adverse events (MDAE), the adverse event reporting format to report the same has been sent to the industry for recommendations and consultations.
While the Union health ministry launched MvPI in the backdrop of cases of malfunctioning of medical devices including the one of hip replacement implant of a leading MNC a couple of years ago, the industry however feels that the format currently designed should be able to offer clarity so that every complaint which is reported should not be treated as a serious adverse event and should not lead to witchhunting.
“A serious adverse event can be determined if it is life threatening in nature, causes harm to the body or leads to a surgical intervention. The mechanism for its effective implementation is currently being worked out so that manufacturers are not harassed in the name of reporting serious adverse events,” according to an official associated with the development.
The programme is unique in the sense that it requires inputs in biomedical engineering unlike in medicines where the mechanism is different for reporting of adverse drug reaction (ADR) reporting.
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. This will also lead to taking systematic measures for common issues confronting the industry. The mechanism is underway to formulate a system of reporting of adverse events of medical devices under MvPI for protecting the industry and the patient.
The biotechnology wing of the Sree Chitra Thirunal Institute of Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram and Indian Pharmacopoeia Commission (IPC) will lead the implementation of the programme 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 WHO collaborating centre for priority medical devices and health technology policy in the National Health Systems Resources Centre.
The MvPI programme has identified 10 medical colleges of the country to take forward the programme. The programme is meant to 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 official, the medical colleges are equipped to collect and disseminate reporting of adverse events due to medical devices. As of today, 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.