The Union health ministry has recommended to various medical device associations to nominate their representatives for Materiovigilance Programme of India (MvPI) on or before March 31, 2016 for preparing draft of MvPI tool kit and guidance document.

The recommendations were a part of the recent industry consultation meet held at Indian Pharmacopoeia Commission (IPC), Ghaziabad to discuss the adverse event reporting format for reporting serious adverse events as a part of the programme among other pertinent areas related to its implementation.

The meet reviewed the draft Medical Device Adverse Event (MDAE) reporting form and MvPI toolkit and unanimously decided that MDAE form will be used as a primary reporting form for reporting serious adverse events (SAE).

The industry has recommended 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. Various technical suggestions were also provided by the industry.

‘Adverse incident will be reported to Shree Chitra Institute of Medical Science and Technology (SCTIMST)-National Collaborating Centre for MvPI which will be provided technical support by Division of Healthcare Technology at National Health Systems Resource Centre under the ministry of health and family welfare, government of India. Indian Pharmacopoeia Commission would coordinate and provide administrative support.

Suggestions also included standard procedures for receiving, documenting, and investigating complaint, developing a robust reporting structure and form determining when complaints are reportable and method of report generation, methodology for closing the complaint and updating the risk management file and how to avoid duplicity of a reported event.

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 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.

MvPI was launched in the backdrop of cases of malfunctioning of medical devices or serious adverse events occurring due to a medical device including the one of hip replacement implant of a leading MNC a couple of years ago. Opines an industry official, “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.”