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Health ministry asks AMCs across healthcare institutions to report adverse events due to medical devices

Shardul Nautiyal, Mumbai
Wednesday, December 6, 2017, 08:00 Hrs  [IST]

The Union health ministry has asked the adverse drug reaction monitoring centres (AMCs) across the country to report serious adverse events during the course of usage of a medical devices as part of the MaterioVigilance Programme of India (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. This will also lead to taking systematic measures for common issues confronting the industry.  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.

As of today, there are in total 250 AMCs in the country.  Around 40 AMCs have recently been identified at district hospitals based in the North Eastern part of India, Uttar Pradesh and Himachal Pradesh to get pan India ADR information.

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

The release of 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.

The Pharmacovigilance Programme of India (PvPI) also has so far reported around 3 lakh adverse drug reactions. IPC has been assigned to update information on ADRs that is being reported in India from across all its centres through Vigiflow software to the Uppsala Monitoring Centre (UMC) in Sweden, which is WHO's collaborating centre for international drug monitoring. Vigiflow is a software given to the PvPI free of cost and prescribed to AMCs based on their efficiency to deliver in terms of frequency and quality of reports.

IPC which is the national coordination centre (NCC) for PvPI serves as a nodal agency for the AMCs. Around 210 registered AMCs across the country play an important role in timely reporting of adverse drug reaction to IPC. Once enrolled NCC will provide logistic and technical support to AMCs for their smooth functioning.

Medical colleges, hospitals and institutes approved by the Medical Council of India (MCI) can act as AMCs. Once enrolled they are required to efficiently collect the adverse event information from the patients, do follow up with them to check the completeness of the ADR reports. IPC is keen on bringing the hospitals under the rural and urban areas under its fold.


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