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IPC launches reporting form for MvPI to ensure safety of medical devices

Shardul Nautiyal, Mumbai
Thursday, April 14, 2016, 14:40 Hrs  [IST]

To ensure safety of medical devices through seamless reporting of adverse events due to medical devices, the reporting form for Materio-vigilance Programme of India (MvPI) was launched today by the Indian Pharmacopoeia Commission (IPC) on the fifth anniversary of Pharmacovigilance programme of India (PvPI).

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 will now be included in the tool kit which would be shared with the proposed materiovigilance centres 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.

Health ministry had earlier 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 (SAEs).

Suggestions during the meet 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 MVPI reporting form was jointly launched in the presence of Sudhanshu Pant, joint secretary, department of pharmaceuticals, KL Sharma, joint secretary, regulations, Health Ministry, Dr GN Singh, drug controller general of India, Prof YK Gupta, national coordinator, PvPI, Dr SK Gupta, national advisor, PvPI, Dr KK Agarwal, secretary general, Indian Medical Association (IMA) and Dr Jitendar Sharma, director, WHO centre for medical devices, National Health Systems Resource Centre (NHSRC).

 

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