Implementation of adverse event reporting for medical devices, India

Bulletin of the World Health Organization
Shatrunajay ShuklaGyanendra Nath Singh

Abstract

Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India. Implementation of national regulations on medical devices started in January 2018. Supported by a nationwide network of monitoring centres, the Indian Pharmacopoeia Commission coordinates adverse event reports from manufacturers, legal representatives and patients or users. The commission follows-up and reviews reports with subject expert groups and sends recommendations on necessary action to the national regulatory authority. Before 2015, no systematic structure was in place to collate adverse events associated with medical devices. Several reports of deaths and hospitalization due to faulty hip implants, cardiac stents and poor-quality devices prompted the health ministry to launch the materiovigilance programme. From July 2015 to October 2019, the commission received 1931 adverse event reports, mostly from marketing authorization holders; 1277 were serious events. Reporting increased markedly after 2017. Cardiac stents were the most reported device (926 events; 47.95%). To encourage a culture of reporting, the commission has raised awareness about the programme among stake...Continue Reading

References

May 9, 2014·Expert Review of Medical Devices·Alice Fouretier, Delphine Bertram
Apr 1, 2014·WHO South-East Asia Journal of Public Health·Vivekanandan KalaiselvanGyanendra N Singh
Feb 13, 2018·Perspectives in Clinical Research·Amita Bhave

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Citations

Oct 31, 2020·Indian Journal of Ophthalmology·Vivekanandan Kalaiselvan, Rohit Saxena
Sep 14, 2021·Environmental Science and Pollution Research International·Deeksha JoshiSachin Kumar Singh

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