An updated review on Materiovigilance for safe use of medical devices

  • Mansi Deshwal Delhi Pharmaceutical Sciences and Research University
  • Manju Nagpal
  • Gitika Arora Dhingra NCRD’s Sterling Institute of Pharmacy, Nerul, Navi Mumbai
  • Geeta Aggarwal Delhi Pharmaceutical Sciences and Research University

Abstract

In the last two decades, there has been an upsurge in the volume of medical devices and thereby increasing medical device-related adverse events. So, materiovigilance is an essential system for identifying, collecting, reporting and analysing adverse events related to medical devices. The Vigilance programme for the medical device was initiated in many countries many years ago but, is a quite new concept for India. The Materiovigilance programme in India was launched on July 6 2015, at the Indian Pharmacopoeial Commission (IPC) with the objective of monitoring adverse events, thereby reducing risks related to use of medical devices and also creating awareness among different stakeholders for improving patients’ safety. The intent of this review article is to provide holistic understanding of medical device related adverse events; classification, reporting criteria, what, where, how, who and why, timeframe and tools used for reporting. Data collected using various search engines and compiled to give complete information regarding the subject matter. The thorough understanding of current status of materiovigilance programme in India including challenges involved in the programme and future directions for improving has been stated. Case studies have been reviewed for Johnson & Johnson’s faulty hip implant and Medtronic premature battery depletion. Implementation of Materiovigilance programme of India (MvPI) version 1.1 lead to safeguard the health of device user by preventing recurrence and risk associated with medical device.

Keywords: Materiovigilance, post-marketing surveillance, Medical Device Monitoring Centres (MDMCs), medical device vigilance, adverse events, Medical Device Rule (MDR), CDSCO, FDA, Materiovigilance programme of India (MvPI), Indian Pharmacopoeial Commission (IPC)

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How to Cite
Mansi Deshwal, Manju Nagpal, Gitika Arora Dhingra, and Geeta Aggarwal. “An Updated Review on Materiovigilance for Safe Use of Medical Devices”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 4, Dec. 2020, pp. 5-13, doi:10.22270/ijdra.v8i4.428.