Current Status of Materiovigilance Globally-an Utter Overview With Clinical Case Perusal

Abstract

Today’s medical devices are the lifesaving tool and these tools are very frequently used globally since long ago. With the increase in the number of medical devices and their uses, there is an increase in the number of adverse events related to such devices. That is why Materiovigilance is an important tool for the identification, collection, reporting, and analysis of any aversive catastrophe related to the use of medical devices and protection of a patient’s life by fending its reiteration. Post marketing surveillance of medical devices has been initiated in many countries, like the United States of America has started a program under the name Medical Device Reporting (MDR), France, Australia and the United Kingdom have also come up with their own programs. Apart from this India has also initiated the Materiovigilance program by Drug Controller General of India (DCGI) at the Indian Pharmacopoeia Commission (IPC) in Ghaziabad in 2015. In this article we have discussed about the risks associated with the use of different classes of medical devices and the need of Materiovigilance program. This article also discusses the adverse events associated with the medical devices, the reporting criteria of those adverse events and the different clinical events of the medical devices.

Materiovigilance: Current status in India analogous to its global status

“…The World Health Organization (WHO) has defined "medical device" as any instrument, apparatus, reagent for in vitro use, implant, device for tissue cutting or wound covering, highly sophisticated computerized medical equipment, software or other related or similar materials which are intended to be used for diagnosis, prevention, monitoring, treatment of disease (Rani et al, 2018;Chauhan et al, 2019).…”

“…In India the surveillance programme related to the medical devices was launched on 6 July 2015 at the Indian Pharmacopoeia Commission (IPC), Ghaziabad by Drug Controller General of India with the name Materiovigilance Programme of India (MvPI). Materiovigilance is the monitoring programme dealing with the identification, collection, reporting, and prevention of adverse events associated with the use of medical devices along with its possible management to safeguard patient health (Chauhan et al, 2019) . Every country has its own regulatory body and guidelines for monitoring and reporting of adverse events due to medical devices.…”

A global comparison of implementation and effectiveness of materiovigilance program: overview of regulations

“…Some of the authors have already produced some fantastic work in the past. Chauhan et al ( 2019 ) examined the risks involved with the use of various types of medical devices, as well as the necessity for a materiovigilance program, with a focus on medical device adverse event reporting. In addition, few papers (Meher 2018 ; Deshwal et al 2020 ; Hoda et al 2020 ) have summarized the concept and viewpoint of materiovigilance in India solely.…”

Regulatory approaches: Global medical device tracking advancement in USA, EU and India

“…Medical device tracking regulation pathway in US, EU and India. [10][11][12][13][14] Complete serial numbers of 97% valves were identified from the manufacturer's shipment and hospital records. Still, clinical records for 16% of valves were missing due to improper implantation centers record storage policy.…”

“…It created awareness among patients and healthcare professionals about benefits and harmful effects asociated with falsified, defected medical devices. 14 Currently, lot no., batch no., assigned by the manufacturer to medical devices are used to track their movement. Manufacturers must keep a record of adverse events, complaints received by healthcare professionals related to medical devices.…”