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

Abstract

Medical devices, being life-saving tools, are considered to be a boon for healthcare system. However, in addition to their therapeutic effects, there are several ill consequences that are caused by these devices. An effective cohort vigilant system was needed to manage such adverse effects. This had led to the introduction of materiovigilance. Materiovigilance is the study and follow-up of occurrences that arise as a result from the usage of the medical equipment. It not only manages adverse events (AE) but also creates harmonization among countries. Keeping these objectives in focus, the principles, perspectives, and practices with regard to materiovigilance that are followed in the USA, Europe, China, Japan, Australia, Canada, and India are being compared. Such a comparison is essential, which will help us to understand the gaps in the current regulatory systems in the above-mentioned countries and furthermore will provide a comprehensive picture to the regulatory authorities to amend any existing laws if required. These amendments may ensure optimal patient safety by providing them a benign experience from the use of medical devices.

Materiovigilance in Perspective: Understanding Its Concept and Practice in the Global Healthcare System

“…Pharmacovigilance (Pv) is a science dealing with the continuous identification, assessment, evaluation, and prevention of acute and chronic adverse reactions caused by newly launched and already marketed medicines [5][6][7][8][9][10]. Pv these days also covers drug therapy-related problems (DTRPs) shown by herbals, traditional, complementary, and alternative medicines (TCAMs), biologicals and blood products, medical devices, and vaccines [6,11,12].…”

“…Thus, like all medicines, all medical devices may also have certain risks. Therefore, monitoring the safety of these devices helps withdraw dangerous or potentially dangerous devices from the market and eliminate defects to improve their quality and performance standards [8,15].…”

“…The International Medical Device Regulators Forum (IMDRF), comprising 10 countries, such as the USA, Japan, EU, China, South Korea, and India, was set up in 2011 to introduce the concept and implementation of the Mv program to monitor medical devices associated adverse events (MDAEs) and to harmonize international medical device regulation via Mv [8]. The materiovigilance program of India (MvPI), launched on July 6, 2015, helps to systematically collect safety data on device use from Indian population, to monitor MDAEs, to raise awareness among health professionals on their reporting, to monitor benefits versus risks, to generate evidence-based suggestions on safety, and to communicate findings to the stakeholders and regulatory authorities [2,14,15,17].…”

Materiovigilance Programme of India

“…Another company under the name of Medtronic Inc. was engaged to pay $2.8 million dollars as compensation to a patient as health-care system was bribing the doctors by giving monthly bonus to use faulty and malfunctioned medical equipment making the treatment way too expensive. [ 19 ]…”

Comparative Materiovigilance Program for US, Europe, Japan, India and Proposed Reporting Mechanism for Indian Scenario

“…This will increase global demand and spur scientific innovation. 3 Harmonization is a crucial initiative that shortens the time needed for these from the market but also enables companies to address and rectify any underlying flaws. This would raise the caliber of the gadgets, ensuring patient and consumer safety.…”