Challenges encountered by health care professionals in monitoring adverse events due to medical devices: A review

Abstract

Materiovigilance is the term used to characterize any negative outcomes brought on by a medical device. The "Materiovigilance Programme of India" is a plan that has been launched in India to track the unfavorable outcomes of the use of medical devices and to take the necessary action to resolve those unfavorable outcomes. On July 6, 2015, DCGI adopted MvPI at the Indian Pharmacopoeia Commission in Ghaziabad. Factors contributing to underreporting of MDAE are Health care system capacity related, Organizational related barriers, and Industry responsiveness. Challenges faced by healthcare professionals in reporting MDAE are administration, healthcare professionals, self-implementation of devices, counter-fit devices, and poor awareness. This approach might offer helpful data for purchasing decisions, and support quality and safety management in hospitals. The present evidence base is of low quality, and there isn't a framework to report error-causing elements, which limits the possibility of learning from mistakes.