Page 7 - ITPS-8-3

INNOSC Theranostics

and Pharmacological Sciences

REVIEW ARTICLE
Leveraging artificial intelligence to revolutionize

medical device safety

Hara Prasad Mishra 1 , Kevil Loriya 2 , Nupur Shah 2 , Shubhima Grover * ,
3
and Smruti Sikta Mishra 4
1 Koita Centre for Digital Health, Ashoka University, Sonepat, Haryana, India
2 Department of Medicine, Parul Institute of Medical Sciences and Research, Parul University,
Vadodara, Gujarat, India
3 Department of Pharmacology, Lady Hardinge Medical College, University of Delhi, Delhi, India
4 Department of Occupational Therapy, Pandit Deendayal Upadhyaya National Institute for Persons
with Physical Disabilities, New Delhi, India
(This article belongs to the Special Issue: Advancing Medicine and Healthcare through Federal
Learning)

Abstract

Materiovigilance is a crucial component of health-care policy designed to ensure
patient safety by monitoring and addressing safety issues associated with medical
devices. However, traditional systems encounter challenges related to timely
reporting, standardization, and the detection of adverse events. Artificial intelligence
(AI) has the potential to transform materiovigilance by improving data processing,
*Corresponding author: real-time monitoring, and predictive analytics. This review explores the potential
Shubhima Grover
(shugrover@gmail.com) of AI in strengthening medical device safety, highlighting its benefits in enhancing
patient safety, personalizing medical devices, and streamlining regulatory reporting.
Citation: Mishra HP, Loriya K,
Shah N, Grover S, Mishra SS. AI-powered systems can detect adverse events, predict patient deterioration, and
Leveraging artificial intelligence provide personalized treatment plans, ultimately improving patient outcomes.
to revolutionize medical device Furthermore, AI enables the analysis of large and complex datasets, facilitating
safety. INNOSC Theranostics
and Pharmacological Sciences. proactive decision-making and the early identification of emerging risks associated
2025;8(3):1-11. with medical devices. By automating routine tasks and improving accuracy, AI can
doi: 10.36922/itps.6204 significantly reduce the administrative burden on health-care professionals. In
Received: November 18, 2024 addition, AI can enhance post-market surveillance by identifying trends and anomalies
in real time, thereby accelerating corrective actions. However, ethical and regulatory
Revised: January 4, 2025
considerations, such as algorithmic biases, data privacy, and accountability, must
Accepted: January 10, 2025 be addressed to ensure the responsible development and implementation of AI in
Published online: January 22, materiovigilance. Establishing robust regulatory frameworks, fostering transparency,
2025 and promoting interdisciplinary collaboration are essential to overcoming these
Copyright: © 2025 Author(s). challenges and fully realizing AI’s potential in health care.
This is an Open-Access article
distributed under the terms of the
Creative Commons Attribution Keywords: Materiovigilance; Artificial intelligence; Medical device safety; Patient safety;
License, permitting distribution, Medical devices
and reproduction in any medium,
provided the original work is
properly cited.
Publisher’s Note: AccScience
Publishing remains neutral with 1. Introduction
regard to jurisdictional claims in
published maps and institutional The term “materiovigilance” refers to a coordinated system for detecting, gathering,
1,2
affiliations reporting, and analyzing adverse events associated with the use of medical devices.
Volume 8 Issue 3 (2025) 1 doi: 10.36922/itps.6204