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Leveraging artificial intelligence to revolutionize medical device safety

Hara Prasad Mishra1 ,  Kevil Loriya2 ,  Nupur Shah2 ,  Shubhima Grover3* ,  Smruti Sikta Mishra4
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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
INNOSC Theranostics and Pharmacological Sciences, 6204 https://doi.org/10.36922/itps.6204
Submitted: 18 November 2024 | Revised: 4 January 2025 | Accepted: 10 January 2025 | Published: 22 January 2025
(This article belongs to the Special Issue Advancing Medicine and Healthcare through Federated Learning)
© 2025 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
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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, real-time monitoring, and predictive analytics. This review explores the potential of AI in strengthening medical device safety, highlighting its benefits in enhancing patient safety, personalizing medical devices, and streamlining regulatory reporting. AI-powered systems can detect adverse events, predict patient deterioration, and provide personalized treatment plans, ultimately improving patient outcomes. Furthermore, AI enables the analysis of large and complex datasets, facilitating proactive decision-making and the early identification of emerging risks associated with medical devices. By automating routine tasks and improving accuracy, AI can significantly reduce the administrative burden on health-care professionals. In addition, AI can enhance post-market surveillance by identifying trends and anomalies in real time, thereby accelerating corrective actions. However, ethical and regulatory considerations, such as algorithmic biases, data privacy, and accountability, must be addressed to ensure the responsible development and implementation of AI in materiovigilance. Establishing robust regulatory frameworks, fostering transparency, and promoting interdisciplinary collaboration are essential to overcoming these challenges and fully realizing AI’s potential in health care.

Keywords
Materiovigilance
Artificial intelligence
Medical device safety
Patient safety
Medical devices
Funding
None.
Conflict of interest
The authors declare they have no competing interests.
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INNOSC Theranostics and Pharmacological Sciences, Electronic ISSN: 2705-0823 Print ISSN: 2705-0734, Published by AccScience Publishing
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