Leveraging artificial intelligence to revolutionize medical device safety

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.