Unveiling Healthcare Professionals’ Perspectives through a Knowledge, Attitude, and Practice Study on Artificial Intelligence in Materiovigilance – An Interventional Study

A BSTRACT Context: Materiovigilance ensures the safe use of medical devices by monitoring, detecting, and preventing adverse events associated with them. The integration of artificial intelligence (AI) into materiovigilance offers potential for enhanced real-time monitoring. However, healthcare professionals (HCPs) often exhibit gaps in knowledge, attitude, and practice (KAP) regarding AI in this domain. Aims: To assess and evaluate the change in KAP among HCPs regarding AI in materiovigilance before and after a structured educational intervention. Settings and Design: A pre-post interventional, questionnaire-based study was conducted among 80 HCPs at a tertiary care hospital. Subjects and Methods: A validated 24-item questionnaire was distributed via Google Forms. An information leaflet served as the intervention, designed using the BALD criteria and evaluated for readability (Flesch Readability Ease = 31, Flesch–Kincaid grade level = 10.5). Statistical Analysis Used: Pre- and postintervention data were statistically analyzed using the Wilcoxon signed-rank test, and effect size was measured using Cohen’s d . Results: The intervention led to significant improvements across all three domains. Awareness of materiovigilance rose from 53.75% to 97.5%, and knowledge about the Materiovigilance Programme of India increased from 62.5% to 100%. Positive attitudes towards AI’s role in reducing medical device-related errors improved from 47.5% to 100%. Practices such as participation in AI discussions and training showed significant gains ( P < 0.00001). Cohen’s d value of 1.10 indicated a large intervention effect. Conclusions: The educational intervention significantly improved HCPs’ KAP regarding AI in materiovigilance. Targeted training programs can bridge existing knowledge gaps and support AI integration in clinical device safety monitoring.