Assessment of knowledge, attitude, and practice towards materiovigilance among resident doctors and interns in a Tertiary Care Hospital of North-East India: a cross-sectional study

Background: Materiovigilance, the systematic identification, reporting, and analysis of medical device associated adverse events (MDAEs), is critical for patient safety. Despite the establishment of the Materiovigilance Programme of India (MvPI), underreporting remains a persistent challenge across the country. Objectives: To assess the knowledge, attitude, and practice (KAP) toward materiovigilance among resident doctors and interns in a tertiary care hospital of North-East India, and to identify key barriers to MDAE reporting. Methods: A cross-sectional questionnaire-based study was conducted from March to April 2025 among 312 resident doctors and interns using a pre-validated, 15-item tool adapted for local relevance. Data were analysed using SPSS version 29.0, applying descriptive statistics, Chi-square and Fisher’s exact tests, and multivariable logistic regression. Results: Participants (mean age 27.3 ± 3.2 years, 60.2% male) showed high awareness of MvPI (85.9%) and strong positive attitudes toward reporting (97.8%), but limited practical engagement, as only 6.7% had encountered an MDAE and 5.1% had ever reported one. Training exposure was extremely low (3.2%). Lack of training (60.3%) and inadequate protocol awareness (25.3%) were the main barriers. Residents demonstrated higher knowledge and reporting rates than interns (p < 0.001). On multivariable analysis, training attendance (AOR 21.31, 95% CI: 5.28–86.01, p < 0.001) and prior MDAE encounter (AOR 158.74, 95% CI: 7.99–3155.80, p < 0.001) were independent predictors of reporting behaviour. Conclusions: Although awareness and attitudes toward materiovigilance were high, translation into reporting practice was poor. Structured training, curricular integration, and strengthened digital reporting systems are essential to improve compliance with MvPI and ensure patient safety. Keywords: Materiovigilance; medical device adverse events; knowledge attitude practice; patient safety; post-marketing surveillance; healthcare professionals