Awareness, Attitude, and Practice of Materiovigilance Among Healthcare Professionals – A Cross-Sectional Study
Abstract
Background: The methodical identification and avoidance of medical device-associated adverse events (MDAEs) is known as "Materiovigilance." The Materiovigilance Programme of India (MvPI) was established in 2015. Despite its importance, reporting of MDAEs remains suboptimal across healthcare settings in India. Objectives: To evaluate knowledge, attitude and practice (KAP) regarding materiovigilance and identify barriers in reporting MDAEs among healthcare professionals. Materials and Methods: This cross-sectional study was approved by the ethics committee (SDUAHER/R&D/CEC/SDUMC-PG/194/NF/2025-26). A validated 25-item questionnaire with Cronbach's α = 0.7 was distributed as Google Forms. The questionnaire comprised sociodemographic data and questions on KAP domains. Knowledge was scored by giving 1 point for each correct answer, attitude and practice using yes/no response. Chi-square, t-test and Pearson’s correlation tests were used. Results: Among 1,012 participants, females 68.6% and 31.4% males. Faculty 35.2% and 64.8% students, medical (54.4%) and paramedical (45.6%). Overall knowledge score was 6.38±1.89. Faculty had significantly higher scores in knowledge (7.02±1.49 vs. 6.02±1.98; p=0.001), attitude (5.66±0.79 vs 5.53±0.95; p=0.01), and practice (0.60±1.48 vs 0.31±0.46; p=0.001). There was no significant difference in medical and paramedical professionals with respect to knowledge (χ²=0.26, p=0.60), attitude (χ²=0.00, p=1.00) and practice (χ²=0.26, p=0.60). A strong positive correlation existed only between knowledge and attitude (r = 0.28, p < 0.001). 67% had never encountered MDAE, and only 4.2% had undergone formal training. Lack of knowledge on how/where to report were barriers for reporting MDAEs. Conclusion: Faculty had better knowledge, there was no difference among disciplines. Knowledge was positively correlated with attitude but a gap existed with actual. Targeted educational interventions are warranted.