Knowledge, Attitudes and Practices Regarding Materiovigilance among Resident Doctors in a Tertiary Care Teaching Hospital

Abstract Background: Medical devices are commonly utilised in healthcare and can sometimes lead to medical device-associated adverse events (MDAEs) and compromise patient safety. The Materiovigilance Programme of India was instituted to monitor and record such instances; however, knowledge and reporting among healthcare personnel remains inadequate. Therefore, this study was conducted to analyse the knowledge, attitudes and practices (KAP) of materiovigilance among resident doctors and to determine the factors impacting the reporting of MDAE. Methods: A cross-sectional questionnaire-based study was undertaken among 210 resident doctors (1 st year to 3 rd year) working in a tertiary care teaching hospital in Navi Mumbai. Data were gathered using a pre-validated 15-item questionnaire to measure KAPs and factors affecting MDAE reporting. Descriptive and inferential statistics were performed using SPSS version 20. Results: Knowledge regarding Materiovigilance was poor in 32.86%, moderate in 49.52% and good in 17.62% of the participants. Overall, most of the residents had positive attitudes and views toward MDAE reporting, as 89.5% reported that it was important for patient safety. However, only 17.14% had ever witnessed an MDAE and just 11.1% had reported it. The main impediments found were lack of awareness of reporting procedures, ambiguity about reporting requirements and time constraints. Facilitators were easy access to reporting forms, simpler reporting systems and training programmes. Conclusion: Resident doctors demonstrated a positive attitude toward materiovigilance but had gaps in knowledge and reporting practices. Regular training, increased awareness and simpler reporting systems could improve MDAE reporting and patient safety.