Materiovigilance Programme of India: Knowledge, Attitude and Practices Among Select Stakeholders of Tertiary Care

Background: Monitoring adverse events associated with medical devices (materiovigilance) is essential to guaranteeing patient safety. Healthcare professionals' (HCPs) knowledge and reporting of adverse events connected to medical devices remains low, despite the growing usage of these devices in healthcare. Objectives: To assess the knowledge, attitude, and practice regarding materiovigilance among healthcare professionals in a tertiary care teaching hospital. Methods: A study using a cross-sectional questionnaire was carried out with 380 medical personnel, including nurses, doctors, and consultants. Their materiovigilance knowledge, attitude, and practice were assessed using a pre-validated structured questionnaire. Data analysis was done using descriptive statistics. Results: Among the participants, 60% demonstrated good knowledge regarding the concept of materiovigilance, with awareness highest among doctors. While 89% agreed that reporting device-related adverse events is essential. Major barriers identified included a lack of awareness about reporting procedures and uncertainty about what constitutes a reportable event. Conclusion: The practice of reporting adverse occurrences was subpar, despite healthcare personnel demonstrating good attitudes and a moderate level of knowledge regarding materiovigilance. To enhance India's materiovigilance system, it is crucial to enhance training initiatives, increase awareness, and streamline reporting procedures.