Knowledge, Attitude, and Practice of Materiovigilance Among Healthcare Professionals at a Tertiary Care Teaching Hospital.

Objective This study aimed to assess the knowledge, attitudes, and practices (KAP) of materiovigilance among healthcare professionals (HCPs) at a tertiary care teaching hospital in South Gujarat, India. Specifically, it sought to identify gaps in current understanding and reporting practices related to adverse events associated with medical devices. Introduction Materiovigilance, the systematic monitoring and assessment of adverse events related to medical devices, is crucial for ensuring patient safety and enhancing device performance. In India, the Materiovigilance Programme of India (MvPI) under the Ministry of Health and Family Welfare oversees the safe use of medical devices, integrating them with the pharmacovigilance framework. Despite these efforts, challenges persist in awareness, reporting practices, and the integration of materiovigilance among healthcare professionals. The knowledge, attitude, and practice (KAP) of these professionals are pivotal for effective adverse event reporting, but underreporting due to a lack of awareness, inadequate training, and perceived administrative burden remains a significant barrier. The study underscores the importance of training programs, improving reporting infrastructure, and fostering a safety culture within healthcare institutions to enhance the effectiveness of materiovigilance in India. Methodology An observational, cross-sectional study was conducted using a questionnaire-based approach. A total of 215 HCPs, including consultant doctors, resident doctors, and nursing staff, participated in the study. The questionnaire covered aspects of knowledge regarding the Materiovigilance Programme of India (MvPI), classification of medical devices, attitudes towards adverse event reporting, and actual reporting practices. Data collection was carried out electronically over the course of one month using Google Forms (Google LLC, Mountain View, California, United States). Results Among the participants, 135 (62.79%) correctly identified MvPI as the program for monitoring adverse events caused by medical devices. A majority of 188 (87.44%) understood that medical devices in India are classified based on a risk-based approach. Positive attitudes towards reporting adverse events were prevalent, with 202 (93.95%) acknowledging the potential for adverse events from medical devices and agreeing on the importance of reporting. However, a significant gap was noted between noticing adverse events (138 participants, 64.19%) and actual reporting (60 participants, 27.91%), indicating a need for improved reporting practices. Only 104 participants (48.37%) had participated in workshops or continuing medical education (CME) sessions on medical device safety. Conclusion The study reveals a strong foundation of knowledge and positive attitudes towards the materiovigilance among HCPs in South Gujarat. However, there is a notable discrepancy between awareness and actual reporting practices. To enhance the effectiveness of materiovigilance, interventions such as targeted educational programs and simplification of reporting procedures are recommended. These efforts are essential to ensure timely detection, reporting, and management of adverse events related to medical devices, thereby enhancing patient safety and overall healthcare quality.