Awareness and outlook of health-care professionals regarding materiovigilance in a tertiary care teaching hospital in South Rajasthan

ABSTRACT

Background: Post-marketing surveillance regulates the safety, quality, and performance of medical devices (MDs). Medical professionals play a key role in the monitoring and reporting of MD Adverse Events (AEs). Since the launch of Materiovigilance (MV) Programme of India, very few published studies were found regarding reporting of MDAE. Aim and Objective: This study aims to know about awareness and outlook of medical professionals regarding MV. Materials and Methods: A cross-sectional study done among medical professionals of various specialties in a tertiary care teaching hospital in South Rajasthan. A pre-validated questionnaire was circulated to 200 doctors containing questions related to knowledge, attitude and practice of MV. Results: About 58.6% of the doctors came to know about the term MV during this study. About 76.7% of participants knew that MD could lead to an AE, but only 11.2% of the participants had the correct knowledge of how to report an AE related to MD. About 66.8% of participants had positive attitude regarding reporting of AE, 23.7% reported the event and 66.6% did not report as they found them mild. Conclusion: Majority of doctors had the knowledge about reporting of AEs, but they were largely unaware of the term MV. Knowledge regarding where to report is very limited. Despite adequate level of knowledge, reporting practices are very limited. Hence, there is a need for regular sensitization and training programs to foster the habit of reporting AE related to MD even if they are mild.