A cross-sectional study to assess the knowledge, attitude, and practice of health-care professionals regarding reporting of medical device-related adverse events in a tertiary care center

Abstract

Background: Medical device-related adverse events (MDAEs) are associated to have serious consequences on consumers; therefore, post-marketing surveillance is essential to ensure the quality and evaluate the safety and performance of medical devices. The first step toward achieving this is awareness about materiovigilance and MDAEs among health-care professionals. Aim and Objective: The aim of this study was to assess the knowledge, attitude, and practice of health-care professionals (HCPs) toward MDAEs and its reporting. Materials and Methods: Details and purpose of the study were explained to the health-care professionals and informed consent with questionnaire was sent to the participant through Google forms link, through Email, or WhatsApp. The questionnaire consisted of 17 questions in total. Results: Among the HCPs (n = 243) the knowledge level was 67.7% indicating moderate levels of knowledge. About 90% of participants think that medical devices can cause adverse event in patients and 78% think that it is a professional obligation to report them. About 70% of HCPs observe their patients for MDAEs; nonetheless, only 28% have reported them. Conclusion: Healthcare professionals in our tertiary care center have moderate knowledge and positive attitude toward materiovigilance and MDAEs reporting, but, unfortunately, the actual practice of MDAE reporting is still deficient among them. Therefore, the study suggests that there is need for interventional education and training to improve the knowledge and reporting.