A Questionnaire-Based Study to assess Knowledge, Attitude, and Practice of Materiovigilance among practicing Interns in a Tertiary Care Hospital, North Karnataka

Abstract

BACKGROUND; Materiovigilance is the study and follow up of incidents that might result from the use of medical devices. It enables to identify the adverse events associated with the use of medical devices. Ministry of Health & Family Welfare, Govt. of India approved and commenced Materiovigilance Programme of India (MvPI) in the country in order to monitor the safety of Medical Devices Associated Adverse Events (MDAEs) in Indian Population. The study aims to assess the knowledge, attitude, and practice of spontaneous reporting of MateriovigilanceofInternsinatertiarycarehospitalandaspire to find effective ways to encourage, educate, and equip them to improve the quality and accuracy of spontaneous medical devices associated adverse events reporting in a hospital set up. OBJECTIVES: To assess the knowledge, attitude, and practice of materiovigilance among Interns in a tertiary care hospital. MATERIALS AND METHODS: Thiswasan observational, cross-sectional, and questionnaire-based study.Datawere collected from willing participants among the practicing Interns from the tertiarycare centre, Bidar using google forms. Data were entered into the Microsoft Excel sheet. The statistical analysis was carried out using Microsoft Excel 2021. Categorical data were presented as numbers and percentages, while continuous data were presented as mean ± standard deviation. RESULTS: Out of 120 participants, 63 have scored <80% and 57 have scored > 80% in knowledge aspect of materiovigilance. Around 92.5% thought that MDAE reporting should be compulsory and 87.5% of participants were willing to report. But 64.2% of participants mentioned that they haven’t been trained on how to report a MDAE and 63.3% haven’t seen a MDAE form. CONCLUSION: From this study we observe that the young doctors had adequate knowledge and positive attitude regarding materiovigilance. But the practice of reporting MDAE was lacking. Hence, sensitization of materiovigilance is necessary on a periodical basis through conferences and CMEs.