A Study on Knowledge, Attitude and Practice of Materio-Vigilance among Allied Health Students at A Tertiary Care Institute – A Cross Sectional Study

Authors

Dr Karthigayan A*; Dr Raja T.A.R; Dr Razia A.R; Dr Vijayalakshmi S; Dr Senthil G; Dr Renugadevi P Author

Keywords:

Medical devices, Medical device-associated adverse events (MDAEs), Materiovigilance.

Abstract

Background: Medical devices are necessary in the diagnosis, monitoring, and management of various diseases. Materiovigilance is the process to study and follow incidents that might result from using medical devices. Many allied health students are not aware of the current Materiovigilance Programme of India initiated by the Government of India to monitor medical device adverse events which is necessary to analyze benefit risk ratio and generate evidence based information on safety of medical devices (deficient pacemaker may risk the life of the patient).
Aim and Objective: The aim of the study is to assess the knowledge, attitude and practice of Materiovigilance among allied health students in a tertiary care hospital.
Material and Methods: It is a cross sectional study conducted among allied health students in a tertiary care institute, participants were selected through random sampling. A self-structured questionnaire was used containing 15 pre-validated questions with 5 questions on Knowledge, 4 based on Attitude and 6 based on Practice and their responses were recorded. Data’s collected were entered in Microsoft Excel and analyzed using SPSS version 23.0.
Results: Among the 125 study participants majority around 62.4% were females and rest were males. The mean age of participants was 20.1 ± 2.3 years ranging from 19 – 21 years. Among them 70 % had optimal knowledge on materiovigilance, 90% had positive attitude on MDAE and its reporting while only 32 % have implemented in their routine work .
Conclusion: The study participants lacked the necessary transitional knowledge and positive attitude to good practice of MDAE reporting. Therefore, it is essential to organize regular workshops and training sessions for students to improve their spontaneous reporting of MDAEs, taking into account these deficiencies and the many factors influencing MDAE reporting.