Knowledge, Awareness and Practice of Materiovigilance among Healthcare Professionals in a Tertiary Care Hospital of Eastern India: A CrossSectional Observational Study

Background: Medical devices are an essential part of modern health care. Despite that there are instances where their uses caused significant morbidity and mortality in the users. So, it is necessary to assess the risk and benefit associated with devices at all stages of development and uses. Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices. Although medical faculties and residents are major stake holders in reporting adverse events related to medical devices at present there are very few published data about their knowledge attitude and practice regarding materiovigilance in India. This study was conducted with an objective to assess the knowledge, attitude and practice of materiovigilance amongst the doctors in a tertiary care teaching hospital of Eastern India. Methodology: This is a cross-sectional questionnaire based observational study. The questionnaire containing 15 questions is made in Google forms and were distributed to all the doctors of this hospital. Among 135 doctors, 125 doctors have answered and the recorded responses have been statistically analysed. Results: Among the responders approx. 74% were not aware of the ongoing program for monitoring adverse events due to medical devices. Despite 46.8% responders facing adverse events relating to medical devices 32.5% of participants have actually seen the reporting form and only 18.4% reported the events. Conclusion: More awareness drive is needed to fulfil the lacunae in the knowledge regarding adverse events related to medical devices