Awareness Regarding Medical Device Safety among Physicians: A Knowledge, Attitude, and Practice Survey

Background: With the huge inflow of medical devices into the healthcare market, it is imperative to monitor the device's safety throughout its period of usage with the help of a systematic, continuous surveillance mechanism.Though the Materiovigilance program of India has been formally introduced since 2015, there exists a dearth of awareness regarding its existence and functioning among the major stakeholders in patient safety.Addressing this gap, the study probes the awareness regarding materiovigilance among the doctors in eastern India.Methods: A cross-sectional questionnaire-based study was carried out using a 20-item structured survey tool to evaluate the knowledge, attitude, and practice of medical professionals regarding the safety surveillance of medical devices.The responses obtained were statistically analyzed and interpreted.Results: The principal elements of medical device events (MDAE) reporting were known to around 40% of respondents.However, the timeframe for reporting an event/incident was found to be grossly unclear.Over 30% of respondents were aware of the effect of MDAEs and that their reporting could enhance patient safety.Items related to practice domains revealed that although around 50% of respondents in either category encountered MDAEs in their practice setup, only 10.95% of faculty and 6.41% of residents have reported it.Less than 5% of the respondents were ever trained on how to report MDAEs.The mean domain score for knowledge was on higher mark for the faculty, while that for attitude and practice domains was higher for the residents.Conclusion: There was a significant lack of awareness regarding materiovigilance among the doctors.Enhanced sensitization regarding medical device safety surveillance at all healthcare levels can definitely help the situation by ensuring patient safety.