Abstract
Abstract Background: With the huge inflow of medical devices into the healthcare market, it is imperative to monitor the device safety throughout its period of usage, with the help of a systematic continual surveillance mechanism. Although 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 of 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 safety surveillance of medical devices. Responses obtained were statistically analyzed and interpreted. Results: Principal elements of medical device adverse event (MDAE) reporting were known to around 40% of respondents. However, the time frame for reporting an event/incident was found to be grossly unclear. Over 30% of respondents were aware of the effect of MDAEs and that its reporting could enhance patient safety. Items related to practice domains revealed that although around 50% of respondents of 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 were higher for the residents. Conclusion: There was a gross dearth of awareness regarding materiovigilance among the doctors. Enhanced sensitization regarding medical device safety surveillance in all healthcare levels can definitely help the situation ensuring patient safety.
Published Version
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