Background:
Materiovigilance is an essential component for enhancing patient safety through proactive measures, including the correction and recall of medical devices, and medical residents are pivotal in reporting adverse events. Despite their critical role, there is a concerning scarcity of published research on the awareness, perceptions, and practices of these healthcare professionals regarding materiovigilance is scarce.
Aim:
This gap in data highlights the need for targeted educational initiatives to improve understanding and reporting practices among medical residents, ultimately fostering a safer healthcare environment.
Method:
This observational questionnaire-based cross-sectional study was conducted among postgraduates at a tertiary care institute. A total of 200 postgraduates participated in the study. The questionnaire covered aspects of knowledge regarding the Materiovigilance Program of India, the classification of medical devices, attitudes toward adverse event reporting, and actual reporting practices. Data collection was carried out electronically using Google Forms.
Results:
Among the participants, 186 (93%) correctly understood the primary objective of India’s materiovigilance program. A majority of participants 169 (84.5%) understood that medical devices in India are classified based on a riskbased approach. Positive attitudes toward reporting adverse events were prevalent, with 174 (87%) acknowledging the potential for adverse events from medical devices and agreeing on the importance of reporting. However, a gap was noted between noticing adverse events (88 participants, 44%) and actual reporting (45 participants, 22.5%), indicating the need for improved reporting practices. Only 32 participants (16%) had participated in workshops or continuing medical education (CME) sessions on medical device safety.
Conclusion:
Our study highlights the crucial need for increased awareness among medical professionals about the reporting of adverse events related to medical devices and the materiovigilance program. To effectively bridge this gap, it is vital to implement ongoing training initiatives, such as CME sessions and workshops led by the coordinators of Medical Device Adverse Event Monitoring Centres. These efforts can help ensure that healthcare providers are informed and equipped to prioritize patient safety and the responsible use of medical devices.
Key words: Adverse events, Materiovigilance, Medical devices, Knowledge, Attitude, Practice
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