Study on knowledge, attitude and practice of materiovigilance among healthcare professionals in south India

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Paul., Liz
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Recently medical devices have been widely used. However, there were several incidents of medical device adverse events across the globe which were even life-threatening. Materiovigilance involves the identification, monitoring and prevention of medical device adverse events. In India, hip implant adverse events and deaths due to incubators led to the implementation of Materiovigilance Programme of India (MvPI). The healthcare professionals must have sufficient knowledge and awareness for proper practice of materiovigilance to ensure patient safety. The research objective was to evaluate the level of knowledge, attitude and practice of materiovigilance among doctors, dentists, nurses and pharmacists in South India and to explore the gaps in the current materiovigilance process. The study identifies strategies and recommendations to improve the process. The study was conducted using a quantitative survey-based method, using a questionnaire prepared in Google Forms. The survey link was shared with healthcare professionals and the participants were sampled randomly. 210 healthcare professionals responded to the survey. The data was analyzed statistically using SPSS software. Only 37.8% of participants were aware of the Materiovigilance Program of India (MvPI). The knowledge about the reporting process and materiovigilance regulations was very low. However, the participants had a high positive attitude. Medical device adverse events were reported by 15% of participants and 98.2% were not trained in materiovigilance. Overall, the participants had below average knowledge and the practice of materiovigilance was very poor among healthcare professionals in South India. A positive correlation of 0.288 with a P value <0.001 was identified between knowledge and practice using the Pearson correlation test. The knowledge, attitude and practice scores among healthcare professionals were compared using Kruskal-Wallis test. The main gaps in the process were lack of training and lack of knowledge of reporting processes and the participants suggested further training and education. The present study focused on opinions for improvement from the healthcare professionals themselves which could be implemented practically by the hospitals or regulatory bodies. Future research could be based on activities to improve the knowledge and practice of materiovigilance

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