Knowledge and Attitudes of Healthcare Professionals Toward Medical Device Safety Reporting: A Cross-Sectional Study in Kerala, India
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2025
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| author | Divya Raj*1, Dilip C.2, Satish Pavuluri3 |
| author_facet | Divya Raj*1, Dilip C.2, Satish Pavuluri3 |
| contents | <p><span>Background: Medical device adverse events (MDAEs) pose significant threats to patient safety, yet underreporting remains a persistent challenge in healthcare systems worldwide. Understanding healthcare professionals' knowledge and attitudes toward materiovigilance is crucial for improving reporting practices. Objective: To evaluate the knowledge, attitudes, and perceptions of physicians and pharmacists regarding medical device adverse event reporting and identify barriers to effective materiovigilance implementation. Methods: A cross-sectional questionnaire-based study was conducted among 100 healthcare professionals (50 physicians and 50 pharmacists) in Ernakulam district, Kerala, India, from April to June 2023. A validated 19-item semi-structured questionnaire assessed knowledge of materiovigilance programs, reporting systems, and attitudes toward MDAE reporting. Results: Only 34% of physicians and 38% of pharmacists were aware of the ongoing Materiovigilance Program of India (MvPI). Significantly, 76% of physicians and 74% of pharmacists had never seen an MDAE reporting form. Despite limited awareness, 84% of physicians and 68% of pharmacists acknowledged that medical devices can cause adverse outcomes. Most participants (88% physicians, 94% pharmacists) recognized the importance of reporting adverse events for patient safety. Conclusion: Healthcare professionals demonstrate positive attitudes toward materiovigilance but lack adequate knowledge and training. Structured educational interventions and policy reforms are essential to enhance MDAE reporting and improve patient safety outcomes.</span></p> |
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| id | zenodo_https___doi_org_10_5281_zenodo_17907185 |
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| publishDate | 2025 |
| publisher | Zenodo |
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| spellingShingle | Knowledge and Attitudes of Healthcare Professionals Toward Medical Device Safety Reporting: A Cross-Sectional Study in Kerala, India Divya Raj*1, Dilip C.2, Satish Pavuluri3 Medical Device Adverse Events, Materiovigilance, Patient Safety, Pharmacovigilance, Healthcare Professionals, Reporting Systems <p><span>Background: Medical device adverse events (MDAEs) pose significant threats to patient safety, yet underreporting remains a persistent challenge in healthcare systems worldwide. Understanding healthcare professionals' knowledge and attitudes toward materiovigilance is crucial for improving reporting practices. Objective: To evaluate the knowledge, attitudes, and perceptions of physicians and pharmacists regarding medical device adverse event reporting and identify barriers to effective materiovigilance implementation. Methods: A cross-sectional questionnaire-based study was conducted among 100 healthcare professionals (50 physicians and 50 pharmacists) in Ernakulam district, Kerala, India, from April to June 2023. A validated 19-item semi-structured questionnaire assessed knowledge of materiovigilance programs, reporting systems, and attitudes toward MDAE reporting. Results: Only 34% of physicians and 38% of pharmacists were aware of the ongoing Materiovigilance Program of India (MvPI). Significantly, 76% of physicians and 74% of pharmacists had never seen an MDAE reporting form. Despite limited awareness, 84% of physicians and 68% of pharmacists acknowledged that medical devices can cause adverse outcomes. Most participants (88% physicians, 94% pharmacists) recognized the importance of reporting adverse events for patient safety. Conclusion: Healthcare professionals demonstrate positive attitudes toward materiovigilance but lack adequate knowledge and training. Structured educational interventions and policy reforms are essential to enhance MDAE reporting and improve patient safety outcomes.</span></p> |
| title | Knowledge and Attitudes of Healthcare Professionals Toward Medical Device Safety Reporting: A Cross-Sectional Study in Kerala, India |
| topic | Medical Device Adverse Events, Materiovigilance, Patient Safety, Pharmacovigilance, Healthcare Professionals, Reporting Systems |
| url | https://doi.org/10.5281/zenodo.17907185 |