KNOWLEDGE, ATTITUDE AND PRACTICE OF MATERIOVIGILANCE AMONG MEDICAL POSTGRADUATE STUDENTS

Aditi Bhandari
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Abstract

Objective: Medical devices have become an indispensable part of the healthcare system in recent times. A major shift towards increasing demand and supply of devices has led to an increase in the number of adverse effects being reported from across the world. “Materiovigilance” (MV) is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of a patient's health by preventing its recurrences. Post-Graduate medical students play a key role in reporting and management of any adverse events associated with medical devices in patients. Therefore, this study was conducted to assess the knowledge, attitude and practice regarding Materiovigilance among the residents. Methods: A cross-sectional observational study was conducted among the Post graduate students of a tertiary care government institute of Southern Rajasthan. A pre-validated questionnaire comprising of 18 questions pertaining to knowledge, attitude, and practice of Materiovigilance was used. Results: Out of 110 participants ongoing programme 73.6% knew about an ongoing programme on Materiovigilance, 29.6% have been trained about MV while 70% consider reporting its ADR necessary, while 6.6% have reported ADRs caused by devices in their department. Conclusion: A large section of PG students was aware of the term “Materiovigilance,” but they need to be provided with more knowledge about the concept and its reporting. The attitude is positive but regular practice of reporting needs to be developed. Educational interventional programmes are required to promote Materiovigilance and ADR reporting due to medical devices in day-to-day practice.
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医学研究生对药物警戒的认识、态度和实践
目的:近年来,医疗器械已成为医疗保健系统中不可或缺的一部分。医疗器械的供求关系发生了重大变化,导致世界各地报告的不良反应数量增加。"材料警戒"(MV)是一个协调系统,用于识别、收集、报告和分析与使用医疗器械相关的任何不良事件,并通过防止其再次发生来保护病人的健康。医科研究生在报告和管理任何与医疗器械相关的患者不良事件方面发挥着关键作用。因此,本研究旨在评估住院医师对医疗器械安全的认识、态度和实践:方法: 在拉贾斯坦邦南部一家政府三级医疗机构的研究生中开展了一项横断面观察研究。研究使用了一份经过预先验证的调查问卷,其中包括 18 个与 "药物警戒 "的知识、态度和实践相关的问题:结果:在 110 名参加正在进行的计划的人员中,73.6% 的人知道有一个正在进行的药物警戒计划,29.6% 的人接受过关于 MV 的培训,70% 的人认为报告 ADR 是必要的,6.6% 的人报告过他们所在科室的器械引起的 ADR:结论:大部分研究生都知道 "药物警戒 "一词,但需要向他们提供更多有关这一概念及其报告的知识。他们的态度是积极的,但需要培养定期报告的习惯。需要开展教育干预计划,在日常实践中推广 "本品警戒 "和医疗器械所致不良反应报告。
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