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Medical device adverse incident reporting in interventional radiology

机译:介入放射学中的医疗器械不良事件报告

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Aim To investigate the current situation concerning adverse incident reporting by members of the British Society of Interventional Radiology (BSIR). Materials and methods A survey of the members of the BSIR was conducted between November 2012 and January 2013. The survey contained questions on the reporting of adverse incidents and attitudes to the reading of "Instructions for Use" for new devices. Results The majority of the 119 members who completed the survey had experienced an adverse incident relating to the use of a device. Around 75% of respondents reported adverse incidents locally with only 42% reporting directly to the Medicines and Healthcare products Regulatory Agency (MHRA), which was explained by both a lack of time and a lack of awareness regarding mechanisms of reporting directly to the MHRA. Conclusion Adverse incidents related to the unexpected failure of medical devices have been experienced by the majority of interventional radiologists. The majority of these are reported, but there is significant confusion as to where and how these should be reported. Improvements in the number and quality of adverse incidents reported requires better education, avoidance of duplication of work, and improved feedback after reports have been made to ensure the delivery of high-quality, safe patient care.
机译:目的调查英国介入放射学会(BSIR)成员有关不良事件报告的现状。材料和方法在2012年11月至2013年1月之间对BSIR成员进行了调查。该调查包含有关不良事件的报告以及对阅读新设备的“使用说明”的态度的问题。结果完成调查的119位成员中,大多数经历了与使用设备有关的不良事件。大约75%的受访者在当地报告了不良事件,只有42%的受访者直接向药品和医疗产品监管局(MHRA)报告,原因是时间不够,而且对直接向MHRA报告的机制缺乏了解。结论大多数介入放射科医生都经历了与医疗设备意外故障相关的不良事件。其中大多数已报告,但在何处以及如何报告这些报告方面存在重大混乱。为了提高所报告的不良事件的数量和质量,需要更好的教育,避免重复工作,并在完成报告后改善反馈,以确保提供高质量,安全的患者护理。

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