Auto-injection devices must be easy and intuitive to use, especially in emergency situations. However, there are many reports of safety-related issues affecting auto-injectors and pen injectors, due to usability deficits. To minimize this type of problem, the identification of potential use errors is an important and critical task in usability engineering. The aim of this systematic, qualitative literature review was to identify and catalog use errors related to disposable auto-injection devices. The key terms “auto-injector”, “usability”, and “safety/errors” were used to search in the PubMed and Scopus databases for articles from peer-reviewed journals and conference proceedings published in English or French between 2000 and 2017. Use errors, close calls, and operational difficulties were identified, extracted and hierarchically classified. The analysis showed that of the 1415 initially identified publications, 38 met all the eligibility criteria. A qualitative analysis identified 232 instances of use errors and close calls, which were classified into 10 main categories and then 39 subcategories. The present results could be used to guide the design, evaluation and risk analyses of disposable auto-injection devices. Our approach is in line with the European Union’s latest regulations on improving the safety of medical devices - especially those concerning transparency and traceability.

中文翻译：

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改善一次性自动注射装置的安全性：对使用错误的系统评价

自动注射设备必须易于使用且直观易用，尤其是在紧急情况下。但是，由于可用性不足，有许多有关安全性问题的报告影响自动注射器和笔式注射器。为了最大程度地减少此类问题，识别潜在的使用错误是可用性工程中的重要任务。这项系统的，定性的文献综述的目的是识别和分类与一次性自动注射装置有关的使用错误。使用关键词“自动注射器”，“可用性”和“安全/错误”在PubMed和Scopus数据库中搜索来自同行评审期刊和会议论文集的文章，这些文章在2000年至2017年之间以英语或法语出版。错误，近距离呼叫和操作困难被识别，提取和分级分类。分析表明，在最初确定的1415个出版物中，有38个符合所有资格标准。定性分析确定了232个使用错误和关闭电话实例，这些实例分为10个主要类别，然后分为39个子类别。本研究结果可用于指导一次性自动注射装置的设计，评估和风险分析。我们的方法符合欧盟关于提高医疗设备安全性的最新法规，尤其是有关透明度和可追溯性的法规。本研究结果可用于指导一次性自动注射装置的设计，评估和风险分析。我们的方法符合欧盟关于提高医疗设备安全性的最新法规，尤其是有关透明度和可追溯性的法规。本研究结果可用于指导一次性自动注射装置的设计，评估和风险分析。我们的方法符合欧盟关于提高医疗设备安全性的最新法规，尤其是有关透明度和可追溯性的法规。