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首页> 美国卫生研究院文献>Cambridge Open Access >MEDICAL TECHNOLOGY AT HOME: SAFETY-RELATED ITEMS IN TECHNICAL DOCUMENTATION
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MEDICAL TECHNOLOGY AT HOME: SAFETY-RELATED ITEMS IN TECHNICAL DOCUMENTATION

机译：在家中的医疗技术：技术文档中与安全相关的项目

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>Objectives: This study aimed to investigate the technical documentation of manufacturers on issues of safe use of their device in a home setting.>Methods: Three categories of equipment were selected: infusion pumps, ventilators, and dialysis systems. Risk analyses, instructions for use, labels, and post market surveillance procedures were requested from manufacturers. Additionally, they were asked to fill out a questionnaire on collection of field experience, on incidents, and training activities.>Results: Specific risks of device operation by lay users in a home setting were incompletely addressed in the risk analyses. A substantial number of user manuals were designed for professionals, rather than for patients or lay carers. Risk analyses and user information often showed incomplete coherence. Post market surveillance was mainly based on passive collection of field experiences.>Conclusions: Manufacturers of infusion pumps, ventilators, and dialysis systems pay insufficient attention to the specific risks of use by lay persons in home settings. It is expected that this conclusion is also applicable for other medical equipment for treatment at home. Manufacturers of medical equipment for home use should pay more attention to use errors, lay use and home-specific risks in design, risk analysis, and user information. Field experiences should be collected more actively. Coherence between risk analysis and user information should be improved. Notified bodies should address these aspects in their assessment. User manuals issued by institutions supervising a specific home therapy should be drawn up in consultation with the manufacturer.
机译：>目标：该研究旨在调查制造商在家庭环境中安全使用其设备的技术文档。>方法：选择了三类设备：输液泵，呼吸机和透析系统。制造商要求进行风险分析，使用说明，标签和上市后监视程序。此外，还要求他们填写一份调查表，以收集现场经验，事件和培训活动。>结果：该风险未完全解决普通用户在家庭环境中操作设备的特定风险分析。大量的用户手册是为专业人员而不是为患者或非专业人士设计的。风险分析和用户信息通常显示不完整的一致性。上市后监视主要基于被动收集现场经验。>结论：输液泵，呼吸机和透析系统的制造商对在家中非专业人士使用的特定风险没有给予足够的重视。预期该结论也适用于其他在家治疗的医疗设备。家用医疗设备的制造商应在设计，风险分析和用户信息中更加注意使用错误，非专业用途和家庭特定风险。应更积极地收集现场经验。风险分析和用户信息之间的一致性应得到改善。公告机构应在评估中处理这些方面。监督特定家庭疗法的机构发行的用户手册应与制造商协商制定。

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