In healthcare sector, medical devices are playing crucial role by serving diverse functions, like diagnosis, prevention, monitoring, treatment, alleviation of diseases or injuries, etc. Medical devices are being used in different settings, from home-based systems to clinics and advanced medical facilities. These diversified benefits of medical devices are accompanied with the risks arising from inappropriate use or misuse of device. These risks can be minimized, mitigated or eliminated by adopting effective human factors engineering.
“人为因素工程”是什么意思？
在医疗设备领域，人为因素工程是工程学的一个分支，它基于从人类的心理和生理特征收集的数据来处理医疗设备和系统的开发。它需要彻底考虑人类行为，用户的局限性，用户能力以及有关使用医疗设备的其他相关方面。
这些工程方面的人为因素旨在确保该设备可以安全地使用，同时最大程度地利用临床益处。它强调以一种方式以一种方式工程，以减少用户犯错或不正确使用设备的潜力，尽可能低。人力因素工程是EUMDR的至关重要的一部分，而设计设备文档需要根据EUMDR要求创建。CE Mark医疗设备顾问我们指导制造商创建CE技术文件。
人为因素工程在医疗设备中的重要性
人为因素工程过程的主要目标是最大程度地提高安全性和临床益处。在医疗设备上应用人为因素的特定好处如下：
- It improves effectiveness and efficiency of a medical device
- 它促进用户满意度和可持续性
- Expands the market for a new medical device by considering potential users of the device
- 它减少了用户对用户手册的依赖性
- It reduces need of user training
- 它有助于降低不良事件的风险
- It reduces overall risk of product recalls following safety issues
- 它促进了更好的用户体验，进而为市场上的竞争对手带来优势
- It ensures long term profitability through better user experience
- 它有助于在设备组件和配件之间建立更安全的连接
- 它改善了用户界面的经验
- 它提高了用户对设备状态和操作的理解
- 它提高了用户对患者医疗状况的理解
- It facilitates more effective alarm signal management
- 它有助于创建用户界面，以鼓励自由使用医疗设备
EU MDR 2017/ 745 Requirements on Human Factors Engineering
欧盟MDR附件I中规定的一般安全和绩效要求涵盖了与设备的可用性有关的方面。
- 附件I指出的第一个一般要求，”设备应实现其制造商打算的性能，并应设计和制造，以便在正常使用条件下它们适合其预期目的。他们应安全有效，不得损害患者的临床状况或安全性，或者在适用其他人的情况下，如果称重时可能与其使用相关的任何风险构成可接受的风险反对对患者的益处，并考虑到公认的最新状态，与对健康和安全的高水平兼容。” Here, emphasis has been given on the use of medical device in such a way that safety and health of both patient’s and user’s is ensured. Additionally, this requirement also gives consideration to the “other persons”, which may include people who interact with the device but do not directly use it, e.g., machine technicians.
- 一般安全性和性能需求3 (c)ates that, “estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse.” To establish compliance with this requirement, adopted usability engineering and risk management process must address the estimated level of risk associated with the use of device. Human factors engineering process is closely linked with risk management process, it evaluates, mitigates and eliminates usability induced use errors that could impose risks for patients and/or users. Usability studies should be performed by considering reasonably foreseeable hazards associated with use scenarios.
- 一般安全和绩效要求5（a）和5（b）通过考虑设备的人体工程学特征以及技术知识，经验，教育，对用户的培训和使用环境，强调了与使用错误有关的风险。可用性工程流程应量身定制，以通过考虑此一般安全性和性能要求中涵盖的方面来满足这些要求。
International Standards on Human Factors Engineering
Recognized standards provide support to comply with General Safety and Performance Requirements quoted in the EU MDR 2017/745. In Europe, EN 62366-1 is the harmonized human factors engineering standard. Compliance with this standard provide evidence of conformity with the requirements of MDR. This standard offers standardized processes for analysis, development and evaluation of usability of medical device. As amedical device regulatory consultant, we make sure that the devices produced by the manufacturer will comply with the correct regulations and manufacturers will not face any issue.
