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Do you need help in finding the best practices guidance in medical device human factors engineering? With the focus of good design being expanded to the entire product life cycle, the issue of insuring adequate medical device usability has taken on new importance. Here at Document Center Inc. our customers have been relying on two standards for this – ANSI/AAMI 75 and IEC 62366.
Human Factors Engineering (HFE) is a new and separate discipline within the medical device industry. It has evolved due to the high concentration of medical device incident reports and recalls involving use error. HFE includes all aspects of a device that users interact with when operating the product. It considers the interaction with the device by operators, maintainers, cleaners, caregivers, and patients. By providing adequate labeling, instruction, and ease of use, manufacturers can reduce use-associated risk.
IEC 62366 Edition 1.0 from 2007, “Medical devices – Application of usability engineering to medical devices,” focuses on the process of analysis, evaluation, and testing methods for developing safe and usable medical devices. It aims to improve usability by reducing design-induced error. Simply stated, IEC 62366 covers human factors design process — what needs to be done and when.
One important aspect in using the standard is the presumption of reduction of risk as defined in ISO 14971. If the usability engineering process detailed in the standard and the acceptance criteria documented in the usability validation plan have both been met, then the residual risks associated with usability of a medical device are considered to be acceptable, unless there is objective evidence to the contrary.
It is my understanding that if you already meet the IEC 60601-1-6, you have most of the requirements of the IEC 62366 already achieved. The document has been adopted for use in Europe as EN 62366: 2008.
ANSI/AAMI HE75-2009, “Human Factors Engineering—Design of Medical Devices,” covers the principles of HFE. The standard provides detailed human factors engineering design guidance, examples, checklists, and case studies. With 445 pages, and extensive illustrations, it is considered an encyclopedia of HFE for specific situations. It covers all aspect of design, from basic human skills and abilities to post-market issues. The standard is a powerful tool in all stages of the design life cycle.
These standards can all be purchased from Document Center Inc. at our website, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). As always, questions and comments are welcome.
