HE75 Standard Tapped as Vital New Practical Resource

Abstract

When Craig Mitchell used to have a specific design question about human factors, he would usually search on Google for resources.Now he plans to turn to AAMI's new human factors standard HE75, Human factors engineering—Design of medical devices, a virtual encyclopedia of human factors information and design specifics that was released earlier this year. The clinical engineers, biomedical equipment technicians, regulators, and students—covers a variety of topics, such as visual displays, software-use interface, packaging design, usability testing, and user documentation.The standard can help in the design of products, whether it's making a device easier to use or creating a better alarm.“I plan to use HE75 to validate new product design currently in development and as a resource for future decisions” says Mitchell, the user experience design manager for PatientSafe Solutions Inc. in San Diego.Although HE75 purchasers haven't been able to use the standard on new product development yet, they have already planned how HE75 will change existing processes regarding human factors and validation.“We are in the process of updating our design validation process flow, and are making adjustments based on information within HE75,” says Glen Wagner, director of design assurance with Intel Digital Health Group in Oregon.“The primary benefit so far is being able to use this document to build up the foundation of our human factors processes to ensure conformance with IEC 62366,i ” says Wagner. “There are many known good approaches to user interaction that can be applied in our products.”While many HE75 users are still getting familiar with the standard, they are confident about its benefits, including creating a “one-stop shop” of human factors information.