Why Human Factors Terminology Needs Updating

Conclusion IEC 62366-1 leaves a chasm between Normal Use and Abnormal Use, so manufacturers might not consider some user actions to be “Use Errors” if these actions do not fit the IEC 62366-1 definition of use. In other words, Use Errors may go undetected, unaddressed, or unmitigated. To protect users and manufacturers, this gap must be closed: IEC 62366-1 should be updated to address user actions that do not fit the current definitions of Normal Use nor Abnormal Use. To mend this gap in IEC 62366-1, we suggest to: Re-define Abnormal Use in terms of abuse. Remove Normal Use. Remove the “Relationships of the Types of Use” figure from the standard. Thank you to Xin Feng, Human Factors Reviewer at the FDA Center for Devices and Radiological Health, for initiating this discussion during the April 2019 IEC Committee 62A Joint Working Group 4 meeting in Geneva, Switzerland, and for laying the groundwork for this article. References Makary, Martin. 2016. “Medical Error—the Third Leading Cause of Death in the US.” BMJ353. IEC 62366-1:2015, “Medical devices – Part 1: Application of usability engineering to medical devices.” FDA 2016, “Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff.” IEC 623...
Source: MDDI - Category: Medical Devices Authors: Tags: Design Source Type: news