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

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Authors: Cron RQ, Chatham WW Abstract The novel coronavirus (SARS-CoV-2) pandemic has spread rapidly throughout the planet. It is believed to have originated in the Wuhan province of China, but this highly contagious respiratory virus has spread to over 140 countries on 6 continents as of mid-March 2020 according to the World Health Organization (WHO). Worldwide, there have been over 164,000 cases identified and over 6,500 deaths attributed to the viral infection. As of March 15, 2020, there are over 3,700 confirmed cases and 68 deaths ascribed to Covid-19 (the disease caused by SARS-CoV-2) in the United States [ht...
Source: Journal of Rheumatology - Category: Rheumatology Tags: J Rheumatol Source Type: research
Authors: Consalvo V, D'Auria F, Salsano V Abstract BACKGROUND: Chronic pain still occurs in 10-12% of patients who undergo surgical groin hernia repair. Considering the high prevalence of this pathology, we performed a single-center prospective study comparing the laparoscopic trans-abdominal pre-peritoneal (TAPP) approach to the standard surgical open technique for primary uncomplicated hernia repair. METHODS: A prospective cohort of 278 patients was extracted from our dataset: 121 received a laparoscopic TAPP approach, and 157 were treated by the Lichtenstein technique in case of inguinal hernia or by the dep...
Source: Surgical Technology International - Category: Surgery Tags: Surg Technol Int Source Type: research
Publication date: Available online 26 March 2020Source: Life SciencesAuthor(s): Krista Minéia Wartchow, Leticia Rodrigues, Lílian Juliana Lissner, Barbara Carolina Federhen, Nicholas Guerini Selistre, Aline Moreira, Carlos-Alberto Gonçalves, Patrícia Sesterheim
Source: Life Sciences - Category: Biology Source Type: research
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Source: Biological Control - Category: Biology Source Type: research
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Source: Medscape Critical Care Headlines - Category: Intensive Care Tags: Infectious Diseases News Source Type: news
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Source: Genetics and Molecular Biology - Category: Genetics & Stem Cells Source Type: research
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Source: SafetyLit - Category: International Medicine & Public Health Tags: Commentary Source Type: news
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Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Infants and Children Source Type: news
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Source: Science - The Huffington Post - Category: Science Source Type: news
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Source: Journal of Spinal Disorders and Techniques - Category: Surgery Tags: Primary Research Source Type: research
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