Exponent : Update to Human Factors Engineering Guidance Coming Soon
March 25, 2024 at 01:25 pm EDT
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Major revision to human factors engineering guidance for the design of medical devices slated for release later this year
In February 2024, the Association for the Advancement of Medical Instrumentation (AAMI) and the Food and Drug Administration co-sponsored the inaugural AAMI Nexus Medical Device Standards Conference, discussing a variety of standards-related topics, including upcoming revisions to current standards, guidance, and recommended practice documents.
According to AAMI members and contributors to HE75, which guides human factors usability engineering standards, a major revision to ANSI/AAMI HE75:2009/(R)2018 Human factors engineering - Design of medical devices is expected to be released later this year. This recommended practice document provides medical device manufacturers with information on fundamental practices for human factors engineering and design guidance for medical devices.
Consistent with FDA's 2016 Human Factors Guidance, the updated HE75 is expected to focus on identifying and mitigating "use error" in the design and risk assessment of medical devices. Currently, FDA recognizes the majority of HE75, with the exception of Section 5, which discusses usability testing, but the agency is expected to recognize the 2024 revision in its entirety.
The conference session leaders also indicated that the 2024 HE75 document will include significant revisions and updates, with each section featuring approximately 40-50% new content based on guidance from multiple human factors documents, including AAMI TIR 51 (Human Factors Engineering - Guidance For Contextual Inquiry) and AAMI TIR 59 (Integrating Human Factors Into Design Controls).
Overall changes to the HE75 document are expected to include improvements such as consistent terminology and formatting, updated references, improved illustrations, and greater clarity. Key updates to specific sections are anticipated as follows:
Section
Topic
Key changes
5
Managing the risk of use error
Consistency with FDA/CDRH 2016 Human Factors Guidance document
8
Environmental, organizational, and structural issues
Expands current section on use environment to include organizational and structural issues that may influence the use environment
9
Usability testing
Consistency with FDA/CDRH 2016 Human Factors Guidance document
Harmonization with ANSI/AAMI/ISO 62366 Parts 1 and 2
Anticipated to be recognized by FDA
10
On-device labeling
Consistency with international standards including ISO 15223 and ISO 7010
11
Instructional and training material
Expands user documentation types discussed
Includes information about modern technologies such as digital labeling, QR codes, embedded instructions, quick reference guides, online videos, and websites
25
Devices used in non-clinical environments by laypersons
Expands the scope of the section beyond "home health care"
26
Integrated systems
New section
Provides guidance on human factors considerations related to device connectivity
27
Combination products
New section
Provides guidance for medical products meeting the FDA definition of combination products
For medical device manufacturers, incorporating the information expected in this update could help reduce the potential for use errors early in the design and development process. The updated document is also anticipated to provide a variety of tools to support:
Identifying initial design specifications based on human capabilities and limitations
Assessing usability and identifying use-related risks during the design process
Designing and executing human factors validation testing for premarket submissions
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25 March 2024 and is solely responsible for the information contained therein. Distributed by
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Exponent, Inc., together with its subsidiaries, is a science and engineering consulting firm. The Company serves clients in chemicals, construction, consumer products, energy, food, beverage and nutrition, government, life sciences, insurance, manufacturing, technology, industrial equipment, transportation, and other sectors. It provides engineering and scientific consulting services to clients around the world. Its service offerings are provided on a project- by-project basis. The Company has two segments: Engineering and Other Scientific, and Environmental and Health. The Engineering and Other Scientific segment is a service group providing technical consulting in different practices, primarily in engineering. The Environmental and Health segment provides services in the area of environmental, epidemiology and health risk analysis. This segment provides a range of consulting services relating to environmental hazards and risks and the impact on both human health and the environment.