Update to Human Factors Engineering Guidance Coming Soon

Equipment and medical devices in modern operating room

March 25, 2024

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:


SectionTopicKey changes
5Managing the risk of use error
  • Consistency with FDA/CDRH 2016 Human Factors Guidance document
8Environmental, organizational, and structural issues
  • Expands current section on use environment to include organizational and structural issues that may influence the use environment
9Usability 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
10On-device labeling
  • Consistency with international standards including ISO 15223 and ISO 7010
11Instructional 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 
25Devices used in non-clinical environments by laypersons
  • Expands the scope of the section beyond "home health care"
26Integrated systems
  • New section
  • Provides guidance on human factors considerations related to device connectivity
27Combination 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

What Can We Help You Solve?

Compliance with HE75 updates will likely require consideration of factors that may not have previously been included in the medical device design process. With Exponent's human factors and regulatory expertise, medical device manufacturers can integrate the guidance updates through usability evaluations, validation studies, use-related risk analyses, and regulatory support.