Medical devices are essential to modern healthcare, but their safety and effectiveness rely heavily on human factors engineering (HFE). HFE helps reduce use errors (a major source of harm), minimizes recalls (over 30% of which are linked to design issues). HFE prevents hospital admissions (with 1 in 20 errors being preventable), and enhances overall usability and safety. Given these impacts, it is no surprise that HFE is a regulatory requirement (mandated by bodies like the FDA and EU MDR) to assure safe and effective user interaction. ANSI/AAMI HE75:2025—Human factors engineering – Design of medical devices provides relevant and useful HFE information, design criteria, and guidelines for medical devices.
Understanding Human Factors Engineering (HFE) in Medical Device Design
Human factors engineering (HFE) involves the application of behavioral science and engineering methodologies to medical device design and evaluation. ANSI/AAMI HE75:2025 defines “Human factors engineering (HFE)” as the following:
“The application of knowledge about human capabilities (physical, sensory, emotional, and intellectual) and limitations to the design and development of tools, devices, systems, environments, and organizations.”
In regards to medical devices, HFE is the discipline of designing devices, interfaces, and packaging to assure safe, efficient, and intuitive use by minimizing errors and risks for patients and healthcare providers.
What Are the Changes in the 2025 Edition of ANSI/AAMI HE75?
The revised ANSI/AAMI HE75:2025 reframes human factors and usability as central drivers of safe and effective medical device design. By structuring user research, anthropometric data, use-related risk management and usability testing into a coherent framework, ANSI/AAMI HE75:2025 helps manufacturers reinforce their human factors dossiers in line with MDR and FDA expectations and design interfaces that reduce use error rather than merely detect it at the end of development.
What Is ANSI/AAMI HE75:2025?
ANSI/AAMI HE75:2025 addresses a broad range of human factors engineering (HFE) topics as they relate to the design and evaluation of medical devices. This American National Standard covers general HFE principles, specific HFE principles geared towards certain user-interface attributes, and applications of HFE to specific types of medical devices (e.g., hand tools). It emphasizes realistic test scenarios, representative users, and tasks derived directly from use-related risk analyses. ANSI/AAMI HE75:2025 can be used during every phase of device design and development, from initial conceptualization through post-market surveillance.
This standard does not provide detailed recommendations on all aspects of the human factors medical device design process.
Who Can Use ANSI/AAMI HE75:2025?
ANSI/AAMI HE75:2025 is expected to be useful to human factors and usability engineering specialists, software developers, industrial, biomedical, mechanical, and electrical engineers and other development personnel.
- Medical device manufacturers can use this document when designing and manufacturing their products.
- Health care facilities can apply the concepts in this document when evaluating devices, developing strategies to minimize use errors or analyzing use errors that have occurred.
- Regulators and other organizational entities can use this document to assess the design of medical devices both in isolation and as part of larger systems.
- Students can use this document to learn more about HFE and good practices in medical device design.
Other users might include clinical personnel and others who evaluate devices before purchase or after user errors have occurred, regulatory agencies, purchasing entities, and others interested in assessing the safety, effectiveness, and usability of medical devices. In sum, anyone with formal human factors training and expertise can use this standard document.
Why Human Factors Matter in Medical Device Design
Medical errors can have serious consequences as poorly designed devices can lead to misuseor delays in care. By applying human factors principles, manufacturers can:
- Reduce user errors that can cause harm or death (medical errors are a leading cause of death)
- Improve efficiency and usability
- Enhance patient safety
- Prevent costly recalls
- Increase regulatory compliance
By embedding human factors principles into every stage of device design, manufacturers can reduce errors, improve user experience, and comply with global regulatory standards. ANSI/AAMI HE75:2025 is therefore an essential guide for medical device manufacturers committed to patient safety and usability.
Where to Find ANSI/AAMI HE75:2025
ANSI/AAMI HE75:2025 is developed The Association for the Advancement of Medical Instrumentation (AAMI).
Please direct any technical questions relating to this American National Standard to the developer. You can find the contact information for all standard developing organizations (SDOs) here: Who to Contact for Standards Related Questions.
ANSI/AAMI HE75:2025—Human factors engineering – Design of medical devices is available on the ANSI Webstore and in the following Standards Packages: AAMI TIR57 / ANSI/AAMI HE75 / ISO 10993-10 – Medical Devices Package and ANSI/AAMI HE75 and ANSI/AAMI/IEC 62366 Human Factor Set.