The safety of medical devices extends beyond electrical safety so that the people who are using and applying the medical device must be able to do so safely and effectively.   There are several terms commonly used to describe the science behind incorporating effective and safe use into a device’s design, including “usability,” “human factors engineering (HFE)” and “ergonomics.” HFE has been added to regulatory requirements to reduce medical device use error, create more operator friendly and intuitive devices and reduce the training costs for both manufacturers and end-users.

FDA Requirements for Human Factors Engineering and Usability

Demonstrating safe use through Human Factors Engineering is one of the key components required by the major regulatory agencies.  Requirements for HFE are included in IEC 60601 3rd edition and IEC 60601-1-6.  The 3rd edition requires compliance with the collateral standards to achieve compliance with the main standard.

FDA has published guidance on HFE requirements for FDA submissions.  It also has published a list of the 16 device categories that the agency will look for HFE or Usability studies.

“I found the HFE team be extremely professional, very knowledgeable and also very adept at solving problems as they arose.  My HFE project manager handled the challenges well which gave me a lot of confidence of the success of the study, which was very much appreciated.” – Alan Kirkpatrick, Medical Device Engineer

Advantages of using UL

State of the art facilities – UL HFE experts can conduct formative and summative usability testing using in our state of the art facilities in Concord, MA and Utrecht The Netherlands, conveniently located near public transportation, universities, hospitals and close to other typical user groups.  Your team can witness the testing and also take advantage of our fully integrated digital environment.

  • Comprehensive services through one provider – UL offers full-service testing, certification and regulatory services, eliminating the need to manage multiple vendors.
  • Integrated assessments – You can receive an integrated assessment to ISO/IEC 62366 and ISO/IEC 60601, the standards recognized by most global regulatory agencies.
  • Global locations, local expertise – You have access to experts in your time zone and language who understand the markets that you are selling to. In addition to gaining compliance you will gain insight on how to increase the marketability of your product.

Standards for Human Factors Engineering

  1.  ANSI/AAMI HE 75:2009, Human factors engineering – design of medical devices. Provides detailed guidance on how to perform specific human factors analyses and provides a wealth of design principles
  2. ISO/IEC 60601-1-6, General requirements for basic safety and essential performance – Collateral standard: Usability
  3. ISO/IEC 62366:2007, Medical devices – application of usability engineering to medical devices.

Additional Resources for HFE



Podcasts & Pre-Recorded Webinars


Published Books

Usability Testing of Medical Devices, Second Edition
By: Michael E. Wiklund, P.E., Jonathan Kendler, Allison Y. Strochlic

Summary (via CRC Press):

Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.

Since publication of the first edition, the FDA and other regulatory groups have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this Second Edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system. Key updates involve the 2011 FDA guidance on human factors engineering, requirements set forth by the third edition of IEC 60601 and closely related IEC 62366-1:2015, linking usability test tasks to risk analysis results, and analyzing root causes of use errors that occur during usability tests.

Written by seasoned human factors specialists, Usability Testing of Medical Devices, Second Edition is an informative, practical, and up-to-date handbook for conducting usability tests of medical devices. The book helps ensure a smooth and painless development process—and thus, safe and effective medical devices.

Click here to purchase this book. Use the code EBE16 and receive 20% off.

Medical Device Use Error: Root Cause Analysis
By: Michael Wiklund, Andrea Dwyer, Erin Davis

Summary (via CRC Press):

Medical Device Use Error: Root Cause Analysis offers practical guidance on how to methodically discover and explain the root cause of a use error—a mistake—that occurs when someone uses a medical device. Covering medical devices used in the home and those used in clinical environments, the book presents informative case studies about the use errors (mistakes) that people make when using a medical device, the potential consequences, and design-based preventions.

Using clear illustrations and simple narrative explanations, the text:

  • Covers the fundamentals and language of root cause analysis and regulators’ expectations regarding the thorough analysis of use errors
  • Describes how to identify use errors, interview users about use errors, and fix user interface design flaws that could induce use errors
  • Reinforces the application of best practices in human factors engineering, including conducting both formative and summative usability tests

Medical Device Use Error: Root Cause Analysis delineates a systematic method of analyzing medical device use errors. The book provides a valuable reference to human factors specialists, product development professionals, and others committed to making medical devices as safe and effective as possible.

Click here to purchase this book. Use the code EBE16 and receive 20% off.

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