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
- 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
- ISO/IEC 60601-1-6, General requirements for basic safety and essential performance – Collateral standard: Usability
- ISO/IEC 62366:2007, Medical devices – application of usability engineering to medical devices.
Additional Resources for HFE
- “Optimize Combination Products: Select a Platform Drug Delivery Device that Reflects Good Human Factors Engineering” MedTech Intelligence (2017)
- “Don’t Blame the User for Being Human, Says MD&M East Speaker” Qmed (2017)
- “Optimize Combination Products: Select a Drug Delivery Device that Meets User Needs” MedTech Intelligence (2017)
- “A Missed Opportunity: Incorporating Human Factors into Product Development” MedTech Intelligence (2017)
- “Human Factors Perspective: Safety Lessons Learned Using Injectable Devices” MedTech Intelligence (2016)
- “Does Your Device Play Well with Others” MedTech Intelligence (2015)
- “Applying Human Factors Engineering: Naturally Safe Software-User Interfaces”, Biomedical Instrumentation & Technology (2013)
- “Conducting Home-Based Usability Test of Home Healthcare Devices”, Horizons, a peer-reviewed publication from the Association for the Advancement of Medical Instrumentation (2013)
- “Human Factors: Identifying the Root Causes of Use Errors” MD&DI (2013)
- “Achieving Success at User Interface Validation” MD&DI (2012)
- “Improving Patient Safety: Checking Errors Off the List” MD&DI (2011)
- “Animated Videos Guide User Interactions with Complex Medical Devices” MD&DI (2008)
- “Designing Usable Medical Devices for People with Diabetes” MD&DI (2008)
- “The Art of Screen Design: Part 1” MD&DI (2007)
- “The Art of Screen Design: Part 2” MD&DI (2007)
Podcasts & Pre-Recorded Webinars
- PRE-RECORDED WEBINAR: Medical Device Use Error – Root Cause Analysis
- Silver Sheet Podcast “10 Tips for Writing Effective IFUs for Medical Devices”– Michael Wiklund & Jonathan Kendler, UL- Wiklund Research & Design
- Texas TECH Talk Podcast “Worldwide Trends in Human Factors Engineering (HFE) with Michael Wiklund” -Michael Wiklund, UL- Wiklund Research & Design
Usability Testing of Medical Devices, Second Edition
By: Michael E. Wiklund, P.E., Jonathan Kendler, Allison Y. Strochlic
Medical Device Use Error: Root Cause Analysis
By: Michael Wiklund, Andrea Dwyer, Erin Davis