Human Factors Engineering

Human Factors Engineering


Human Factor Engineering (HFE) is a engineering discipline that looks to understand the relationship between people and the systems that surround them. HFE looks to understand and optimize how people use and interact with technology such as Avoid reliance on memory, Use forcing functions, Simplify key processes, Standardize work processes, and Design systems with feedback and monitoring mechanisms. It is now being applied to address use error problems in medicine. Human Factors analysis and testing should be applied throughout the entire life-cycle of a medical device.[1] Its fundamental goal is to:

  • Minimize workplace hazards and injuries
  • Minimize user and system-related errors
  • Maximize worker efficiency, productivity, and safety [2] [3]


HFE advnatages are:

  • Mitigates and reduces errors in multiple high reliability organizations
  • Predicts and provides an understanding of human performance in complex environments
  • Discovers underlying systemic factors that lead to error
  • Provides a framework for medical device evaluation
  • Identifies areas to improve patient safety [4]

Environmental Factors[]

Some common environmental factors include:

  • Light
  • Noise
  • Distraction
  • Motion/Vibration
  • Room layout [5]

Other factors[]

include ...

  • Fatigue
  • Ergonomics
  • Mislabeling

Usability Testing[]

Testing for ease and accuracy of use is the only way to ensure that users can safely and effectively operate, install, and maintain devices. By means of iterative prototyping, individual concepts of design can be tested, refined, and retested throughout the development process. This process culminates with full testing of a model embodying all the user-interface characteristics for both hardware and software of a fully functioning device.[6]


It is prudent to start looking ahead of time for signs of (red flags) user and system-use related errors before an incident occurs, such types of evaluations of already purchased medical devices are:

  • User training offered has been slow or arduous on the user to find time conducting it
  • Only a few staff members seen able to use the device
  • Staff refuses to use or mentions how difficult it is to the device
  • Many reports from BMETs of "No problems found"
  • Installation of accessories seem difficult on users or perhaps incorrectly installed
  • Alarms and batteries often fail (perhaps users don't know how or when to change them out?)
  • Displays are difficult to read and/or understand for the user
  • Controls poorly located or improperly labeled.
  • Alarms difficult to hear or overly loud and annoying to staff (results in deactivation)
  • Device is confusing or hard to use by staff.[7]


  1. Reducing Use Error: Center for Devices and Radiological Health, OHIP FY2000 Annual p. 37.
  2. Gosbee, J. Human Factors Engineering and Patient Safety. Quality Safety health Care. 2002.Human factors engineering and patient safety
  3. Painter, Frank. Human factors and Medical Device Accidents. University of Connecticut. 2005.
  4. Gebara, Rani. "Incorporating Human Factors Engineering into Clinical Engineering Practice". Beaumont Services Company. June 15, 2006.
  5. Kaye R. and Crowley. J. Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, Center for Devices and Radiological Health (CDRH)., July, 2000.
  6. Do it by Design: An Introduction to Human Factors in Medical Devices, Dick Sawyer, December 1996
  7. Painter, Frank. Human factors and Medical Device Accidents. University of Connecticut. 2005.



See also[]