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U.S. Department of Health and Human Services

Medical Devices

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General Human Factors Information and Resources

What is Human Factors/Usability Engineering?

Human factors/usability engineering focuses on the interactions between people and devices. The critical element in these interactions is the device user interface, depicted as the green zone in the figure below.

 

 Flow chart in a loop showing Human Info Perception, Info Processing, and Control actions crossing Interface into Machine Input, Processing & Reaction, and Output, which recrosses Interface and loops back to the Human side.
Flow chart adapted from Redmill and Rajan (1997).

 

To understand the human-machine system, it’s important to understand the ways that people:

  • Perceive information from the device,
  • Interpret the information and make decisions about what to do, and
  • Manipulate the device, its components, and/or its controls.

It’s also important to understand the ways that devices:

  • React to input from the user, and then
  • Provide feedback to the user about the effects of their actions.

Human factors/usability engineering is used to design the machine-human (device-user) interface. The user interface includes all components with which users interact while preparing the device for use (e.g., unpacking, set up, calibration), using the device, or performing maintenance (e.g., cleaning, replacing a battery, making repairs).


Why is HFE important to medical devices?

For medical devices, the most important goal of the human factors/usability engineering process is to minimize use-related hazards and risks and then confirm that these efforts were successful and users can use the device safely and effectively.

Specific beneficial outcomes of applying human factors/usability engineering to medical devices include:

  • Easier-to-use devices,
  • Safer connections between device components and accessories (e.g., power cords, leads, tubing, cartridges),
  • Easier-to-read controls and displays,
  • Better user understanding of the device’s status and operation,
  • Better user understanding of a patient’s current medical condition,
  • More effective alarm signals,
  • Easier device maintenance and repair,
  • Reduced user reliance on user manuals,
  • Reduced need for user training and retraining,
  • Reduced risk of use error,
  • Reduced risk of adverse events, and
  • Reduced risk of product recalls. 
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CDRH Human Factors Presentations (Most Recent)

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