HFE & UE
All medical devices have a unique and thorough set of testing requirements enforced by the U.S. Food and Drug Administration (FDA), and other international regulatory bodies that need to be fulfilled before entering the marketplace. Physicians play an essential role in the development, testing and extensive training involved in producing effective and safe medical devices. The intended users of a medical device should be able to use the device without making use errors that could compromise medical care or patient or user safety.
Understanding how people interact with technology and studying how user interface design affects the interactions people have with technology is the focus of human factors engineering (HFE) and usability engineering (UE).
Medical device manufacturers must be mindful of the fact that laws limiting the liability of healthcare providers put them at greater risk of product liability litigation—even if their product is not defective. Adequate warnings, effective training, and the use of HFE/UE analysis to avoid physician error will help provide a strong defense against allegations.
Why Conduct Human Factors Studies?
- Lowers the number of potential use or user errors
- Reduces the risks associated with the use of the device
- Lowers training costs for the end-‐users
- Reduces costly device service and support