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The US Food and Drug Administration (FDA) has published a new guidance titled "Applying Human Factors and Usability Engineering to Medical Devices", available from here.

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).

HFE/UE considerations in the development of medical devices involve the three major components of the device-user system: (1) device users, (2) device use environments and (3) device user interfaces.

Device Users

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.

Depending on the specific device and its application, device users might be limited to professional caregivers, such as physicians, nurses, nurse practitioners, physical and occupational therapists, social workers, and home care aides. Other user populations could include medical technologists, radiology technologists, or laboratory professionals.  Device user populations might also include the professionals who install and set up the devices and those who clean, maintain, repair, or reprocess them. The users of some devices might instead be non-professionals, including patients who operate devices on themselves to provide self-care and family members or friends who serve as lay caregivers to people receiving care in the home, including parents who use devices on their children or supervise their children’s use of devices.

The ability of a user to operate a medical device depends on his or her personal characteristics, including:

Device Use Environment

The environments in which medical devices are used might include a variety of conditions that could define what is a good user interface design. Medical devices might be used in clinical environments or non-clinical environments, community settings or moving vehicles.  Examples of environmental use conditions include the following:

Device User Interface

A device user interface includes all points of interaction between the user and the device, including all elements of the device with which the user interacts. A device user interface might be used while user setups the device (e.g., unpacking, set up, calibration), uses the device, or performs maintenance on the device (e.g., cleaning, replacing a battery, repairing parts). It includes: