Human Factors Engineering Influence Medical-Equipment Design

Oct. 8, 2014

The one tool or resource biomedical engineers can use to improve medical-device design, quality, and validation methods is encapsulated in the FDA’s guidelines on Human Factors Engineering (HFE). They are widely respected and treated as de facto standards in the industry.

Jim Ford

Advances in engineering and medicine constantly change the way medical equipment is used. Technological advances, for example, are making once stationary equipment such as ultrasound and X-ray machines more portable and suitable for smaller hospitals and clinics. However, not all designs are “created.”

In 2013 alone, over 1,100 were issued by the U.S. Food and Drug Administration (FDA) — a 9% jump from 2012. Most of those recalls were due to device failures or health risks rather than gaps in design. Still, research indicates that successful designs prevent warranty issues and ensure end users are truly satisfied—an important lesson for all engineers.

The one tool or resource biomedical engineers can use to improve medical-device design, quality, and validation methods, are encapsulated in FDA’s guidelines on Human Factors Engineering (HFE). They are widely respected and treated as de facto standards in the industry.

HFE is best described as the study of how humans use and interact with technology and equipment. For medical-equipment designers, HFE guidelines involve the equipment, the places it will be used, and limitations of patients and health-care workers operating the equipment. The guidelines address design considerations such as size and maneuverability, ease and range of adjustments, weight capacity, equipment limitations, and ease of cleaning to protect against infectious contamination.

By following HFE guidelines, designers can create equipment that is:

• Easy and intuitive to use in its primary function

• Simple to operate in its environment

• Accommodating to the physical and intellectual capabilities of health-care workers operating it

• Less prone to operator error

• Easier to maintain and repair

Ideally, devices must accommodate all end users regardless of variations in attributes such as height, strength, and vision. By applying HFE and usability engineering to medical equipment, manufacturers can prevent poorly designed devices and accompanying potential for user errors and accidents.