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Human factors engineering (HFE) is the science and the methods used to make devices easier and safer to use. When applied to medical devices, HFE helps improve human performance and reduce the risks associated with use.

An Institute of Medicine report, To Err Is Human - Building a Safer Health System, released in November 1999 estimated that as many as 98,000 people die each year from medical errors in hospitals. This is more than the number who die yearly from motor vehicle accidents, breast cancer, or AIDS. Though many of these errors are not associated with medical devices, some are directly or indirectly related to medical device use.

Medical devices can sometimes harm patients, family members, or healthcare providers. The potential harm arises from two sources:

• Failure of the device
• Actions of the user (or use-related errors)

Hazards associated with device use are a serious problem. A combination of influences leads to use-related errors with medical devices. These include:

• Medical devices can be complex;
• Medical devices are often used under stressful conditions;
• Users may think differently than device designers do;
• Consumers now use devices that were originally designed for experienced medical personnel; and
• People blame repeated use errors on the user, rather than on poor product design or inadequate instructions for use, so people don’t recognize the need for human factors.

Research* has suggested that the frequency and consequences of medical device use errors far exceed those arising from device failures. Therefore, product developers must consider device use and use-related hazards to ensure that their devices will be safe.

* References:

Cooper, J. (1978). Preventable anesthesia mishaps: A study of human factors. Anesthesiology, 49:399-406.
Leape, L. (1994). Error in Medicine. Journal of American Medical Association, 21(3) 272.

Updated 3/13/2003

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