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About Human Factors

• What is Human Factors?
• Why is Human Factors Engineering Important for Medical Devices?
• What is FDA's Human Factors Program?

What is Human Factors?

Human factors (HF) is the study of how people use technology. It involves the interaction of human abilities, expectations, and limitations, with work environments and system design.

The term “human factors engineering” (HFE) refers to the application of human factors principles to the design of devices and systems. It is often interchanged with the terms "human engineering," "usability engineering," or "ergonomics."

The goal of HFE is to design devices that users accept willingly and operate safely in realistic conditions. In medical applications, HFE helps improve human performance and reduce the risks associated with use error.

In many cases, HFE focuses on the device user interface (also called the UI or the man-machine interface). The user interface includes all components and accessories necessary to operate and properly maintain the device, including the controls, displays, software, logic of operation, labels, and instructions.

Specific benefits of HFE include:

• Reduced risk of device use error;
• Better understanding of device status and operation;
• Better understanding of a patient’s current medical condition;
• Easier to use (or more intuitive) devices;
• Reduced need for training;
• Reduced reliance on user manuals;
• Easier to read controls and displays;
• Safer connections between devices (i.e. power cords, leads, tubes, etc.);
• More effective alarms; and
• Easier repair and maintenance.

HFE should take place early in the product development process. It should include tools such as analysis of critical tasks, use error hazard and risk analysis, and realistic use testing.

Why is Human Factors Engineering Important for Medical Devices?

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.

What is FDA's Human Factors Program?

FDA works with manufacturers to help ensure the application of human factors engineering to the design of new products.

FDA's human factors program:

• Evaluates manufacturers' design validation documents required by the Quality System Regulation;
• Develops Guidance documents to help manufacturers understand and use human factors engineering;
• Educates manufacturers about the need for human factors programs;
• Provides training and guidance for other FDA personnel about the importance of human factors in product design;
• Inputs human factors principles into medical device standards;
• Collaborates with professional organizations to educate the public about human factors; and
• Encourages users and manufacturers to report serious adverse incidents involving medical devices through the Medical Device Reporting (MDR) system.

Updated October 5, 2006