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Reducing Use Error - Human Factors

• What is Human Factors?
• How Important is Human Factors?
• What is FDA doing?

What is Human Factors?

Human factors (HF) is a science devoted to the interaction of people and equipment. "Human factors," "human engineering," "usability engineering," and "ergonomics" are often used interchangeably. In the field of medicine, the objective is to improve human performance and reduce the likelihood of use error and patient injury.

HF involves designing a device according to the needs of users, including their abilities, limitations and work environments. One key to the HF approach is to strive for good performance under less than ideal conditions.

In HF, we look at the user interface of a device — including controls, displays, software, labels, and instructions — anything the user would need to operate and maintain a device. However, HF is not merely the application of "common sense" or checklists and guidelines. HF analysis and testing needs to be included early in the development of a device with tools such as analysis of critical tasks, use error hazard and risk analysis, and realistic use testing.

The result should be:

• Intuitive operation and low reliance on manuals;
• Easy-to-read displays;
• Easy-to-use controls;
• Positive and safe connections;
• Effective alarms; and
• Easy repair and maintenance.
  

How Important is Human Factors?

HF is extensively utilized by the military, the transportation industry, and in some consumer areas, but medicine lags far behind. Poor user interface design in medical devices is responsible for thousands of adverse incidents each year.

On November 29, 1999, the National Academy of Sciences issued a report on medical error, "To Err is Human," which includes this stunning fact: In hospitals alone, medical errors of all kinds kill between 44,000 and 98,000 people a year, more than the number killed by highway accidents, breast cancer, or AIDS.

Human error is a significant problem in medicine for many reasons, including:

Medical devices are complex and are often used under extremely stressful conditions;
Often, designers think differently than users do;
Some devices were originally designed for use by medical personnel and are now being marketed for use by lay users; and
Repeated use errors are often blamed exclusively on the user — instead of poor design or instructions — so that the need for human factors goes unrecognized.

What is FDA doing?

FDA is now undertaking an aggressive approach to HF in medical devices by:

• Encouraging manufacturers to apply HF during design and development, and
• Verifying this by evaluating the manufacturer’s design validation documentation, as required by the Quality System Regulation.

The Human Factors Engineering Group’s program includes:

• Developing HF documents
• Outreach to manufacturers
• Providing premarket guidance to FDA reviewers
• Training FDA reviewers
• Providing HF input during development of medical device standards
• Encouraging users and manufacturers to report serious adverse incidents involving medical devices through the Medical Device Reporting (MDR) system.
  

Updated September 1, 2002

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