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: •