ABSTRACT

Care Systems ..................................................................................................52 4.3 Causes of Patient Injuries and Medical Device Accident

Classification...................................................................................................53 4.4 Medical Devices With a High Occurrence of Human Error .........................54 4.5 Anesthesia-Related Most Frequent Incidents, Associated Factors, and

Medical Device-Related Operator Errors.......................................................54 4.6 General Approach to Human Factors in the Medical Device

Development Process to Reduce Human Errors............................................55 4.7 Human Error-Related Analysis Methods Useful for Health

Care Systems ..................................................................................................57 4.7.1 Failure Mode and Effect Analysis (FMEA).......................................57 4.7.2 Throughput Ratio Method ..................................................................57 4.7.3 Probability Tree Method.....................................................................59 4.7.4 Fault Tree Method ..............................................................................60

4.8 Reducing Medical Device/Equipment User-Interface-Related Errors...........62 4.8.1 Comprehensive Guidelines .................................................................63 4.8.2 General Guidelines .............................................................................65

4.9 Problems .........................................................................................................66 References................................................................................................................66

Human errors are universal and committed each day. Usually, most are trivial, but some can be very serious or fatal. Two well-publicized examples of disasters due to the human error are the Three-Mile-Island and Chernobyl nuclear accidents. Even though the precise data on the extent of human error as a percentage of all system failures are difficult to obtain and vary from one system to another, one study indicates that it can vary from 90% in air traffic control to 19% in the petroleum industry.