ABSTRACT
Human error in medicine, and the adverse events that may follow, are problems of psychology and engineering, not of medicine. The Anesthetic and Life Support Drugs Advisory Committee of the Food and Drug Administration (FDA) also needs to know these things. It is currently the case that medical devices may be approved by the FDA if they meet the criteria of being safe and effective when used as intended. The causal mechanisms of medical errors, if there are any, must be the same as those of errors in nuclear power plants or aircraft, or in the kitchen. It is common to discuss errors in medical settings in terms of their expressions, that is, what was done wrong. The high level of sophistication of modern medicines and medical devices makes the effect of misadministration more likely to be harmful than would be the case, for example, if the medicines were pharmaceutically inert.
