Human Error in Medicine

By Marilyn Sue Bogner | Go to book overview

9 s
Medical Devices, Medical Errors, and Medical Accident

J. W. Senders EMSCO, Inc.

Human error in medicine, and the adverse events that may follow, are problems of psychology and engineering, not of medicine. The following brief description of a serious problem stemming from a simple, well-established and very low-tech medical device shows that even in such technology there is much room for improvement. The case also reveals that there is even more room for improvement in the philosophy and general outlook of the people who design, manufacture, and market such devices -- they need to know some psychology. They need to know about human behavior, ergonomics, and statistics.

The Anesthetic and Life Support Drugs Advisory Committee (ALSDAC) 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. It would be even better if the manufacturers added one more small criterion of their own before requesting approval for new medical devices: That devices be safe, even if not effective, when used in ways other than that which was intended.

The manufacturers' lack of interest in ensuring that devices be safe when used other than as intended opens the door to disaster. For example, it has led to a series of deaths and injuries over a 14-year period between the introduction and the withdrawal of preloaded syringes of concentrated Lidocaine. As described in the following case study, the intended use was that it be diluted by injection into bags or bottles in intravenous (IV) infusion systems.

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