Misadventures of Medical Labeling: Lessons Learned

Abstract

Medical errors are increasingly being brought to the attention of the public through articles and reports that cite cases of patient death or injury through errors in doseage, misuse of medical devices, or procedural error. The incidence of such errors is extremely high. Over 180,000 deaths per year have been attributed to medical error, the equivalent of the loss of a 747 aircraft load of passengers every day of the year. Most of these errors are preventable and may be the primary health care problem in the U.S. today. The authors present a selection of case studies of error in medical treatment, with particular attention to those that can be related to, or that have implications for, medical device and drug labeling. Cases will be highlighted that could have been avoided had good human factors practices been followed. In contrast to much of the recent emphasis on blaming clinical personnel for medical errors, it is suggested that adoption of existing human factors engineering guidelines for both labeling and device design can have a significant, positive effect on this serious, societal problem.