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From 1985 to 1987, according to the Medical Device Reporting System of the United States Food and Drug Administration, 1554 deaths were ascribed to medical devices either wholly or in part; another 29 176 patients were seriously injured. Anesthesia machines were the subject of 1807 malfunction reports during this time and were the medical device sixth most likely to cause death. An award of 15 million dollars was made in the United States for failure to detect a change in anesthetic concentration. Cost of anesthesia vapor monitoring varies, but the costs of additional training in its use have also to be considered. If anesthesia vapor monitoring is to become universal, the versatility of the anesthesia machine and circuit can be cut down.
anesthesiology, assessments, design standards, government, medical equipment/medical equipment failure, performance evaluation, standardization
Professor of Anaesthesia and Respiratory Therapyprofessor in the Department of Health Policy and Management, Harvard School of Public Health, Harvard University, Boston, MA