When Is "Dead"?

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In 1996, 60 Minutes ran a story about the ethical issues associated with procuring organs from individuals who have been declared dead using cardiopulmonary criteria--so-called non-heart-beating (NHBDs). They raised questions about the ethical appropriateness of the procedure, intimating that patients were being given drugs that would shorten their life order to improve organ quality. The story was quickly picked up by newspapers around the country that ran headlines such as Murder She Wrote.[1] In response, 1997 the U.S. Department of Health and Human Services asked the Institute of Medicine to explore the medical and ethical balance between steps to ensure the availability of as many organs the best condition for the transplant and the rights of patients who may become donors to the highest quality of care separate from extraneous conditions such as donor organ supply.[2] The IOM's report found a great deal of variability how different transplant centers procured NHBDs. In effort to set standards, the report also presented recommendations for NHBD protocols. One of the more controversial topics the IOM faced was the timing of death controlled NHBD protocols. Because of the need to reduce warm ischemia, organs must be taken as quickly as possible after death is pronounced. There are no clear clinical guidelines upon which to make such a declaration. The question is, when, the course of ascertaining death, is the patient dead, so that the organs can be taken?[3] There is a tension between making certain that the organs are viable and making certain that the patient is dead when they are removed. Most NHBD policies never confronted this issue, allowing doctors to declare death in the traditional manner. The University of Pittsburgh Medical Center policy argued that death should be declared two minutes after loss of cardiopulmonary function.[4] Critics at the First International Conference on Non-Heart-Beating Donors, held 1995, said that there were insufficient data to be certain that the heart could not autoresuscitate at two minutes and that one needed to wait ten minutes.[5] After reviewing the data, the IOM recommended that an interval of at least 5 minutes elapse after complete cessation of circulatory function ... before death is pronounced and organ perfusion and removal begins.[6] However, only eleven organ procurement officers revised their protocols to correspond to the report's recommendations. Nineteen did not modify their protocols. Some, including the University of Pittsburgh Medical Center, formally discussed the IOM recommendations and rejected them, retaining a two-minute interval.[7] Empirical and Conceptual Issues Whether or not the interval is appropriate, the IOM has marshaled neither sufficient clinical data nor compelling conceptual reasoning to support its decision. Likewise, however, there is neither sufficient data nor compelling reasoning to opt for either of the proposed alternatives. Waiting five minutes--or two or ten minutes--after the cessation of cardiopulmonary function prior to declaring death is problematic for two reasons. First, the clinical data do not clearly demonstrate when the criteria for death have been met. Second, the five-minute rule is conceptually unsound--that is, it simply doesn't make sense to many people. While these two requirements might seem straightforward at first, they are, fact, quite subtle and complex. Let us begin by examining the data undergirding the interval. The empirical question is how much time after cardiopulmonary function is lost one must wait to ensure that spontaneous recovery will not occur. Data on autoresuscitation humans are limited. Only five investigators have reported their observations of a total of 108 patients who died while having their electrocardiogram monitored.[8] Nevertheless, no patient resumed spontaneous circulation after more than two minutes of asystole and apnea. …