Traditionally, organ retrieval from cadavers has taken place only in cases where the declaration of death has occurred using “brain death” criteria. Under these criteria, specific tests are performed to demonstrate directly a lack of brain activity. Recently, as a result of efforts to increase organ procurement, attention has been directed at the use of so-called “non-heart-beating” donors : individuals who are declared dead not as a result of direct measurements of brain function, but rather as a result of the (...) cessation of heart and respiratory functions. Attempts to obtain organs from such individuals have recently resulted in substantial negative publicity. Claims were made that the deaths of patients were being accelerated in order to get organs, and that sometimes organs were being removed from patients who were not yet dead. (shrink)

There has been growing concern about whether individuals who satisfy neurological criteria for death or who become non-heart-beating organ donors are really dead. This concern has focused on the issue of the potential for recovery that these individuals may still have and whether their conditions are irreversible. In this article I examine the concepts of potentiality and irreversibility that have been invoked in the discussions of the definition of death and non-heart-beating organ donation. I initially focus on the recent challenge (...) by D. Alan Shewmon to accepting any neurological criterion of death. I argue that Shewmon relies on a problematic and unrealistic concept of potentiality, and that a better, more realistic concept of potentiality is consistent with accepting a neurological criterion for death. I then turn to an analysis of how the concept of irreversibility has been used in discussion of non-heart-beating organ donation. Similarly, I argue that some participants in this discussion have invoked a problematic and unrealistic concept of irreversibility. I then propose an alternative, more realistic account of irreversibility that explains how "irreversibility" should be understood in the definition and criteria of death. (shrink)

The popularization of the term “clinical death” for the absence of vital signs suggests the possibility of a radical change in our understanding of death. While death used to be considered something that we do not have the power to reverse, contemporary optimism suggests that we may be able to restore life to a dead organism. In this article, I examine how the term “death” is used today to clarify what kind of irreversibility we ought to assign to it. I (...) conclude that the kind of irreversibility closest to our concept of death is one that depends on implicit metaphysical commitments: we generally treat death as though it were metaphysically irreversible, and therefore not reversible by us. (shrink)

Patients in a minimally conscious state (MCS) fall into a different diagnostic category than patients in the more familiar vegetative states (VS). Not only are MCS patients conscious in some sense, they have a higher chance for recovery than VS patients. Because of these differences, we ostensibly have reason to provide MCS patients with care that goes beyond what we provide to patients with some VS patients. But how to justify this differential treatment? I argue we can’t justify it solely (...) by looking to MCS patients’ actual levels of consciousness. We must look also to the ways in which these patients are potentially conscious. Specifically, I argue that certain sensible and well-regarded policy recommendations cannot be justified by looking solely to patients’ actual levels of consciousness, but that they can be justified by looking to patients’ potential for consciousness. Insofar then as we have prima facie reason to follow the recommendations, we also have prima facie reason to view the potential for consciousness as morally salient. If that is true, however, several important implications follow: first, if the potential for consciousness is morally salient, this translates into actual and pressing obligations to patients with disorders of consciousness generally. Second, if the potential for consciousness is morally salient, this has implications that go beyond our obligations to patients with disorders of consciousness. Indeed, if the potential for consciousness is morally salient, this adds an important layer of complexity to the normative landscape, a layer we may not have sufficiently noticed before. (shrink)

In 1968, the Harvard criteria equated irreversible coma and apnea with human death and later, the Uniform Determination of Death Act was enacted permitting organ procurement from heart-beating donors. Since then, clinical studies have defined a spectrum of states of impaired consciousness in human beings: coma, akinetic mutism, minimally conscious state, vegetative state and brain death. In this article, we argue against the validity of the Harvard criteria for equating brain death with human death. Brain death does not disrupt somatic (...) integrative unity and coordinated biological functioning of a living organism. Neurological criteria of human death fail to determine the precise moment of an organism’s death when death is established by circulatory criterion in other states of impaired consciousness for organ procurement with non-heart-beating donation protocols. The criterion of circulatory arrest 75 s to 5 min is too short for irreversible cessation of whole brain functions and respiration controlled by the brain stem. Brain -based criteria for determining death with a beating heart exclude relevant anthropologic, psychosocial, cultural, and religious aspects of death and dying in society. Clinical guidelines for determining brain death are not consistently validated by the presence of irreversible brain stem ischemic injury or necrosis on autopsy; therefore, they do not completely exclude reversible loss of integrated neurological functions in donors. The questionable reliability and varying compliance with these guidelines among institutions amplify the risk of determining reversible states of impaired consciousness as irreversible brain death. The scientific uncertainty of defining and determining states of impaired consciousness including brain death have been neither disclosed to the general public nor broadly debated by the medical community or by legal and religious scholars. Heart-beating or non-heart-beating organ procurement from patients with impaired consciousness is de facto a concealed practice of physician-assisted death, and therefore, violates both criminal law and the central tenet of medicine not to do harm to patients. Society must decide if physician-assisted death is permissible and desirable to resolve the conflict about procuring organs from patients with impaired consciousness within the context of the perceived need to enhance the supply of transplantable organs. (shrink)

The most controversial issue in organ donation after the circulatory determination of death is whether the donor was truly dead at the moment death is declared. My colleagues and I further analyzed this issue by showing the relevance of the distinction between the “permanent” and the “irreversible” loss of circulatory functions. Permanent cessation means that circulatory function will not return because it will not be restored spontaneously and medical attempts to restore it will not be conducted. By contrast, irreversible cessation (...) means that circulatory function cannot be restored using currently available technology. In this issue of the Report, Kevin Munjal and colleagues criticize the unjustified application of the permanent‐irreversible distinction, which my colleagues and I developed for cDCDD, to their well‐designed and carefully conducted experimental protocol of uncontrolled DCDD (uDCDD) in New York City, for which our analysis was not targeted. They claimed that to determine a donor's death in uDCDD, it is unnecessary to show that permanence is a valid surrogate indicator of irreversibility because the unsuccessful attempt to resuscitate the patient comprises prima facie evidence of circulatory irreversibility. Ironically, that potent justification defending death determination in uDCDD yields limitations that are similar to those created when our permanent‐irreversible distinction is applied to death determination in cDCDD. (shrink)

Despite continuing controversies regarding the vital status of both brain-dead donors and individuals who undergo donation after circulatory death (DCD), respecting the dead donor rule (DDR) remains the standard moral framework for organ procurement. The DDR increases organ supply without jeopardizing trust in transplantation systems, reassuring society that donors will not experience harm during organ procurement. While the assumption that individuals cannot be harmed once they are dead is reasonable in the case of brain-dead protocols, we argue that the DDR (...) is not an acceptable strategy to protect donors from harm in DCD protocols. We propose a threefold alternative to justify organ procurement practices: (1) ensuring that donors are sufficiently protected from harm; (2) ensuring that they are respected through informed consent; and (3) ensuring that society is fully informed of the inherently debatable nature of any criterion to declare death. (shrink)

Assessments of the acceptability of new transplantation practices require a pinpointing of not only the meaning of death, but also the timing of death. They typically perceive elective ventilation as occurring just prior to death and non-heart-beating donor protocols as operative just after death. However, such practices in fact highlight the general vagueness and ambiguity surrounding these issues in both law and ethics. Supply-side dilemmas in transplantation lend real urgency to this "life or death" debate.

In debates about criteria for human death, several camps have emerged, the main two focusing on either loss of the "organism as a whole" (the mainstream view) or loss of consciousness or "personhood." Controversies also rage over the proper definition of "irreversible" in criteria for death. The situation is reminiscent of the proverbial blind men palpating an elephant; each describes the creature according to the part he can touch. Similarly, each camp grasps some aspect of the complex reality of death. (...) The personhood camp, in contrast to the mainstream "organism" camp, recognizes that a human organism can still be a biological living whole even without brain function. The mainstream camp, in contrast to the personhood camp, recognizes that a person can be permanently, even irreversibly unconscious, and still be a living person so long as his/her body is alive. The author proposes that hylomorphic dualism incorporates both these key insights. But to complete the picture of the entire "death elephant," a fundamental paradigm shift is needed to make sense of other seemingly conflicting insights. The author proposes a "semantic bisection" of the concept of death, analogous to the traditional distinction at the beginning of life between "conception" and "birth." To avoid the semantic baggage associated with the term "death," the two new death-related concepts are referred to as "passing away" (or "deceased") and "deanimation," corresponding, respectively, to sociolegal ceasing-to-be (mirror image of birth) and ontological/theological ceasing-to-be of the bodily organism (mirror image of conception). Regarding criteria, the distinguishing feature is whether the cessation of function is permanent (passing away) or irreversible (deanimation). If the "dead donor rule" were renamed the "deceased donor rule" (both acronyms felicitously being "DDR"), the ethics of organ transplantation from non–heart-beating donors could, in principle, be validly governed by the DDR, even though the donors are not yet ontologically "deanimated." Thus, the paradigm shift satisfies both those who insist on maintaining the DDR and those who claim that it has all along been receiving only lip service and should be explicitly loosened to include those who are "as good as dead." Even so, a number of practical caveats remain to be worked out for non–heart-beating protocols. (shrink)

Two contemporary strategies in cadaver organ transplantation, both with the potential to affect significantly expanding organ transplant waiting list sizes, have evolved: elective ventilation and use of nonheart-beating donors. Both are undergoing a period of critical review. It is not clear how widely EV is practiced around the world. In Great Britain, the Royal Devon and Exeter Hospital was the first hospital to develop an EV protocol, in 1988, after which other British hospitals followed suit. In the 1980s, new NHBD (...) protocols of two distinct types were implemented worldwide, although both rely on death confirmed by traditional cardiopulmonary criteria. The first type involves the removal of organs immediately after death, the preeminent example being the University of Pittsburgh Medical Center Protocol. The second involves the perfusion and cooling of kidneys immediately following death and subsequent organ removal. Protocols of this type have sprung up in Holland, Great Britain, Italy, France, Spain, Japan, and the United States. (shrink)

A combination of emerging life support technologies and entrenched organ donation practices are complicating the physician's task of determining death. On the one hand, technologies that support or replace ventilation and circulation may render the diagnosis of death ambiguous. On the other, transplantation of vital organs requires timely and accurate declaration of death of the donor to keep the organs as healthy as possible. These two factors have led to disagreements among physicians and scholars on the precise moment of death. (...) In this article, I suggest that the debate about exactly when a person dies can benefit from distinguishing the strict biological concept of death from the medical standards for determining human death, and I show how an appreciation of the difference between the permanent and irreversible cessation of circulation is helpful in understanding the reasons for the two approaches to determining when death should be declared. (shrink)

The family of a patient who is unconscious and respirator-dependent has made a decision to discontinue medical treatment. The patient had signed a donor card. The family wants to respect this decision, and agrees to non-heart-beating organ donation. Consequently, as the patient is weaned from the ventilator, he is prepped for organ explantation. Two minutes after the patient goes into cardiac arrest, he is declared dead and the transplant team arrives to begin organ procurement. At the time retrieval begins, it (...) is not certain that the patient's brain is dead or that cardiac function cannot be restored. Procurement follows uneventfully, and two transplantable kidneys are retrieved. (shrink)

Organ donation after cardiac or circulatory death (DCD) has been introduced to increase the supply of transplantable organs. In this paper, we argue that the recovery of viable organs useful for transplantation in DCD is not compatible with the dead donor rule and we explain the consequential ethical and legal ramifications. We also outline serious deficiencies in the current consent process for DCD with respect to disclosure of necessary elements for voluntary informed decision making and respect for the donor's autonomy. (...) We compare two alternative proposals for increasing organ donation consent in society: presumed consent and mandated choice. We conclude that proceeding with the recovery of transplantable organs from decedents requires a paradigm change in the ethics of organ donation. The paradigm change to ensure the legitimacy of DCD practice must include: (1) societal agreement on abandonment of the dead donor rule, (2) legislative revisions reflecting abandonment of the dead donor rule, and (3) requirement of mandated choice to facilitate individual participation in organ donation and to ensure that decisions to participate are made in compliance with the societal values of respect for autonomy and self-determination. (shrink)

Protocols for retrieving vital organs in consenting patients in cardiovascular arrest rest on the assumptions that irreversible asystole a) identifies the instant of biological death, and b) is clinically assessable at the time when retrieval of vital organs is possible. Unfortunately both assumptions are flawed. We argue that traditional life/death definitions could be actually inadequate to represent the reality of dying under intensive support, and we suggest redefining NHBD protocols on moral, social, and antrhopological criteria, admitting that irreversible asystole can (...) only equate a clinically determinable point of no return in the process of dying, where organ retrieval can be morally and socially accepted in previously consenting patients. (shrink)

Donation after circulatory determination of death (DCDD) is an accepted practice in the United States, but heart procurement under these circumstances has been debated. Although the practice is experiencing a resurgence due to the recently completed trials using ex vivo perfusion systems, interest in thoracoabdominal normothermic regional perfusion (TA-NRP), wherein the organs are reanimated in situ prior to procurement, has raised many ethical questions. We outline practical, ethical, and equity considerations to ensure transplant programs make well-informed decisions about TA-NRP. We (...) present a multidisciplinary analysis of the relevant ethical issues arising from DCDD-NRP heart procurement, including application of the Dead Donor Rule and the Uniform Definition of Death Act, and provide recommendations to facilitate ethical analysis and input from all interested parties. We also recommend informed consent, as distinct from typical “authorization,” for cadaveric organ donation using TA-NRP. (shrink)

In transplant medicine, the use of normothermic regional perfusion (NRP) in donation after circulatory determination of death raises ethical difficulties. NRP is objectionable because it restores the donor's circulation, thus invalidating a death declaration based on the permanent cessation of circulation. NRP's defenders respond with arguments that are tortuous and factually inaccurate and depend on introducing extraneous concepts into the law. However, results comparable to NRP's—more and higher‐quality organs and more efficient allocation—can be achieved by removing organs from deceased donors (...) and using normothermic machine perfusion (NMP) to support the organs outside the body, without jeopardizing confidence in transplantation's legal and ethical foundations. Given the controversy that NRP generates and the convoluted justifications made for it, we recommend a prudential approach we call “ethical parsimony,” which holds that, in the choice between competing means of achieving a result, the ethically simpler one is to be preferred. This approach makes clear that policy‐makers should favor NMP over NRP. (shrink)

Two contemporary strategies in cadaver organ transplantation, both with the potential to affect significantly expanding organ transplant waiting list sizes, have evolved: elective ventilation and use of nonheart-beating donors. Both are undergoing a period of critical review. It is not clear how widely EV is practiced around the world. In Great Britain, the Royal Devon and Exeter Hospital was the first hospital to develop an EV protocol, in 1988, after which other British hospitals followed suit. In the 1980s, new NHBD (...) protocols of two distinct types were implemented worldwide, although both rely on death confirmed by traditional cardiopulmonary criteria. The first type involves the removal of organs immediately after death, the preeminent example being the University of Pittsburgh Medical Center Protocol. The second involves the perfusion and cooling of kidneys immediately following death and subsequent organ removal. Protocols of this type have sprung up in Holland, Great Britain, Italy, France, Spain, Japan, and the United States. (shrink)

Expressing doubts about death criteria can serve healthy purposes, but can also cause a number of harms, including decreased organ donation rates and distress for donor families and health care staff. This paper explores the various causes of doubts about death criteria—including religious beliefs, misinformation, mistrust, and intellectual questions—and recommends responses to each of these. Some recommended responses are relatively simple and noncontroversial, such as providing accurate information. However, other responses would require significant changes to the way we currently do (...) business. Policymakers should establish minimum national standards for determining death to foster a trustworthy system; academics and publishers have a duty to publish only materials that substantially engage and advance the debate to minimize the harm caused by divided expert opinion; and opposition to the dead donor rule should be conceptually separated from doubts about death criteria. (shrink)

Traditionally, organ retrieval from cadavers has taken place only in cases where the declaration of death has occurred using “brain death” criteria. Under these criteria, specific tests are performed to demonstrate directly a lack of brain activity. Recently, as a result of efforts to increase organ procurement, attention has been directed at the use of so-called “non-heart-beating” donors : individuals who are declared dead not as a result of direct measurements of brain function, but rather as a result of the (...) cessation of heart and respiratory functions. Attempts to obtain organs from such individuals have recently resulted in substantial negative publicity. Claims were made that the deaths of patients were being accelerated in order to get organs, and that sometimes organs were being removed from patients who were not yet dead. (shrink)

The imbalance between supply of organs for transplantation and demand for them is widening. Although the current international drive to re-establish procurement via non-heart beating organ donation/donor is founded therefore on necessity, the process may constitute a desirable outcome for patient and family when progression to brain stem death does not occur and conventional organ retrieval from the beating heart donor is thereby prevented. The literature accounts of this practice, however, raise concerns that risk jeopardising professional and public confidence in (...) the broader transplant programme. This article focuses on these clinical, ethical, and legal issues in the context of other approaches aimed at increasing donor numbers. The feasibility of introducing such an initiative will hinge on the ability to reassure patients, families, attendant staff, professional bodies, the wider public, law enforcement agencies, and the media that practitioners are working within explicit guidelines which are both ethically and legally defensible. (shrink)

Interest in the retrieval of organs from non-heart-beating cadaver donors has been rekindled by the success of transplantation of solid organs and the insufficient supply of donor organs currently obtained from heart-beating cadaver donors. There are currently two retrieval techniques being evaluated, the in situ cold perfusion approach and the controlled death approach. Both, however, raise ethical concerns. Reanimation is a new method which has been used successfully in animals. We believe this new approach overcomes the ethical objections raised to (...) these other methods. (shrink)

In 1991, the University of Pittsburgh Medical Center implemented a policy that permitted the recovery of organs from cadavers pronounced dead using standardized cardiac criteria. This policy allowed families that had made a decision to forgo life sustaining treatment to then request organ donation. This entailed taking the patient to the operating room, discontinuing therapy, and after the patient is pronounced dead, procuring organs.

The family of a patient who is unconscious and respirator-dependent has made a decision to discontinue medical treatment. The patient had signed a donor card. The family wants to respect this decision, and agrees to non-heart-beating organ donation. Consequently, as the patient is weaned from the ventilator, he is prepped for organ explantation. Two minutes after the patient goes into cardiac arrest, he is declared dead and the transplant team arrives to begin organ procurement. At the time retrieval begins, it (...) is not certain that the patient's brain is dead or that cardiac function cannot be restored. Procurement follows uneventfully, and two transplantable kidneys are retrieved.Many people now consider such cases of non-heart-beating organ donation to be ethically permissible. However, widespread disagreement persists as to how such practices are to be justified and whether such practices are compatible with the Uniform Declaration of Death Act. In this paper, I argue that non-heart-beating organ donation can be ethically justified, that in the justified cases the patients are in fact dead, and that the early declarations of death required for such donation do comply with the UDDA. (shrink)