Clinical Ethics in Anesthesiology. A Case-Based Textbook

2. End-of-life issues

20. Ethical issues in organ donation after cardiac death

Richard L. Wolman

The Case

Mr. Gift is a 59-year-old man who is permanently quadraplegic and ventilator dependent due to a C2–3 fracture dislocation following a fall during an equestrian competition 8 weeks ago. Since the accident he has undergone several surgeries, including C-spine stabilization, tracheostomy, jejunostomy tube placement, and intramedullary fixation of a femur fracture. He is scheduled for a tracheostomy revision tomorrow, due to intermittent partial obstruction of the trachea and tracheal stenosis.

Mr. Gift is awake, alert, and finds life intolerable in his dependent state. He does not want the scheduled surgery. He views his situation as both emotionally and financially draining for his family. In the event of a cardiac arrest, he has stated he does not want to be resuscitated, and he has a Do-Not-Resuscitate (DNR) order in his chart. Mr. Gift has further requested that his ventilator support be terminated, that he be given comfort measures only to relieve dyspnea and anxiety, and that his organs be donated for transplantation after his death. He has read that sometimes life-supporting therapy can be withdrawn in an operating room, and organ procurement carried out immediately after death. In order to provide the greatest possible number of organs, he has talked to an organ procurement organization (OPO) representative, and requests that this be arranged. His family is supportive of the DNR order, but unsure about withdrawal of life-supporting therapy and organ donation.

While discussions are ongoing, Mr. Gift is accidentally extubated while being turned in bed. Attempts to replace the tracheostomy tube fail. By the time the resuscitation team arrives, Mr. Gift is unconscious, hypoxemic, and hypotensive. Physicians are unsure of whether to attempt intubation, given the DNR order. The OPO representative, who happens to be on the unit when these events unfold, demands that they continue to attempt to intubate Mr. Gift and initiate cardiopulmonary resuscitation despite his DNR order, so that arrangements can be made for a controlled cardiac arrest in the OR followed by organ donation per his wishes.

The transplantation program in the US is an altruistic program based on the premise that organ donation is a gift, and relying on ethical principles of autonomy, respect for persons (beneficence, nonmaleficence), and justice. Public confidence in this system assumes obligations of grateful use, grateful conduct, and reciprocation, and the core shared societal values of voluntarism, respect for family preferences, promotion of a sense of community through generosity, and improving the quality of life for others.1 The legislative basis of this system of transplantation is the 1968 Uniform Anatomical Gift Act (UAGA) that defined the ability of individuals to donate their organs via an opt-in approach to organ donation that honored the free “autonomous” choice of individuals to donate their organs via a “first person consent” or “donor designation” process.

Since the early days of organ transplantation, there has been general acceptance of the dead donor rule, an ethical axiom that states it is unethical for organ procurement to cause death or injury and, except in the case of living donation, it is unethical for organ procurement to precede death. This rule illustrates society’s respect for the donor as a person (autonomy), the donor’s interests, and life (nonmaleficence). It was also necessary to safeguard and protect the interests of vulnerable populations, avoid “slippery slope” situations, and to insure public support for a voluntary system of organ donation.2 Adherence to the “dead donor rule” presupposes an acceptable, stringent definition of death.

Defining death

Initially, the only accepted definition of death was cardiopulmonary death, and organs were only procured from nonheartbeating donors. This placed practical limitations on transplantation of many organs, such as hearts, lungs and livers, whose viability declines rapidly with circulatory arrest. In the meantime, redefining death became important for the ever-increasing population of unconscious patients being subjected to aggressive and potentially non-beneficial life-supporting medical therapies. Such patients not only presented ethical and medical dilemmas (resource utilization, futility, end-of-life care and right to die decisions), but were also a potential source of organs for transplantation. In 1968, Henry K. Beecher and the ad hoc committee of the Harvard Medical School defined clinical criteria for “brain death” or death of the whole brain and brainstem.3 (See Chapter 19.)

A legislative “stringent” definition of death in the US was provided by the 1980 Uniform Determination of Death Act (UDDA), which defined death as either cardiopulmonary death (irreversible cessation of circulatory and respiratory function) or brain death (irreversible cessation of all functions of the entire brain and brain stem). Despite this broadening of the definition of death, the shortage of viable organs has remained a problem, and transplant waiting lists continue to grow.a The shortage of organs for transplantation resulted in renewed interest in vital organ procurement from nonheartbeating donors (donation after cardiac death or DCD) in 1992.4

Donation after cardiac death (DCD)

A non-heart-beating organ donor is “[a] cadaver, whose death was determined by demonstrating irreversible cessation of cardiopulmonary function (simultaneous and irreversible unresponsiveness, apnea, and absent circulation) from whom organs are procured.”5 DCD may be “uncontrolled” or “controlled.” Uncontrolled DCD may follow, for example, a failed cardiopulmonary resuscitation. ControlledDCD occurs when organ donation follows death after a planned withdrawal of life support that is expected to result in rapid death (either in the operating room or intensive care unit).

In order for controlled DCD to be ethically acceptable, three independent discussions and questions need to be answered by the prospective donor and/or surrogates without coercion from conflicted parties. Each discussion must be separated from the others by a functional “firewall”. The first is a discussion and decision to forgo resuscitation in the event of cardiopulmonary arrest. Then, a discussion and decision to withdraw life-sustaining therapies with continuation of comfort care can be reached. Finally, and only after the first two decisions have been made, a discussion and decision regarding organ donation can occur. Important procedural questions regarding controlled DCD may only be discussed after a decision regarding organ donation is made. These include where and by whom withdrawal of life-sustaining therapies will occur and informed consent for premortem procedures to promote organ viability – such as placement of vascular cannulae to allow premortem administration of medications to enhance organ preservation, and the infusion of preservative solutions at the time of death.

Life-sustaining therapy may be withdrawn in the intensive care unit or in an operating room with family present. After diagnosis of pulmonary and circulatory arrest, the family, if present, leaves the operating room. A waiting period of 2 to 10 minutes, depending on institutional protocol and national standards, is observed prior to declaring death. Organ procurement can begin once death is declared. In the event that cardiopulmonary death does not occur within a reasonable period of time, often defined as 1–2 hours, the patient is returned to the ICU or to a palliative care unit, and is no longer considered a potential donor.

It was hoped that DCD would significantly reduce the shortage of viable organs for transplantation, as well as provide closure and meaning to patients and their families who wished to donate organs after death. The concept of DCD was supported by the Society of Critical Care Medicine,5 Opinion 2.157 of the AMA’s Code of Medical Ethics,6 the Institute of Medicine (IOM),7 and a national conference on organ donation after cardiac death.8 However, despite increasing annual numbers of DCD donors, they still represented less than 11% of all deceased donors in 2008.9 Attempts to increase the number of DCD donors have included relaxation of the strict criteria for donation after cardiac death, and administrative, legislative, and social changes to the organ donation process. These measures have resulted in ethical and moral controversies and have only increased the public’s preexisting misperceptions and fears regarding organ procurement and DCD. These fears include those of physicians’ potential conflicts of interest favoring donation over saving the life of a “potential donor” or over end-of-life care for the “potential donor”. Other fears include worries that physicians will hasten the death of potential donors to facilitate organ transplantation and fears of not being dead at the time of organ donation. Such fears could potentially result in a decrease in agreements to sign donor cards and increased unwillingness to donate under DCD protocols.10

Legal precedents

Legislative precedents in the United States are unambiguous, allowing any competent or previously competent individual to exercise their autonomous decision to withdraw what they believe are non-beneficial life-sustaining therapies and donate their organs. These autonomous rights to have non-beneficial life sustaining therapies withdrawn in favor of comfort care are supported by the AMA Code of Medical Ethics,11 the American Thoracic Society,12 and a Task Force on Ethics of the Society of Critical Care Medicine.13 Some jurisdictions in the United States do limit the ability to withdraw care in incompetents without clear (advance) directive who are not in a persistent vegetative state.14

Ethical controversies

Ethical dilemmas in DCD are confounded by the fact that DCD combines two morally complex events – decisions and care of the donor at the end of life, and the gift of organ donation. Dilemmas include conflicts of interest in the separation between end-of-life care and donation, use of the presumptive approach to consent (in which the donor is presumed to consent unless concrete proof exists to the contrary), possible violations of the donor’s autonomous wishes when consent is presumed or obtained from surrogates, supremacy of donation over the donor’s advance directives and end-of-life care wishes, the determination of who withdraws life-sustaining therapies, the appropriateness of premortem use of organ protection agents, and the irreversibility of circulatory arrest in the age of cardiopulmonary resuscitation (CPR).

The practice of DCD has been even more ethically problematic than the concept of DCD. In 1998, the Department of Health and Human Services, Health Care Financing Administration (HCFA) changed the Medicare (Hospital) Conditions of Participation (COP) rules to require that a member of the Organ Procurement Organization (OPO) or an OPO trained “designated requestor” initiate the request for organ donation.15 This breached the firewall between end-of-life care and organ donation and presented an extreme conflict of interest, since employees of organizations whose livelihood is to obtain organs for transplantation can clearly not be assumed to represent the donor’s interests first and foremost. The breaking down of barriers between the three critical decisions necessary in DCD – to forgo resuscitation, to end life-sustaining treatments, and to donate vital organs – raises the potential for intended or unintended coercion of the potential donor or their family.

With the change in COP rules, OPOs began to adopt a “presumptive approach” to organ donation, in which it is presumed that patients want to donate organs unless proven otherwise. OPOs justified an aggressive approach by promulgating the belief that everyone should donate organs, since it is the right thing to do, and therefore any approach that leads to increased organ donation may be justified by the beneficent end of more organ availability.16 Since the “rightness” of organ transplantation is far from a universally accepted concept, and even in some cases may violate cultural and religious beliefs of individuals, such beliefs by organ transplant agencies are at the least insensitive, and may at times frankly violate ethical principles of respect for individuals. Many have concluded that this approach is misleading, manipulative and/or coercive, undermines some of the core elements of informed consent, and is ethically questionable under the principle of nonmaleficence.17, 18 Others point out that the involvement early in the process of professionals knowledgeable and involved in organ donation (OPO personnel) may result in a “dual advocacy” that considers the interests of both the donor and their family and the transplant recipient.19

Truog compares organ donation with participation in research, involving altruistic gifts, benefits to others, potential risk or harm to the patient or family, and obligations of clinicians to support the desires of patients.17, 18 He notes that the meticulous safeguards present in research consent are absent in the presumptive approach to consent for organ donation. Clearly, under the principle of nonmaleficence, a potentially coercive, conflicted, and presumptive approach would not be tolerated in research-informed consent. Ultimately, the presumptive approach has the potential to undermine the public’s confidence in the organ procurement process and further decrease the donor pool.

Families that revoke a donor’s autonomous intention to donate present additional practical, ethical, and possibly legal challenges to those involved in organ procurement. In 1998, the Center for Organ Recovery and Education (CORE), an OPO in regions of New York, Pennsylvania, and West Virginia, began a controversial policy of respecting and acting on the documented wishes of the patient to donate independent of the family’s consent. This shifted the approach to families from one of seeking consent, to one of informing that the individual’s documented decision to donate would be respected. It rarely resulted in opposition to the donation by the families. As discussed by May and colleagues,20 there was a firm ethical basis for this policy shift that was morally permissible and morally required. The CORE policy respects: (1) the autonomous rights of patients to donate their organs (respect for persons) by adhering to a donor directive that is definitive and applicable; (2) patients by having their interests survive their death by the fulfillment of their wishes; (3) the grieving families by relieving them of a burdenous decision at a time of loss; and (4) the caregivers, by moving them out of a possible conflict between opposing viewpoints.

Other attempts to increase the donor pool have not been so enthusiastically supported in the United States. Pressure from advocacy groups, such as the Presumed Consent Foundation,21 to shift the national organ transplant system to an opt-out program in which an individual would be required to register opposition to avoid automatically becoming an organ donor upon death, is extremely controversial. Although considered by national organizations such as the American Medical Association, the Health and Human Services Advisory Committee on Organ Transplantation, and UNOS as a means of increasing organ donation, well accepted as national policy in some European countries, and supported by British Prime Minister Gordon Brown, a shift in US national organ donation policy to that of presumed consent was neither supported by a 1994 US survey (71% of those opposed the practice )22 nor a 2006 IOM report.23 Differences in primary ethical priorities from autonomy and beneficence in the United States to beneficence and social justice in the European Union may account for this. Concerns in such an opt-out system include the protection of vulnerable populations such as non- or poorly English speaking persons, the young, elderly, and those who are educationally, economically, or socially disadvantaged. Such populations may neither be aware of the need to actively “opt-out” nor have access to resources to make sure that they can exercise such options.

A more recent legislative attempt to increase the number of organ donors included the 2006 revision of the UAGA,24 which had both unintended and unacceptable consequences for end-of-life care. The ethical and legislative problems for end-of-life medical decision-making that were raised by UAGA 2006 are discussed in detail in Chapter 21.

Beneficence and nonmaleficence require that to avoid even the perception of conflict of interest, the person withdrawing life-sustaining therapies should not be involved in the transplantation process. In addition, the person withdrawing life-sustaining care should have expertise in palliative care, should participate voluntarily, and have an established patient–physician relationship with the patient. Withdrawal of life-sustaining medical therapies is complex, requires special knowledge or training, and lack of knowledge may result in suffering by patients and their families and therefore, harm.25Participation by other physicians, e.g., noncritical care anesthesiologists, is improper and may raise misconceptions regarding the priority of care. The involvement of operating room anesthesiologists may further foster the misperception that anesthesia is needed because organs are actually being removed prior to death, or that anesthetics are needed for the purpose of killing the donor.

Hastening death and declaring death

Two of the most controversial questions in the practice of DCD are: (1) whether premortem administration of organ preservation agents is acceptable, since they do not benefit the donor, and may hasten death; and (2) how long the interval must be between the onset of circulatory arrest and the declaration of death. A 2005 National Conference on DCD8 supported both the administration of organ preservation agents and a very short time interval for declaration of death, noting that the intent of the patient and/or their family is to donate viable organs and therefore, practices to improve this goal are in the best interests of the patient’s/family’s goals. However, the ethical concerns regarding both practices bear some review.

Organ preservation and the potential to hasten death

Heparin and phentolamine are examples of two drugs which might hasten death in violation of the dead donor rule, and are therefore not generally used in non-donors who suffer from conditions similar to those of DCD donors, e.g., intracranial pathology or trauma, or other conditions in which enhanced bleeding might be fatal. The argument that the unintended “evil” that might occur is balanced by the potential “good” of increasing organ viability superficially sounds like the principle of double effect, which is even invoked by some of its proponents. However, the principle of double effect refers to a treatment that is intended to benefit a patient (and does), but also causes harm as an unintended side effect to that patient. Administration of organ preservation drugs has no potential benefit for the donor, and therefore can only have no effect, or will actually harm the donor. The principle of double effect therefore does not apply. Although a utilitarian philosophy might support administration of such drugs under a principle of beneficence, because it helps the recipient, the practice would not be supported from a deontological perspective, because it clearly treats the donor as a means rather than an end unto themselves. (For more on the principle of double effect, see Chapter 15.)

Declaring death … a matter of timing?

The timing of the declaration of death in DCD is extremely controversial, both legally and ethically. For death to be declared, circulatory arrest must be irreversible, in compliance with the UDDA’s definition of cardiopulmonary death. A primary goal in DCD is to minimize warm ischemic time – the time between cessation of circulation and organ reperfusion in the recipient. However, the time between circulatory arrest and declaration of death cannot be so short that irreversibility is not established, lest the patient be killed in the organ donation process. The University of Pittsburgh decided to set the appropriate duration of asystole at two minutes prior to declaration of death, based upon controversial evidence from 180 patients that autoresuscitation (spontaneous return of pulse and circulation) did not occur after that time. However, Adhiyaman and colleagues dispute the claim that there is no autoresuscitation after 2 minutes, noting reported survival of patients following much longer periods of cardiac arrest.26

In order to counter concerns that 2 minutes of asystole is not long enough to assure that circulatory arrest is “irreversible,” some have argued that, for a patient who will not be resuscitated, “irreversible” and “will not be reversed (or resuscitated)” are ethically identical. However, these situations are clearly not equivalent ethically, at least under deontological principles. In deontological reasoning, actions are determined to be “right” or “wrong” independent of their outcomes. This is because the actor does not have control over all of the consequences of an action, and accountability is therefore difficult to assign when based on the outcomes alone. Under deontological reasoning, the morality of an action is dependent on the intent of the actor, as much if not more than the outcome, because intention is more likely than outcome to be under the actor’s control.

Inability to reverse a cardiac arrest although one intends to do so is not morally the same as never intending and not even attempting to reverse a cardiac arrest even though one might be able to do so if they tried. A potential rescuer who fails in their efforts to save a drowning person is not morally equivalent to someone who might be able to save the victim if they try, but intentionally stands by and watches them drown.

Moreover, a drowning person who is struggling in the water but who will not be rescued is not “dead,” but rather is “going to die”. Prediction of death must not be confused with a diagnosis of death. By such flawed reasoning, anyone who is ever going to die would have to be defined as already dead. The controversial definition of “irreversibility” creates an irresolvable paradox, because death describes a state that, biologically, socially, or morally, is exclusive of life in whatever way we might choose to define life. Under the proposed definition in which irreversibility is equivalent to “will not be reversed,” an individual is at once both living (as an integrated organism) and dead (because they will not be rescued) immediately preceding and immediately following a cardiac arrest, even though they can only be either dead or alive, but not both, at any given time. Clearly, when the definition of death depends on the intentions and motives of a third party and not the physical state of the person whose heart has stopped, then pronouncement of death represents a social construct and not a biological fact.

The dead donor rule presents major conceptual and procedural ethical problems in DCD, and limits this method of organ donation. Importantly, however, society seems willing to accept violations of this rule without compromising the trust necessary for our voluntary system of organ donation. In a survey of 1351 Ohio residents, 45% of those with consistent answers were willing to violate the dead donor rule and donate organs of patients they considered to be alive.27 Furthermore, a survey of terminally ill adult cystic fibrosis patients found that one-third desired to donate their kidneys under anesthesia and be allowed to die when admitted for terminal care.28

Solutions to the lack of donor organs are neither clear nor without political and ethical controversy. We must decide whether as a society we should accept the concept that the dead donor rule is a violation of autonomy, or whether we should ignore the dead donor rule and allow donation from patients who have lost personhood (irreversibly neurologically impaired but do not reach the definition of brain death) or those who have decided that they wish to donate organs prior to their death or submit to other nontherapeutic procedures – whether or not these invasions result in death. Alternatively, society can abandon our strong emphasis on autonomy and develop more communitarian principles, a difficult political shift in a country founded under concepts espoused by the Enlightenment of individual life, liberty and the pursuit of happiness. The conflict arises when one pits the individual’s rights (autonomy, personal beneficence, nonmaleficence, and justice) against the welfare of society, and utilitarianism cannot solve this conflict.

Ethical frameworks

Individualism: utilitarian and deontological perspectives

Liberal individualism may be supported by both utilitarian and Kantian (deontologic) ethical concepts. Steinbock, Arras, and London note that “[w]hether ethical norms are conceived in terms of enlightened self-interest, maximized utility, or the recognition of autonomy and human rights, they are applicable to all times and places.”29 Thus, looking at the most controversial suggestion, the right of a person to donate vital organs prior to death (and thus be killed by organ donation) or submit to nontherapeutic invasion (whether or not these actions result in their death), utilitarianism would support such rights under appropriate safeguards. Utilitarian theory, as espoused by Mill, would support the ethical right of persons with decisional capacity as well as those with precedent autonomy (advance directives) to make this autonomous decision, based on their values, desires, and wants, irrespective of harm to self.30 Mill values the ability of persons to choose and follow their own life plans with little interference. If the decision to donate vital organs and die as a result is based upon reason and rationality (e.g., the patient is terminal and certain to die and their current suffering is worse than death) then, the patient has made a moral decision. If the decision results in the most happiness (greatest happiness principle) then it is morally correct based on utilitarian concepts.31 Here, the only harm is to self and that is morally permissible because “the individual is not accountable to society for actions, in so far as these concern the interests of no person but himself.”30

On first glance, deontologic (Kantian) ethics would forbid patients to donate organs for the good of society if such donation resulted in their death, as the patients would be treated as means rather than as ends.32 However, if a priori, patients decide that their duty is not to burden themselves, their families or society with continued life, then the decisions are morally correct based on Kantian concepts as long as patients treat themselves as ends and not means. They are judged by their intentions and not the consequences of their decisions. Based upon these concepts, the state or any other power structure (medical profession, judiciary, etc.) has no right to interfere. Coercive or paternalistic disruption of the patient’s autonomous decision is unacceptable to both Kant and Mill. For Kant, refusing to allow the donation might be to treat the patient (potential donor) as a means and not an end. For Mill, the interference would also be morally unacceptable. According to Englehardt, “it is not medicine’s responsibility to prevent tragedies by denying freedom, for that would be the greater tragedy.”33

In contrast, if patients are incompetent and without reason, they cannot be autonomous and Kantian theory is not applicable. Utilitarianism also falls by the wayside if patients are unable to define what grants them the greatest happiness. In this model of principlism, decisions based on beneficence, nonmaleficence, and justice (best interests) would trump nonexistent autonomy. Decisions based upon the best outcomes (consequences) would pass moral muster, and controlled paternalism, with interest only for the patients, would be acceptable.

Communitarianism

In the situation where there is no autonomy and no precedent autonomous choices, communitarianism may provide the moral answer. Individual account of a good life will not resolve the problem of what care to give patients who are not and never were competent. Moving beyond individualism and autonomy, toward an ethic of interdependence, may provide the moral and ethical answers to thesedilemmas.34 According to Emanuel,35 the principles of autonomy do not apply in the care of incompetent patients because they have no choice, decisions are made by another person (surrogate), the question of treatment is procedural, and we have avoided the question of what treatment incompetent patients should receive. Emanuel recognizes the substantive standard of best interests and realizes the multifactorial ways of determining what is best for the patient. He bases his solution on the development of democratically determined community consensus that defines the substantive content of best interests based on particular conceptions of the good life. In contrast, Callahan36 recognizes that there is inherent conflict between the individual’s best interests and what is best for society as a whole. His criteria for deciding on healthcare priorities give priority to the good to society over the good to individuals. Therefore, Callahan’s version of communitarianism, with prohibitions protecting vulnerable groups, would support the ability of persons to donate their organs, even if the donation resulted in their death. He would also support the changes in Centers for Medicare and Medicaid Services (CMS) regulations and presumed approach for obtaining consent for organ donation, concepts of presumed consent, and therefore, the unconsented perfusion of organs following uncontrolled cardiac death. Kantian (deontologic) and utilitarian theory, while supporting some of the 2006 revisions of the UAGA that enforced the patient’s right to donate over the objections of the family, would find most of the other revisions (e.g., Section 21), as well as the changes in CMS regulations, the presumed approach for obtaining consent, presumed consent, and the unconsented perfusion of organs following uncontrolled cardiac death morally unacceptable.

We live in a pluralistic liberal society, with no privileged perspective of the good, where respect for individual autonomy trumps the other principles of beneficence, nonmaleficence, and justice. These individual positive and negative liberty rights, imprinted in our Constitution and enforced by statutory and common law, allow self-harm but prohibit harm to others, and form the basis of our moral thought. Respect for autonomy involves respect for the legal and moral right to be free of nonconsensual interference. Therefore, it is just as unethical to force a person to become an organ donor as it is not to allow them the opportunity to become one, so long as the individual’s actions are free of harm to others. Respecting the ethical and judicial rights of both donors and recipients in DCD may require moving beyond the dead donor rule to accommodate the informed wishes of dying patients.

Key points

• Organ donation after cardiac death (DCD) is controversial because it combines two ethically complex events: withdrawal of life-supportive therapies as part of end-of-life care of the dying patient, and the altruistic gift of organ donation.

• The dead donor rule presents ethical problems for expansions of DCD, and some legislative and practice changes to counteract these limitations may have presented even greater ethical problems than the dead donor rule itself.

• DCD by its very nature incorporates conflicts of interest between the care of the donor and the needs of the recipient.

• Firewalls should separate the three key decisions involved in DCD: the decision to forgo resuscitation, the decision to withdraw life-sustaining therapies, and the decision to donate organs after death.

• Physicians involved in DCD should have expertise and special training in end-of-life care – involvement of general anesthesiologists can be harmful, and may lead to the mistaken belief that donors may be alive and/or suffer during vital organ procurement.

• Administration to the donor of drugs for the sole purpose of organ preservation is ethically problematic when those drugs may hasten death.

• The timing of declaration of death is also controversial, since the point of “irreversibility” of cardiac arrest has not been defined.

• Resolving conflicts in the DCD process may require revisiting the dead donor rule.

Notes

a According to data from www.unos.org and www.optn.transplant.hrsa.gov in 2009 there were 14 632 donors (8 021 deceased and 6611 living) resulting in 28 465 transplants (21 854 from deceased donors and 6 611 from living donors). As of June 2010, there were 107 970 patients on waiting lists and up to 30% will incur significant morbidity or mortality while waiting for transplantation.

References

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2 Robertson, J.A. (1999). The dead donor rule. Hastings Cent Rep29(6), 6–14.

3* A definition of irreversible coma. (1968). Report of the Ad Hoc Committee of the Harvard Medical School to examine the definition of brain death. JAMA205(6), 337–40.

4* University of Pittsburgh Medical Center policy and procedure manual. (1992). Management of terminally ill patients who may become organ donors after death. Kennedy Inst Ethics J3, A1–15.

5 Ethics Committee, American College of Critical Care Medicine, Society of Critical Care Medicine. (2001). Recommendations for nonheartbeating organ donation. Crit Care Med29(9), 1826–31.

6 Council on Ethical and Judicial Affairs, American Medical Association. (2008). Opinion 2.157: Organ donation after cardiac death. Code of Medical Ethics of the American Medical Association: Current Opinions with Annotations, 2008–2009 Edition. Chicago, IL, American Medical Association, p. 71.

7* Institute of Medicine National Academy of SciencesNon-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement, 1997 and Non-Heart Beating Organ Transplantation:Practice and Protocols, 2000, both Washington, DC, National Academy Press.

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9 www.unos.org.

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15 Medicare and Medicaid programs; hospital conditions of participation; identification of potential organ, tissue, and eye donors and transplant hospitals’ provision of transplant-related data – HCFA. Final rule. (1998). Fed Regist, 63(119), 33856–75 and

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17 Truog, R.D. (2008). Consent for organ donation-balancing conflicting ethical obligations. N Engl J Med358(12), 1209–11.

18 Waisel, D.B. and Truog, R.D. (1997). Informed consent. Anesthesiology 87(4), 968–78.

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20* May, T.Aulisio, M.P., and DeVita, M.A. (2000). Patients, families, and organ donation: who should decide? Milbank Q78(2), 323–36.

21 http://www.presumedconsent.org.

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23 Childress, J.F. and Liverman, C.T., eds. (2006). Committee on Increasing Rates of Organ Donation of the Institute of Medicine of the National Academies. Organ Donation: Opportunities for Action.Washington, DC: National Academy Press, pp. 1–358, available at http://www.nap.edu.

24 http://www.anatomicalgiftact.org.

25* Van Norman, G. (2003). Another matter of life and death: what every anesthesiologist should know about the ethical, legal, and policy implications of the non-heart-beating cadaver organ donor.Anesthesiology98(3), 763−73.

26 Adhiyaman, V.Adhiyaman, S. and Sundaram, R. (2007). The Lazarous phenomenon. J R Soc Med100(12), 552–7.

27 Siminoff, L.A.Burant, C., and Youngner, S.J. (2004). Death and organ procurement: public beliefs and attitudes. Kennedy Inst Ethics J14(3), 217–34.

28* Fost, N. (2004). Reconsidering the dead donor rule: is it important that organ donors be dead? Kennedy Inst Ethics J14(3), 249–60.

29 Steinbock, B.Arras, J.D., and London, A.J. (eds.) (2003). Ethical Issues in Modern Medicine. Boston, MA, McGraw Hill, p. 26.

30 Mill, J.S. (1986). On Liberty. Amherst, NY, Prometheus Books, pp. 106–129.

31 Mill, J.S. (1987). Utilitarianism. Amhurst, NY, Prometheus Books, pp. 16–7.

32 Kant, I. (1988). Fundamental Principles of the Metaphysic of Morals. Amherst, NY, Prometheus Books.

33 Englehardt, H.T. Jr. (2003). Commentary. In Ethical Issues in Modern MedicineSteinbock, B.Arras, J.D., and London, A.J. (eds.). Boston, MA, McGraw Hill, pp. 307–8.

34* Gaylin, W. and Jennings, B. (2003). The Perversion of Autonomy: Coercion and Constraints in a Liberal Society. Washington DC, Georgetown University Press, pp. 251–68.

35* Emanuel, E.J. (1991). The Ends of Human Life: Medical Ethics in a Liberal Polity. Cambridge, MA, Harvard University Press.

36* Callahan, D. (1990). What Kind of Life: The Limits of Medical Progress. Washington DC, Georgetown University Press, pp. 103–34.

Further reading

Arnold, R.M. and Youngner, S.J. (1993). The dead donor rule: should we stretch it, bend it, or abandon it? Kennedy Inst Ethics J3(2), 263–78.

Fost, N. (1999). The unimportance of death. In The Definition of Death: Contemporary ControversiesYoungner, S.J.Arnold, R.M., and Schapiro, R. (eds.). Baltimore, MD, Johns Hopkins University Press, pp. 161–78.

Joffe, A.R. (2007). The ethics of donation and transplantation: are definitions of death being distorted for organ transplantation? Philos Ethics Humanit Med2, 28.

Robertson, J.A. (1988). Relaxing the death standard for organ donation in pediatric situations. In Organ Substitution Technology: Ethical, Legal, and Public Policy IssuesMethieu, D. (ed.). Boulder, CO,Westview Press, pp. 69–76.

Volk, M.L., Warren, G.J.Anspach, R.R., et al. (2010). Attitudes of the American public toward organ donation after uncontrolled (sudden) cardiac death. Am J Transplant, 10(3), 675–80, Epub 2010 Feb 1.