Inconsistency between the Circulatory and the Brain Criteria of Death in the Uniform Determination of Death Act.

The Uniform Determination of Death Act (UDDA) provides that "an individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead." We show that the UDDA contains two conflicting interpretations of the phrase "cessation of functions." By one interpretation, what matters for the determination of death is the cessation of spontaneous functions only, regardless of their generation by artificial means. By the other, what matters is the cessation of both spontaneous and artificially supported functions. Because each UDDA criterion uses a different interpretation, the law is conceptually inconsistent. A single consistent interpretation would lead to the conclusion that conscious individuals whose respiratory and circulatory functions are artificially supported are actually dead, or that individuals whose brain is entirely and irreversibly destroyed may be alive. We explore solutions to mitigate the inconsistency.

Inequitable Access to Transplants: Adults With Impaired Decision-Making Capacity.

Inequitable access to deceased donor organs for transplantation has received considerable scrutiny in recent years. Emerging evidence suggests patients with impaired decision-making capacity (IDC) face inequitable access to transplantation. The "Ethical and Legal Issues" working group of the European Society of Transplantation undertook an expert consensus process. Literature relating to transplantation in patients with IDC was examined and collated to investigate whether IDC is associated with inferior transplant outcomes and the legitimacy of this healthcare inequality was examined. Even though the available evidence of inferior transplant outcomes in these patients is limited, the working group concluded that access to transplantation in patients with IDC may be inequitable. Consequently, we argue that IDC should not in and of itself be considered as a barrier to either registration on the transplant waiting list or allocation of an organ. Strategies for non-discrimination should focus on ensuring eligibility is based upon sound evidence and outcomes without reference to non-medical criteria. Recommendations to support policy makers and healthcare providers to reduce unintended inequity and inadvertent discrimination are set out. We call upon transplant centres and national bodies to include data on decision-making capacity in routine reporting schedules in order to improve the evidence base upon which organ policy decisions are made going forward.

The ethics of semantics in medicine.

In this paper, we discuss the largely neglected topic of semantics in medicine and the associated ethical issues. We analyse several key medical terms from the informed perspective of the healthcare professional, the lay perspective of the patient and the patient's family, and the descriptive perspective of what the term actually signifies objectively. The choice of a particular medical term may deliver different meanings when viewed from these differing perspectives. Consequently, several ethical issues may arise. Technical terms that are not commonly understood by lay people may be used by physicians, consciously or not, and may obscure the understanding of the situation by lay people. The choice of particular medical terms may be accidental use of jargon, an attempt to ease the communication of psychologically difficult information, or an attempt to justify a preferred course of action and/or to manipulate the decision-making process.

Addressing ethical confusion in deceased donation and transplantation research: the need for dedicated guidance.

Innovative research in deceased donation and transplantation often presents ethical challenges for researchers and those responsible for ethical governance of research. These challenges have been recognized as potential barriers to the conduct of research. We review the literature to identify and describe ethical considerations that may cause confusion or uncertainty in the context of research involving potential deceased donors or deceased donor transplantation. We normatively examine these considerations and discuss their implications for the ethical conduct of research. In addition to the complexities of research involving critically ill, dying or recently deceased individuals, uncertainty may arise regarding the ethical status of various individuals who may be involved in research aimed at improving availability and outcomes of organ transplantation. Consequently, routine ethical guidelines for clinical research may fail to provide clear guidance with regards to the design, conduct and governance of some deceased donation or transplantation studies. Ethical uncertainty may result in delays or barriers to research, or neglect of important ethical considerations. Specific ethical guidance is needed to support research in deceased donation and transplantation as the ethical considerations that arise in the design and conduct of such research may not be addressed in the existing guidelines for human research.

Inconsistencies Between the Criterion and Tests for Brain Death.

The whole-brain criterion of death provides that a person who has irreversibly lost all clinical functions of the brain is dead. Bedside brain death (BD) tests permit physicians to determine BD by showing that the whole-brain criterion of death has been fulfilled. In a nonsystematic literature review, we identified and analyzed case reports of a mismatch between the whole-brain criterion of death and bedside BD tests. We found examples of patients diagnosed as BD who showed (1) neurologic signs compatible with retained brain functions, (2) neurologic signs of uncertain origin, and (3) an inconsistency between standard BD tests and ancillary tests for BD. Two actions can resolve the mismatch between the whole-brain criterion of death and BD tests: (1) loosen the whole-brain criterion of death by requiring only the irreversible cessation of relevant brain functions and (2) tighten BD tests by requiring an ancillary test proving the cessation of intracranial blood flow. Because no one knows the precise brain functions whose loss is necessary to fulfill the whole-brain criterion of death, we advocate tightening BD tests by requiring the absence of intracranial blood flow.

The ethical obligation of the dead donor rule.

The dead donor rule (DDR) originally stated that organ donors must not be killed by and for organ donation. Scholars later added the requirement that vital organs should not be procured before death. Some now argue that the DDR is breached in donation after circulatory determination of death (DCDD) programs. DCDD programs do not breach the original version of the DDR because vital organs are procured only after circulation has ceased permanently as a consequence of withdrawal of life-sustaining therapy. We hold that the original rendition of the DDR banning killing by and for organ donation is the fundamental norm that should be maintained in transplantation ethics. We propose separating the DDR from two other fundamental normative rules: the duties to prevent harm and to obtain informed consent.

Aligning the Criterion and Tests for Brain Death.

Disturbing cases continue to be published of patients declared brain dead who later were found to have a few intact brain functions. We address the reasons for the mismatch between the whole-brain criterion and brain death tests, and suggest solutions. Many of the cases result from diagnostic errors in brain death determination. Others probably result from a tiny amount of residual blood flow to the brain despite intracranial circulatory arrest. Strategies to lessen the mismatch include improving brain death determination training for physicians, mandating a test showing complete intracranial circulatory arrest, or revising the whole-brain criterion.

Uncontrolled Donation After Circulatory Determination of Death: A Systematic Ethical Analysis.

Uncontrolled donation after circulatory determination of death (uDCDD) refers to organ donation after a refractory cardiac arrest. We analyzed ethical issues raised by the uDCDD protocols of France, Madrid, and New York City. We recommend: (1) Termination of resuscitation (TOR) guidelines need refinement, particularly the minimal duration of resuscitation efforts before considering TOR; (2) Before enrolling in an uDCDD protocol, physicians must ascertain that additional resuscitation efforts would be ineffective; (3) Inclusion in an uDCDD protocol should not be made in the outpatient setting to avoid error and conflicts of interest; (4) The patient's condition should be reassessed at the hospital and reversible causes treated; (5) A no-touch period of at least 10 minutes should be respected to avoid the risk of autoresuscitation; (6) Once death has been determined, no procedure that may resume brain circulation should be used, including cardiopulmonary resuscitation, artificial ventilation, and extracorporeal membrane oxygenation; (7) Specific consent is required prior to entry into an uDCDD protocol; (8) Family members should be informed about the goals, risks, and benefits of planned uDCDD procedures; and (9) Public information on uDCDD is desirable because it promotes public trust and confidence in the organ donation system.

Positive HIV Test Results from Deceased Organ Donors: Should We Disclose to Next of Kin?

In the context of deceased organ donation, donors are routinely tested for HIV, to check for suitability for organ donation. This article examines whether a donor's HIV status should be disclosed to the donor's next of kin. On the one hand, confidentiality requires that sensitive information not be disclosed, and a duty to respect confidentiality may persist after death. On the other hand, breaching confidentiality may benefit third parties at risk of having been infected by the organ donor, as it may permit them to be tested for HIV and seek treatment in case of positive results. We conclude that the duty to warn third parties surpasses the duty to respect confidentiality. However, in order to minimize risks linked to the breach of confidentiality, information should be restrained to only concerned third parties, that is, those susceptible to having been infected by the donor.

Controlled Donation After Circulatory Determination of Death.

Controlled donation after circulatory determination of death (cDCDD) concerns donation after withdrawal of life-sustaining therapy (W-LST). We examine the ethical issues raised by W-LST in the cDCDD context in the light of a review of cDCDD protocols and the ethical literature. Our analysis confirms that W-LST procedures vary considerably among cDCDD centers and that despite existing recommendations, the conflict of interest in the W-LST decision and process might be difficult to avoid, the process of W-LST might interfere with usual end-of-life care, and there is a risk of hastening death. In order to ensure that the practice of W-LST meets already well-established ethical recommendations, we suggest that W-LST should be managed in the ICU by an ICU physician who has been part of the W-LST decision. Recommending extubation for W-LST, when this is not necessarily the preferred procedure, is inconsistent with the recommendation to follow usual W-LST protocol. As the risk of conflicts of interest in the decision of W-LST and in the process of W-LST exists, this should be acknowledged and disclosed. Finally, when cDCDD programs interfere with W-LST and end-of-life care, this should be transparently disclosed to the family, and specific informed consent is necessary.

Donation after brain circulation determination of death.

BACKGROUND: The fundamental determinant of death in donation after circulatory determination of death is the cessation of brain circulation and function. We therefore propose the term donation after brain circulation determination of death [DBCDD]. RESULTS: In DBCDD, death is determined when the cessation of circulatory function is permanent but before it is irreversible, consistent with medical standards of death determination outside the context of organ donation. Safeguards to prevent error include that: 1] the possibility of auto-resuscitation has elapsed; 2] no brain circulation may resume after the determination of death; 3] complete circulatory cessation is verified; and 4] the cessation of brain function is permanent and complete. Death should be determined by the confirmation of the cessation of systemic circulation; the use of brain death tests is invalid and unnecessary. Because this concept differs from current standards, consensus should be sought among stakeholders. The patient or surrogate should provide informed consent for organ donation by understanding the basis of the declaration of death. CONCLUSION: In cases of circulatory cessation, such as occurs in DBCDD, death can be defined as the permanent cessation of brain functions, determined by the permanent cessation of brain circulation.

Practical Considerations in Donation After Circulatory Determination of Death in Switzerland.

Faced with similar issues of organ scarcity to its neighbors, Switzerland has developed donation after circulatory determination of death (DCDD) as a way to expand the organ pool since 1985. Here, we analyze the history, practical considerations, and ethical issues relating to the Swiss donation after circulatory death programs. In Switzerland, determination of death for DCDD requires a stand-off period of 10 minutes. This time between cardiac arrest and the declaration of death is mandated in the guidelines of the Swiss Academy of Medical Sciences. As in other DCDD programs, safeguards are put to avoid physicians denying lifesaving treatment to savable patients because of being influenced by receivers' interest. An additional recommendation could be made: Recipients should be transparently informed of the worse graft outcomes with DCDD programs and given the possibility to refuse such organs.

The ethics of extracorporeal membrane oxygenation in brain-dead potential organ donors.

Organ-preserving extracorporeal membrane oxygenation (OP-ECMO) is defined as the use of extracorporeal support for the primary purpose of preserving organs for transplantation, rather than to save the patient's life. This paper discusses the ethics of using OP-ECMO in donation after brain determination of death (DBDD) to avoid the loss of organs for transplantation. We review case reports in the literature and analyze the ethical issues raised. We conclude that there is little additional ethical concern in continuing OP-ECMO in patients already on ECMO if they become brain dead. The implementation of OP-ECMO in hemodynamically unstable brain-dead patients is ethically permissible in certain clinical situations but requires specific consent from relatives if the patient's wish to donate is not clear. If no evidence of a patient's wish to donate is available, OP-ECMO is not recommended. In countries with presumed consent legislation, failure to opt out should be considered as a positive wish to donate. If a patient is not-yet brain-dead or is undergoing testing for brain death, OP-ECMO is not recommended. Further research on OP-ECMO is needed to better understand the attitudes of professionals, families, and lay people to ensure agreement on key ethical issues.

Cardio-pulmonary resuscitation of brain-dead organ donors: a literature review and suggestions for practice.

"Organ preserving cardiopulmonary resuscitation (OP-CPR)" is defined as the use of CPR in cases of cardiac arrest to preserve organs for transplantation, rather than to revive the patient. Is it ethical to provide OP-CPR in a brain-dead organ donor to save organs that would otherwise be lost? To answer this question, we review the literature on brain-dead organ donors, conduct an ethical analysis, and make recommendations. We conclude that OP-CPR can benefit patients and families by fulfilling the wish to donate. However, it is an aggressive procedure that can cause physical damage to patients, and risks psychological harm to families and healthcare professionals. In a brain-dead organ donor, OP-CPR is acceptable without specific informed consent to OP-CPR, although advance discussion with next of kin regarding this possibility is strongly advised. In a patient where brain death is yet to be determined, but there is known wish for organ donation, OP-CPR would only be acceptable with a specific informed consent from the next of kin. When futility of treatment has not been established or it is as yet unknown if the patient wished to be an organ donor then OP-CPR should be prohibited, in order to avoid any conflict of interest.

An analysis of heart donation after circulatory determination of death.

BACKGROUND: Heart donation after circulatory determination of death (DCDD) has provoked ethical debate focused primarily on whether heart DCDD donors are dead when death is declared and when organs are procured. OBJECTIVE AND DESIGN: We rigorously analyse whether four heart DCDD programmes (Cape Town, Denver, Australia, Cambridge) respect the dead donor rule (DDR), according to six criteria of death: irreversible cessation of all bodily cells function (or organs), irreversible cessation of heart function, irreversible cessation of circulation, permanent cessation of circulation, irreversible cessation of brain function and permanent cessation of brain function. CONCLUSIONS: Only death criteria based on permanency are compatible with the DDR under two conditions: (1) a minimum stand-off period of 5 min to ensure that autoresuscitation is impossible and that all brain functions have been lost and (2) no medical intervention is undertaken that might resume bodily or brain circulation. By our analysis, only the Australia heart DCDD programme using a stand-off period of 5 min respects the DDR when the criteria of death are based on permanency.