Dead Donor Rule Research Articles

Computed Tomography Angiography as Ancillary Testing for Death Determination by Neurologic Criteria: A Technical Review.

The determination of death by neurological criteria (DNC) stands as a pivotal aspect of medical practice, involving a nuanced clinical diagnosis. Typically, it comes into play following a devastating brain injury, signalling the irreversible cessation of brain function, marked by the absence of consciousness, brainstem reflexes, and the ability to breathe autonomously. Accurate DNC diagnosis is paramount for adhering to the 'Dead donor rule', which permits organ donation solely from deceased individuals. However, complexities inherent in conducting a comprehensive DNC examination may impede reaching a definitive diagnosis. To address this challenge, ancillary testing such as computed tomography angiography (CTA) has emerged as a valuable tool. The aim of our study is to review the technique and interpretation of CTA for DNC diagnoses. CTA, a readily available imaging technique, enables visualization of the cerebral vasculature, offering insights into blood flow to the brain. While various criteria and scoring systems have been proposed, a universally accepted standard for demonstrating full brain circulatory arrest remains elusive. Nonetheless, leveraging CTA as an ancillary test in DNC assessments holds promise, facilitating organ donation and curbing healthcare costs. It is crucial to emphasize that DNC diagnosis should be exclusively entrusted to trained physicians with specialized DNC evaluation training, underscoring the importance of expertise in this intricate medical domain.

In Defense of Normothermic Regional Perfusion.

Normothermic regional perfusion (NRP) is a relatively new approach to procuring organs for transplantation. After circulatory death is declared, perfusion is restored to either the thoracoabdominal organs (in TA-NRP) or abdominal organs alone (in A-NRP) using extracorporeal membrane oxygenation. Simultaneously, surgeons clamp the cerebral arteries, causing a fatal brain injury. Critics claim that clamping the arteries is the proximate cause of death in violation of the dead donor rule and that the procedure is therefore unethical. We disagree. This account does not consider the myriad other factors that contribute to the death of the donor, including the presence of a fatal medical condition, the decision to withdraw life support, and the physician's actions in withdrawing life support and administering medication that may hasten death. Instead, we claim that physicians play a causative role in many of the events that lead to a patient's death and that these actions are often ethically and legally justified. We advance an "all things considered" view according to which TA-NRP may be considered ethically acceptable insofar as it avoids suffering and respects the wishes of the patient to improve the lives of others through organ donation. We conclude with a series of critical questions related to the practice of NRP and call for the development of national consensus on this issue in the United States.

What Italian PICU Healthcare Providers Think About Donation After Cardiocirculatory Determination of Death: A National Survey

ABSTRACTBackgroundItaly presently does not have a pediatric organ donation program after cardiocirculatory determination of death (pDCDD). Before implementing a pDCDD program, many centers globally have conducted studies on the attitudes of pediatric intensive care unit (PICU) staff. This research aims to minimize potential adverse reactions and evaluate the acceptance of the novel donation practice.MethodsWe conducted an electronic and anonymous survey on attitudes toward pDCDD among healthcare professionals (HCPs) working at eight Italian PICUs. The survey had three parts: (I) questions about general demographic data; (II) 18 statements about personal wishes to donate, experience of discussing donation, and knowledge about donation; (III) attitudinal statements regarding two pediatric Maastricht III scenarios of organ donation.ResultsThe response rate was 54.4%, and the majority of respondents were nurses. Of those who responded, 45.3% worked in the Center, 40.8% in the North, and 12.8% in the South of Italy. In total, 93.9% supported pediatric organ and tissue donation, 90.3% supported donation after neurological determination of death (DNDD), 78.2% supported pDCDD, and 69.7% felt comfortable about the idea of participating in pDCDD on Type III patients, with a higher percentage of supportive responses in the Center (77.2%) than in the North (65.1%) and South (54.5%) of Italy (p‐value < 0.004). Concerning scenarios, 79.3% of participants believed that organ retrieval took place in a patient who was already deceased. Overall, 27.3% considered their knowledge about DCDD to be adequate.ConclusionsOur study provides insight into the attitudes and knowledge of PICU staff members regarding pDCDD in Italy. Despite a general lack of knowledge on the subject, respondents showed positive attitudes toward pDCDD and a strong consensus that the Italian legislation protocol for determining death based on cardiocirculatory criteria respects the “dead donor rule.” There were several distinctions among the northern, central, and southern regions of Italy, and in our view, these disparities can be attributed to the varying practices of commemorating the deceased. In order to assess how practice and training influence the attitude of PICU staff members, it would be interesting to repeat the survey after the implementation of a program.

An Ethics Committee’s Evaluation of Normothermic Regional Perfusion (NRP) in 2018–Unsatisfactory Answers Then—and Now

An adult university hospital ethics committee evaluated a proposed TA-NRP protocol in the fall of 2018. The protocol raised ethical concerns about violation of the Uniform Determination of Death Act and the prohibition known as the Dead Donor Rule, with potential resultant legal consequences. An additional concern was the potential for increased mistrust by the community of organ donation and transplantation. The ethics committee evaluated the responses to these concerns as unable to surmount the ethical and legal boundaries and the ethics committee declined to endorse the procedure. These concerns endure.

Ethical and Equity Guidance for Transplant Programs Considering Thoracoabdominal Normothermic Regional Perfusion (TA-NRP) for Procurement of Hearts

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.

Organ Donation by the Imminently Dead: Addressing the Organ Shortage and the Dead Donor Rule.

The dead donor rule (DDR) has facilitated the saving of hundreds of thousands of lives. Recent advances in heart donation, however, have exposed how DDR has limited donation of all organs. We propose advancing the moment in the dying process at which death can be determined to increase substantially the supply of organs for transplantation. We justify this approach by identifying certain flaws in the Uniform Determination of Death Act and proposing a modification of that law that permits earlier procurement of healthier organs in greater numbers.

Sowing “seeds of trust”: How trust in normothermic regional perfusion is built in a continuum of care

Normothermic regional perfusion (NRP) is a promising technology to improve organ transplantation outcomes by reversing ischemic injury caused by controlled donation after circulatory determination of death. However, it has not yet been implemented in Canada due to ethical questions. These issues must be resolved to preserve public trust in organ donation and transplantation. This qualitative, constructivist grounded theory study sought to understand how those most impacted by NRP perceived the ethical implications. We interviewed 29 participants across stakeholder groups of donor families, organ recipients, donation and transplantation system leaders, and care providers. The interview protocol included a short presentation about the purpose of NRP and procedures in abdomen versus chest and abdomen NRP, followed by questions probing potential violations of the dead donor rule and concerns regarding brain reperfusion. The results present a grounded theory placing NRP within a trust-building continuum of care for the donor, their family, and organ recipients. Stakeholders consistently described both forms of NRP as an ethical intervention, but their rationales were predicated on assumptions that neurologic criteria for death had been met following circulatory death determination. Empirical validation of these assumptions will help ground the implementation of NRP in a trust-preserving way.

Organismal Superposition Problem and Nihilist Challenge in the Definition of Death.

According to the mainstream bioethical stance, death constitutes the termination of an organism. This essay argues that such an understanding of death is inappropriate in the usual context of determining death, since it also has a social bearing. There are two reasons to justify this argument. First, the mainstream bioethical definition generates an organismal superposition challenge, according to which a given patient in a single physiological state might be both alive and dead, like Schrödinger's cat. Therefore, there is no clear answer as to whether organ retrieval from a brain-dead patient is an act of killing or not. Second, when combined with the dead donor rule, the mainstream position in the definition of death might lead to ethically unacceptable verdicts, since there is a discrepancy between terminating an organism and depriving someone of moral status.

Catholics United on Brain Death and Organ Donation

The Dead Donor Rule is an important component of the protections afforded to donors in organ donations. It states that medical professionals must be certain that a patient has truly passed away before procuring their organs for transplantation. One method of assessing this is using the neurological criteria. Patients satisfying these criteria have achieved what is commonly referred to as Brain Death. However, the question of whether brain death is true death is one hotly contested in some areas of Catholic bioethics. Recently, however, new guidelines provided by the American Academy of Neurology have given rise to a new disagreement: whether these new guidelines accurately assess brain death at all. This article gives an introduction to a longer call to action, Catholics United on Brain Death and Organ Donation, which describes the issues with this new guidance and objects to its use.

Standards and Ethics Issues in the Determination of Death: A Position Paper From the American College of Physicians.

The determination of a patient's death is of considerable medical and ethical significance. Death is a biological concept with social implications. Acting with honesty, transparency, respect, and integrity is critical to trust in the patient-physician relationship, and the profession, in life and in death. Over time, cases about the determination of death have raised questions that need to be addressed. This American College of Physicians position paper addresses current controversies and supports a clarification to the Uniform Determination of Death Act; maintaining the 2 current independent standards of determining death, cardiorespiratory and neurologic; retaining the whole brain death standard; aligning medical testing with the standards; keeping issues about the determination of death separate from organ transplantation; reaffirming the importance and role of the dead donor rule; and engaging in educational efforts for health professionals, patients, and the public on these issues. Physicians should advocate for policies and practices on the determination of death that are consistent with the profession's fundamental and timeless commitment to individual patients and the public.

On the ethical permissibility of in situ reperfusion in cardiac transplantation after the declaration of circulatory death

Transplant surgeons in the USA have begun performing a novel organ procurement protocol in the setting of circulatory death. Unlike traditional donation after circulatory death (DCD) protocols, in situ normothermic...

The Moral Illicitness of Relying Solely on Neurological Criteria for the Determination of Death: A Catholic Response to "Brain Death".

This paper presents the biological, philosophical, and theological arguments against "brain death" or death determined strictly through neurological criteria. It is rooted in a realistic, Thomistic metaphysical and anthropological view of the human person and the objective reality of death. Part I of the paper reviews the medical evidence that the bodies of those declared brain death are alive and makes clear that the bodies of "brain dead" patients are not biologically analogous to severed body parts. Part II presents the philosophical and theological argument that it is impossible to be a live human being and not a person. Since then those declared brain dead are somatically alive, they are live human persons with the right to life and cannot be subject to the extraction of vital, unpaired organs, since this would violate the dead donor rule. Part III reviews why the Magisterium has not unconditionally approved the determination of death through neurological criteria, and why it would be within the competence of the Magisterium to preclude medical professionals from determining death strictly through neurological criteria. The paper argues that there should be a ban on all vital, unpaired organ donation from "brain dead" donors.

Dilemmas concerning heart procurement in controlled donation after circulatory death.

With an expanding population at risk for heart failure and the resulting increase in patients admitted to the waiting list for heart transplantation, the demand of viable organs exceeds the supply of suitable donor hearts. Use of hearts after circulatory death has reduced this deficit. Two primary techniques for heart procurement in circulatory death donors have been described: direct procurement and perfusion and thoraco-abdominal normothermic regional perfusion. While the former has been accepted as an option for heart procurement in circulatory death donors, the latter technique has raised some ethical questions in relation to the dead donor rule. In this paper we discuss the current dilemmas regarding these heart procurement protocols in circulatory death donors.

Understanding the Brain-based Determination of Death When Organ Recovery Is Performed With DCDD In Situ Normothermic Regional Perfusion.

Understanding the Brain-based Determination of Death When Organ Recovery Is Performed With DCDD In Situ Normothermic Regional Perfusion.

The Chinese Organ Business of Concern – Field Research on The Institutional Determinants of Health in PRC

The field research adopted a grounded theory approach to the criminal organ harvesting behaviors of the People’s Republic of China (PRC). With ethics reviews and case studies, the research presents the PRC conducts that do not violate the “dead donor rule” technically but still criminal in nature. With the “tribute medicine” system of PRC, the world’s public health resources can be monopolized by the Communist Party of China (CPC) in times of global needs. The systematic murders and silencing in PRC for persons’ transplantation needs in power positions can target even on underaged persons. The monetarization of organ sources and organ transplantation business by CPC-led PRC can constitute systematical crimes up to crime against humanity with its erosions to medical ethics and basic human morality.

Legislation and Policy Recommendations on Organ and Tissue Donation and Transplantation From an International Consensus Forum.

Using the nominal group technique, a group composed of legal academics, a transplant coordinator/clinician, and a patient partner identified topic areas and recommendations on foundational legal issues. The recommendations were informed by narrative literature reviews conducted by group members based on their areas of expertise, which yielded a range of academic articles, policy documents, and sources of law. Best practices were identified from relevant sources in each subtopic, which formed the basis of the recommendations contained herein. We reached consensus on 12 recommendations grouped into 5 subtopics: (i) legal definitions and legislative scope, (ii) consent requirements for donation' (iii) allocation of organs and tissue' (iv) operation of OTDT systems' and (v) travel for transplant and organ trafficking. We have differentiated between those foundational legal principles for which there is a firm basis of support with those requiring further consideration and resolution. Seven such areas of controversy are identified and discussed alongside relevant recommendations. Our recommendations encompass some principles staunchly enshrined in the OTDT landscape (eg, the dead donor rule), whereas others reflect more recent developments in practice (eg, mandatory referral). Although some principles are widely accepted, there is not always consensus as to how they ought to be implemented. As the OTDT landscape continues to evolve, recommendations must be reconsidered for the law to keep pace with developments in knowledge, technology, and practice.

Variability in criteria for death determination in the intensive care unit

PurposeVariability in practice exists in death determination by circulatory criteria in the context of organ donation. We sought to describe the practices of intensive care health care professionals for death determination by circulatory criteria with and without organ donation.MethodsThis study is a retrospective analysis of prospectively collected data. We included patients with death determination by circulatory criteria in intensive care units at 16 hospitals in Canada, three in the Czech Republic, and one in the Netherlands. Results were recorded using a checklist for the determination of death questionnaire.ResultsA total of 583 patients had their death determination checklist reviewed for statistical analysis. The mean (standard deviation) age in years was 64 (15). Three hundred and fourteen (54.0%) patients were from Canada, 230 (39.5%) were from the Czech Republic, and 38 (6.5%) were from the Netherlands. Fifty-two (8.9%) patients proceeded with donation after death determination by circulatory criteria (DCD). The most common diagnostic tests reported for the whole group were absent heart sounds by auscultation (81.8%), flat continuous arterial blood pressure (ABP) tracing (77.0%), and flat electrocardiogram tracing (73.2%). In patients who successfully underwent DCD (N = 52), death was determined most frequently using a flat continuous ABP tracing (94%), absent pulse oximetry (85%), and absent palpable pulse (77%).ConclusionIn this study, we have described practices for death determination by circulatory criteria both within and between countries. Though some variability exists, we are reassured that appropriate criteria are almost always used in the context of organ donation. In particular, the use of continuous ABP monitoring in DCD was consistent. It highlights the need for standardization of practice and up to date guidelines, especially within the context of DCD where there is both an ethical and a legal requirement to adhere to the dead donor rule, while minimizing time between death determination and organ procurement.

Forced Organ Harvesting

Forced Organ Harvesting

Autonomy to a fault: The confluence of organ donation, euthanasia, and the dead donor rule.

Five countries now permit organ donation after euthanasia, on the basis of respecting donor autonomy. Some now openly consider performing euthanasia itself via organ extraction to better preserve organ viability, albeit in violation of the dead donor rule. Proponents argue that respect for patient autonomy requires this option; the dead donor rule is inapplicable since it fulfills donors' wishes. Other ethical arguments, not addressed herein, explore issues including dying at home, impact on clinicians, and societal faith in donation enterprise, but these concerns are not insurmountable. This paper instead solely critiques proponents' oversimplified understanding of autonomy with an autonomy-based argument against any linkage of organ donation and euthanasia, regardless of its timing. Respect for patient autonomy does not unilaterally require fulfilling patients' every wish. Moreover, the very possibility of organ donation with euthanasia limits donor autonomy qualitatively and quantitatively substantially more than by offering it. In fact, organ donation after euthanasia violates the purpose of the dead donor rule, even if not its technicalities.

Heart Transplantation after Circulatory Death: It Is Time to Redefine Death According to Irreversible Cessation of the Circulation and Reconcile It with Irreversible Cessation of Brain Function

In this article, we examine whether organ procurement of the heart and transplantation contravenes the dead donor rule and Australian legislative definitions of death as an irreversible cessation of the circulation. We contend that this practice upholds a long-held belief that donors of any organs after cessation of the circulation are not actually dead at the time of procurement – principally because of insufficient time lapse between cessation of the circulation and procurement of organs. Moreover, the fact that the transplanted heart functions in a recipient proves the donor’s circulation had never actually ceased irreversibly. Nonetheless, we suggest that this practice may be legitimised by amending legislation to redefine death as an irreversible cessation of brain function preceded by cessation of the circulation and requiring medical proof that the donor’s cortical brain function has ceased function before organ procurement.