<Table Of Contents

Negotiating Life and Death in Organ Procurement: Normothermic Regional Perfusion and The Anticipatory Corpse

by Anjola Onadipe, 2024 Medical Fellow

Introduction

Normothermic Regional Perfusion (NRP) is a recent modification to protocols for obtaining organs for transplantation. It is performed in some patients who are declared dead after blood stops circulating throughout the body. The NRP method involves using a machine to recirculate blood in the donor-patient several minutes after death is declared. As a result of this process, sometimes the heart starts beating again. NRP has been shown to improve the quality of organs obtained for transplant; however, it blurs the lines between life and death and has sparked significant ethical controversy.

Medically and legally speaking, there exist two categories of death: 1) circulatory death in which the heart and lungs stop working, leading to the cessation of blood circulation and 2) brain death in which there is irreversible and complete loss of function of the entire brain, even if the heart and lungs are artificially functioning (e.g., with a ventilator). Correspondingly, there are two general protocols for organ procurement: donation after circulatory death (DCD) and donation after brain death (DBD). NRP only occurs in DCD. The protocol for DCD without NRP includes a five-minute “hands-off” period after the donor-patient is declared dead to ensure no signs of the return of life. Organ procurement starts after the hands-off period. However, by the time the organs are obtained, they can be partially damaged due to the time without blood flow. NRP modifies the DCD protocol by using an artificial life support machine to restart blood circulation after the five-minute hands-off period. Prior to recirculation, the main blood vessels that supply the brain are blocked due to concerns that recirculation to the brain could restore some brain function.

The ethical firestorm ignited by NRP over the past few years has not only sparked debate about organ procurement practices but also prompted questions about what it means to be alive, how we characterize death, the moral status of people who fall in the liminal space between life and death, and our moral responsibility towards them. How do we reflect properly about such consequential questions that have implications not only for organ procurement but also for the practice of medicine writ large? One helpful source is the 2011 book The Anticipatory Corpse: Medicine, Power, and the Care of the Dying by Jeffrey Bishop, a physician and philosopher.1

Bishop gives a rich historical analysis to demonstrate that the way we take care of dying patients reveals unspoken yet ubiquitous philosophical assumptions in medicine, and how these implicit commitments shape our social understanding of death. The general argument of this book is that medicine operates inside largely unstated philosophical frameworks—such as biological reductionism—which view the body as devoid of intrinsic meaning. On this view, however, bodies can acquire meaning by serving as instruments to serve other ends—such as expanding individual autonomy, improving medical innovation for its own sake, and advancing utilitarian societal goals (e.g., organ transplantation). The body thus becomes an instrument to be efficiently controlled to meet these ends, and this instrumentalization leads to dehumanization.

Parts of the book discuss how these dynamics are demonstrated in our organ transplantation practices, and at least three themes are relevant for discussions about NRP: that biopolitical incentives to procure more organs may indirectly lead to methods that push ethical boundaries, that our organ procurement practices shape our definitions of death, and that organ procurement protocols rely on unambiguous definitions of death which deny the reality that death is a mysterious process. The aim of this essay is to describe these themes and how they manifest in NRP. Before describing the themes, I will briefly characterize the ethical debate surrounding NRP.

Characterizing the Ethical Debate

NRP has sparked vigorous debate in multiple contexts. Among professional medical societies, there is disagreement on the ethical permissibility of the practice. The American Society of Transplantation (AST) deems NRP permissible, but the American College of Physicians (ACP) does not.2 After the ACP released a statement against NRP, the AST released a statement of rebuttal against the ACP’s position.3 Notable medical and bioethical journals have hosted rigorous debates, including recent commentary in the Journal of the American Medical Association4 and in an issue of the American Journal of Bioethics devoted to NRP.5 Conversations about NRP have extended beyond professional and scholarly circles and into the popular press through news outlets like The New York Times and National Public Radio.6

One of the major sticking points about NRP is the dead-donor rule, which is an ethical norm in organ transplantation that has two related but slightly distinct components: 1) vital organs must not be taken from patients until they die, and 2) patients must not be killed by the process of organ procurement.7 Opponents argue that NRP violates one or both of these principles. Donor-patients are typically considered dead based on circulatory criteria; however, by restoring circulation, they no longer meet these standards and may better be characterized as alive. The patient could still be considered dead based on brain-death criteria because cutting off circulation to the brain—which is part of the NRP method—would lead to brain death. But this understanding suggests that the organ procurement process would be the proximal cause of death and thus a violation of the dead-donor rule. Some proponents of NRP believe that it does not violate the dead-donor rule because the patient has always been declared deceased before NRP commences. Other proponents believe it does violate the dead-donor rule but think that clinicians should abandon the dead-donor rule to make it permissible for organ retrieval to lead to death, as long as the patient consents to it.

Proponents of NRP also tend to support it because it leads to a higher number of and better-quality organs and consequentially extends the life of organ recipients. Moreover, there exists a history of ethical reticence in the cases of prior major advances in organ transplantation; however, these objections have subsided with time. Advocates assume the same will happen in this case. It should also be noted that NRP occurs in only a portion of organ donations. Lastly, NRP respects patient autonomy by allowing a person to fulfill their wishes, namely organ donation.

However, this notion of patient autonomy remains contested, as some opponents note that there is not adequate informed consent. When a person signs up to be an organ donor, they are not informed about the possibility of NRP. Furthermore, organ procurement organizations often explain NRP in an intentionally vague manner to donors’ loved ones out of concern that their loved ones will be less likely to proceed with organ donation if they understand the procedure clearly. Opponents have also cited technical considerations to avoid NRP, such as the possibility that circulation to the brain could still occur due to collateral vessels (e.g., from the spinal arteries) despite cutting off supply to the main brain vasculature.8 Collateral vessels could at least in theory supply enough blood flow to stave off brain death, but no formal brain-death testing is done during NRP. More broadly, some opponents have a gut feeling that NRP does not seem right or violates human dignity, though this feeling can be hard to put into words.9

Though an oversimplification, the driving thrust of ethical justification for NRP relies on utilitarian or consequentialist ethics, while the ethical arguments against it tend to embrace a deontological approach.

Biopolitics and Biopower in Organ Transplantation

The first theme of The Anticipatory Corpse that helps us understand the phenomenon of NRP is that this procedure is an expression of biopolitics or biopower. The book engages heavily with the work of Michel Foucault—a renowned 20th century French historian of ideas—who coined the terms biopolitics and biopower. These terms are distinct but deeply interrelated and as such will be used interchangeably for the sake of this essay. They generally refer to the regulation of bodies to fit the aims of modern nation states.

Foucault was a pioneering thinker about the nature of power and how structures of authority produce political and social arrangements. He argued that prior to the 18th century, states exercised power directly by setting up disciplinary institutions that shaped norms of individual behavior. However, over the past few centuries, the power of the state has become indirect. Power now takes effect through regulation of non-governmental social networks and social institutions, which themselves form structures of knowledge and norms.10

The field of medicine is one such institution as it holds specialized knowledge and thus the power to define social norms within its jurisdiction of managing health and illness. The state exerts power to shape our normative conceptions of the body by regulating medicine in ways that align with the goals of the state (e.g., managing a population to keep it healthy and produce enough workers). These regulations have downstream effects on the norms formed for individuals. Biopower refers to this potency of the state expressed through medicine. As the rest of this section discusses, NRP—at least in an American context—is likely the outcome of such incentives and regulatory pressures.

NRP is at least in part a downstream effect of state entities providing incentives to increase organ transplantation. The Anticipatory Corpse does not discuss NRP because it was written before NRP was commonplace. The book does, however, explore some of the incentives in organ procurement practices that preceded NRP. Hospitals partner with Organ Procurement Organizations (OPOs) to do transplants. Both follow guidelines set up by the Centers for Medicare and Medicaid Services (CMS) and the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO).11 CMS and JCAHO regulate many aspects of health and medicine, one of which is the relationship between hospitals and OPOs. This regulation is good and necessary. There ought to be oversight over organ donation practices. CMS and JCAHO, however, do not merely provide oversight but also provide incentive structures to increase the number of successful requests for organ donation. For example, in the late 2000s, CMS and JCAHO encouraged OPOs to try to increase DCD donations and started requiring hospitals to contact their OPO for every death of a hospitalized patient.12 Another example of such incentivization is the formation of the Transplant Growth and Management Collaborative (TGMC), which was a series of collaborative efforts from 2004 to 2008 between OPOs and government bodies aimed at increasing the supply of organs and the efficiency of procurement.13

Pressure to increase donations remains strong. See, for instance, the 2020 CMS revisions for OPO outcome measures, which took effect in 2022. Some of the provisions include modifying performance metrics to drive more donations, increasing competition among OPOs that serve the same donation service area, stratifying OPOs relative to each other, and withholding certification from OPOs in the lower tiers of stratification.14 In the context of national agencies pushing for more organs, it is not a surprise that NRP has emerged in U.S. organ procurement practices. Pressure to increase the number of organs will drive new strategies, including strategies that may be ethically controversia

Organ Procurement Practices Shape our Understanding of Death

Another point that Bishop makes that resonates with NRP is that our practices surrounding organ procurement shape our social understanding of death. This insight was true when organ transplants began in the mid-twentieth century and remains true now.

The concept of brain death emerged in the mid-twentieth century. Prior to this time, death was only understood medically and legally as the cessation of heart and lung function. However, medical innovations of the time, such as the mechanical ventilator, made it such that we could keep the heart and lungs functioning in people with profound brain failure and permanent unconsciousness. People debated the moral status of these people who were in a state of what we would now call brain death. Before brain death emerged as a concept, different terms were used to describe these patients (e.g. “irreversible coma”), but they were not systematically or legally defined as dead.15 The term “brain death” was not systematically used among medical professionals until after the 1968 report of the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death. This committee’s report is the first known use of the term “brain death” in print and was an important event leading up to the Uniform Declaration of Death Act in 1981, which was key in solidifying the medical and legal validity of brain death.

The connection between brain death and organ transplantation is clear in the committee’s stated purposes, one of which was to legitimize organ procurement from people with irreversible coma by defining irreversible coma as a legitimate criterion for death.16 As one committee member put it in an early version of the report, “the question before this committee cannot be simply to define brain death. This would not advance the cause of organ transplantation.”17 In order for organ procurement to be non-controversial, our understanding of death needed to change. Changes to our understanding of death are normal, as death is both a biological reality and a social construction. As societal knowledge and norms change, so do our ideas and attitudes around death. For our purposes, what is important is that the inception of brain death as a concept is inseparable from organ procurement practices.

Bishop also notes that the organ transplant apparatus aims to reimagine our social conceptions of death in ways that support more organ transplantation. Bishop makes this point in his discussion of the TGMC:

The TGMC also states, as part of its goals, that any failure to bring to the patient’s or the surrogate’s attention the possibility of organ donation denies dying patients and grieving families the “opportunity to give the gift of life” and results in the “potential death of patients on the waiting list.”18

Here, Bishop quotes parts of the TGMC’s goals from the U.S. Department of Health and Human Services’ website. This is a striking statement by the TGMC as it suggests that grieving families have a prima facie desire to think about organ donation amidst the tragedy of losing a loved one. This statement assumes that offering to give one’s organs is a standard part of the dying process and an ideal way for death to have meaning. To the extent that this is not the norm, the TGMC desires to cultivate practices and dispositions that shape our experience and meaning of death in ways that promote the transplant apparatus’ success. A contemporary practice that aims to normalize organ donation as a good death is the honor walk, whereby hospital staff and guests recognize the donor-patient’s gift by lining up the halls from the patient’s room to the operating room immediately before donation occurs. As Bishop and two of his former trainees point out, honor walks are less about honoring the donor and more about promoting greater acceptance of transplantation despite discomfort.19 In this view, it is not enough to respect death as a significant moment in and of itself. A good death is one where the body can be used for the greater good of society.

With NRP, our habits and practices around death change in the name of transplantation. Restoring circulation to a person whose heart stopped beating used to unequivocally mean keeping them alive (unless brain death had been declared). NRP, however, better fits certain utilitarian social goals. As a result, we may end up modifying our understanding of death to make it acceptable to restore circulation and not consider this act resuscitation. Amidst this shift, we run into an odd paradox of initiating a life support machine in a person considered to be dead.

Denial that Death is a Process

In the background of this entire conversation lies an essential question: what does it mean for a person to die? In one sense, this question is intuitive. In another, however, it is deeply mysterious. Death is the absence of life, but when we probe deeper into what this means, we find that it is difficult to adequately define death (or life for that matter).

The case of Jahi McMath serves as a difficult example of this tension. Jahi was a teenager who lived in California and was declared brain dead in 2013 after complications following surgery. As with most brain-dead patients, her heart and lungs were still functioning through artificial means (i.e., a ventilator). New Jersey law regarding death contains a provision that allows families to reject the concept of brain death if it goes against their beliefs. For example, individuals may have cultural or religious beliefs that a person is not dead if they are still breathing (even through artificial means). Jahi’s family did not accept brain death as true death and had her transferred to a hospital in New Jersey. She died “again” in 2018 when she suffered from liver failure. For five years she was legally dead in California but legally alive in New Jersey.

During those five years, there were signs of integrated function of her body. She continued to grow vertically, started menstruating, and exhibited a limited ability to follow simple commands. Analysis from experienced neurologists validated that Jahi did meet the criteria for brain death in 2013; however, in the months and years after this evaluation, she no longer did.20 So, was Jahi dead or alive during those five years she was on the ventilator? Opinions vary. If Jahi’s body were actively decomposing in 2013, there would be no dispute about her being dead. If in 2013 she recovered enough to regain consciousness and interact with the environment, there would be no dispute about her being alive. But Jahi was caught in a liminal space between life and death. Death remains, it seems, a mystery, difficult to fully define.

As we have seen, organ transplantation benefits from having death seem clear and unambiguous, a fact noted even during the early days of transplantation when brain death was emerging as a concept. To quote Bishop:

There were those who understood that death is not the absolutely thin and definable line between life and decay […] The proponents of transplantation, however, needed death to be what it had always been since the end of the eighteenth century, a precise moment definable in space […] If death is thought of as the end of a long process, in which the body gradually disintegrates after neurological injury, the possibility of doing transplants is threatened.21

There were people who acknowledged in early conversations about organ transplantation that death is a process. But this acknowledgement was set aside because it could stifle innovation and the benefits of organ transplantation. To keep momentum in organ procurement, there have been efforts to diminish the ambiguity around death. NRP aligns with this biopolitical incentive.

To be clear, we do need to employ straightforward definitions for practical reasons. We need to define when one is alive or dead so we can, for instance, withdraw life-sustaining therapies, start funeral arrangements, execute a will, etc. However, caution is warranted amidst uncertainty. NRP presents a quagmire, making it difficult to ascertain biologically and legally if life has been restored. At the very least, that death is a process should be acknowledged in conversations about the ethical implications of NRP.

Concluding Thoughts

NRP will likely remain controversial as long as the practice continues. As further conversations proceed, some of the themes of The Anticipatory Corpse are worth pondering. For instance, if Bishop is right that medicine largely operates under implicit philosophical frameworks that view the body as devoid of intrinsic meaning, this way of understanding influences how medicine thinks about the ethics of NRP. The moral significance of restarting circulation in a person declared dead will depend on our normative conceptions of how we treat the bodies of the deceased. If one’s view of the body is that it is merely biology and physiology in motion, this perspective might lead a person to think differently than another person who, for example, sees the body as having intrinsic and/or transcendent meaning and purpose. One’s philosophical starting points can have downstream effects on how one views ethical issues. Recognizing and discussing those starting points, especially with people who have different initial perspectives, is helpful in our quest to be ethical professionals.

The three themes highlighted in this essay are worth considering in future conversations about NRP. How ought we think about the biopolitical and regulatory pressures that seek to increase the number of donors? On one hand there is a significant utilitarian justification for efforts to improve organ transplantation. On the other hand, this utilitarian impulse leads to practices that many people believe violate important ethical norms. Policy changes may be needed to promote the good that comes from organ transplantation and to mitigate some of the negative unintended consequences of current regulatory pressures. The themes highlighted also invite us to reflect on our personal and collective ideas about what it means to die and how our practices in medicine have the power to shape those ideas. If our practices in medicine conflict with norms surrounding dying, then to what extent do we change our practices in medicine versus change those surrounding dying? The debate about NRP, like definitions of death itself, requires close attention.

Anjola Onadipe was a 2024 FASPE Medical Fellow. He is a fourth-year medical student at the University of Michigan Medical School and plans to pursue residency training in combined Internal Medicine and Pediatrics.

Notes

  1. Jeffrey Paul Bishop, The Anticipatory Corpse: Medicine, Power, and the Care of the Dying, Notre Dame Studies in Medical Ethics (Notre Dame, Ind: University of Notre Dame Press, 2011).
  2. “Normothermic Regional Perfusion (NRP),” American Society of Transplantation, accessed August 9, 2024, https://www.myast.org/normothermic-regional-perfusion-nrp.“Ethics, Determination of Death, and Organ Transplantation in Normothermic Regional Perfusion (NRP) with Controlled Donation after Circulatory Determination of Death (cDCD): American College of Physicians Statement of Concern,” American College of Physicians, April 17, 2021, https://www.acponline.org/sites/default/files/documents/clinical_information/resources/end_of_life_care/ethics_determination_of_death_and_organ_transplantation_in_nrp_2021.pdf.
  3. Brendan Parent et al., “Response to American College of Physician’s Statement on the Ethics of Transplant after Normothermic Regional Perfusion,” American Journal of Transplantation: Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons 22, no. 5 (May 2022): 1307–10, https://doi.org/10.1111/ajt.16947.
  4. Robert D. Truog, Andrew Flescher, and Keren Ladin, “Normothermic Regional Perfusion-The Next Frontier in Organ Transplants?,” JAMA 329, no. 24 (June 27, 2023): 2123–24, https://doi.org/10.1001/jama.2023.9294; Kari Esbensen and Kenneth Prager, “Organ Procurement Using Normothermic Regional Perfusion,” JAMA 330, no. 14 (October 10, 2023): 1389–90, https://doi.org/10.1001/jama.2023.16884; Anji E. Wall, Carrie Thiessen, and Elizabeth Anne Pomfret, “Organ Procurement Using Normothermic Regional Perfusion,” JAMA 330, no. 14 (October 10, 2023): 1390, https://doi.org/10.1001/jama.2023.16887; Robert D. Truog, Andrew Flescher, and Keren Ladin, “Organ Procurement Using Normothermic Regional Perfusion-Reply,” JAMA 330, no. 14 (October 10, 2023): 1390–91, https://doi.org/10.1001/jama.2023.16890.
  5. David Magnus, ed., The American Journal of Bioethics 24, no. 6 (June 2, 2024): 1–91.
  6. Joseph Goldstein, “When Does Life Stop? A New Way of Harvesting Organs Divides Doctors,” The New York Times, November 22, 2023, https://www.nytimes.com/2023/11/22/nyregion/organ-donors-transplants-legally-dead.html. Rob Stein, “Doctors Try a Controversial Technique to Reduce the Transplant Organ Shortage,” NPR, July 8, 2024, https://www.npr.org/sections/shots-health-news/2024/07/08/nx-s1-4896568/transplant-organ-shortage-nrp-normothermic-regional-perfusion.
  7. Robert M. Arnold and Stuart J. Younger, “The Dead Donor Rule: Should We Stretch It, Bend It, or Abandon It?,” Kennedy Institute of Ethics Journal 3, no. 2 (June 1993): 263–278.
  8. Alex Manara et al., “Maintaining the Permanence Principle for Death during in Situ Normothermic Regional Perfusion for Donation after Circulatory Death Organ Recovery: A United Kingdom and Canadian Proposal,” American Journal of Transplantation 20, no. 8 (August 2020): 2017–25, https://doi.org/10.1111/ajt.15775.
  9. During the FASPE discussion on NRP, another participant aptly described this phenomenon as the “ick factor.”
  10. Gerald P. McKenny, To Relieve the Human Condition: Bioethics, Technology, and the Body (Albany, N.Y: State University of New York Press, 1997), 184–210.
  11. Bishop, 171–76.
  12. Bishop, 176.
  13. Bishop, 174.
  14. “Organ Procurement Organization (OPO) Conditions for Coverage Final Rule: Revisions to Outcome Measures for OPOs CMS-3380-F | CMS,” accessed August 9, 2024, https://www.cms.gov/newsroom/fact-sheets/organ-procurement-organization-opo-conditions-coverage-final-rule-revisions-outcome-measures-opos.
  15. Bishop, 146–60.
  16. Bishop, 157.
  17. Bishop, 159.
  18. Bishop, 175.
  19. Jay R. Malone, Jordan Mason, and Jeffrey P. Bishop, “Ritual and Power in Medicine: Questioning Honor Walks in Organ Donation,” HEC Forum, March 20, 2024, https://doi.org/10.1007/s10730-024-09525-6.
  20. Rachel Aviv, “What Does It Mean to Die?,” The New Yorker, January 29, 2018, https://www.newyorker.com/magazine/2018/02/05/what-does-it-mean-to-die.
  21. Bishop, 151–152.