© Springer International Publishing Switzerland 2016
Ralf J. Jox, Galia Assadi and Georg Marckmann (eds.)Organ Transplantation in Times of Donor ShortageInternational Library of Ethics, Law, and the New Medicine5910.1007/978-3-319-16441-0_2929. Protocols for Uncontrolled Donation After Circulatory Death. The Thin Red Line Between Life (Resuscitation Attempts) and Death (Organ Retrieval After Circulatory Death)
(1)
Division of Critical Care Medicine, Montreal Children’s Hospital (MCH), Montreal, Canada
(2)
Departamento de Filosofia I. Facultad de Filosofia, Universidad de Granada, Granada, Spain
(3)
Joint Centre for Bioethics, university of Toronto, Ontario, Canada
Iván Ortega-Deballon
is a research associate at the Division of Critical Care Medicine, Montreal Children’s Hospital (MCH). He is working within the Deceased Organ Donation research program at MCH and the Loeb Chair and Research Consortium at the University of Ottawa. He is interested in working on the complex intersection of pre-mortem life-saving versus post-mortem organ-preserving interventions such as high quality Resuscitation and ECMO. He is also involved with health policy development relevant to deceased donation with Canadian Blood Services and Canadian National Transplant Research Program. Ivan is a specialist in law and medical ethics and an associate professor at the University. He is also a Flight Emergency Nurse Practitioner and has worked in the Helicopter Emergency Medical Services and ground Mobile Intensive Care Units in Spain, France and Denmark. In Madrid, he was responsible for the care of potential organ donors during transport after cardiac arrest and for the approach to the next-of-kin of the potential donor.
David Rodríguez-Arias PhD,
is Investigador Ramón y Cajal at the Departamento de Filosofía I, Facultad de Filosofía, Universidad de Granada, Spain. He also belongs to the Group of Excellence G-41 on Applied Ethics of the University of Salamanca. His doctoral research included a broad international survey on the concept of death employed by 600 professionals in France, the US and Spain (INCONFUSE study). In 2009, his PhD dissertation received a research distinction (best dissertation defended in the Philosophy Department) and the National Bioethics Prize by the Víctor Grífols i Lucas Foundation. He has been a visiting fellow at Case Western Reserve University, the University of Toronto Joint Center for Bioethics and the Hastings Center. His research is mainly devoted to the ethical and international aspects of organ transplantation, with a focus on the determination of death.
Maxwell J. Smith
is a PhD candidate in Public Health Sciences and Bioethics at the Dalla Lana School of Public Health and Joint Centre for Bioethics at the University of Toronto, where he is studying the concept and role of justice in public health emergency preparedness and response. He is also a Canadian Institute’s of Health Research (CIHR) fellow in Public Health Policy, a CIHR Frederick Banting and Charles Best Canada Graduate Scholar, and a research associate with the University of Toronto Munk School of Global Affairs’ Comparative Program on Health and Society. In 2012, Max was awarded the CIHR Douglas Kinsella Doctoral Award for Research in Bioethics, the Peter A. Singer Graduate Award in Bioethics, and the Mervis-Simon Family Award in Bioethics. He recently completed a residency as a visiting researcher at the Brocher Foundation (2013).
29.1 Introduction
In the 1990s, the ever-increasing demand for organs led Spain, and later also France as well as other European countries, to authorise uncontrolled donation after circulatory death (uDCD). More recently, NYC developed its own uDCD protocol.
DCD is a form of organ donation that takes place after the cessation of circulatory function, but not of all brain function. Controlled DCD occurs in a hospital when life support is removed. In turn, uDCD is initiated following an unexpected, mostly although not always, out-of-hospital cardiac arrest (OHCA), where, after resuscitation attempts are judged futile and the patient is declared dead, interventions are restarted to preserve his or her organs. Following legislation and policy adoption in Spain and France, uDCD is also beginning to be considered and implemented in the United States.
Since its inception, uDCD has generated both excitement and concern. On the one hand, these protocols potentially increase organ donation rates by making potential donors out of individuals who suffer OHCAs. On the other hand, uDCD raises a number of ethical concerns regarding the truthfulness of the information provided to donor relatives, and the possibility that organ donation could compromise treatment for some patients in refractory cardiac arrest.
Between July 2007 and September 2010, government officials, subject experts, and community participants collaborated to derive a clinically appropriate and ethically sound uDCD protocol for NYC. Although this protocol addresses some ethical issues that have been raised in response to European uDCD protocols, new ethical issues have also emerged from the NYC protocol. In this chapter, we will discuss the strengths and possible ethical challenges of the NYC uDCD protocol by comparing it to current Spanish and French protocols . By highlighting and elucidating ethical concerns with existing uDCD protocols, it is our goal to affect positive policy change in those protocols and others that are likely to be developed worldwide.
29.2 Spanish and French uDCD Protocols
In both France and Spain, when an OHCA is reported by emergency medical services (EMS), an ambulance or a helicopter staffed by a physician, an emergency nurse, and emergency medical technicians is commissioned to the scene. After ordinary life support attempts—i.e. 30 min of advanced cardiopulmonary resuscitation—by the medical team are judged futile, the individual is transferred to a hospital with continued mechanical chest compression and ventilation to preserve the individual’s organs. The individual is declared dead at the hospital following a 5-min no-touch period of asystole. Then, normothermic extracorporeal membrane oxygenation (nECMO) is initiated to preserve organs until authorization for donation is obtained from the individual’s family (Rodriguez-Arias et al 2013 HCR).
29.3 NYC uDCD Protocol*
In contrast, the New York City (NYC) (Wall et al 2011, AJT) protocol commissions a dedicated organ preservation unit (OPU) to the scene, which is staffed with a family services specialist, two organ preservation technicians, and an emergency medicine physician seeking to preserve the organs of individuals who have suffered an OHCA. Once resuscitation maneuvers are judged unsuccessful, according to termination of resuscitation (TOR) EMS policies, the individual is declared dead. Unlike European protocols, the death of the potential donor is declared before he or she arrives at the hospital (Matesanz et al 2012, ONT). Organ preservation techniques are implemented immediately. The OPU staff arrives at the OHCA location in an organ preservation vehicle (OPV) within 2 min of TOR and determines whether there is evidence of prior first person consent for organ donation. The OPU conducts pre-hospital screening examinations including clinical brain stem assessment and, if the OHCA victim is eligible for organ procurement, starts organ preservation in the OPV. Mechanical ventilation and chest compressions are used and an intravenous dose of heparin and/or a tissue plasminogen activator (t-PA) is administered. At the hospital, nECMO is established to preserve the organs. The next of kin is approached to confirm prior consent.
(*) So far, the NYC protocol has not obtained any solid organ despite of enrolling several potential donors from the prehospital setting (Note from the authors, updated when writting this chapter)
29.4 Ethical Issues in uDCD Protocols: Spanish and French vs NYC Protocols
29.4.1 Policy and Decision-Making Process Transparency
Some authors have claimed that Spanish and French policies on uDCD have been introduced without previous societal consensus and without transparency (Rodriguez-Arias 2010, Lancet; Rodriguez-Arias 2013, HCR) . In Spain, uDCD was performed for 4 years before a law explicitly authorized its use, while in France in 2006, and in Spain in 2000, laws were quietly passed without previous debate by experts or groups designated to represent each respective society’s values and interests (Adnet et al 2009; Agence de la biomédecine 2008; Tenaillon 2009). In contrast, the NYC uDCD protocol has been a pioneer in this respect by involving the active participation of stakeholders (Wall SP et al. 2011, AJT).
29.4.2 Place and Timing of Death Determination and its Communication to the Family
In Spanish and French uDCD protocols, the potential donor’s death is certified at the hospital, even though a pre-hospital emergency physician authorized to declare death is always part of the EMS unit and could therefore declare death at that point. In fact, if the individual is not a suitable candidate for organ procurement, death is declared in situ. The individual will only be transported to the hospital, where a formal death declaration takes place, if organ retrieval is planned (Matesanz et al 2012, ONT; Rodirguez-Arias et al 2013, HCR; Agence de la biomédecine 2008; Antoine C et al 2007; Tenaillon 2009).
This differs significantly from the NYC protocol (Wall et al 2011, AJT), where a declaration of death is always signed at the OHCA scene. In Spain and France this choice is strategic (Rodriguez-Arias et al 2013, HCR); it avoids having to inform the next of kin that the victim is being transported to the hospital merely as a potential organ donor. In both countries, a soft opt-out model for organ retrieval exists, implying that the absence of explicit individual refusal automatically makes an individual a potential donor, but requires that an individual’s possible refusal to donate should be sought by checking their belongings and consulting with proxy decision makers. However, in practice, organ procurement is not undertaken if the family refuses donation. In Spain, this policy is commonly interpreted to support the placement of a cannula for nECMO without exploring the family’s opinion, even though this is not supported by law (Matesanz et al 2012 ONT; Roriguez-Arias et al 2013, HCR; Real 2070/1999; Ley 41/2002; Rodriguez-Arias et al 2010, Lancet). By contrast, in the NYC protocol the donor’s next of kin is informed about the fact that the only reason his or her relative is being transported to the hospital is the possibility of him or her becoming an organ donor. As such, preservation techniques are initiated only after a relative’s authorization. The first person consent in the NYC protocol justifies being transferred to the hospital with the OPU, which makes it possible to honor the individual’s known wishes about organ donation.
In Spain, some EMS professionals have questioned whether relatives of potential donors should be made aware of the actual reasons why individuals are transferred to the hospital (Rodriguez-Arias et al 2013, HCR; Rodriguez-Arias et al 2012, Lancet; Matesanz et al 2012, ONT). The official protocol recommends that “the family should only be told that the patient has been transferred to the hospital.” This recommendation contradicts the Spanish Law on Patient Autonomy, health professionals’ codes of ethics, and several recommendations for DCD in Europe and in the US (Committee on non-heart beating transplantation, IOM 2000; Ley 41/2002 de 14 de Noviembre; Quigley et al 2008 JME; (Real 2070/1999; Rodriguez-Arias et al 2010, Lancet; Rodriguez-Arias et al 2013 HCR). In most cases, this information is not provided to the next of kin, even though there are shortcomings among professionals in their ability to communicate bad news in these countries, as well. In France, the Agence de la Biomédecine took a positive step when discussing the opportunity to inform relatives about the real reason for transporting patients to the hospital as potential organ donors. However, the final recommendation of this official institution still includes the use of unclear language regarding the status of the patient and deceptive expressions about the purpose of administering organ preservation techniques, which are explicitly referred to as “therapeutic measures” (Agence de la biomédecine 2008).
Related posts:
The Ethics of Organ Donation: Foundations and Challenges
Challenges to the Dead Donor Rule: Configuring a Biopolitical Response
Legal Consequences of Organ Transplantation Malpractice
Xenotransplantation and Tissue Engineering Technologies: Safeguarding Their Prospects sans Sacrificing our Future
Is an Absolute Prohibition of Living Kidney Donation by Minors Appropriate? A Discussion of the Arguments in Favor and Against
Organ Donation and Transplantation in Germany
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