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--> Executive Summary This report examines medical and ethical issues in recovering organs from non-heart-beating donors (NHBDs) who do not meet the standard of brain death. These are patients who are either severely ill on life support, and life support can be withdrawn with proper consent, or they have suffered unexpected cardiac arrest, whether previously ill or not, and cannot be resuscitated. These patients are called, respectively, controlled or uncontrolled NHBDs—controlled because death and organ removal can be predictably controlled and planned following withdrawal of life support; uncontrolled because the occurrence of cardiac arrest is unplanned and the timing and some other aspects of organ removal are not controlled; and non-heart-beating because death is determined by cessation of heart and respiratory function, not whole brain function. This report makes recommendations to implement the following general conclusion: the recovery of organs from NHBDs is an important, medically effective, and ethically acceptable approach to reducing the gap that exists now and will exist in the future between the demand for and the available supply of organs for transplantation. Discussions and media reports about recovery of organs from NHBDs arising from the Pittsburgh protocol and the Cleveland Clinic proposal have generated questions about whether the use of organs from NHBDs raises unique or insurmountable ethical problems. The problems raised require attention, but they are, in fact, not significantly different from those that arise in cadaveric transplantation generally. The design and implementation of standards and procedural guidelines for organ recovery from NHBDs based on the principles that support the retrieval of organs from brain-dead donors, would address these problems and allow the development of non-heart-beating organ donation as an important source of organs for transplantation. Such an enhancement of organ donation would be of significant societal value.
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--> Solid organ transplantation activities in the United States include health care financing, program assistance, oversight, and research support from the Department of Health and Human Services (DHHS). National data collection, analysis, and reporting and allocation of organs from the United Network for Organ Sharing; donor procurement by more than 60 organ procurement organizations working with about 1,300 donor hospitals; and health care delivery in about 275 transplant centers—all of which make up the national Organ Procurement and Transplantation Network—are also part of transplantation services. In addition, there are organizations of physicians and other procurement and transplant personnel, recipients, and donor families among other groups that support and advocate transplantation. Much of this activity is pursuant to federal, state, or local law and regulation. This effort exists because of, and cannot succeed without, members of the public, who donate organs for transplantation. During life, they volunteer as living donors or execute donor cards or other advance directives to provide organs at death, or in the absence of directives, at death their families consent to the removal of organs for transplantation. Unfortunately, this national effort is inadequate in the sense that donor numbers are growing only slowly at the same time that demand for organs increasingly exceeds the supply. This is happening as research has led to a better understanding of transplantation biology and transplantation technology and results have been consistently improving. The current situation demands enhanced organ recovery from traditional donors, the exploration of new approaches to organ donation and recovery, and the implementation of national donor procurement and care standards that adhere strictly to ethical and scientific norms and will reinforce public confidence in the donor process. This study is the Institute of Medicine's response to a request from the DHHS. That request, in essence, posed the general question, how can the United States have a good organ donor and transplantation program? The actual request letter (see Appendix A) was focused more specifically and circumscribed the question to, what are the alternative medical approaches that can be used to increase the availability of organs and at the same time ensure the ethically and medically sound treatment of donor patients before and after death? The IOM was also asked to review some specific interventions that are undertaken in donors to preserve organs for transplantation, such as the administration of anticoagulants and vasodilators. Furthermore, the DHHS request focused the study on very severely ill or injured, but not brain dead, patients with informed consent for withdrawal of life support (primarily mechanical ventilation) or patients who suffer cardiac arrest and cannot be resuscitated, called, as noted earlier, respectively, controlled and uncontrolled NHBDs. The premises that organ transplantation is a valuable treatment that should be supported and extended to all suitable patients with organ failure and that organs from NHBDs are an underutilized, although potentially very significant,
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--> source of organs for transplantation that deserves careful exploration were starting points for this report. The data on total organ supply from all kinds of donors, the national demand for organs, the disparity between supply and demand, and the avenues that might be taken to improve supply from existing kinds of donors are explored. Analysis of the evidence suggests that supply could and should be enhanced but that, without scientific breakthroughs, demand probably always will exceed the organs available from human sources. The four different categories of NHBDs (one controlled and three uncontrolled) are described in this report, and the most recent data on U.S. transplantation with these donors along with the results, which are comparable to results of transplants involving organs recovered from brain-dead patients, are reported. The background material includes a short history of organ transplantation in the United States, and reviews development of the definition and criteria for brain death and of the state laws for defining death as cessation of function of either the whole brain or the circulatory and respiratory systems. The point is made that there is an unmet need for organs, as well as scientific and clinical justification and historical precedent that support an exploration of the alternatives to increase organ availability including recovery of organs from NHBDs. The analysis of the potential role of these donors in transplantation includes a survey of all 63 current organ procurement organizations and the NHBD protocols that have been approved or are under development in 34 of them. This analysis describes variations and contradictions among protocols and—within the context of a set of identified principles—provides a framework for organizing the issues and recommendations involved. The principles identified indicate the ways in which viable organs can best be recovered from NHBDs in a manner that is consistent with appropriate medical and ethical standards. The main principles, or general approaches, which are relevant to all cadaveric donors including NHBDs, are summarized in Box 1. The five headings used to organize the issues are (1) policies and oversight, (2) medical interventions and ethics, (3) conflicts of interest, (4) determination of death, and (5) families. Box 1 Principles 1. The societal value of enhancing organ donation. 2. Organ donors must be dead at organ removal. 3. Absolute prohibition of active euthanasia. 4. Complete openness about policies and protocols. 5. Commitment to informed consent. 6. Respect for donor and family wishes.
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--> Box 2 Recommendations for National Policy 1. Written, locally approved NHBD protocols. 2. Public openness of NHBD protocols. 3. Case by case decisions on anticoagulants and vasodilators. 4. Family consent for premortem cannulation. 5. Conflict of interest safeguards—separate times and personnel for important decisions. 6. Determination of death in controlled NHBDs by cessation of cardiopulmonary function for at least 5 minutes by electrocardiographic and arterial pressure monitoring. 7. Family options (e.g., attendance at life support withdrawal) and financial protection. Local policies and protocols may appropriately reflect local differences in custom and practice. There should, however, be some national uniformity. Outright contradictions—for example, a blanket prohibition of anticoagulants and vasodilators as hastening death in one case and their routine administration to living donors before withdrawal of life support in other cases, citing the inadequacy of pulse palpation for determining death in one case and relying on it in another, or using different definitions of death—are not likely to engender public confidence in the management of NHBDs. Although the consequences of these inconsistencies may be more perceived than real, this report recommends that they be resolved. The recommendations that are important for national policy are summarized in Box 2 and this section of the report. They are described in greater detail in the Analysis section of this report. First of all, protocols should be open, public documents, and given the ethical and medical complexity of NHBDs, organ procurement should be carried out only after advance thought and planning that has been reduced to a written protocol developed with public input (including the views of patient and donor families) and approved by appropriate local oversight bodies. The medical-ethical issues specific to the DHHS request concerned administration of the anticoagulant heparin and the vasodilator phentolamine (RegitineTM). The NHBD protocols reviewed are divided evenly between allowing the use at some stage in the donation process of one or both of these agents and expressly prohibiting or not mentioning them. In most cases, careful administration is appropriate. Nevertheless, because under certain circumstances in certain patients, there is a concern that these agents might be harmful, this report recommends case-by-case decisions on the use of anticoagulants and vasodilators, and consideration of additional safeguards such as involvement of the patient's attending physician in prescribing decisions. Major vascular cannulation for organ perfusion with cooling and preserving solutions is discussed. Premortem cannulation of controlled NHBDs is acceptable, but requires
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--> informed family consent. The pros and cons of postmortem cannulation in potential donors without consent are presented. This issue remains open. In the absence of a clear ethical resolution, the best policy may be to require consent. This report discusses and reinforces the safeguards against conflicts of interest. These include separating decisions about and management of care with respect to life support withdrawal and donation, determination of death and organ removal by appropriate timing and by keeping the responsibilities of attending patient care physicians and other personnel separate from those of transplant or procurement physicians and personnel. Also discussed are the difficulties of eliminating ''institutional" biases toward donation and transplantation in settings such as transplant hospitals where there are institutional advantages to increasing donor and transplant numbers. As noted earlier, the definitions of death and standards for determining death differ in protocols across the country. Defining death is a matter for state law and may vary. However, defining and determining death are much more critical in organ donors than in other patients. In heart-beating, brain-dead donors there is a need for clear understanding and implementation of the criteria for brain death to ensure that the donor patient is dead. Concerns of organ viability are relieved by continued circulation. In NHBDs there is a requirement to ensure than the donor patient is dead so as to avoid even the perception of organ removal from a living person, but at the same time, to bring removal as close as possible to the cessation of circulatory and respiratory function in order to ensure organs in the most viable condition. Existing NHBD protocols either are unclear or specify organ removal from immediately to 5 minutes after heart stoppage. In view of the critical nature of this decision, this report recommends that not less than a 5-minute interval, determined accurately by electronic and arterial pulse pressure monitoring, be required to determine donor death in controlled NHBDs. No recommendations are made for uncontrolled NHBDs, and for the time being, details of how to define and determine death in these donors are left to the judgment of local medical experts. This report strongly encourages discretion and sensitivity with respect to the circumstances, views, and beliefs of families (language of U.S. Code 42:1320b-8(a)(1)(A)). Families need to be fully informed, given privacy and time to adjust, and provided with the option of attending the withdrawal of life support and the death of their loved ones. Appropriate follow-up after donation and the Bill of Rights for Donor Families are discussed and supported. Some NHBD protocols contain explicit guarantees that donors will not incur costs. Donors and their families should not suffer financial penalties by altruistically contributing to the national donation effort. Not all issues were addressed in this study that could have been, and as noted, some that were raised have been left for future discussion. Changes in the nationwide transplant effort described and recommended here (and summarized
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--> in Box 2) should be made. The process could involve participation by the transplant community, donor families, recipients, and the public in consultative roles. An open process to identify and address problems is important because public perceptions of deficiencies in the care of NHBDs can damage ongoing organ recovery efforts and because organs donated by families of NHBDs can provide a potentially important contribution to efforts to bring organ supply closer to demand.
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