1
Introduction

This report is about transplanting solid organs—primarily kidneys but also livers and to a lesser extent hearts, pancreases, and lungs—from cadavers to recipients in whom one or more of these organs have failed. The focus is on organs recovered from cadavers under specific circumstances. These cadavers are called non-heart-beating donors (NHBDs)* to distinguish them from the more usual brain-dead (but heart-beating) and living, healthy donors. The report, most importantly, is concerned with identifying and addressing the issues raised in consideration of the NHBD as part of the effort to achieve the valuable goal of an organ supply that is closer to demand and yet to remain within the ethical boundaries that ensure the rights and welfare of donor patients.

The ethical and legal requirements for donor patient care and the imperatives of the organ conservation, recovery, and transplant process seem to render actions on behalf of donors as patients and as donors, and on behalf of organs that are in condition to give recipients the best possible chance for new hope and life, difficult or even impossible to reconcile. The issues raised by these actions

*  

Although "donor" is standard usage, most NHBDs are not donors as the word is usually understood outside of this context, because they themselves did not consent. Instead, their responsible family members or a legal surrogate gave permission for organ donation. Nevertheless, the words "donor" or "donation" are generally understood in this context, and possible replacements like recovery, removal, retrieval, and procurement are not synonyms, do not capture the sense of altruism implicit in ''donation," and in practice are unwieldy to use uniformly. Thus the words "donor" and "donation" are used in this report with the knowledge that they recognize the gift but inaccurately attribute it.

  

"Brain-dead" is legally identical to "dead." The unnecessary and confusing modifier serves the practical purpose of specifying which legal determination of the primary cause of death, whole brain or cardiopulmonary, is meant.



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--> 1 Introduction This report is about transplanting solid organs—primarily kidneys but also livers and to a lesser extent hearts, pancreases, and lungs—from cadavers to recipients in whom one or more of these organs have failed. The focus is on organs recovered from cadavers under specific circumstances. These cadavers are called non-heart-beating donors (NHBDs)* to distinguish them from the more usual brain-dead† (but heart-beating) and living, healthy donors. The report, most importantly, is concerned with identifying and addressing the issues raised in consideration of the NHBD as part of the effort to achieve the valuable goal of an organ supply that is closer to demand and yet to remain within the ethical boundaries that ensure the rights and welfare of donor patients. The ethical and legal requirements for donor patient care and the imperatives of the organ conservation, recovery, and transplant process seem to render actions on behalf of donors as patients and as donors, and on behalf of organs that are in condition to give recipients the best possible chance for new hope and life, difficult or even impossible to reconcile. The issues raised by these actions *   Although "donor" is standard usage, most NHBDs are not donors as the word is usually understood outside of this context, because they themselves did not consent. Instead, their responsible family members or a legal surrogate gave permission for organ donation. Nevertheless, the words "donor" or "donation" are generally understood in this context, and possible replacements like recovery, removal, retrieval, and procurement are not synonyms, do not capture the sense of altruism implicit in ''donation," and in practice are unwieldy to use uniformly. Thus the words "donor" and "donation" are used in this report with the knowledge that they recognize the gift but inaccurately attribute it. †   "Brain-dead" is legally identical to "dead." The unnecessary and confusing modifier serves the practical purpose of specifying which legal determination of the primary cause of death, whole brain or cardiopulmonary, is meant.

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--> and the responses they have engendered are identified and addressed later in this report on the medical and ethical issues in procuring organs for transplantation. They are also the ones that have occupied the biomedical and ethics communities in clinical and research efforts to solve them. These issues are particularly salient in the NHBD because interventions in the heart-beating donor occur in a brain-dead cadaver, and the living donor involves an autonomous, consenting person for whom every effort in his or her care is addressed toward a healthy, medically uncompromised survival. There is a relentlessly increasing need for organs for patients with life-threatening organ failures that requires the recruitment of donors and timely intervention to obtain the donated organs in the best possible transplantable condition. Delay because of insufficient organ supply proves fatal to one-third of waiting heart and liver recipients. The total number of waiting list deaths now exceeds 4,000 each year, and for all those waiting, morbidity, pain, depression, and economic costs are a constant part of their lives (Perkins, 1987; UNOS, 1996; Youngner and Arnold, 1993). At the same time, persons who have been or may be designated as donors have, during a final illness, rights to health care that meets appropriate, prevailing medical and ethical standards (Sadler et al., 1968). This care must promote the individual's welfare and provide the best chance for recovery, no matter how small, or for a death with as much comfort and dignity as possible. Any exceptions to the principle that decisions about, and the administration of, health care should be separate from, and uninfluenced by, any considerations of transplantation must be explicit, ethical, and subject to informed consent. Donor patients must not be killed or their death hastened by the taking of organs (the "dead donor rule," which operationally has meant that donors must be dead before donation). Furthermore, their welfare and care must not be compromised by preparation for organ retrieval, and the sensitivity and grief of family and friends must be respected. These considerations and principles apply to all kinds of cadaver donors, and they must be preserved in the face of the interventions desirable to obtain organs in the best transplantable condition. The best organs are those that are perfused by warm, oxygenated blood up to the very moment of their removal from the donor's body. These conditions are met only in heart-beating—that is, living and brain-dead—donors. Attempts to approach or simulate these ideal conditions for recovery of organs from NHBDs, therefore, pose challenges that are complex and in certain respects different from those of other donors. The preferred NHBD in the United States is the "controlled" NHBD. Those caring for and carrying out transplantation from controlled NHBDs must manage patients with severe injury or disease, usually involving the brain, who do not meet the legal test for death by neurologic criteria and whose cardiopulmonary function has been resuscitated or is being supported through medical technology. Physicians must maintain as normal as possible blood and oxygen supply

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--> to organs, provide organ-conserving interventions as necessary, discontinue breathing and circulatory support when a proper decision and proper consent to do so has been obtained to allow the irreversible cessation of cardiac and pulmonary function so as to meet the legal standard of death, and then begin preserving and removing organs as soon as possible before they deteriorate. This tightly scheduled management of the donor patient and the transplantable organs must, as noted, satisfy a number of important ethical principles, including the dead donor rule, respect for family wishes, prohibition against euthanasia, and informed consent. To some extent in this country, and more often in Europe, transplantation involves a category of NHBDs who are not controlled by technological support of respiration and heart function. These individuals (uncontrolled NHBDs) have suffered cardiopulmonary arrest as a result of severe illness or injury just before admission or during their hospital stay. This "uncontrolled" event dictates great speed in retrieving organs, early organ preservation interventions, or sequences of resuscitation efforts that start and stop depending on the status of the donor and the transplantable organs. This process must meet ethical principles similar to those for controlled NHBDs. Because the medical and ethical issues and the problems of all NHBDs, controlled or uncontrolled, are similar in so many essential ways, this report should and does examine all categories of NHBD.