Cadaveric Donors

The Association of Organ Procurement Organizations (AOPO) estimates that potential cadaveric organ donors have stabilized at 11,000 to 14,000 yearly. A few (less than 5 percent) are non-heart-beating donors, but in the vast majority cardiovascular circulation remains intact until organs are removed. Despite broad public awareness of the need for and benefit from organ transplants, less than half of the immediate relatives of potential cadaveric donors give their consent to remove vital organs. Consequently, the number of donors is stalled between 6,000 and 7,000 each year. Moreover, the quality of organs has diminished as age of the typical cadaveric donor increases and the cause of death shifts from head trauma to stroke in 44 percent of donors. Transplant centers and potential recipients have turned increasingly to organs from "extended criteria cadaveric donors". Altogether in 2001 roughly 6,100 cadaveric donors provided 7773 kidney, 800 simultaneous pancreas/kidney, 446 pancreas, 25 islet, 48 intestine, 4,800 liver, 992 lung and 1973 heart transplants, but nearly 100,000 potential recipients remained on the waiting lists at the end of the year.

The gap between waiting list and available cadaveric organs widens every year. Few believe that the number of cadaveric organ transplants will increase more than one or two percent yearly during the next decade. Perhaps educational programs in primary and secondary school will lead the next generation to broader support of cadaveric organ donation based on altruism, enlightened self interest, or some form of compensation to the donor's estate.

The supply of cadaveric donors is just as inadequate in many European countries with presumed consent laws as it is in English speaking countries, where consent to remove organs must be obtained from the closest relative. In many countries where transplantation is not a high priority, individuals who are moribund and considered not salvageable are not admitted to intensive care units. Temporary ventilatory support is withheld and cardio circulatory collapse follows. In other potential donors ventilatory support may be initiated, but inadequate attention is paid to maintaining normal physiologic function in organ systems after brain death has been diagnosed. The striking exceptions are Spain, Austria and Belgium, all of which have presumed consent laws. In all three countries national government recognizes maximum retrieval of transplantable organs as a national priority. Spain in particular has engaged participation of anesthesiologists in most of its hospitals to lead identification of potential donors, implementation of protocols to improve cardiopulmonary function, approaching potential donor families and continuing donor medical management until organs are removed.1,2 Spain's rate of cadaveric organ donation approaches 40 per million population which is twice the rate in the United States.

The message from Europe is that presumed consent alone will not yield high donor rates. But, presumed consent coupled with national determination and systems to identify and stabilize potential donors in every trauma center and emergency room will maximize the opportunity for cadaveric organ transplantation. However, most English speaking countries are unlikely to implement presumed consent laws. Presumed consent for removal of transplantable organs springs from the Napoleonic legal code that gave final authority for autopsy of dead bodies to the state rather than the family. As organ transplantation evolved, removal of transplantable organs was viewed as the first steps of an autopsy and thus covered under presumed consent. But under English common law it was the next of kin who was responsible for appropriate disposition of the relative's body and for granting permission for autopsy. Thus, maximizing the potential for cadaveric organ transplantation in most English speaking countries will require informed and willing public motivated by altruism or something else.

That half of the relatives of potential organ donors in the United States refuse consent implies that the public lacks information and understanding of organ donation or lacks long-term self-interest and sufficient altruism. For the past two decades clergy have supported organ donation in their sermons, staff from organ procurement organizations have spoken at schools and to many organizations, and television has dramatized the miracle of transplantation; so the public is rather well informed. Self-interest should also serve to motivate, because no one knows when failure of one of his own vital organs might call for transplantation; but self interest may not be immediate enough to motivate consent. Consequently, many believe that financial incentives passed through the potential donor's estate, perhaps as a funeral benefit or other consideration, are needed to increase motivation.

Debate intensified in 2002 over financial and other incentives to stimulate consent. Boards of Directors of the American Medical Association, UNOS, and the American Society of Transplant Surgeons voted to study and test changes to U.S. law that would permit compensating cadaveric donor's estates and burial costs. The American College of Surgeons and the Board of the National Kidney Foundation expressed vigorous opposition for even the testing of offering financial incentives to donate. A non financial incentive discussed at the December 2002, Congress on Ethics in Organ Transplantation (Munich) would reward family members of a cadaveric organ donor with preferred status on the transplant waiting list; that should appeal to enlightened self interest. Moreover, it is consistent with current UNOS policy that gives waiting list priority to living kidney donors who may need a kidney transplant in the future. The Munich Congress passed resolutions that allocation policies should aim at giving equal concern and respect to all potential recipients; equity and justice in organ allocation are as important as seeking maximum utility; and all societies should make every effort to maximize cadaver organ donation. Even with these resolutions the Congress recognized that living donor kidney transplantation should be encouraged and adopted as widely as possible.3,4

UNOS (United Network for Organ Sharing) is a not-for-profit corporation that has operated the nation's Organ Procurement and, Transplant Network (OPTN) since 1985 after the United States Congress passed the National Organ Transplant Act (NOTA). UNOS operates the OPTN under contract with the United States Department of Health and Human Services and ultimately reports to the Secretary of the Department. UNOS and its representative working committees achieved broad consensus with respect to the set of rules that governed organ transplantation until 1998-2000. But disagreement over rules for allocating scarce cadaveric livers eventually prevented consensus, and in 2000 the Secretary appointed a committee of forty members to serve as an Advisory Committee on Transplantation. Satisfactory rules for sharing livers fell into place without resorting to the new committee, but the Advisory Committee convened in November 2002 at the Secretary's request to consider issues related to well-being of living donors, shortage of cadaveric donors and equal access to organ transplantation. The Advisory Committee made nine recommendations designed to increase cadaveric organ donation, two recommendations to encourage equal access to minority populations and seven recommendations with respect to living donors.5 The seven that concern living donors will be presented later in this review, but the eleven recommendations on cadaveric donation and equal access are these:

1. That legislative strategies be adopted that will encourage medical examiners and coroners not to withhold life-saving organs and tissues from qualified organ procurement organizations.

2. That the Secretary of HHS, in concert with the Secretary of Education, should recommend to states that organ and tissue donation be included in core curriculum standards for public education as well as in the curricula of professional schools, including schools of education, schools of medicine, schools of nursing, schools of law, schools of public health, schools of social work and pharmacy schools.

3. That in order to ensure best practices, organ procurement organizations and the OPTN be encouraged to develop, evaluate, and support the implementation of improved management protocols of potential donors.

4. That in order to ensure best practices at hospitals and organ procurement organizations (OPO), the following measure should be added to the CMS (Center for Medicare/Medicaid Services). Conditions of Participation: Each hospital with more than 100 beds should identify an advocate for organ and tissue donation from within the hospital clinical staff.

5. That in order to ensure best practice at hospitals and OPOs, the following measure should be added to the CMS Conditions of Participation: Each hospital should establish, in conjunction with its OPO, policies and procedures to manage and maximize organ retrieval from donors without a heartbeat.

6. That the following measure be added to the CMS Conditions of Participation: Hospitals shall notify OPO prior to the withdrawal of life support to a patient, so as to determine that patient's potential for organ donation. If it is determined that the patient is a potential donor, the OPO shall reimburse the hospital for appropriate costs related to maintaining that patient as a potential donor.

7. That the regulatory framework provided by CMS for transplant and OPO certification should be based on principles of continuous quality improvement. Subsequent failure to meet performance standards established under such principles should trigger quality improvement processes under the supervision of the Health Resources and Services Administration (HRSA).

8. That all hospitals, particularly those with more than 100 beds, be strongly encouraged by CMS and the Agency for Health Care Research and Quality c

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