Non-Heart-Beating Organ Transplantation Medical and Ethical Issues in Procurement (1997) / Chapter Skim
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6 Analysis, Findings, and Recommendations
6 Analysis, Findings, and Recommendations
Pages 45-64
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From page 45... ...
Second, the recovery of organs from NHBDs should be considered a reasonable source of organs whose potential deserves a serious exploration. It was further noted that it would be well to address both controlled and uncontrolled NHBDs.
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From page 46... ...
Donor families stress that openness and the involvement and approval of interested members of the public are important in protocol development, in OPO goven~ance and transplant program operation, in donor recruitment, and in other public education efforts. Such efforts, carried out through informational material, public advisory groups and boards, and educational campaigns can enhance public trust and support of organ donation and transplantation (Coolican, 19974.
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From page 47... ...
Five OPOs had protocols covering uncontrolled as well as controlled NHBDs, and some OPOs were recovering organs from one or the other kind of NHBD without protocols. The protocols were uniform in separating discussions and decisions on withdrawal of life support from those on donation and in requiring the independence of those responsible for declaration of death from those involved in procurement.
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From page 48... ...
On the other hand, protocols should not be inconsistent among OPOs and hospitals in ways that raise questions about the motives and priorities of transplant programs or the scientific and ethical standards of care for donor patients. Fundamental scientific and ethical principles do not vary from region to region.
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From page 49... ...
Uncontrolled NHBDs such as those in categories I or II, who could not be resuscitated after a heart attack, present the danger that prematurely abandoning resuscitation to turn to organ donation may forfeit the life of a patient who is otherwise a salvageable, competent person. The issues of timing and determination of death do not arise in category IV uncontrolled NHBDs because the patient has already been determined (brain)
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From page 50... ...
This includes those that resuscitate or sustain life and maintain organ function but under the circumstances of an actual donor patient perhaps because of the severity of the damage due to injury or disease or because of a prior decision to forgo further treatment their administration or the timing of their administration raises questions of whose welfare is being served. Still other interventions include organ conservation measures by specific preservation and treatment technologies or by monitoring which can also ensure that life has ended and organ removal is not premature.
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From page 51... ...
Of the average $33,997 hospital stay cost, $17,385 was considered "futile" for the patient, but probably "necessary for improved organ procurement rates." With the understanding that designation as a donor undoubtedly changes, in a similar way, what happens to a NHBD patient, the overarching questions here include the following: is this change and are these interventions ethically acceptable; is the timing of these interventions ethically problematic; for which interventions is informed consent a requirement; and are there modifying conditions to the use ofthese interventions that might be necessary or helpful? Within the context of the social value of enhancing donation and the other principles and provisions previously noted, this report concludes that these interventions can be appropriate, although only two are discussed in detail.
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From page 52... ...
Physicians responsible for the care of individual donors should be able to make a clinical judgment on the advisability of using either heparin or phentolamine or both without hastening donor death. This report recommends that individual clinical judgments be made and also that consideration be given to in volving the donor's attending physician as either the responsible prescriber or a required consultant or co-decision maker with the procurement or transplant team to improve patient protection, lessen conflicts of interest, and strengthen public confidence.
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From page 53... ...
may have been discussed, the great majority of uncontrolled NHBDs suffer cardiopulmonary death unexpectedly and most often without family decisionmakers immediately at hand to give consent for measures such as Cannulation and cooling. At the same time, the pressure for cooling is greatest in these donors because they are likely to have the longest intervals of organs unrecovered in the body at normal body temperature.
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From page 54... ...
Patients with valid organ donor cards or other advance directives that grant permission are patients with legal consent, and this report concludes that in such instances, cannulation, cooling, and organ retrieval should proceed consistent with the donor patient's clear wishes. Individual procurement organizations or programs generally discontinue organ preservation and recovery if families are located and object, given the possibility of adverse public reaction.
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From page 55... ...
All procurement organizations and transplant programs appear to understand the need for strong safeguards to ensure that conflicts of interest do not lead to violations of prevailing medical and ethical standards of care for patients who may become or already are designated donors. These safeguards require separating major decisions and discussions in patient care (withdrawal of life support, discontinuing CPR, and declaration of death)
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From page 56... ...
Nevertheless, many NHBD patients are managed at transplant centers. Here, personnel, even if not part of the transplant program, are likely to be at least aware of the possible benefits in prestige, research support, patient care reimbursement, and staff recruitment that may accompany a successful, growing transplant program.
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From page 57... ...
This kind of admixture of patient care and donation objectives provides sustaining care interventions for patients, meets obligations to enhance organ donation, and is reasonable as long as patient and family needs are met within a policy of openness. It is difficult or impossible even to isolate the donation effort in such instances.
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From page 58... ...
Withdrawal of life support undoubtedly leads to cessation of circulatory function that, even if the possibility of spontaneous return of effective heartbeat is left aside, might sometimes be reversed if life support were restored or other resuscitative measures were initiated. In the situation of the controlled NHBD, however, a valid refusal of further treatment is in hand, and a decision has been made to withdraw life support with an understanding of the consequences.
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From page 59... ...
In patients with depressed body temperatures, death is more difficult to determine; time and resource constraints did not allow a thorough exploration of this challenging situation in this report, however. Based Ott expert information and advice Tom its senior special experts, this report recommends that in controlled NHBDs, an interval of at least 5 minutes elapse after complete cessation of circulatory function, as measured by standards described later ifs this chapter, before death is pronounced and organ perfusion or removal begins.
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From page 60... ...
CPR is involved in other uncontrolled NHBDs who suffer unexpected cardiopulmonary arrest yet may have considerable potential for a return to normal life. In these donors there are major concerns regarding the vigor and duration of attempts to restore circulation, the standards for determining death, and the timing of organ removal.
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From page 61... ...
For the definition of death recommended in this report for controlled NHBDs or any definition float includes a specific time interval of absent heart function to be meaningful, an unambiguous time of cessation of function and monitoring to detect any return of function is required. This report recommends, in adhering to the controlled NHBD definition of at least 5 minutes of absent heart function, that accepted medical detection standards include electrocardiographic changes consistent with absent heart function by electronic monitoring and zero pulse pressure as determined by monitoring through an arterial catheter.
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From page 62... ...
Many families would also appreciate some follow-up support of the kind mentioned in the Bill of Rights for Donor Families. It is to be hoped that attending physicians and responsible resident physicians would continue to have an interest in donor families and be willing to discuss and explain matters to them, to visit on occasion, and to be willing to help with follow-up questions.
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From page 63... ...
Donor families should not be penalized for altruistically contributing to the social good by enhancing organ procurement and for consenting to make a contribution to the national transplantation program. Several NHBD protocols reviewed in this report already provide that no costs after consent for donation will be borne by donor families whether or not donation is successfully accomplished.
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From page 64... ...
This report provides information, analysis, conclusions, and recommendations to the sponsor, the Department of Health and Human Services, regarding the issues that the department raised as particular concerns and regarding additional issues that were identified as currently salient.
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