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Executive Summary
Pages 1-6

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From page 1...
... These are patients who are either severely ill on life support, and life support can be withdrawn with proper consent, or they have suffered unexpected cardiac arrest, whether previously ill or not, and cannot be resuscitated.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.
From page 2...
... The current situation demands enhanced organ recovery from traditional doctors, 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.
From page 3...
... 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.
From page 4...
... The medical-ethical issues specific to the DHHS request concerned administration of the anticoagulant heparin and the vasodilator phentolamine (Regitine_~. 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.
From page 5...
... 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.
From page 6...
... 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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