Observatorio de Bioética, UCV

A Consensus On Death Criteria As It Pertains To Tissue And Organ Donation is proposed

Bioética / Bioética / Pacientes en coma / Cuidados paliativos / Eutanasia / FINAL DE VIDA / Trasplante de órganos / Suicidio asistido / Testamento vital

A Consensus On Death Criteria As It Pertains To Tissue And Organ Donation is proposed
18 julio
12:22 2014

An interesting tesis about an ethical actual matter published with the express authorization from the author by our Bioethics Observatory.

THESIS: A Consensus On Death Criteria As It Pertains To Tissue And Organ Donation Can Be Achieved By Some Criteria That Are Based On A More Comprehensive Ancillary Multiple Tissue And Organ Analysis.

Author: CAJETAN I. ODUNZE, MA, MS.

Thesis advisor: EDWARD J. FURTON, PhD; Fr. TADEUSZ PACHOLCZYK, PhD.

Holy Apostles College And Seminary, Cromwell, Connecticut. 06416 USA. www.holyapostles.edu

ARTICLE ABSTRACT:  Arguments have been made that organ donors declared dead based only on evaluations of neurological function, were actually alive because they had intact cardiopulmonary function.  Arguments have likewise been made that organ donors declared dead based only on evaluations of cardiopulmonary function, were actually alive because they had intact neurological function. This paper proposes that declaration of death should be based on multiple organs using a more comprehensive ancillary analysis. Concurrent evaluation of Brain function, Cardiac function, Blood flow, Breathing, and Oxygenation are suggested. Concurrent evaluation of multiple organs and tissues should indicate the effect of loss of integration due to total loss of brain function; as well as the effect of loss of cardiopulmonary function on other organs and tissues.  

 INTRODUCTION

 The Catholic Bioethics justifies human organ donation because it is an act of heroic Charity as it is a gift of self, and is justified by the Principles of Fraternal Charity. [1] But for the donation to be licit, it must not create a serious danger to the health of the donor. When donation involves a single or unpaired organ, removal must be done when the donor is dead in order to assure moral certainty which is a necessary and sufficient basis for an ethical correct course of action, as to remove an unpaired human organ from a living human being is tantamount to intentionally causing the death of the human person. The Catholic Catechism states that it is morally illicit and ethically wrong to cause the death of one human being in order to save another. [ 2]

To ascertain that a human being is dead with complete certainty is one of the main controversial issues surrounding the issue of death and human organ donation. One reason for this controversy is that there is no consensus on what death of a person really is, and when this death has occurred. Philosophers, Theologians, and Medical Scientists have their views of what death is. But because of the epistemological differences inherent in these fields, it is not easy to arrive at a general consensus of what death really is. Hence different jurisdictions have different criteria for death evaluation. One jurisdiction may evaluate death based only on the brain stem,  another jurisdiction may evaluate the whole brain including the brain stem, and another may evaluate only the heart, or blood circulation. Yet those that evaluate death based on the heart may still lack consensus on criteria. The result is that a patient may be declared dead in one place and alive in another. So people question whether the evaluation of death based on one organ or tissue guarantees ethical and moral certainty sufficient for human organ donation. The  purpose of this paper is to indicate that a consensus on death criteria as it pertains to tissue and organ donation can be achieved by some criteria that are based on a more comprehensive ancillary multiple tissue and organ analysis.

Defining Death

It is not easy to define death in a way that will fit everyone’s line of thought, or in a way that is acceptable to everyone. Theologically, death is defined as that single act whereby the Soul separates from the body of a living human being. But philosophical definition of death depends on one’s philosophical orientation. According to the Aristotelian-Thomistic thought, the death of a person may be defined as, “A single event, consisting in the total disintegration of that unitary and integrated whole that is the personal self. It results from the separation of the life-principle (or Soul) from the corporal reality of the person.” [3]  This definition is in line with the Christian understanding of human life as well as to sound Philosophy.

Some Philosophical thoughts with reductionist and utilitarian tendencies do suggest that death is loss of awareness, a component of consciousness. According to this Philosophical thought, loss of awareness suggests loss of personhood, and loss of personhood suggests that death of a person has occurred. But one weakness with this line of thought is that consciousness has two components: awareness and arousal, and while loss of awareness may suggest that death has occurred, the arousal component is intact, and suggests that the donor is alive. Those in persistent vegetative state (“awake but unaware”) who have lost awareness but have intact arousal are therefore dead as they have lost their personhood. But how can one who is awake be also dead? This is a big question that Philosophers, Theologians, and Medical Scientists are wrestling with. But according to Machando, “any vestige of consciousness is inconsistent with death.” [4]

The Biological definition of death also has variations. According to Tonti-Filippini, in Australian law, death is defined as (a) irreversible cessation of cell function of the brain or (b) irreversible cessation of the circulation of blood in the body. In the United Kingdom, brain death is defined as brain-stem (mid-brain, pons, medulla) death which is the irreversible loss of the capacity for consciousness together with the irreversible loss of the capacity to breath. In the United States death definition states that an individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem is dead. [5] Another brain death definition is the “higher brain“ definition. Death is said to have occurred when the cerebrum which has control of consciousness, thought, memory, and feeling has ceased functioning. In this case, the person is dead even though the brain stem is functioning and there is a breathing living human body. [6]

The weakness inherent in these definitions is that they are based only on one organ, or a part of it, or on a tissue. An organ or a tissue is a part but not the whole of the organism. The organism dies as a whole but not in part. So to base the definition of the death of the whole organism on the loss of function of  a part of it, while other parts are alive, does not agree with the Principles of Biology.

Although these definitions differ, but their differences are really subtle, since the key organ functions are interdependent. The death of one organ may necessitate or enhance or directly cause the death of the others. Irreversible cessation of all functions of the brain stem disrupts communication between the medulla of the brain stem and the intercostal muscles and diaphragm, thus disrupting spontaneous breathing. This disruption inhibits the diaphragm from inflating and filling the lungs with air. The cessation of diaphragmatic function inevitably causes the dysfunction of the lungs which in turn deprives the heart the oxygen that it needs. Lack of oxygen in the heart leads to death of cardiac cells;  death of cardiac cells leads to cardiac dysfunction. If the heart can not pump enough oxygenated blood to the brain, the brain cells die from ischemia, and anoxia. So, the major body organs are interdependent, and the death of one inevitably, in time, leads to the death of the others.

Most people will consent that a body with rigor mortis, no heart beat, and no breathing or ventilatory movements, is a dead body. Most people however, will not consent that an individual who looks alive, and has heart beat and normal blood pressure, spinal reflexes, and normal kidney functions, and of course breaths, though with assistance, is really dead. Under this condition, people are doubtful that moral certainty which they need in order to participate in organ donation is met. Truog, and Robinson argued that the concept of brain death “fails to correspond to any coherent biological or philosophical understanding of death,” and have suggested that people should be permitted to donate their organs if they happen to become neurologically devastated or are imminently dying, without first being declared dead. [7] [8]

“Brain-death” And The “Principles Of Integration”

The presupposition underlying some consensus on the “brain-death” is that “death” is cessation of the life of a human being, or a human person as a unified organism. “Brain-death” is commonly misunderstood to mean the death of an organ. It is argued that, while organs can cease to function, what dies is the living organism whose organs failed to function. [9]  Invariably, some organs may cease to function while the organism lives. This may not be the case where there is total destruction of the brain; the brain is the main organ which integrates the functions of the others. Hardly is there a tissue or organ in the body that is not innervated by the nervous system. “Brain-death” proponents argue that loss of this integration leads to loss of coordination of the body parts and therefore death of the organism . However, Shewmon who has argued against the brain as integrator organ has indicated that brain devastated individuals have lived for a prolonged period of time. [10]

Another presupposition underlying “brain death” is that the brain is the central integrating organ of the human body in human beings who have progressed beyond the embryonic stage. [11] [12] As can be inferred from the argument in the preceding paragraph, the destruction of the brain or its irreversible loss of function therefore means loss of body integrative unity or total disintegration of the organism as a whole unit. In other words, the irreversible functions of the brain as a result of total destruction of all brain cells translates to total dysfunction or irreversible cessation of all cells, tissues, and organs that are under the control of all the divisions of the nervous system.

The brain has a function that no other organ has; it has control over the physiological processes of the body. With regard to this, Rabbi Tendler said that the Jewish tradition would recognize cessation of brain function as “physiological decapitation” and hence accept it as a basis for declaring death. [13] Loss of body integrative unity or total disintegration of the organism as a whole due to irreversible loss of brain function connotes “physiological decapitation” as there is hardly any tissue or organ in the body that lacks neurological integration, or interdigitation with the nervous system.

The argument that the brain is the integrator organ is congruent with the Theological argument that the Soul is the life-giving principle of the human body, and when it departs, the person dies. The Soul is the life-giving principle that endows the body with intellect which sets the person apart from other primates and animals. And the intellect resides in the Soul. And no one can live without the Soul just as no one can live without the brain. The Scripture indicates that the human body became a living being after it received the breath of life. [14] The late British neurologist Christopher Pallis, in his defense of the neurological criteria indicated that the Judeo-Christian tradition maintains that “breath” and “consciousness” are two definitive features of human soul. According to Pallis, “Loss of the capacity for consciousness is much the same as the departure of the conscious soul from the body, just as the loss of the capacity to breath is much the same as the loss of the breath of life.” [15] [16] [17]

The President’s Commission in its 2008 White Paper abandoned the terms “brain death” for the term “total brain failure.” It also abandoned the concept of “integration,” (the assumption that the brain is the “integrator” of vital functions). In its place, it formulated another concept,  “the concept of the fundamental vital work of a living organism.” This concept is defined as, “The need of self-preservation, that is achieved through the organism’s need-driven commerce with the surrounding world.” [18] Thus the diagnoses of “total brain failure” is an indication that an injury has irreversibly destroyed an organism’s ability to perform its fundamental vital work, and as such, has died as a whole. This ability to perform fundamental vital work, depends on three fundamental capacities: (1) receptivity to stimuli, (2) ability to act upon the world, and (3) basic felt need. [19] The decision to abandon the concept of “integration” was based on arguments that indicated that there might be some integrating functioning in patients diagnosed with “total brain failure.”

Since the Catholic Church affirms the “Principles of Integration,” the Pontifical Academy of Sciences had to addressed the issue of doubts about “the Concept of Integration,” and death as diagnosed by brain death criteria in general, and argued for the following conclusions: (1) “There is no more than one form of death. (2) Brain-death means the irreversible cessation of all the vital activity of the brain (the central hemispheres and the brain stem). This involves an irreversible loss of function of the brain cells and their total, or near total destruction. The brain is dead and the functioning of other organs is maintained directly and indirectly by artificial means. (3) Loss of all brain function is death because it is associated with loss of integration of the body as a single whole. (4) Death by the brain criteria can be diagnosed with certainty only with evidence that there is no blood supply to the brain. (5) The “established clinical criteria” are in most circumstances a reliable indicator for the loss of all brain function.” [20] [21]

Pope John Paul II in his address to the 18th International Congress of the Transplantation Society declared that, “The criterion adopted in more recent times for ascertaining the fact of death, namely the complete and irreversible cessation of all brain activity (in the cerebrum, cerebellum and brain stem) if rigorously applied, does not seem to conflict with the essential elements of a sound anthropology.” [22]

This means that in so-far-as there is compliance with accepted criteria chosen by specialist groups, brain-death criteria should be valid for criteria for diagnosis of  “total brain failure.”

This paper affirms the “Principles of Integration” and argues that to bring more clarity to brain death as  valid for death determination, confirmatory evaluation of other organs should be performed concurrently using ancillary analysis. Concurrent evaluation of multiple organs or tissues should indicate the effect of loss of integration on tissues and organs as a result of total loss of brain function; as well as the effect of loss of cardiopulmonary functions on other organs and tissues. With this background, the following argument could now be presented: the current evaluation of death criteria is based on the analysis of one tissue, or one organ; this results in lack of consensus for death criteria.

 CURRENT EVALUATION OF DEATH CRITERIA IS BASED ON ONE TISSUE OR ONE ORGAN EVALUATION

 Traditionally, evaluation of death is based on the observation that a body is non-responsive to stimuli, has non-beating heart, and has no signs of breathing. Added to these signs is the rigidity (rigor mortis) of the body which appears with time. Death is determined on evaluation of multiple organs and tissues: Brain, Heart, Lungs, Blood flow, and Muscle. This traditional evaluation of death is no longer used today due to advanced technological innovations that have produced equipment that can mimic body organs, such as the heart and the lungs, but not the brain. As such some functions of the heart and lungs can now be provided artificially. The result is that the traditional definition of what death is has changed. But this change has not been widely accepted by the public at large.

The current evaluation of death is based on brain, or cardiac function. A major problem with this single organ evaluation is that a patient may be declared dead based on evaluation of the one organ, but alive based on the other. Many people therefore do not accept that evaluation of one body organ alone or tissue is sufficient for determination of death. There are those who do not accept brain death as death of a person, as has been discussed above. Likewise, there are those who do not accept cardiac death as death of a person as will be discussed in the succeeding  paragraphs.

In a study of relatives of brain dead patients, about 141 of those evaluated, only 10% believed that their relative was dead, two-thirds accepted the death intellectually, but felt emotionally that their relative was still alive before the organ harvesting. [ 23]  According to Pellegrino, “The reasons that favor the neurological standard are not compelling. The clinical tests and signs that support it are as subject to doubt as those of the cardiopulmonary standard. The Philosophical arguments for both suffer from the same conceptual and empirical difficulties. [ 24]  The implication of this argument is that neither the neurological standard nor the cardiopulmonary standard alone is valid for death declaration.

Lack Of Consensus For Death Criteria Is Due To One Tissue Or One Organ Evaluation

 In the United Kingdom, and in some Commonwealth Countries death evaluation is based on brain stem status. A patient is declared dead if there is irreversible cessation of brain stem function. But in the United States of America, and some other parts of the World, death declaration is based on the whole brain, including the brain stem, or on the cardiopulmonary system. This implies that a patient who is declared dead in the UK and some Commonwealth Countries would be alive in the USA. In the USA, patients who suffer irreversibility of the brain stem are classified as being in Vegetative State, but not declared dead, and are not candidates for organ donation. While they have lost the awareness component of consciousness, the wakefulness component is intact. So while they are unaware, they are awake, and an awake patient is definitely alive.

There is inconsistency in criteria for death if a patient is declared dead in one jurisdiction, but alive  in another. Apparently, different protocols of neurological criteria are used, and without global consensus. This inconsistency may cause concern in the public and professionals alike about the validity of evaluation. Inconsistencies may result from lack of consensus on criteria for evaluation. Lack of consensus for death criteria may depend on what organ or tissue that you measure, and on what you measure on these organs and tissues. Unlike the traditional standard where the most vital organs are evaluated, in the current standard, only one organ, for example, the brain is evaluated. In some jurisdictions, certain tests are performed, but in others, those tests are not performed.

Criteria Used In Death Evaluations

 Methods of organ retrieval from dead donors fall under three categories: (1) using the old criterion when there is loss of respiration, loss of cardiac function, and there is rigor mortis; (2) when the patient is declare to have suffered “total brain failure,” and (3) when the patient has suffered “cardiac death” or “irreversible loss of pulmonary and respiratory function.” The two main organs evaluated in death diagnosis are the brain, and the heart.

aTotal Brain Failure Criteria

 The criteria for diagnoses of  “total brain failure” requires both clinical and laboratory, or ancillary evaluations. For clinical evaluation to be valid, the patient is tested for the presence of Barbiturates and other sedative drugs, and for hypothermia (body temperature must be 32.2 degrees Centigrade or 90 degrees Fahrenheit) or higher. The donor is also evaluated for severe hypotension (shock). These are ruled out since their presence would compromise the test result. The clinical assessment is done by a neurologist, neurosurgeon, or a medical personnel qualified to do the evaluation. The criteria for evaluation include: (1) Coma, with cerebral unresponsivity (2) Apnea, (3) Absence of brain stem reflexes, and (4) Persistence of condition for 6 to 24 hours. Confirmatory tests for determining “total brain failure” include Angiography, Electroencephalography (EEG), Transcranial Doppler Sonography (TDS), Cerebral Blood Flow, and Magnetic Resonance Imaging Studies. The use of these studies again varies from jurisdiction to jurisdiction. In some jurisdictions, confirmatory tests are mandatory especially in “total brain death” evaluation. [25]

While there are those who argue against “total brain failure” as valid for declaring the loss of total body integration, and the death of a human person based on clinical evaluation alone;  there are others who argue that clinical criteria alone are not sufficient. Tonti-Filippini argued that maintenance of the endocrine system which is moderated by the hypothalamic pituitary axis of the brain, may indeed be active and functional in patients in whom death has been diagnosed by the clinical criteria alone. Tonti-Filipini maintained that, “Shewmon’s empirical observations of integrative functions in those diagnosed as dead according to the brain criteria are due to widespread but improper diagnosis by the clinical criteria alone which permits the diagnosis even though some functions of the brain continue.” Shewmon’s argument therefore is not a sufficient basis under which the loss-of-integration thesis which the Church had supported should be abandoned. [26] The brain is integrated to other parts of the body through hormones and neurons, and when the brain ceases to function, this bodily integration correspondingly ceases to function.

Bernat indicated that, “the most confident way to demonstrate that the global loss of clinical brain functions is irreversible, is to show the complete absence of intracranial blood flow.” Bernat maintained that brain cells are irreversibly damaged after a few minutes of complete cessation of intracranial blood flow, and are globally destroyed when blood flow completely ceases for about 20 to 30 minutes. When intracranial blood flow is permanent, the result is total brain infarction. [27] The corollary to this fact is that brain cells are not irreversibly damaged where there is still some intracranial blood flow.

Intracranial blood flow assessment is an ancillary evaluation, a confirmatory test for total brain failure. Machedo et al. have indicated that Transcranial Doppler Ultrasongraphy (TCD), and CT Angiography are highly sensitive and specific for the diagnosis of “total brain failure.” [28] In some jurisdictions, confirmatory tests are mandatory for assurance purposes. But in other jurisdictions, these confirmatory tests are not rigorously followed, therefore there is lack of assurance that the clinical evaluation was valid, or achieved moral certitude. As Pope John Paul II has indicated, “the criteria for total brain failure, when rigorously followed, would assure one the basis for arriving at ethical and moral certitude that are considered as necessary and sufficient for ethical correct course of action”. [29]

 b.   Cardiac Death Criteria

 The heart is a major organ of the body, and people readily accept that death has occurred when the heart permanently stops beating. The heart generates pressure that pumps blood that carries nutrients, oxygen, hormones, et cetera to cells, tissues, and organs of the body. Blood circulation is directly linked to the heart, and to external respiration (mechanism by which oxygen is transferred to the lungs and carbon dioxide is eliminated). Therefore, cardiac death is directly linked to loss of circulatory and respiratory function. Cardiac death or “irreversible loss of circulation and  respiratory function” may be diagnosed on a patient who has suffered severe head injury but not severe enough for “total brain failure” criteria. Such patients qualify for “controlled non-heart-beating donation,” and require respiratory assistance, and are not resuscitated. The tag “control” means that their time of death is controlled. Another set of candidates are those who have suffered sudden cardiac arrest (non-controlled non-heart-beating individuals). This group can be resuscitated, and their time of dead is not controlled.

A typical non-heart-beating candidate would be 5 to 55 years old, a perfect healthy individual, unconscious from a car crash, in an emergency department, in coma, and on a ventilator, and whose treatment has been deemed futile. With the relative’s permission, the ventilator is withdrawn, and if the heart stopped beating in an hour, the surgeon would wait for about 2 to 5 minutes before initiating organ procurement. But if the heart did not stop beating within the prescribed time, the patient would be transported to the hospital bed to die without any further treatment. At this stage, the candidate can not be an ideal donor as lack of oxygen may have damaged the organs. [30]

In the United States of America, cardiac standard of declaring death in non-heart-beating donors is cardiac mechanical asystole (or absent artificial pulse) lasting from 75 seconds to 5 minutes. [31]

However, there are arguments against cardiac standard for death evaluation. Verheijde, argued that the cardiac or circulatory standard has numerous flaws based on the following: (1) It is based on expert opinion of zero chance of autoresuscitation after 65 seconds of asystole. (2) The fact that transplanted hearts have innate mechanical and electrical functions after transplantation is an indication that mechanical asystole is reversible and does not constitute an acceptable standard for irreversibility. (3) The extent of recovery of brain functions during surgical procurements is not known. Recordings of EEG during the dying process have shown increases in brain electrical activities in pulseless patients for several minutes. [ 32] All these are  indications of neurological function, and based on the neurological or brain criteria, the donor is alive.

Fry-Revere, and Bastani have also argued that, “if circulatory criteria are sufficient for a determination of death without any reference to brain criteria, then the only certainty required is that autoresuscitation is impossible.” [33] This is to say that for cardiopulmonary standard to be valid, the brain has to be in total failure (totally dead), similar to traditional criterion, to guarantee zero chance of spontaneous recovery. All these arguments point against cardiac death as valid for death determination required for unpaired organ donation.

In addition to the arguments above, Machondo and Korein expressed doubt that a non-heart-beating donor is really dead. They concluded that the cardiopulmonary criterion of death only assures irreversibility when asystole is prolonged enough to assure that ischemia and anoxia have destroyed the brain. [34] On the other hand, the President’s White Paper argues that the cardiopulmonary standard has a higher degree of certainty of death than there is with a heart-beating donor (patient with total brain failure) because heart, lung, and brain have all ceased functioning. [35] All together, there is lack of consensus for death criteria based on either brain or cardiac evaluation, and it could be argued that this is due to the evaluation of a single tissue or organ.

Another criticism against controlled “non-heart-beating donation” is that the assumption that the patient is dead five minutes after the heart stopped beating is disputable. It is incorrect to assume that the heart has suffered irreversible function or lost autoresuscitation, as patients can easily be resuscitated after this short interval. It is also argued that if the heart is reactivated in the recipient, the donor from whom the heart was taken can not have been dead according to the cardiac criteria.

And if the heart and lungs are kept functioning during the organ harvesting in the DCD donor, and where loss of circulatory functions are not confirmed, it therefore suggests that the patient might be alive as the brain has not irreversibly lost function. Opponents of DCD donation argue that total brain damage does not occur within two to five minutes interval of asystole. Many patients will survive and have normal neurological function if resuscitated at this point. Supporters of DCD also admit that it may take ten to fifteen minutes of no circulation for the brain to suffer irreversible damage.[36]

What donation after cardiac death implies is that organ harvesting is done while lung and heart functions have ceased, but not while the brain function has ceased. The donor most likely is alive. This is a serious criticism against DCD; the criticism that organ harvesting after two to five minutes of asystole, in the absence of total loss of brain function, causes the death of the donor. Therefore it is an act of murder, which is against the precept of the Dead Donor Rule.

According to Harrington, the Maastrich University Hospital in the Netherlands rejected the Pittsburgh protocol, but in its place allowed a ten-minute waiting time before organ harvesting, in order to ascertain that the donor’s brain has sustained total loss of function, an equivalent situation to brain death. [37] The Maastrich University Hospital not only requires cardiopulmonary loss of function, it also requires total brain loss-of-function, a situation that is close to traditional death. What differentiates this protocol from the traditional death where the major organs or tissue such as brain, heart, blood, and lung irreversibly cease, is that it lacks the signs of irreversible death such as rigor mortis.

Harrington commented that removing organs within seventy five seconds after the heart stops beating, and transferring hearts from donors who have not lost total brain function are two other recent developments in DCD that test the legal and ethical boundaries of organ transplantation. [38]  Based on all these arguments, one may confidently conclude that there is lack of consensus for death criteria.

Lack Of Consensus For Death Criteria Raises Ethical And Moral Concerns For Tissue And  Organ Donation

 People want to be sure that they are really dead before their organs are procured, and judging from the preceding arguments it appears that most unpaired organ donors were really alive. Some of the reasons for this, is lack of uniformity for death determination, as well as the variability of criteria used by different institutions for organ procurement protocols. And this puts the moral legitimacy of consent for donation in question.

Moral and ethical rules are violated whenever the Death Donor Rule is ignored, or manipulated, as in premature declaration of death after a limited period of cardiac arrest, in order to procure organs. It is illicit to harvest the organs of a living human being, because that human being is dying and will never recover. It is morally and ethically unjustifiable to expose human beings to procedures that pose harm, for benefits that accrue to others. The Judeo-Christian thought affirms the great dignity of each human person created in the image and likeness of God. As such, human beings can not be used as means as promulgated by the Nuremberg Code in 1947. The Church has a tradition that the sanctity of all human life from conception to death must absolutely be respected and upheld.

With particular reference to the DCD protocol, Stanger et. al argued that DCD does not involve assessment of, and makes no claims about cessation of all brain function at the time of organ removal. They claimed that DCD protocol permits removal of organs from patients who are dying but not really dead. “DCD feels intuitively improper, even profane. It is rational mutilation of the body, and death by protocol.”  The protocol also raises the issues regarding the withdrawal of ventilation, determination of length of waiting-time following circulatory arrest, and the use of heparin (an anti-coagulant). [39]

Stanger, et al. argued that DCD violates the promise to “do no harm.” They indicated that the pre-mortem interventions induced in the process, for example, the use of bronchoscopy, heparin, phentolamine, cannula insertion, et cetera, constitute violations of the Principles of Non-maleficence, as these procedures pose risk for the donor who probably gave no consent for such a procedure. The alert patient with intact capacity, for example, a patient with cervical injury, or ALS is most likely to meet the standard for a truly informed consent. And there is doubt that the surrogate of a DCD patient acts in concert with the wishes of the patient. In most cases surrogates give tacit but not explicit consent, because they may not have all the information they may need.[40]

 ACCURATE EVALUATION OF DEATH CRITERIA CAN BE BASED ON MULTIPLE TISSUE AND ORGAN EVALUATION

It is possible to continue unpaired organ donation without violating the prevailing moral and ethical norms. Prevailing norms prescribe that it is illicit to remove a vital organ from someone who is alive. For this reason, it is essential to be able to determine the point of death, at least the point where it could be ascertained that the body has lost its unitary cohesion or integration. That point is achievable with the aid of multiple tissue and organ evaluation. This means that the main vital body organs are evaluated simultaneously, in addition to clinical evaluation. This protocol will escape the inherent weakness in declaring death based only on the evaluation of one organ or tissue, as neurological criteria alone are not sufficient for death declaration when an intact cardiopulmonary system is functioning, just as cardiopulmonary criteria alone are not sufficient for death declaration when an intact neurological system is functioning. Simultaneous evaluation of the two systems is required to indicate the status of any given system at any given instant. Thus instantaneous tracing of a given tissue or organ is always available.

 

Because there is no consensus on clinical or diagnostic criteria, therefore it is necessary to rely on ancillary evaluations. Ancillary evaluations nonetheless, are recommended  when specific components of the clinical evaluation can not be reliably ascertained. The montage for this protocol should be capable to monitor for cerebral blood flow (CBF), neuronal activities, cardiac status, external respiration, or Apnea, Oxygenation, and possible muscle activity. This montage could be added to an existing one, or be expanded to incorporate other body activities, and used for continuous evaluation of patients in the Intensive Care Unit. This montage has the advantage of analyzing both the neuronal and cardiopulmonary status simultaneously. And it is easy to read, or interpret and it is inexpensive.

Bernat, has indicated that, “The most confident way to demonstrate that the global loss of clinical brain functions is irreversible, is to show the complete absence of intracranial blood flow.” Transcranial Doppler Ultrasonogrphy (TCD), and CT angiography have been shown to be sensitive and specific for diagnosis of total brain failure. [41] George Annas, and others have indicated that medical tests, including the elecroencephalogram (EEG) demonstrated irreversible cessation of brain activity. [42] The use of electrocardiogram (EKG), and Oxygenation sensors have universal application. And measurement of Apnea will be non-invasive. Simultaneous measurement of the cardiopulmonary and neurological systems will enable us to observe the effect of loss of neurological integration on the other organs, and tissues  as well as the effect of cardiopulmonary loss-of-function on the other organs and tissues. We need to conduct research studies based on the application of this protocol in order to confirm its effectiveness and applicability.

 

CONCLUSION

The lack of consensus as it pertains to death and  human unpaired organ donation is a complex issue. This complexity derives from the fact that it involves people who have different philosophical, and religious orientations. As a result each group sees things in the light of their own thought. One defines death based on personhood, the other defines it based on separation of Soul from the body, yet another defines it as total loss of brain function. Before the advent of organ transplantation, death was said to have occurred when there is evidence of non-responsiveness, absence of heart beat, absence of breathing, and with passage of time, rigor mortis. This standard no longer applies today due to the use of procedures that can mimic the human organs.

Now, one can be kept alive with artificial respirators, and artificial heart, but not yet with artificial brain. The implication is that it is now difficult to determine whether one is alive or really dead. The situation is even compounded when death is declared based only on one organ or tissue. A person may be dead based on his or her cardiopulmonary status, but alive based on his or her neurological status. Also there is lack of consensus on clinical or diagnostic criteria. In this state of chaos, the Dead Donor Rule brings some order.

The Catholic tradition, has also maintained that it is illicit to remove an unpaired organ from a living human being. To maintain this standard, a protocol that simultaneously evaluates the status of multiple parameters has been proposed. Human organ donation is a heroic act of fraternal charity, as it is the gift of self, and as such the donors should not be exposed to undue harm. We can still maintain unpaired human organ donation program without violating the prevailing moral and ethical standards.

 

 

 CITATION INDEX

 

 William E. Mays, Defining Death and Organ Transplantation, Catholic Bioethics And The Gift Of Human Life, p.353, Second Edition

 

The Catholic Catechism. NO 2296

 

Pope John Paul II Address of August 24 2000, to the Eighteenth Meeting of the Transplantation Society.

 

Calixto Machando, “Consciousness As A Definition Of Death: Its Appeal And Complexity.

Institute of Neurology And Neurosurgery, Ciudad de La Habana, Cuba.

 

Nicholas Tonti-Filippini, “Secularism And Loss Of Consciousness About The Diagnosis Of Death. The National Catholic Bioethics Center Vol. 10, Autumn 2010 No.3. p491-514

 

William E. Mays, p.338

 

Truog, R. D. and Robinson, W. M. “Role Of Brain Death And The Dead-donor Rule In The Ethics Of Organ Transplantation.” Crit. Care Med. 2003; 31: 2391-96

 

Kerridge I. H, Saul P, Lowe M, McPhee J, and Williams D. “Death, Dying And Donation: Organ Transplantation And Diagnosis Of Death. J Med Ethics 2002; 28: 89-94

 

Morris B. Abram, Chairman. “A Report On The Medical, Legal And Ethical Issues In The Determination Of Death,” President’s Commission For The Study Of Ethical Problems In Medicine And Biomedical And Behavioral Research. July, 1981.

 

Shewmon D. Alan. Brainstem Death, Brain Death, And Death: A Critical Re-evaluation Of The Purported Evidence. Issues Law 1998; 14: 125-45 PubMed.

 

William E. Mays, p.321-322

 

Morris B. Abram, Chairman, “A Report On The Medical, Legal And Ethical Issues In The Determination Of Death,” President’s Commission For The Study Of Ethical Problems In Medicine And Biomedical And Behavioral Research. July, 1981.

 

Ibid p.11

 

Genesis 2: 7

 

Edmund D. Pellegrino, et al. “Controversies In The Determination Of Death.” A White Paper By The President’s Council On Bioethics, Washington, D.C. 2008

www.bioethics.gov

 

 

C. Pallis and D. H. Harley. ABC Of Brainstem Death. Second ed. London: BMJ Publishing Group, 1996

 

C. Pallis. “On The Brainstem Criterion Of Death,” in The Definition of Death: Contemporary Controversies, ed. S. J. Youngner, R. M. Arnold, and R. Schapiro (Baltimore: The Johns Hopkins University Press, 1999, 93-100

 

Edmund D. Pellegrino, et al. “Controversies In The Determination Of Death.” A White Paper By The President’s Council On Bioethics, Washington, D. C. 2008 p60

 

Ibid p.61

 

Pontifical Academy Of Sciences, “Why The Concept Of Brain Death Is Valid As A Definition Of Death.”  Excerpt Of Scripta Varia 110, September 11-12, 2006

 

Nicholas Tonti-Fillipini, p.501

 

John Paul II, Pope. “International Congress On Organ Transplants,” Address Of The Holy Father John Paul II To The 18th International Congress Of The Transplantation Society.

Tuesday 29t h   August 2000

www.vatican.va/holy_father/john_paul_iii/speeches/2000jul_sep

 

Nicholas Tonti-Filippini, Has The Definition Of Death Collapsed? Southern Cross Bioethics Institute. Research Notes Vol 21 Issue 4, December 2008

 

Edmund D. Pellegrino, et al. p.114

 

Mohammed, M. Jan, “Brain Death Criteria: The Neurological Determination Of Death,”

Neuroscience 2008; Vol. 13(4): 350-355

 

Nicholas Tonti-Fillipini p. 502

 

Bernat, J.L. “On Irreversibility As A Prerequisite For Brain Death Determination.”

Adv. Exp. Med. Biol. 2004; 550: 161-167

 

Calixto Machdo, J. Perez, C. Scherle and J. Korein. “When are Ancillary Tests Recommended In Brain Death Confirmation?” The Internet Journal Of Neurology. 2010 Vol. 12 No.2

 

John Paul II,

 

Joseph L. Verheijde, “When And By What Criteria Is It Acceptable To Declare Death In DCD Donors? News And Views That Matter To Physicians. Internal Medicine News. Digital Network April 15, 2010

www.internalmedicinenews.com/index.php

 

John B. Shea, “ Organ Donation: The Inconvenient Truth,” Catholic Insight, September 1, 2007

www.thefreelibrary.com/cardiac

Maxine M. Harrington, The Flat Line: Redefining Who Is Legally Dead In Organ Donation After Cardiac Death. Denver University Law Review Vol 86: 2, File: Harrington final, Created February 14, 2009.

 

Ibid p. 26

 

Ibid p. 5

 

Ibid p. 114

 

S. Fry-Revere and B. Bastani, “Death In The Eyes Of The Beholder” Commentary,

Int. J. Org Transplant Med. Vol 1(2) 2010

 

Machando, C. and Dorein J. “Irreversibility: Cardiac Death Versus Brain Death,” Institute of Neurology and Neurosurgery, Havana Cuba. Rev. Neurosci 2009, 20(3-4):199-202

infomed.sld.cu

 

Edmund D. Pellegrino, et al. p.114

 

Jon Stanger, et al.. Donation After Cardiac Death, Bioethics Committee Contra Costa Regional

Medical Center & Clinics, January 2007.

 

Ibid, p. 27

 

Bernat, JL. p. 5

 

George J. Annas, “Brain Death And Organ Donation: You Can Have One Without The Other,”

18 HASTINGS CTR. REPORT 28, 28(1988).

A Consensus On Death Criteria As It Pertains To Tissue And Organ Donation is proposed
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SINOPSIS: This paper proposes that declaration of death should be based on multiple organs using a more comprehensive ancillary analysis. Concurrent evaluation of Brain function, Cardiac function, Blood flow, Breathing, and Oxygenation are suggested. Concurrent evaluation of multiple organs and tissues should indicate the effect of loss of integration due to total loss of brain function; as well as the effect of loss of cardiopulmonary function on other organs and tissues.

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