Summary
- Australia has a shortfall in donated hearts for transplantation.
- Hearts are usually procured from brain dead donors, but procurement from circulatory dead donors is a potential additional source.
- However, heart transplantation after circulatory death of the donor may not conform to the dead donor rule.
- An amendment in law is required to permit heart procurement for transplantation after circulatory death.
Australia has an increasing shortfall in transplantable hearts. Over the past decade, the number of all donors per million population increased from 10.0 in 20051 to 16.1 in 2014.2 However, the number of heart donations per million population over the same period has declined slightly from 3.8 to 3.4, with an annual average of 3.3.3 Procurement of organs has always been conducted according to the dead donor rule — that is, after death of the donor — but this practice is being challenged.
The law defines death in all Australian jurisdictions (eg, in s 41 of the Human Tissue Act 1982 [Vic]) as either “irreversible cessation of all functions of the brain” (brain death) or as “irreversible cessation of circulation of blood in the body” (circulatory death), but it does not define irreversible or how to determine irreversibility (Box). Exceptionally, circulatory death is not defined in Western Australian legislation.
Although the procurement of organs such as livers, kidneys and lungs is permitted after either brain death or circulatory death according to Acts in all jurisdictions, the procurement of hearts has traditionally only been from brain dead donors with functioning hearts. The definition and diagnosis of brain death is not without controversy4,5 and may explain in part why more reliance is being placed on circulatory death, which reduces availability of hearts.6,7 Alternatively, organ procurement from patients after circulatory death may be perceived as more realisable than after brain death. Indeed, circulatory death as the source of solid organs has increased from 10% of 204 donors in 2005 to 28% of 378 donors in 2014.1,2 More total organs have been procured (from 726 to 1193) but the number of hearts has increased only slightly from 72 of 204 donors (35%) to 79 of 378 donors (21%) over the same period.1,2 Only 39 hearts were procured from 189 donors (21%) during the first 6 months of 2015.8
Organ donation and procurement after circulatory death
In the practice of organ donation after circulatory death (DCD), life-sustaining treatment such as mechanical ventilation is commonly withdrawn because of a devastating neurological injury that has not progressed to brain death. The withdrawal of treatment from the donor is staged to facilitate organ transplantation to recipients. The procurement of organs is specified in the Australian national DCD protocol published by the Organ and Tissue Authority9 and enacted through the DonateLife network. It is not declared why the heart is not included in the protocol’s list of organs that may be procured.
Expeditious organ procurement may be commenced after death has occurred — defined in Australia as 2–5 minutes after cessation of the donor’s circulation,9 and after 2 minutes in United States.10 The donor’s arrested heart has not usually been procured. However, to increase the availability of hearts, routine procurement after circulatory death is proposed but not yet sanctioned in the current national DCD protocol.9 It is probable that the protocol is under review given that the Organ and Tissue Authority lauded St Vincent’s Hospital in Sydney, where two adults were transplanted with hearts procured after circulatory death in 2014.11 In those cases, the donor hearts were reanimated and kept beating and warm inside a container (ex-vivo Organ Care System, TransMedics) pending transplantation.12
This practice poses ethical,13 legal and medical problems. Foremost of the medical difficulties is the poor condition of the procured heart after it has ceased to circulate blood in the donor. However, the heart can be resuscitated with the aid of extracorporeal techniques, as was performed for the two adult recipients at St Vincent’s Hospital.11,12
Heart transplantations after cardiac death have been performed in three infants in North America14 but were followed by consternation and a medical call for a moratorium on all organ procurement after cardiac death and the accusation that doctors and hospitals were biased towards organ procurement.15 The basis for the opposition was that the infants may not have been dead and possibly were conscious at the time of organ procurement. Of the three infants, one was declared dead 3 minutes after cessation of cardiocirculatory function before the process of organ procurement was initiated, and two were declared dead after 75 seconds.14
Medical interpretation of the legal definition of death
The source of the problem of heart transplantation after circulatory death is the medical interpretation of the legal definition of circulatory death. From a medical point of view, in other contexts, death is not necessarily defined by cessation of the circulation, unless it is of sufficient duration to result in brain death. It is not rare, for example, to be able to resuscitate a victim from a short duration cardiac arrest with complete neurological recovery or to sustain the circulation of a patient for lengthy periods by an extracorporeal circulation with subsequent intrinsic cardiac recovery.
The fact that a transplanted heart can function and sustain life in a recipient must mean that the circulation of the donor is never ceased irreversibly and therefore that the donor of the heart is never dead until his or her heart is removed.
The question is thus posed — how is it possible to procure the heart of a donor under the premise of circulatory death and yet expect it to sustain life in a recipient? Put differently, should the procurement of the heart be a criminal offence in such cases, because its procurement is the cause of death of the donor?
A possible argument to justify heart procurement for transplantation after circulatory death is that legal irreversible cessation of the circulation may be interpreted medically as “will not be resuscitated” rather than “cannot be resuscitated”. However, that interpretation does not appear to be open to the medical profession. From a legal point of view, the meaning of legislation is governed by statute law. In the jurisdiction considered here, it is the Interpretation of Legislation Act 1984 (Vic) and Acts Interpretation Act 1901 (Cwlth) that apply, but these are not helpful in defining “irreversible”.
If a word or phrase is not defined in an Act, resort is made to common law interpretations, which may be described as literal or purposive. The literal interpretation of legislation was defined by Justice Higgins in the High Court of Australia as:
The fundamental rule of interpretation, to which all others are subordinate, is that a statute is to be expounded according to the intent of the Parliament that made it; and that intention has to be found by an examination of the language used in the statute as a whole. The question is, what does the language mean; and when we find what the language means, in its ordinary and natural sense, it is our duty to obey that meaning, even if we think the result would be inconvenient or impolitic or improbable.16
The literal approach may be too restrictive if a word or phrase has more than one meaning. In such instances, legal resort is made to a reputable dictionary — in Australia, usually the Macquarie Dictionary. Since that dictionary defines “irreversible” as “not reversible; that cannot be reversed”, a legal and hence medical interpretation of irreversible cannot logically be “will not be resuscitated”. Doctors cannot simply redefine the meaning of words in legislation to suit their practice.
Notwithstanding that the natural and ordinary meanings of words are the starting points in interpreting Acts,17 a purposive interpretation may be considered when a literal approach produces ambiguity or inconsistency (Acts Interpretation Act, s 15AA). Such an interpretation would be one that best achieves the purpose or object of the Act, whether expressly stated or derived from the content of the Act.
In Victoria, the stated aim of the Human Tissue Act is to make provision for removal of human tissue for transplantation and, among other aims, to provide a definition of death. The purpose of defining death is not declared but s 26 of the Act allows a designated officer and medical officers to remove tissue for transplantation only when the proposed organ donor has fulfilled the definition of death under s 41. In other words, a purpose of the Act is to prevent tissue and organ procurement from a donor who is not dead. Thus, heart procurement for transplantation under the practice of DCD is not possible under either a literal or purposive interpretation of the Act.
A similar problem with the interpretation of legislation has occurred in the United States, where death is defined in the Uniform Determination of Death Act 1982, on which Australian legislation has been modelled. The US Act also defines circulatory death as “irreversible cessation of circulatory and respiratory functions”. In a purposive approach, Bernat18 has proposed that as doctors diagnose death by permanent cessation of circulatory and respiratory functions, this satisfies the requirements of death statutes and does not violate the dead donor rule. Bernat also proposes that “permanence is a perfect surrogate indicator for irreversibility” and thus permits heart donation after DCD. This argument is similarly not sustainable. The Macquarie Dictionary defines “permanent” as “lasting or intended to last indefinitely; remaining unchanged; not temporary; enduring; abiding”. Clearly, a heart that has ceased functioning in a donor and functions later in a recipient has not ceased functioning irreversibly or permanently. Moreover, permanent cessation of the circulation is not the legal definition of death, and the concept, wrong that it is, is similarly not available to doctors to justify heart transplantation after circulatory death.
Another putative justification for heart procurement after DCD is that, whereas the heart may have stopped irreversibly in the donor’s body, it is able to function in that of the recipient. This is also a spurious argument, because the only reason that the heart stops in the donor is the elective, and hence reversible, withdrawal of life-sustaining treatment such as mechanical ventilation. The heart had obviously been functioning well in the donor’s body before its procurement.
Possible solution
This potential problem of heart procurement being the cause of the donor’s death arises because death has been mistakenly defined in the legal sense as cessation of the circulation, without any reference to brain function. A possible alternative would be to retain the present definition of brain death as irreversible cessation of all function of the brain, but to omit the requirement for irreversibility in the definition of circulatory death and to redefine it as cessation of circulatory function with cessation of higher brain function. Under this proposition for the redefinition of circulatory death for the purpose of transplantation, procurement of a heart for the purpose of its transplantation could proceed without legal risk and without risk of retained consciousness of the donor.
Conclusion
Organ transplantation is ethical whether after brain death or circulatory death, and it is proper to maximise organ procurement, but only as permitted by law. We have shown that heart transplantation after DCD does not conform to present statute law. When the way forward is not clear in a medicolegal conundrum such as this one, legislation needs to be refined. Otherwise, as some legal academics have argued,19 procurement of a heart after cardiac death for transplantation under present legislation does not conform to the dead donor rule. This may be a potential criminal offence, an accusation that may need to be made in order to encourage law reform. Alternatively, the dead donor rule, which would arguably be violated in heart transplantation after circulatory death, needs societal, legal and medical debate followed by revision or abandonment.13 Otherwise, Australia’s improving organ donor program is at risk of adverse publicity and damage if doctors, hospitals and our organ procurement agencies are perceived as procuring organs from patients not legally dead.
Multimedia
Click here to hear a related podcast with Associate Professor James Tibballs, deputy director of the Intensive Care Unit at the Royal Children's Hospital in Melbourne, and Dr Neera Bhatia, also available as a video.
Australian statute law governing procurement of organs for transplantation
Jurisdiction |
Act |
Provision |
|||||||||||||
NSW |
Human Tissue Act 1983 |
s 33 |
|||||||||||||
Qld |
Transplantation and Anatomy Act 1979 |
s 45(1) |
|||||||||||||
SA |
Transplantation and Anatomy Act 1983 |
s 24(2) |
|||||||||||||
Death (Definition) Act 1983 |
s 2 |
||||||||||||||
Tas |
Human Tissue Act 1985 |
s 27A |
|||||||||||||
Vic |
Human Tissue Act 1982 |
s 41 |
|||||||||||||
WA |
Human Tissue and Transplant Act 1982∗ |
s 24(2) |
|||||||||||||
ACT |
Transplantation and Anatomy Act 1978 |
s 45 |
|||||||||||||
NT |
Transplantation and Anatomy Act 2014 |
s 23 |
|||||||||||||
∗Note: circulatory death is not defined in Western Australian legislation. | |||||||||||||||
Provenance: Not commissioned; externally peer reviewed.
Andrew Turner
The arguments of Tibballs and Bhatia1 concerning the legality and moral legitimacy of organ donation after circulatory death (DCD) are neither novel nor compelling. The semantic inadequacy (that no prospective definition of ‘irreversibility’ is possible) of the (US) Uniform Definition of Death Act and similar (Australian) acts, is well reported e.g. 2-4. Something can only be said to have been, in retrospect, ‘irreversible’, after all possible reversal strategies have failed. In the circumstance of possible DCD, such strategies (perhaps even extracorporeal membrane oxygenation after very prolonged CPR5) would be morally repugnant and contrary to acceptable clinical practice. Australasian DCD practice is consistent with many professional standards, requiring absence of responsiveness, breathing and circulation for not less than two minutes before death is determined to have occurred. The ability to restore cardiac function, including in subsequent heart transplant recipients , does not invalidate such a clinical practice as the legal issue is the death of the donor, not the post-mortem function of any transplanted organ. We agree with the authors that the statutory definition of death in most Australian jurisdictions (but not in New Zealand or WA) may be semantically inadequate, but their proposal to redefine circulatory death as “cessation of circulatory function with cessation of higher brain function” is also inadequate. If “irreversibility” of “cessation of higher brain function” is required this would mandate the determination of brain death and if not required, this criterion is redundant as “cessation of higher brain function” invariably accompanies “cessation of circulatory function”.
1) Tibballs J, Bhatia N. Transplantation of the heart after circulatory death of the donor time for a change in law? Med J Aust. 2015 Sep 21;203(6):268-70.
2) Cole D. Statutory definitions of death and the management of terminally ill patients who may become organ donors after death. Kennedy Inst Ethics J. 1993 Jun;3(2):145-55
3) Whetstine L, Streat S, Darwin M, Crippen D. Pro/con ethics debate: when is dead really dead? Crit Care. 2005;9(6):538-42
4) Bernat JL. How the distinction between “irreversible” and “permanent” illuminates circulatory-respiratory death determination. J Med Philos. 2010 Jun;35(3):242-55
5) Kelly RB, Porter PA, Meier AH, Myers JL, Thomas NJ. Duration of cardiopulmonary resuscitation before extracorporeal rescue: how long is not long enough?
ASAIO J. 2005 Sep-Oct;51(5):665-7
Competing Interests: Associate Professor Turner is State Medical Director for DonateLife Tasmania
Assoc Prof Andrew Turner
President Australian and New Zealand Intensive Care Society
Andrew McGee
The legal position in Australia in respect of circulatory death is that death is ‘the irreversible cessation of the circulation of blood of the person’.1
Tibballs and Bhatia assume that ‘irreversible’ has a single meaning.2 This is not so. It can either refer to cases where auto-resuscitation is no longer possible, or to cases where both auto-resuscitation and resuscitation via cardio-pulmonary resuscitation (CPR) are no longer possible. A court considering manslaughter will examine both these meanings, and not merely the impossibility of resuscitation via CPR. It will then take into account the meaning that applies to the case in question, as determined by medical practice.3
When declaring death in cases where CPR is not appropriate, doctors don’t need to wait until the time at which resuscitation via CPR is no longer possible. The time at which a 92 year old lady with a do not resuscitate decision could theoretically be brought back to life by CPR is simply not relevant.
It is because of cases like this, and not merely organ donation cases, that death is understood as the permanent cessation of circulation in any relevant circumstance. ‘Relevant circumstance’ refers either to cases where only auto-resuscitation needs to be excluded, or cases where resuscitation by CPR also needs to be excluded.4
We should remember what Eugène Bouchut first proposed in 1846:4 5 if, in the absence of resuscitation attempts and after listening to the heart for five minutes, there are no heart sounds, it is safe to declare death.
1. Criminal Code Act 1995 (Cth) s 4(1) (Dictionary attached to Sch 1, the Criminal Code); Transplant and Anatomy Act 1978 (ACT) s 45(1); Criminal Code Act 2002 (ACT) s 3 (Dictionary attached to the Criminal Code); Human Tissue Act 1983 (NSW) s 33; Transplantation and Anatomy Act (NT) s 23; Transplantation and Anatomy Act 1979 (QLD) s 45; Definition of Death Act 1983 (SA) s 2; Human Tissue Act 1985 (SA) s 27A; Human Tissue Act 1982 (Vic) s 41; Interpretation Act 1982 (WA) s 13C (note the authors did not locate this section in their research, incorrectly claiming that circulatory death is not defined in WA legislation).
2. Tibballs J, Bhatia N. Transplantation of the heart after circulatory death of the donor: time for a change in law? Med J Aust 2015; 203:268-270.
3. Stock v Frank Jones (Tipton) Ltd [1978] 1 WLR 231. Gardiner D, Shaw D. Time to Diagnose Death in Modern Hospital Practice. Funct Neurol Rehabil Ergon 2014; 4(2-3):107-111.
4. McGee A, Gardiner D. Donation after Circulatory Determination of Death: Some Replies to Recent Criticisms. J Med Philos (forthcoming).
5. Bouchut E. Traité des signes de la mort et des moyens de prévenir les enterrements prématurés. 1849. Paris: J.B. Baillière.
Competing Interests: No relevant disclosures
Dr Andrew McGee
Queensland University of Technology
George Skowronski
The authors’ proposal of a legislative change to restrict the irreversibility requirement to brain function will not solve the problem, because we cannot guarantee the complete irreversibility of brain non-function after a few minutes of asystole either. Indeed, as the authors admit, even brain death is problematic in this regard.
Rather than continuing to stretch the definition of death beyond social norms in order to meet the requirements of transplantation, the only real solution is to revisit the dead donor rule itself, and this is beginning to happen.(2) Until we do this, DCD will remain on ethically shaky ground.
1. Tibballs J, Bhatia N. Transplantation of the heart after circulatory death of the donor: time for a change in law? Med J Aust 2015; 203(6): 268-270.
2. Miller FG, Truog RD, Brock DW. The DDR: Can It Withstand Critical Scrutiny? Journal of Medicine and Philosophy 2010; 35: 299–312.
Competing Interests: No relevant disclosures
Assoc Prof George Skowronski
St George Hospital, Sydney
Greg Snell
Tibbals etal have misinterpreted the process of donation after circulatory death (DCD)1. DCD proceeds only when a potential donor’s specialists and family agree that due to irreversible organ failure death is inevitable, that organ donation is appropriate, and that artificial life supports should be withdrawn. Thereafter, donation may only proceed when circulation ceases within a pre-specified timeframe. As the intent in withdrawing support is that life may end, restoration of support is inappropriate. Removing organs for transplantation in this context, including the heart2, is in complete accordance with law and NSW DCD Guidelines3 that state “there are no legal barriers to using hearts removed from DCD donors for transplantation”.
Tibbals1 and subsequent media reports risk undermining the solidarity of legal, ethical, medical and community values underpinning past, present and future public donation efforts. The legal, donation and transplant communities will continue to work on definitions, processes and audits to safeguard the rights and health of all Australians. However, be in no doubt, all deceased donors are correctly legally certified as dead and transplantation within Australia is conducted in accordance with law.
1. Tibballs J and Bhatia N. Transplantation of the heart after circulatory death of the donor: time for a change in law? Med. J. Australia 2015;203:268-270
2. Dhital KK, Iyer A, Connellan M et al. Adult heart transplantation with distant procurement and ex-vivo preservation of donor hearts after circulatory death: A case series. Lancet. 2015 Jun 27;385(9987):2585-91.
3. GL2014_008 Organ Donation After Circulatory Death: NSW Guidelines.
Competing Interests: No relevant disclosures
Prof Greg Snell
The Alfred Hospital, Victoria
Wendy Rogers
This claim contains errors of logic as well as errors of law. It is mistaken to equate failure of circulation with cessation of cardiac function. The heart is an integral part of intact circulation in a living person, but circulation relies upon more than a functioning heart. Patients considered for DCD are dying due to catastrophic injuries incompatible with ongoing life. The cessation of the circulation is the result of these injuries, and occurs not because the heart itself is necessarily terminally damaged, but because the complex system that maintains circulation has failed.
Regarding the law, the interpretation of the Act presented by Tibballs and Bhatia is restrictive and overlooks the fundamental intent of the Parliament which is to assist with defining the death of particular patients; the definition of death does not address the question as to whether it is possible to ‘reanimate’ organs elsewhere. The key question posed by the legislation is: can circulation be reversed in this patient? And the answer is clearly no as the system as a whole had failed. Therefore, there is irreversible cessation of circulation of blood in the body, and no violation of the dead donor rule.
Competing Interests: Prof Rogers has served on the NHMRC National Donations after Cardiac Death Protocol Development Working Party; been a member of the Steering Committee of Australians Donate National Organ Donation Collaboratives Planning Group and co-chaired the AHEC working group responsible for the 2007 NHMRC Ethical Guidelines on Organ and Tissue Donation for Transplantation.
Prof Wendy Rogers
Macquarie University
Wendy Rogers
This claim contains errors of logic as well as errors of law. It is mistaken to equate failure of circulation with cessation of cardiac function. The heart is an integral part of intact circulation in a living person, but circulation relies upon more than a functioning heart. Patients considered for DCD are dying due to catastrophic injuries incompatible with ongoing life. The cessation of the circulation is the result of these injuries, and occurs not because the heart itself is necessarily terminally damaged, but because the complex system that maintains circulation has failed.
Regarding the law, the interpretation of the Act presented by Tibballs and Bhatia is restrictive and overlooks the fundamental intent of the Parliament which is to assist with defining the death of particular patients; the definition of death does not address the question as to whether it is possible to ‘reanimate’ organs elsewhere. The key question posed by the legislation is: can circulation be reversed in this patient? And the answer is clearly no as the system as a whole had failed. Therefore, there is irreversible cessation of circulation of blood in the body, and no violation of the dead donor rule.
Competing Interests: Prof Rogers has served on the NHMRC National Donations after Cardiac Death Protocol Development Working Party; been a member of the Steering Committee of Australians Donate National Organ Donation Collaboratives Planning Group and co-chaired the AHEC working group responsible for the 2007 NHMRC Ethical Guidelines on Organ and Tissue Donation for Transplantation.
Prof Wendy Rogers
Macquarie University
Ari RJoffe
Tibballs and Bhatia have described a problem: death is irreversible. Common usage of the term ‘death’ includes that death is not reversible: we can resuscitate from the process of dying, but we cannot resurrect from the state of death. Irreversible (‘not capable of being reversed’) is different from permanent (‘will not be reversed’). Regardless of how often it is repeated/insisted that “permanent is a construal of irreversible”; the fact is, it is not. After even 10 minutes of absent circulation, that absence of circulation is not irreversible. Bernat, Capron, and other members of the President’s Commission have unambiguously written that DCD does not comply with the intent of the UDDA: death is irreversible (not capable of being reversed) [1].
Flaws in the assertion that brain death (BD) is death are also insurmountable. Death is a biological event that marks the time that an organism is no longer functioning as a whole: the organism is no longer resisting entropy, and is irreversibly disintegrated, and disintegrating. Irreversible absence of circulation is a criterion for this, but BD is not. Emergent functions of the integrated organism in BD include: growth, puberty, fighting infections, assimilating nutrients, excreting wastes, and metabolic regulation. The mistake was to assume that the brain is the supreme integrator of the organism, or even that there is an integrator necessary for emergent functions (of the organism as a whole) at all [2].
We keep insisting that both DCD and BD donors are dead, when they are not.
References:
1. Joffe AR, Carcillo J, Anton N, DeCaen A, Han YY, Bell MJ, Maffei FA, Sullivan J, Thomas J, Garcia Guerra G. Donation after cardio-circulatory death: a call for a moratorium pending full public disclosure and fully informed consent. Phil Ethics Humanities Med 2011;6:17.
2. Joffe AR. The neurological determination of death: what does it really mean? Issues Law Med 2007;23(2):119-140.
Competing Interests: No relevant disclosures
Dr Ari RJoffe
University of Alberta
Ari RJoffe
DCD/BD donors have a dismal prognosis: they do not have a quality of life that is of benefit to them, and it is in their best-interests to allow death to occur. If deception is to be avoided, options are:
1. Disallow vital organ donation [OD]: this is not desirable.
2. Allow OD in the setting of DCD and/or BD: this requires a change in law to make violating the dead donor rule permissible.
3. Allow OD in patients meeting the standard of BD and/or DCD: with consent, these patients could be taken to the operating room, given full anesthetic, and have vital organs removed (during ongoing circulation). This too requires a change in law to make violating the dead donor rule permissible in this circumstance.
This may seem alarming. But we already carry out “justified killing” when we withdraw life-support (WD) [3]. We, with consent, WD (an action) and accept the consequence (death) of this action (the cause). The action causes death, and because this is in the best-interests of the patient and done with consent, this is justified. If this exact same action (WD) is done without consent, and causes the exact same consequence (death), we call this non-justified killing (murder). For OD we would similarly, with consent, perform an action (organ procurement) and accept the consequence (death) as in the best-interests of the patient (justified) [3].
More discussion is required. But I agree with Tibballs and Bhatia: continuing the deception is not a good solution.
References:
3. Miller FG, Truog RD. Rethinking the ethics of vital organ donations. Hastings Center Report 2008;38(6):38-46.
Competing Interests: No relevant disclosures
Dr Ari RJoffe
University of Alberta
James Tibballs
Thank you for your comments.
In contrast to your claim, we did not address any moral legitimacy of organ donation after circulatory death. Our argument was entirely legally based which you have not countered. We disagree that the subject of our article has been “well reported”. Indeed, arguments presented elsewhere are flawed. For example, there is no legal difference between “irreversible cessation” and “permanent cessation” of circulation. To claim otherwise is fiction.
In your reasoning you have committed an ignoratio elenchi. You claim a concept was introduced by us then claimed it was false – which is a “red herring” if the intention was to divert our argument. In contrast to your claim, we did not suggest that there should be “irreversibility” of “cessation of higher brain function” to be required to accompany a redefinition of circulatory death. We limited our suggestion to “cessation of higher brain function” and thus absence of any prospect of consciousness - which could be determined for example by absent somato-sensory evoked potentials, silent electroencephalogram or absence of cerebral perfusion determined by radionuclide scanning. Moreover, contrary to your suggestion, this would not represent determination of brain death since legislation requires irreversible cessation of not just cerebral function but of all brain function, a concept which we add in passing, is eschewed in the guidelines of the organization (ANZICS) which you represent.
Competing Interests: No relevant disclosures
Assoc Prof James Tibballs
Royal Children's Hospital Melbourne
James Tibballs
We thank you for pointing out that WA does indeed have a legal definition of circulatory death but it is in fact s 13C of the Interpretation Act 1984.
Contrary to your claim, we have not at all assumed that “irreversible” has a single meaning but have argued on a legal basis that indeed it does have such. We have considered both a literal and purposive sense of the word in legislation as suggested by your British reference (Stock v Frank Jones (Tipton) Ltd [1978] 1 WLR 231). The same principles to determine the meaning of a word in legislation are to be found in Australian case law which we used in our argument.
We do agree however with your inference that a Court needs to consider the meaning in the context in which it is interpreted by the transplantation sector. Neither the legislation per se nor for example the second reading of the Victorian Human Tissue Bill bestow any meaning on the word other than its common meaning defined in dictionaries. Instead, the Bill mentions that the law will in the future have to deal with situations which “could happen if the new medical knowledge is not used in a responsible manner” (Hansard, 1982, vol 367, p. 1061) which we posit is precisely the current emerging practice of heart procurement for transplantation after “circulatory death”.
Competing Interests: No relevant disclosures
Assoc Prof James Tibballs
Royal Children's Hospital Melbourne
James Tibballs
We thank you for constructive contribution to the debate.
However we did not argue on an ethical basis, it was, but not merely, a legal argument. It may be the ethical case that no organs should be procured after “circulatory death” but we did not argue that case. We considered only cessation of the circulation, which undeniably means cessation of cardiac function, as the subject of legislation. It may be ethical to discard the “dead donor rule” but since ethics cannot trump the law, it is necessary to amend the law first before considering ethical questions.
Contrary to the suggestion, we did not argue for the irreversibility of brain non-function as a component of the definition of circulatory death. We argued for the cessation of higher brain function to be incorporated into legislation. We did not mention total brain function or any aspect of irreversible non-function of the brain.
With the invention of restoration of function of an arrested procured donor heart, we now have an innovative medical technique to enable its transplantation. Now we need appropriate innovative legislation to sanction a practice not envisaged by previous legislators.
Competing Interests: No relevant disclosures
Assoc Prof James Tibballs
Royal Children's Hospital Melbourne
James Tibballs
We are quite aware of the process of donation after circulatory death. One of us has instigated, directed and participated regularly in organ procurement by this process since 2010, but we have argued that heart procurement for transplantation after circulatory death does not conform to present statute law. We infer that this practice should not be undertaken until our legal system, either by legislation or common law, sanctions it to reduce legal risk to personnel involved.
We strongly disagree that drawing public, legal and medical attention to the practice is likely to undermine public donation of organs. On the contrary, we maintain that if the law is amended, society will reap the benefits of increased donation resulting from greater trust in our medical system which unfortunately at the moment relies upon a patently false and concocted interpretation of the word “irreversible”.
Competing Interests: No relevant disclosures
Assoc Prof James Tibballs
Royal Children's Hospital Melbourne
James Tibballs
Thank you.
It is necessary to explain basic physiology and to expound further our legal criticism of the practice of heart transplantation after DCD.
You have confused the structure of the circulation and its function. In the 1600s, William Harvey discovered that the rhythmic pumping action of the heart and action of its valves alone were responsible for the circulation of blood in living animals. No additional motor force has since been discovered. Cessation of this function is the condition required for procurement of organs. When doctors determine whether circulation has or has not ceased in the setting of determining cessation of the circulation prior to DCD, they observe and palpate for a pulse which is obviously a consequence of heart function, as advised by the ANZICS guidelines. Of course, the “circulation” is composed anatomically of numerous components in addition to the heart and the blood itself, but “cessation of circulation” in legislation means the cessation of the flow of blood, which is imparted by the heart, not anything else. “Cessation of the circulation of blood” in legislation means arrest of the pumping action of the heart. The claim that it means anything else is simply obfuscatory nonsense.
The very fact that a non-functioning procured donor heart can be made functional for a recipient must, ipso facto, mean that it had not irreversibly ceased function in the donor. The usual reason that the heart had ceased function in the donor is not due to “failure as a whole of the system”, but usually due to intentional withdrawal of life-supporting treatment (mechanical ventilation) which is also obviously reversible. You advance no logical criticism of our legal argument.
Competing Interests: No relevant disclosures
Assoc Prof James Tibballs
Royal Children's Hospital Melbourne
James Tibballs
Statute law forbids organ procurement unless the donor is dead, but doesn’t specify how doctors should diagnose death. Over the decades the clinical and philosophical definition of death has been altered and bedside tests chosen to facilitate the diagnosis of brain death, creating a "deception" that the donor is dead but in reality showing the donor is dying or so badly damaged they would die.
Dr Joffe offers solutions to end medical deception. We favour novel legislation for organ procurement from donors not fulfilling the so-called "dead donor rule". We have already discussed the clinical falsity of "circulatory death", warranting no further discussion, but diagnosis of "brain death" does.
Statute law requires all brain function to cease irreversibly before organ procurement but ANZICS guidelines to diagnose "brain death" strangely still recommend a test for spontaneous breathing, apnoeic-oxygenation, which is inaccurate and if the prospective donor is not dead may itself create the very condition (brain death) which it is supposed to diagnose 1. The best test for cessation of all (each and every) brain function is of brain blood perfusion using radionuclide Tc-99m HMPAO. Complete lack of brain blood flow is, faute de mieux, the best test for brain death. The apnoeic-oxygenation test should never be performed.
1. Tibballs J. A critique of the apneic oxygenation test for the diagnosis of “brain death”. Pediatr Crit Care Med 2010; 11: 475-478.
Competing Interests: No relevant disclosures
Assoc Prof James Tibballs
Royal Children's Hospital Melbourne
Andrew McGee
‘Irreversible’ means either ‘not capable of auto-resuscitation’ or ‘not capable of being reversed by human action’. If 'irreversible' (on the second interpretation) were part of the meaning of 'death', then 'death is irreversible' would be a tautology. The logical possibility of resurrection shows otherwise, as does Dr Joffe's need to state that death is irreversible. Further, it is not true to say that it is part of the common usage of 'death' that it is irreversible. Laypeople speak of a cardiac arrest victim as having died and been brought back to life.
Resuscitation by human action is a relatively recent phenomenon. By contrast, human beings have been dying for over 200,000 years. It is not and never was built into our concept of death that a person is not dead until it is impossible to reverse the cessation of circulation by human action.
We can therefore declare death when autoresuscitation is no longer possible. My collaborator Dale Gardiner and I have asked:1 If we insist nobody is dead until revival by CPR is not possible, why stop with CPR? Why not instead say: nobody is dead until they can’t be revived with the use of the best resuscitative technology, such as ECMO? Of course, the use of ECMO will in many cases be inappropriate. But so, in many cases, is CPR! If we can validly declare death where it is not appropriate to use ECMO resuscitation technology, then we can validly declare death where conventional CPR is not appropriate.
Finally, withdrawal of life-support is not killing.2
1. McGee A, Gardiner D. Donation after Circulatory Determination of Death: Some Replies to Recent Criticisms. J Med Philos (forthcoming).
2. McGee A. Does withdrawing life-sustaining treatment cause death or allow the patient to die? Med Law Rev 2014; 24: 26-47; McGee A. Acting to Let Someone Die. Bioethics 2015; 29: 74-81.
Competing Interests: No relevant disclosures
Dr Andrew McGee
Australian Centre for Health Law Research, QUT