2008/25: Do Australia's national guidelines on organ donation give donors sufficient protection?
2008/25: Do Australia's national guidelines on organ donation give donors sufficient protection?
What they said... 'Death of the brain stem alone is not death. Diagnosis of death requires evidence of the damage to the other parts of the brain such that all function of the brain is destroyed. I advise families to ask for an image showing loss of blood supply to the brain. They can then be confident that death has occurred'
Associate Professor Nicholas Tonti-Filippini, PhD
'No patients, who would otherwise have survived, die in intensive care because they have consented for organ donation. Every effort is made to ensure that dying and recently deceased patients are cared for with dignity and respect. This is in accordance with national and international guidelines, and is how it should be'
Associate Professor Bill Silvester
The issue at a glance
In July 2008, the Rudd Government announced its intention to spend $136 million in a bid to increase organ donation rates in Australia. It intends to deploy teams of specialist staff in hospital intensive-care units and emergency departments.
More organ-transplant doctors, counsellors and organ-donation co-ordinators will be employed in public and private hospitals to work with dying patients and their families.
Later in 2008, the Australian and New Zealand Intensive Care Society (ANZICS), released its revised Statement on Death and Organ Donation.
In October, 2008, in an article, published in the Journal of Law and Medicine, Associate Professor James Tibballs, wrote that organ donations occurred in a way that clashed with the law. Dr Tibballs claimed that organs were being taken from patients who were not 'dead' in the sense defined under Australia law.
Dr Tibballs notes that Australian law allows organs to be taken from donors when all their brain functions have stopped irreversibly or when irreversible cessation of blood circulation has occurred.
Dr Tibballs argues that clinical guidelines commonly used to diagnose brain death could not prove irreversible cessation of all brain function, and that the concept of brain death introduced into Australian law in 1977 was a 'convenient fiction' that had allowed the development of organ transplantation.
Dr Tibballs' views have met with criticism for a variety of reasons. There are those who dispute his claims. There are others who condemn him for running the risk of reducing Australia's organ donation rate even further.
Background Brain death and cardiac death
(The following explanation of brain death and cardiac death is that supplied by Sydney Children's Hospital. It is intended to make sense to people without a medical background and, though a simplification of procedures applied, is in accord with Australian and New Zealand Intensive Care Society Statement on Death and Organ Donation.
The full text of the Sydney Children's Hospital explanatory statement can be found at http://www.sch.edu.au/health/factsheets/joint/?brain_death_and_organ_donation.htm)
Most people understand that death occurs when a person's heart and breathing stop. This is called cardiac death and is how most people die. When someone has died of cardiac death, they do not breathe or move, they do not have a heart beat and their skin colour changes since blood is no longer circulating around the body. However, no one actually dies until the brain dies. The brain dies when blood stops being pumped to it. Other organs such as the heart and kidneys can stop working completely and in some circumstances are able to be revived - but not the brain. This is why people who have had a heart attack where their heart has stopped beating can be resuscitated - the heart may have stopped beating for a few minutes but because the brain hasn't died, the person may still be able to recover.
Death also occurs when the brain and brainstem stopped working completely - this is called brain death. The kinds of injuries which may cause the brain to die include accidents where there is trauma to the head, bleeding into the brain, infections or a long period of time without oxygen. As part of the treatment for these conditions, the person will be connected to a machine called a ventilator, which artificially pushes oxygen into the lungs, causing the chest to rise and fall as if the person is breathing. Even though the heart may still be beating and all other organs may still be working, brain death is death. The person cannot ever recover because the brain, once dead, can never be repaired.
A person who has died as a result of brain death will look very different to a person who has died from cardiac death. Because they are attached to the ventilator and receiving oxygen, the heart will continue to beat and the skin will be pink and warm. This is why it can be difficult to understand and accept that someone who is pink and warm and appears to be asleep is actually dead.
What causes the brain to die?
Like all of our organs, the brain needs a constant supply of oxygenated blood to keep working. When any part of the body is injured it swells. The brain is no different. An injured finger or ankle can keep expanding because there is nothing to restrict it. The brain however, is contained within the rigid skull that limits how much it can expand. As the brain continues to swell, pressure builds up within the skull.
It is this increased pressure within the skull that causes so many damaging and permanent effects:
The blood and oxygen stop flowing to the brain because the blood vessels get squashed.
Without the oxygen, brain cells die and cannot re-grow or recover. This may cause further swelling.
The swelling causes the brain to push down on the brainstem, which is where the spinal cord and the brain join at the back of the neck, and stops the functions of the brain stem.
The brain stem controls breathing, heart rate, blood pressure and body temperature.
Rates of organ donation in Australia
Australia has one of the best records in transplantation outcomes in the world; however, more than 1,800 Australians are waiting for a transplant at any given time owing to a shortage of donors.
Australia's organ donation rate has hovered around 200 donors per annum for many years. Although surveys indicate more than 90 per cent of Australians support the idea of organ and tissue donation, the country continues to have one of the lowest rates of donation in the Western world.
In 2000, the Australian organ donation rate was 10 per million population. There was considerable variation in the rates for the States and Territories. South Australia had the highest rate, 20 donors per million population. In other States for which reliable rates could be calculated, rates of donation ranged from 9 per million population for New South Wales, to 12 for Western Australia.
Compared with other countries for which information is available, Australia's donation rate of 10.2 per million population - the number of people who die and become donors out of the (live) population - is low. When organ donation rates are compared per 1,000 deaths, the difference between the donation rate for Australia and some other countries is reduced. In 2000, Australia's donation rate of 1.5 per 1,000 deaths was comparable with estimated rates for New Zealand and for several European countries, including the United Kingdom and Ireland, the Netherlands and Germany.
In 2000, Spain had the highest donation rate, whether calculated per million population (33.9) or per 1,000 deaths (3.9). Over the 1990s Spain had a high and increasing rate of donors per million population. The rate rose rapidly from 14.3 per million population in 1989 to more than 20 in 1991, and had exceeded 30 by 1998. This has been attributed to procedures introduced by a national transplant organisation set up in 1989, which included having donation coordinators in hospitals, training medical staff in requesting donation, and closely monitoring potential and actual donation.
In September 2008, the Australian and New Zealand Intensive Care Society (ANZICS) released the third edition of The ANZICS Statement on Death and Organ Donation. This is the most authoritative statement of the procedures to be followed in determining donor death and performing organ transplants.
The full text of the statement can be found at http://www.anzics.com.au/uploads/ANZICSstatementfinal26sept08.pdf
In October, 2008, the National Health and Medical Research Council issued a media release seeking to reassure potential organ donors that claims that organs were taken from people who were still technically alive.
The full text of this media release can be found at http://www.nhmrc.gov.au/health_ethics/health/organ.htm
Arguments suggesting Australia needs more rigorous guidelines to protect organ donors
1. New South Wales has more rigorous guidelines than those which apply nationally
Critics of the national guidelines claim they do not offer the same quality of protection for donors that the New South Wales guidelines do.
Under rules introduced by the NSW Government last year, doctors cannot give drugs to donors to optimise their organ function while they are still alive. Other interventions to increase the viability of organs, including the insertion of cannulas into vessels to enable rapid cooling of organs, are also banned when the donor is alive.
In June 2007 the New South Wales Minister for Health, Reba Meagher, announced the introduction of new guidelines aimed at providing greater clarity on organ donation following cardiac death.
'NSW is the first state in Australia to develop and introduce organ donation after cardiac death guidelines,' Ms Meagher said.
'These new guidelines will provide greater clarity on a number of clinical, legal and ethical issues and will hopefully see an increase in the number of donations - particularly kidney donations.'
Ms Meagher further stated, 'Having clarity on donation after cardiac death, in addition to brain death, means many more patients who have expressed a desire to donate, can now be considered for this life-giving and generous act...
This initiative will help families and doctors make important decisions based on clear and comprehensive information and an understanding of the benefits that organ donation can bring to others.
Importantly, these guidelines affirm that comfort and care of the dying patient who wants to be an organ donor is the absolute priority and is not comprised by this donation process.'
2. Some critics have claimed that Australian guidelines allow the harvesting of organs from those who are not 'brain dead' and from who blood circulation may not have stopped irreversibly.
Associate Professor James Tibballs, of Melbourne, is an intensive care specialist at the Royal Children's Hospital. The professor has stated his belief that doctors could not be sure all brain function or blood circulation had ceased irreversibly when organs were taken.
The Professor has called for brain death tests to be strengthened and for Australians to be fully informed of how organs are retrieved to ensure informed consent.
Dr Tibballs has claimed that clinical practice clashed with the law, which says organs can be taken from a donor when they have either irreversible cessation of all functions of their brain or irreversible cessation of blood circulation.
He said guidelines used to diagnose brain death and cardiac death (cessation of blood circulation) could not prove irreversible cessation and that some interventions to ensure the viability of organs could actually harm or cause the death of a donor. 'The question of when is it permissible to retrieve organs is now phrased not in terms of whether death is present or not, but rather "how dead is enough",' Dr Tibball has claimed.
Dr Tibballs has called for a test of brain blood flow to be made mandatory to improve the certainty of brain death diagnosis.
The same position has been adopted by Associate Professor Nicholas Tonti-Filippini, PhD, a consultant ethicist and associate dean and head of Bioethics at the John Paul II Institute, Melbourne. Professor Tonti-Filippini has stated, 'Death of the brain stem alone is not death. Diagnosis of death requires evidence of the damage to the other parts of the brain such that all function of the brain is destroyed. I advise families to ask for an image showing loss of blood supply to the brain. They can then be confident that death has occurred.'
3. Some organs are currently being donated without properly informed consent
Melbourne bioethicist Dominic Wilkinson, an intensive care specialist now based at Oxford University, has claimed there is a tendency for the medical profession to gloss over the details of how organs are retrieved because it could confuse or alienate potential donors.
Dr Wilkinson stated his view that informed consent was vital and that all Australian laws governing donation should required that informed consent be given prior to donation.
'We think that it is important for individuals to give informed consent for their organs to be used after they have been declared dead. That means that they should know exactly what they are agreeing to when they sign on to an organ donation register,' he said.
Associate Professor James Tibballs, an intensive care specialist at the Royal Children's Hospital, has indicated that donors should know exactly what could happen to them so that they could give informed consent.
'If someone can't understand the arguments during a time of peace, how could they be expected to understand it when they are looking at their severely injured child or loved one in hospital,' Dr Tibballs has asked.
4. Clear guidelines would lead to increased confidence among potential donors and recipients
Rigorously applied guidelines for determining when death has occurred are not inconsistent with high organ donation. Some critics of our current practices have argued that the more stringent the guidelines and procedures the more likely people are to be prepared to donate because they will have confidence that their own care will not be compromised should they be on the organ donor register.
Associate Professor Nicholas Tonti-Filippini, PhD, a consultant ethicist and associate dean and head of Bioethics at the John Paul II Institute, Melbourne, has stated, 'Many countries with successful donation programs, including Spain, France and Singapore, adopt regulations that would comply with the recommendations that (Professor) Tibbals makes (that we guarantee irreversible brain death has occurred)...
To facilitate organ donation, there does need to be community discussion about procedures undertaken before withdrawal of treatment and hence before death.'
Professor Tonti-Filippini has indicated that he himself has refused a kidney transplant for twenty years because he is not satisfied about the procedures which surround the taking of organs from organ donors. Professor Tonti-Filippini's concerns indicate that some organ recipients' peace of mind may be compromised if they are uncertain about or not satisfied with the manner in which organs are taken from donors.
5. Clear guidelines would give peace of mind to the relatives of donors
The secretary of the Department of Health and Ageing, Jane Halton, has said it was important the public had confidence in Australia's organ donation system so more lives could be saved. Ms Halton has stated, 'It is very important that we provide assurance to the community that they can have complete confidence in the system.'
The virtualmedicalcentre.com gives the following overview of the situation in Australia. The Centre's Internet site states, 'Although most Australians are comfortable with organ donation, relatively few register their legal consent. In the face of uncertainty, relatives usually opt not to proceed with donation.'
The Centre's Internet site also notes, 'Public perceptions may also contribute to the low donation rate in Australia. It is hoped that basic education about the process and procedures involved will allay some unfounded fears. In particular, the concept of 'brain death' appears to be widely misunderstood.
Some people mistakenly believe that retrieving organs from a brain dead person will cause them to die prematurely. Also, there is the fear that allowing organ donation is agreeing to mutilation. Again, information about the surgical procedure itself may reassure family members and make them more comfortable with the decision to donate.'
Given the apparent popular fears already in existence about 'brain death', there are those who are that relatives will only have peace of mind about allowing their loved ones' organs to be used for transplants if they are confident that rigorous guidelines exist and are adhered to ensure that brain death has irreversibly occurred.
Arguments suggesting that Australia's guidelines are sufficient to protect organ donors
1. Australia's national guidelines protect the rights of the donor.
Senator McLucas, the parliamentary secretary to the Minister for Health and Ageing, has stated, 'The needs of the patient and their family will always take precedence over the retrieval of organs for transplantation.'
Senator Jan McLucas has also reassured the public that their organs would only be taken when they were clinically dead.
Senate Lucas has assured the community, 'Australians should be confident that our processes for transplantation are among the best in the world.'
Dr Dominic Wilkinson, a neonatologist and Nuffield Medical Research Fellow at Oxford Uehiro Centre for Practical Ethics, University of Oxford, has stated, 'The community has nothing to fear from consenting to organ donation, either for themselves or for their loved ones. In all of the intensive care units that I have worked in, in Britain and Australia, decisions about the declaration of death and the withdrawal of life support are made independently of decisions about eligibility for organ donation.
No patients, who would otherwise have survived, die in intensive care because they have consented for organ donation. Every effort is made to ensure that dying and recently deceased patients are cared for with dignity and respect. This is in accordance with national and international guidelines, and is how it should be.'
2. Australia's guidelines have only recently been reviewed
Associate Professor Bill Silvester, the director of Victoria's organ donation service, LifeGift, has argued that the guidelines for organ donation, laid down for this country by the Australian and New Zealand Intensive Care Society (ANZICS), have been revised as recently as this year.
The ANZICS Statement on Death and Organ Donation was released in 2008. Its foreword notes that this is the third set of guidelines to be produced and indicates that the 'exhaustive' process that was gone through and the additional areas that have been covered.
The foreword states, 'This third edition builds on the first two, but provides greater detail on the determination of brain death and the responsibilities of intensive care staff. An additional chapter has been added on donation after cardiac death (DCD), in recognition of the increasing DCD activity in Australia and New Zealand. We recognise that so-called cardiac death includes death of the person as a whole, with death of the brain being an inevitable consequence of permanent cessation of the circulation.
The process of revision for the third edition of the Statement has been exhaustive, with a comprehensive review of relevant literature, including comparable documents from other countries, and a complete rewriting of the content to enhance clarity and expand the detail around the more complex issues. An exposure draft was made available for comment to ANZICS members, medical and nursing colleges, state-based organ donation agencies, other societies and associations. These comments were collated and reviewed by the Committee, with further changes being made to the draft Statement where appropriate.'
3. There is no confusion around when death has occurred
Many of those who operate in the area of intensive care and organ harvest and transplantation argue that the conditions which need to be met for death to be certified are clear and well-known.
Associate Professor Bill Silvester, the medical director of LifeGift (Victorian Organ Donation Service) and Senior Intensive Care Specialist at the Austin Hospital, has stated, 'Brain death ... is carefully determined by a very specific set of clinical tests of the brain reflexes. These tests include an assessment of the brain's ability to respond to any stimulation and the ability to breathe without an artificial ventilator.
If it is clear that the patient is comatose (completely unconscious), unable to breathe and without any brain reflexes, and this condition has no other possible cause, then it can be determined that the patient's brain has died with zero chance of recovery.
The clinical tests are done twice, by two independent and appropriately qualified senior doctors. In certain uncommon, but well recognised, circumstances, these clinical tests cannot be done and then the intensive care doctor undertakes a specific investigation to look for blood flow within the brain.
In recognition of the importance and gravity of these tests to diagnose the death of a person's brain, the specific technical details of how to conduct these tests are carefully stipulated in medical guidelines.'
4. Reopening the debate around organ donation guidelines could give needless distress to relatives of donors
It has been stated that further debate about the guidelines that are used to determine whether death has occurred and organs can therefore be harvested can only cause distress to the relatives of donors.
It has been suggested that at the time of death of a loved one, relatives need confidence and reassurance not unfounded doubts about the validity of a diagnosis of death.
Associate Professor Bill Silvester, the medical director of LifeGift (Victorian Organ Donation Service) and Senior Intensive Care Specialist at the Austin Hospital, has stated, 'When I am speaking to the family of a patient whose brain has just died, it is of crucial importance to convey the certainty of the diagnosis. They are hearing, from a doctor that they hardly know, that there is no hope for their loved one who is lying in a bed in the ICU, whose chest is going up and down as the ventilator pushes air into the lungs, with warm hands and feet and a beating heart, looking like he or she is just asleep.
It is following this understanding and acceptance of the death of their loved one that the intensive care specialist raises the possibility of organ donation with the family. There is no other time to raise this because there is only a matter of time before those organs start deteriorating, following the death of the brain.
It never fails to amaze me how bereaved families, in the midst of the struggle with their loss, are prepared to briefly put their grief aside to consider, and agree to, the unconditional donation of their loved one's organs to help other people that they will never know and never meet...
They frequently say that "this is the only positive thing that can come out of this tragedy" or "we can fulfil/honour his/her wishes".'
It has been stressed that any appearance of uncertainty in such circumstances can only add to the pain and distress of the potential donor's family.
5. Reopening the debate around organ donation guidelines could create doubt in the minds of potential donors
Numerous prominent people involved with organ transplants have expressed concern that a debate around what constitutes death in potential organ donors could lead many to reconsider becoming donors.
Jan McLucas, the parliamentary secretary to the Minister for Health and Ageing rejected any call for a review of organ donation guidelines and said donors could be sure they would be dead if their organs were ever retrieved.
Senator McLucas condemned critical comments made by Dr Tibballs as 'irresponsible' and said she was concerned they could erode confidence in Australia's transplantation process with 'devastating' effects for those waiting for life-saving transplants.
The National Health and Medical Research Council (NHMRC) has recently issued a media release expressing its concern that the current debate around organ donation and how it was determined that potential donors had in fact died might lead to a decline in organ donations.
The NHMRC stated recent media misinformation 'is of concern to us because the information might have an adverse impact on the donation rate of critically-needed organs and tissues.
Suggestions in the media have been that in order to increase organ donation rates, health authorities are under pressure to allow doctors to obtain organs from patients who are still "technically alive".
The NHMRC wishes to reassure the public that this will not occur. It will continue to be illegal and unethical to remove organs before people are dead.
There is also no intention or need to change the definition of death to facilitate organ donations, or for any other purpose.'
Further implications
Australia's organ donation rate is relatively low by world standards. The Rudd Government has recently directed $136 million toward improving the nation's organ donation rate. In such a context it may appear regrettable that critics such as Professor Tibballs have publicly raised doubts about the rigorousness of the procedures applied when determining brain death and harvesting organs from Australian donors.
However, Australia's rate of organ transplantation would appear to imply that many in the community are already either ill-informed about or frankly sceptical of the procedures that actually apply when organs are taken from donors.
Surveys have repeatedly indicated that there is an apparently high rate of acceptance of organ donation among the Australian community which is not translating into practical support for transplantation in terms of actual donations. It would appear that for whatever reason the altruistic urge to assist those in need of replacement organs often does not survive when the real-life opportunity to donate presents itself.
There is a range of possible reasons for this. One of this would appear to be confronting the concerns that some in the community have about the safeguards surrounding the certification of death and the donation of organs.
Professor Tibballs has indicated that there may be grounds for strengthening the criteria used to determine whether brain death has occurred. He has suggested that some of the interventions used to ensure that organs can be harvested after cardiac death may not be in the best interests of the patient. He has further suggested many relatives and donors are not fully informed of the procedures to be applied when organs are taken from a donor.
One option which has been proposed to help resolve these issues is to have more than one form of donor agreement to organ donation.
It has been suggested that some potential donors might agree to donate their organs only under the most rigorous standards of irreversible brain death outlined by Professor Tibballs and others such as Professor Tonti-Filippini.
Others might agree to donate organs under a less rigorous standard, which would allow pre-death interventions (such as the administration of anti-coagulants) and the use of brain stem death as a standard (rather than total brain death and the cessation of circulation to the brain) as the point at which death can be certified.
Such a flexible approach to gaining donor agreement would involve a dramatic increase in public education about the nature of death and the various manners in which it might be determined.
This two-level approach would, theoretically, have the advantage of giving donors complete control of the circumstances under which their organs were harvested. It is conceivable that this might help to increase the rate of organ donation in this country. It is, however, dependent on a dramatic increase in the level of public knowledge of the issue.
This approach also presupposes that potential donors would have indicated their wishes regarding organ donation prior to suffering a life-threatening injury or disease. Decisions of this complexity could only realistically be made in advance of the situation where they were required to be acted upon.