Organ donation an outline for general practitioners
It is becoming increasingly important for general practitioners to have basic knowledge about the process of organ donation. This paper is written with that in mind, but is not intended to cover the subject in great depth. Suggestions for further reading are listed at the end of the document.
Many organs are now being considered as potentially suitable for transplantation, both human to human and animal to human. The discussion points in this paper refer solely to solid organs – such as kidney, liver, pancreas, heart and lung. The donation of tissue cells and fluid, such as bone marrow, blood and gametes, is not covered, and may require exploration in a further document.
The first successful solid organ transplant was carried out on 23 December 1954. Dr Joseph Murray transplanted the kidney from one identical twin to the other in Boston, USA. The first heart transplant was performed by Dr Christian Barnard in 1967 in South Africa.
Transplant technology and survival rates have advanced to such an extent that demand for organs vastly exceeds supply in most countries with transplant programmes. The shortage of organs is compounded now that the criteria for eligibility for transplant have been broadened to be more inclusive and equitable by including, for example, the elderly. If we accept that organ transplantation is a medically desirable and ethically acceptable procedure, then we need to explore energetically ways of overcoming the problem.
- At the end of December 2001, 6,842 people were on the active and temporarily suspended transplant waiting list in the UK. The waiting list continues to grow each year.
- Despite a small rise in the number of cadaveric organ donors during 2000, the total number of organ transplants fell by 1%.
- Of patients registered during 2000, 11% on the cardiothoracic list and 7% on the liver list had died by the end of the year without receiving a transplant. Others will have died without even reaching the waiting list.
- Studies show that around 70% of the population would be willing to donate organs after their death, yet only 15% of the population are registered on the NHS Organ Donor Register.1
It is important to recognise that there are doctors and members of the public who do not agree with this point of view, for a variety of reasons. Their views ought to be respected. We must also understand the logic behind the argument that we need to do more to prevent conditions predisposing to organ failure. Early identification of hypertension and its aggressive treatment could have some effect in reducing kidney failure for example, but it would not make dialysis programmes entirely redundant.
Why is it important for GPs to be well informed about organ donation?
This paper makes the assumption that most of those who read it agree that organ transplantation is beneficial to patients who would otherwise die, or have severely restricted lives.
If we agree this premise, then we will agree that increasing the number of available organ donors is a beneficial exercise. It would be easier for us as GPs to influence the exercise if we all knew more about organ donation, both conceptually and practically. In particular, we need to be aware of some of the concerns that may affect public thinking and the decisions made by our patients. It is important that we put ourselves in the position of being able to discuss these issues in the consulting room as and when they arise.
Carrying a donor card
Many people know, or think they know, about ‘donor cards’. Few have one in their possession, fewer have completed the form which places them on the donor register, and even fewer carry one on their person when they go out. In any case, these cards are quite difficult to get hold of, unless the individual is determined.
There is an opportunity for new patients filling in a registration form for the practice to complete the ‘donor boxes’ on the back of the form, and some GP practices have donor cards displayed in their waiting rooms. There are differing opinions about whether reception staff ought to point this out to patients: some are very positive about it, and others prefer to leave it to patients to discover the option. GPs themselves are divided in their opinions as well, and many would hesitate to include any input on organ donation in their first interview with a new patient.
It is disappointing to know that few register their wishes or carry cards. It is more surprising to be told that those hospital doctors working in ITUs only rarely access the official donor register. It may not be surprising that family members can – and sometimes do – override the wishes of the possible donor by refusing permission for removal of organs. Overall, an aggressive ‘carry a card’ publicity programme may improve public awareness, but may not provide much benefit for the money spent. We could be more positive in our GP practices in encouraging people to think seriously about organ donation. This would help family members faced with difficult decisions to be better prepared. It may also help young people to discuss their own wishes with their families, and to be quite clear about what these are.
It is possible that many people are reticent about ‘signing up’ as an organ donor because they have very real fears about the process of obtaining their organs. These fears are also present in relatives of potential donors. ‘Will I (they) be really dead?’ and ‘will I (they) feel pain and be powerless to protest?’ If we are better prepared to discuss these fears with our patients and to provide them with clear information, then they will be more likely to view the donor state positively.
Opting in/ opting out/ presumed consent
"Societies across the world…eschew…the ‘taking’ of organs from cadavers, so-called routine procurement, without at least some form of … ‘consent’ to the removal"2. Price goes on to say that we do not see any objection to an individual giving permission in advance for the use of his or her organs after death, but asks where does the right of a relative to consent or to refuse such use come from?
At present in the UK, we have the system of ‘contracting, or opting in’. This relies on individuals making a conscious decision to donate organs after death, a decision that may be difficult to contemplate for the young person in particular. Some countries in Europe, most notably Belgium and Austria, have introduced the system of ‘opting out’, where consent is presumed unless there is evidence to the contrary. Price comments that we could ask, with some justification, whether this is any more than the routine taking of organs, implying public ownership of the cadaver. Yet there is no evidence to show that relatives’ wishes would be countermanded in the interests of the transplant programme of the countries with this system. In both Belgium and Spain, where there is legislation for presumed consent, relatives are asked for their views and their wishes are respected.3,4 and refusal rates are similar to those in the ‘opting in’ system.
Whichever system is in operation, we need to question the rights and wrongs of countermanding the dead person’s expressed wishes. Not only are those wishes being overruled by the relative, but also the refusal denies another person the possibility of receiving an organ. Thus we are placing the rights of the relative far above the integrity of the dead person and the need of the possible recipient. According to the Human Tissue Act 1961, the hospital administrative officer is in lawful possession of the body, and in theory ought to follow the wishes of the deceased. In practice, this has the potential of adding to the suffering of the relatives, and it could be seen as cruel to pursue retrieval in these circumstances, however beneficial it might be to another patient5.
"While this may be very good and sympathetic medicine, it is, paradoxically, doubtful medical ethics - effectively, the last autonomous wish of the individual is being thwarted simply because he or she is in no position to object."6 Fortunately, in practice it is rare for a conflict to occur between the wishes of the dead person to donate and those of the relative, who does not agree.7
Cadaveric donation and death confirmed by brain stem tests (or ‘brain stem death’)
The majority of organs for donation come from cadavers - people who are dead. However, death is a process not an event, if considered in biological terms, yet it needs to be defined as an isolated moment, for legal reasons. The person’s legal status changes radically after death. On the one hand, the diagnosis of death, not merely the process of dying, but actual death, is important. On the other hand, time is crucial in the harvesting of organs, especially hearts, livers and lungs: the fresher the organ, the better the outcome. These organs will deteriorate rapidly as soon as perfusion, natural or artificial, ceases, and will cease to be suitable for transplantation.
It is for this reason that many successfully transplanted organs are donated by patients who have been artificially ventilated in ITUs and have been medically certified by the use of specific tests as ‘brain stem dead’8. "The concept and diagnosis of brain stem death9 is central to cadaveric donation, and to intensive care in general; but it is one which is often difficult for the general public to understand, although it is no longer controversial for most of the medical profession"10.
There is a clear link between reluctance to donate organs by family members and lack of knowledge about brain stem death. "Lack of comprehension or support fosters anxiety as to the possibility of being declared dead8 prematurely and reflects itself in the reluctance of some to assent to the removal of organs."11
Most GPs have no difficulty in pronouncing a patient dead when the death occurs outside hospital, and the time of death is clear. However, in ITU the moment of death may not be so clear cut. In the UK, a diagnosis of ‘brain stem death’ may have been made and confirmed, yet the patient’s breathing may still be artificially maintained - and his heart may continue to beat. Is he dead, and if so, at what moment did death occur?
To the lay observer or non-medical relative, it may be difficult to look on someone who is warm, pink and perfused as dead. Without the opportunity to understand the concept of brain stem death, how could that relative possibly agree to the harvesting of organs from such an individual? In Denmark, the Council of Ethics did indeed recognise the difficulty, and rejected the principle of brain stem death in 1989.12 Their argument relied on the community's view of death as occurring when cardiac function ceased. Under this argument, there can be no ‘heart beating donor’, and cardiac transplantation is ethically precluded.
In the UK however, it is both medically accepted and legally endorsed that persons whose brain stems are dead are certifiably dead. It remains to improve public understanding of what this really means, and how the diagnosis of brain stem death is made; better understanding may reduce any public misgiving. We need to reconcile the repugnance felt by many with regard to removing organs from a warm pink heart beating donor, whatever the state of his or her brain.13 It may be that those thinking about becoming donors are inhibited by this strong feeling. ‘Will they take my organs before I’m really dead?’ We might question whether the benefit to another which ensues from receiving a fresh organ outweighs any possible harm from the treatment of the donor.14
There are three phases in the diagnosis of brain stem death15
- Exclusion of reversible causes of coma and diagnosis of cause of irreversible brain damage
- Testing for destruction of brain stem components
- Confirmation of inability to breath spontaneously
Once the diagnosis has been made, the cadaver can become an organ donor,16providing that
- There is no reason to suppose that in life the individual had expressed any objection, and
- There is no objection from the nearest available relative(s)
(In general, family refusal amounts to 26% in Europe, and has been reported as 30% in the UK17)
In any discussion on this topic with patients, the GP needs to be clear in his or her own mind on the issue of brain stem death. The medical and legal position in the UK is clearly stated. It is the moral argument for and against that must be resolved, possibly on an individual basis.
We need to be aware of two other controversial aspects of cadaveric donation
- The use of anaesthetic agents during organ retrieval
Those members of the public who read media reports on medical matters will remember some controversy reported on this activity. It is more or less standard practice for anaesthetic agents to be used during organ retrieval.
The logic behind this will escape those who say ‘if the donor is dead, why is an anaesthetic needed – and if he’s not dead, you should not be doing this.’ The difficult truth, as stated by the anaesthetists and surgeons, is that the cadaver may retain some reflex movement that hinders the smooth retrieval of organs and makes the transplant surgeon’s work difficult. The use of muscle relaxants, for example, helps the process. The reasons have been well argued by the College of Anaesthetists, and, for the time being, have been generally accepted by the profession.
Elective ventilation (EV)
This is a uniquely British phenomenon. It began in Exeter as a means of increasing the availability of donor organs by the identification of potential future donors amongst patients admitted to the medical wards.18 Patients who suffer a devastating stroke and are deeply comatose over a period of time are known to have an extremely small chance of survival, and eventually succumb to brain stem death. According to the Exeter protocol, patients in this category would be transferred to ITU and maintained on ventilation until brain stem death occurred. ITU support was needed during this period of time of between 3 and 41 hours. This use of a scarce resource, such as ITU care, raises an important question on its ethical acceptability in utilitarian terms.
At the time, elective ventilation resulted in 100% rise in donor rate over the UK. It shifted the emphasis away from the prolongation of life for these afflicted patients towards the maintenance of the vitality of their organs. Ethically and legally, it is important to be clear whether this change of tack occurred during the ‘dying process’ or when the patient was already dead. It would be morally unacceptable and against the best interests of the dying patient to prolong any discomfort associated with dying in the best interests of another individual. In particular, there was no way that the dying person could have given a valid consent to such a procedure. It was decided eventually that this was the case, and that it was both ethically and legally unacceptable. It was declared to be unlawful (battery) in 1994.
Even so, if someone makes an advance statement to the effect that they wish for EV if appropriate, this may influence a court, particularly if that individual had been aware of the very real risk of inducing a persistent vegetative state if ventilated close to death, and that ventilation would not be continued for longer than 48 hours19. Not many members of the public are aware of this, and it may be that they should be informed of the possibility of making that choice at the time of making an advance directive.20
The living donor
Is there any good reason why organ removal cannot be justified, providing it is intended for a therapeutic purpose, such as transplantation, and valid consent has been given?
Again, "if the body is merely instrumental to our ends…then continuing functioning of the body is morally insignificant, so that death may properly be declared despite the continued working of lower brain…functions. Moreover, there is no reason why one should not be able to sell body parts, as with most anything else which belongs to us".21
Not everyone would agree with this view. Moreover, there is a fundamental ethical problem to be resolved when considering solid organ donation from the living donor. "The principle of non-maleficence, or primum non nocere, may favour cadaveric organ donation; it would not endorse donation by a living donor, however competent and consenting, who, of necessity, has no pre-existing ailment that it is the intention to cure."22
Can the surgeon operating to remove a kidney from a healthy individual, not a patient, be behaving towards that person with non-maleficence? As Price says, he could be said to be behaving with maleficence by mutilating the body of the donor, leaving him less well, and damaged. It is clearly a non-therapeutic procedure, not an operation done with the donor’s best interests in mind. Even if the donor insisted that he gave his full and informed consent, in law no one may consent to being seriously injured.
In spite of this, the use of living donors has been dealt with in law by the acceptance that consent to such a non-therapeutic procedure is valid as long as it is in ‘the public interest’. A life-saving procedure for the recipient is thereby interpreted as being in the public interest.
Consent of the live donor has always been recognised as a difficult issue, mainly because of the importance of excluding any element of coercion. Payment for organs is forbidden in many countries as well as the UK. The offer from the donor has to be non-directed and therefore, based on altruism. The Human Organ Transplants Act 1989 was designed to foster unrewarded altruism and self-sacrifice by limiting donations to strangers whilst allowing donations to genetically linked persons. A provision for other donors exists under the Unrelated Live Transplant Regulatory Authority (ULTRA) which considers requests by unrelated donors, such as spouses and living partners.
The number of organ donations is increased by the inclusion of live donors, in particular, kidney donors. These numbers could be increased in some ingenious ways. For example, there may be a situation where there is tissue incompatibility between two pairs of related donor/recipients yet cross compatibility exists between a member of one pair and a member of the other pair, and vice versa. In another case, with a willing yet incompatible donor, the donor’s kidney may be retrieved for the kidney ‘pool’ whilst his incompatible relative moves up a place on the waiting list. It is unclear at the moment whether these transplants would be sanctioned by ULTRA, but there does not seem to be any obvious reason why they should not go ahead.
The recipient and the disease-free transplant
In the unlikely event that a patient asks about transmission of disease, for example HIV infection or even cancer, from a donor organ, a GP cannot give full, reassurance. There is always going to be a risk; as time is of the essence in the retrieval of viable organs, it would be unrealistic to carry out exhaustive testing before transplantation. We ought to feel confident that potential recipients are fully informed on this point during discussions with their consultants. The question is more likely to come from someone not immediately involved, particularly if they have picked up something reported in the media. Nevertheless, the GP has a responsibility to ensure that patients have access to the latest information on this point.
More information – more donors?
- Potential donors and relatives of potential donors need a full and clear understanding of ‘brain stem death’, in particular, that the heart can continue to beat spontaneously in a ‘brain stem dead’ person. Written information on these points could be provided as a reminder.
- They need to know how such persons are maintained clinically once they have been medically certified as brain stem dead, prior to donation.
- They need to be aware of the use of anaesthetic agents during organ retrieval, to the extent of full anaesthesia.
If, in the light of solid information about the clinical circumstances of death confirmed by brain stem tests and with due assurances about the possibility of providing full-spectrum anaesthesia where requested, people are then happy to offer themselves as donors, then the ethical requirements for valid consent to be a donor are fulfilled. When someone is irretrievably dying, presumed to be irreversibly unconscious, and guaranteed to be insensate by anaesthesia, then that individual might view his or her organs as of no further use to them. Given such a guarantee, many would consent to the donation of their organs, or those of their dying relative, for the undisputed benefit to others.
The GP is in a good position to provide this information, and allay the fears that trouble many people. They would then be prepared to accept the possibility of helping someone else to live after their own life, or the life of their relative, had come to an end.
1. Extract from the Draft Parliamentary Brief The BMA’s position on a "soft" system of presumed consent for organ donation for transplantation purposes 12/02/02
2. D. Price (2000) Legal and Ethical Aspects of Organ Transplantation Cambridge University Press. Cambridge
3. R. Matesanz (1998) Cadaveric organ donation: comparison of legislation in various countries of Europe. Transplantation 1998. Nephrol Dial transplant; 13: 1632-1635
4. P Michielson (1996) Presumed consent to organ donation: ten years experience in Belgium. Journal of the Royal Society of Medicine 89: 663 - 666
5. It is interesting to note that relatives often change their minds in the days immediately following the death, and agree to donation. Highly skilled local transplant coordinators, such as exist in Spain, together with the availability of ITU beds, contribute to this to a large degree. For further information on the Spanish system, see Organ donation: the way forward (2001) The National Kidney Research Fund
6. J K Mason and R A McCall Smith (1994) Law and Medical Ethics p304 Butterworths. London
7. Whilst acknowledging the difficulties experienced by family members which might lead them to over-ride the wishes of a possible donor, the RCGP Patient Liaison Group members were not sympathetic towards a state of affairs in which an individual’s decision, taken deliberately, to donate organs could be over-ridden by relatives. The Group agreed that family members should not be asked for permission. Consideration should be given to the communication skills of those given the job of letting family know of the wishes of the patient sensitively and, if possible, allowing them some time to come to terms with the information – without seeking their permission
8. The term ‘death confirmed by brain stem tests’ is now preferable. The older phrase ‘brain stem death’ may be less accurate, but is used in this paper for brevity
9. Many jurisdictions now incorporate brain death as a legal entity.
10. King’s Fund Institute A question of give and take Research report 18 (1994) King’s Fund Institute London
12. M. Evans (1990) Death in Denmark Journal of Medical Ethics 16:191-194
13. M.Evans (1994) Against Brainstem Death. In: R.Gillon (ed) Principles of Health Care Ethics John Wiley and Sons Ltd
14. M.Evans (1990) A plea for the heart Bioethics Volume 4 Number 3:227-231
15. It has been suggested that written information on the brain stem and its function could be provided for patients. This would facilitate better understanding (RCGP Patient Liaison Group)
16. Clearly, it is unlawful to kill a patient either for or by organ retrieval (the ‘dead donor’ rule).
17. S.M.Gore, C.J.Hinds and A.J.Rutherford (1989) Organ Donation from Intensive care Units in England British Medical Journal 1193
18. T.G.Feest, H.N.Riad, C.H.Collins et al (1990) Protocol for Increasing Organ Donation after Cerebrovascular Deaths in a District General Hospital Lancet 335: 1133
19. It is clear that any patient who considers making am advance directive that includes the choice for EV must be fully informed of the implication of survival in a persistent, or prolonged, vegetative state.
20. As with any adult in the UK excluding Scotland, a relative may not consent to EV by proxy.
21. D.Price (2000) Legal and Ethical Aspects of Organ Transplantation Cambridge University Press. Cambridge
- D.G. Jones (2000) Speaking for the Dead: Cadavers in Biology and Medicine Ashford (reviewed in Journal of Medical Ethics Feb 2002 Vol 28 no 1 pp57-58
- Ian Kennedy and Andrew Grubb (1994) Medical Law: Text with Materials Butterworths. London
- Ian Kennedy and Andrew Grubb (eds) (1998) Principles of Medical Law Oxford University Press. Oxford
- Mason and McCall Smith (1994) Law and Medical Ethics Butterworths. London
- David Price (2000) Legal and Ethical Aspects of Organ Transplantation Cambridge University Press. Cambridge
- Peter Singer (1994) rethinking Life and Death Oxford University Press. Oxford
Members of the RCGP Ethics Committee, in particular, Dr Martyn Evans.
Members of the RCGP Patients' Liaison Group
Dr Ann Orme-Smith MA FRCGP (On behalf of the Committee on Medical Ethics) March 2002