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CHAPTER 4
RELATED ISSUES

Over the course of the study, several issues were identified as having particular characteristics that made them distinct from the general considerations highlighted previously. This chapter of the report looks at children, donor families, and brain death.

A. CHILDREN

The Committee heard on several occasions about the particular needs of children. Issues included: individual consent, training for healthcare professionals in approaching families, allocations of organs, and data collection.

In relation to individual intent and consent, some witnesses expressed concerns about the appropriateness of having parents register intent on behalf of their children. The Committee heard about the possibility of registering the donor choice of a child on his or her health card or through other possible consent mechanisms such as the income tax forms. Some witnesses pointed out that, obtaining prior consent from one parent could prove to be problematic in the event of family breakdown.

Witnesses talked about the general unease experienced by healthcare professionals when approaching grieving families to request donation is particularly acute when the potential donor is an infant or child. While most witnesses acknowledged that these parents are particularly overwhelmed, some perceived that requests in such situations are unjustified while others felt that, when approached with the appropriate sensitivities, parents often feel good about producing a positive outcome from an otherwise tragic situation.

In the area of allocation and transplantation, many witnesses described how pediatric cases create unique sharing necessities. In addition to the required tissue compatibility when matching a donor organ or tissue to a potential recipient, there must also be size compatibility when considering primarily the heart and lungs. These organs cannot be reduced in size in order to fit within the smaller chest cavity of a child. Likewise, the heart of an infant would not be able to perform sufficiently within the chest of a grown man. The Committee heard that because of this need to match in size, particularly with the heart and lungs, it is important to promote the need for younger donors and it is necessary to apply size restrictions in allocation algorithms.

The CORR program at CIHI indicated that it collects data for transplants performed on children under 17 years of age. With respect to donors, the current CORR annual report shows that in 1996 there were 49 organ donors in Canada who were 14 years of age or younger. Additionally, there were 28 pediatric kidney transplants and 40 pediatric liver transplants. Information from CORR also showed that unlike the older age ranges in which an intra-cranial event is a significant proportion of the causes of death, motor vehicle accidents and unknown or other causes were the predominant cause of death for those 14 years of age and under. The Committee heard that some of the causes of death in the very young such as shaken baby syndrome and crib death are unique to that age range.

Of the considerable discussion generated on brain death, the Committee heard that, although the criteria for brain death in adults are well established and generally accepted throughout the medical community, this is not the case for brain death in the very young. Three Canadian neurological associations have recently proposed additional criteria for the diagnosis of brain death in neonates and young children; these are discussed in the brain death section of this chapter.

7. The Committee understands the unique requirements of the pediatric transplant recipients and recommends that the new national body oversee that:

7.1 The real-time waiting lists for solid organs include a distinction of all pediatric cases;

7.2 All sharing rules established for heart and lungs take into account the pediatric requirements; and,

7.3 The Canadian Organ Replacement Register include in its data collection a distinction of all pediatric figures.

B. FAMILIES OF DONORS

According to the majority of witnesses, the involvement of family is indispensable, primarily at the donation end of the continuum. Witnesses felt that it is essential for families to discuss individual intent with respect to organ donation. The Committee was told that, when families know the wishes of individuals they will seldom refuse when approached about organ donation. In fact it was indicated that families would consent up to 96% of the time if aware of the individual's intent, compared to only 58% of the time if unaware of the intent. Several discussions focused on mechanisms for encouraging family discussions. These included the need to establish a specific area on donor cards to ask about family discussion and perhaps a space for the name of a close family member who has witnessed the individual's intent to donate.

The Committee members expressed a particular interest in promoting more frequent family discussion on organ and tissue donation and considered ways to bring this issue to a greater number of Canadians. Recognizing that, as federal parliamentarians, they reach almost the entire population through the regular dissemination of information to their constituents in their "householders," they concluded that, these mail-out publications could provide a useful vehicle for promoting family awareness.

8. To assist in the process of educating and involving families, the Committee recommends that:

8.1 The Speaker of the House of Commons consider working with Members to develop an awareness insert for annual inclusion in the "householder" developed by each Member of Parliament at a time close to National Organ Donor Week.

Family involvement, particularly where the potential donor's intent is known, was considered vital to the procurement stage. The Committee heard arguments both for and against the practice of approaching families for consent, even when the potential donor has clearly indicated an intent to donate (for example, through health card, driver's licence or donor card). Several witnesses felt that family members have no right to override an individual's wishes while others observed that it would create ill will and more grief to dismiss family wishes.

9. The Committee agrees that the involvement of families in the donation process is essential and recommends that the new national body oversee that:

9.1 Any national public awareness campaign on donation provide reassurance that consent of next-of-kin will be acquired regardless of the patient's intent status.

Witnesses argued that the families who consent to donation are the "real heroes" and as such, deserve to have tangible national recognition for the gift that they make possible and the lives saved or improved because of their generosity. Two suggestions emerged: first, that a medal or plaque be issued to the family in honour of the donor and second, that a ceremony be held annually in which the family would be recognized and acknowledged. Currently, both actions take place in Canada, however, as local initiatives, they prove quite costly to local organizations.

10. The Committee agrees that the donors deserve recognition through their families and recommends that:

10.1 The Governor General of Canada consider offering commemorative medals or plaques in a ceremony to all donor families.

C. BRAIN DEATH

1. Definition and Basis of Brain Death

The Committee heard that, traditionally death was pronounced when both the breathing and the heart had stopped. However, advances in technology have resulted in artificial means to maintain both of these life functions. The concept of brain death dates back to 1968 when it was proposed that death could be considered when the brain stopped functioning. Thus brain death was equivalent to death of the individual. This led to the establishment of committees throughout the world to set the criteria for the diagnosis of brain death. In 1987, a group of Canadian neurologists, neurosurgeons and neurophysiologists proposed a set of criteria which was subsequently adopted by the Canadian Medical Association (CMA). This was updated in January 1999 to include the criteria for diagnosis of brain death in neonates, infants and young children.

The basis for brain death was also explained. The brain consists of two hemispheres, which comprise the cognitive portion of the brain, and a brain stem that connects these two hemispheres with the spinal cord. The brain stem contains vital control centres for breathing, heart rate, blood pressure, temperature and other functions necessary for the maintenance of life. Conditions exist in which patients may have a dysfunctional upper brain, hemispheres, or brain stem. These conditions are distinct from brain death and must be distinguished from it. The physician must determine that the hemispheres as well as the brain stem have irreversibly lost all function before pronouncing death.

The Committee was told that the definition of brain death is the irreversible loss of the capacity for consciousness combined with the loss of all brain stem functions including the capacity to breath. In relation to organ donation, the prevailing medical view considers that brain death is synonymous with death. The outcome for the individual is death regardless of whether the patient will become an organ donor. The patient will be removed from all mechanical devices once brain death is established. Remaining on artificial support is not an option for a brain dead individual. In cases where the individual is to be maintained as a donor, the artificial support measures are retained only in order to maintain the organs for donation. Additionally, the Committee learned that the time of death on the death certificate is recorded as the time of brain death diagnosis, not the time at which all artificial support is withdrawn.

2. Criteria for Brain Death

The criteria for the determination of brain death were developed such that any physician in any milieu could confidently diagnose it. All criteria must be met before a diagnosis of brain death can be made:

• The patient must be unconscious.
• The patient must be unable to breathe spontaneously and would therefore be on a ventilator.
• There must be no response to external stimuli (verbal, pain).
• There must be no response (eye movement) to passive head movements or to ice water syringed into the ears.
• There must be no blinking in response to touching the cornea.
• There must be no pupil response to a bright light shone into the eyes.
• The patient must be unable to maintain blood pressure, control fluids and electrolytes or body temperature.

The physician also has to consider the patient's body temperature when consciousness was lost and whether there are drugs in the patient's system that could mimic brain death. In the event that brain death cannot be reliably confirmed clinically, usually due to injuries, it may be confirmed by the absence of cerebral perfusion as determined by cerebral angiography or radionuclide scintigraphy.

3. Brain Death in Neonates, Infants and Young Children

Diagnosis of brain death in neonates, infants and young children has been studied to establish whether the same criteria could be applied as are applied to adults. Recently the Canadian Neurocritical Care Group published practice guidelines for the diagnosis of brain death in the Canadian Journal of Neurological Sciences, which updated the criteria to include infants and children. These guidelines state that, in children older than two months post-term, the adult criteria for brain death diagnosis can be applied. Under this age the clinical criteria alone are not sufficient. For full-term newborns and young infants a radionuclide brain flow study should also be done. For infants two months to one year of age there should be two examinations and electroencephalograms separated by at least 24 hours, or a single EEG followed by a radionuclide brain flow study. For children over one year of age, an observation period of at least 12 hours is recommended. The diagnosis of brain death in pre-term infants is still uncertain.

4. Safeguards

There must be safeguards to ensure that brain death is never prematurely diagnosed. First, there must be a reason to suspect brain injury. The physician must be experienced in diagnosing it, and have no stake in the diagnosis; specifically it cannot be a transplant physician who makes the diagnosis. Also, the above criteria have to be established by two different physicians on separate occasions. The irreversibility of the state is established by allowing an interval of 2-24 hours between examinations. In cases where there is any doubt, another examination must be performed many hours later, possibly the next day. The diagnosis is never to be made hastily.

5. Arguments against Brain Death

The Committee heard from some witnesses that acceptance of the brain death concept is not universal. A few witnesses expressed the view that brain death is perhaps not synonymous with death of the individual but merely a state in which death is imminent and inevitable. Other testimony stated that doctors must be sensitive to the fact that there are groups and individuals that do not accept the concept of brain death.

Some testimony expressed doubts as to the infallibility of the diagnosis of brain death. This drew attention to the criteria followed for the diagnosis of brain death. A few witnesses feared that these criteria could be met while an individual was not actually brain dead. While the expert testimony on brain death did not dispute this, it was also pointed out that the diagnosis cannot be based solely on the satisfaction of the criteria. Attention to the safeguards eliminates the possibility of misdiagnosis. Several witnesses testified that recovery from brain death is impossible and that reports of recoveries from `the diagnosis of brain death' were seen as examples of misdiagnosis.

11. The Committee wants to ensure that the brain death criteria are applied consistently and recommends that the new national body, through its provincial and territorial members, encourage:

11.1 Hospitals where donation takes place to develop clear protocols for determination of brain death, ensure professional and institutional accountability for each instance of a diagnosis, and provide thorough and periodic training for all healthcare professionals on the concept of and criteria for brain death.