Kerala shows way with SOPs for brain death certification

Under the existing laws relating to transplant and organ donation, ‘brain stem death means the stage at which all functions of the brain stem have permanently and irreversibly ceased’.

There has always been a debate on ethical and moral grounds about seeking organ donation following brain death.

With well-defined clinical protocols regarding the brain-death certification of patients and organ donation, Kerala has set standards for other states to follow.

According to a January 19 government order, doctors get the right to decide whether a patient certified as brain dead needs to be taken off life support for which the family’s consent won’t be required.

Along with alleviating the fear of litigation among clinicians, the order also ensures timely availability of organs for transplants.

Under the existing laws related to transplant and organ donation, ‘brain stem death means the stage at which all functions of the brain stem have permanently and irreversibly ceased’.

The rule was passed through a government order prescribes tests and procedures supervised by a panel of medical experts before declaring a person brain dead.

Dr Sunil Shroff, president-elect, the Indian Society of Organ Transplantation and managing trustee of MOHAN Foundation, says that at the moment, brain death is mentioned only in the context of organ transplants and donations under the Transplant of Human Organs Act (THOA) in 1994.

The Government Order passed on January 19, 2020 states
  • Clinical evidence of an acute central nervous system catastrophe… compatible with a clinical diagnosis of brain death should be established before subjecting a person to further tests for evaluating brain stem death.
  • Medical practitioners should speak to the relatives and caregivers about the medical status and prognosis of the patient on whom the brain-stem death test is to be conducted.
  • Assessment of brain-stem reflexes should be done using a series of tests… which are to be repeated after an interval of six hours by a panel of four doctors.
  • The apnoea test (meant to “show the lack of function of the respiratory centres of the brain stem when physiological stimulus takes place”) is the last brain-stem reflex test to be performed, “and that too, only if all other tests confirm the absence of brain-stem reflexes”
  • All prescribed tests to be conducted twice by the panel of doctors “to ensure there has been no observer error”.
  • A neurophysiological or imaging study to prove the absence of electrical activity or blood flow should be carried out if doctors who are certifying are in doubt about the diagnosis of brain stem death.
  • If the criteria for brain death are met after the required tests are completed, the patient must be declared “brain dead”, and the date and time recorded.
  • Time of death is the time when the arterial PCO2 (pressure of carbon dioxide) has reached its target value in the second apnoea test.
  • Family member of the patient should be provided with the brain stem death confirmation report signed by all four panel doctors.
  • All treatment including cardio-respiratory support must be discontinued once brain stem death is pronounced.

“When a person is brain dead, clinicians in the Intensive Care Units (ICU) usually ask counsellors to talk to the family members on organ donation.  If they say no, then the person continues to be on the ventilator. In a private or a government facility, in such cases, somebody dead on a ventilator, escalates the costs. These guidelines, therefore, bring about the clarity,” he adds.

Should be emulated across states

Adding that the same set of guidelines should be adopted by states across the country, Dr Shroff says that brain stem death should be delinked from organ donation.

“What is required is to ‘define death’ in the same standard terminology in both the Registration of Births and Deaths Act and the THOA. Therefore, the Registration of Births and Deaths Act should define death as death of an individual who has sustained either ‘irreversible cessation of circulatory and respiratory functions or irreversible cessation of all functions of the brain stem. Also as the first step towards delinking, it is recommended that the clause in the brain stem death certificate that states ‘has the patient or next of kin agreed to any donation of organ and or tissue’ (Form 10 of Rules 2014) be removed,” he said.

Dr HV Easwer, professor, neurosurgery, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, points out that the guidelines have put an end to the allegations regarding unethical maintenance on ventilators.

“Many times, in government hospitals, people refuse to accept their beloved is no more when they are brain dead and the patient is continued to be on ventilator. These are limited resources in government hospitals, as for every patient on a ventilator, three of them are waiting outside,” he added.

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A fillip for organ donation systems across the country

Earlier this week, a 54-year old man, Udhaya Kumar, a small-town entrepreneur from Devikuppam, Tiruvannamalai in Tamil Nadu, who met with an accident, was declared brain dead, at the Fortis Malar Hospital in Chennai.  After the family’s consent, a team of doctors harvested four of his organs—kidneys, liver, and corneas. His family wasn’t aware of the concept of brain death and its connection with organ donation. However, upon counselling, they were willing to donate, as it was line with his dedication to social service.

However, there has always been a debate on ethical and moral grounds regarding organ donation following brain death. Dr Easwer points out that many a time, it is seen in a shadow of doubt due to the money involved. “In recent times, due to films like Joseph, a medical thriller, it has met with criticism.”

While in states like Tamil Nadu, Kerala, Maharashtra, organ donation systems and networking are robust, experts agree that there is a lot more to achieve.

Dr Ananth Mohan Pai, medical director, Fortis Malar Hospital, says, “Thanks to the efforts made by central and state governments several NGOs and several hospitals and individuals, organ donation have resulted in a lot of awareness, but we still have a long way to go. There are a number of challenges on this front. The first is that people understand cardiac death better than brain death. The second roadblock is some religious beliefs and an overall poor understanding of organ donation. The understanding of organ donation comes from sources. It is often looked at as an underhand dealing and we very commonly come across people calling it unethical.”

Dr Shroff says that organ donation is the only positive outcome in a tragedy. “And the family should be given a chance to decide whether they should donate or not,” he said.

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