The Government Orders (GOs) issued by the Kerala and Gujarat governments in January and February 2020 respectively provide clarity on discontinuation of cardiorespiratory support in a brain death situation. This could be a gamechanger for the deceased donation programme in the country. For the first time they address the dilemma of intensive care doctors when the relatives say no to organ donation in a brain death situation. In such cases very often the ventilation and support continue and this creates an ethically challenging situation.  Majority of the intensive care doctors in India have never been comfortable in such situations. On the other hand, it has been said that brain stem death is defined as death in the context of organ donation as it is mentioned only in the Transplantation of Human Organs Act (THOA), 1994. The Registration of Births and Deaths Act (RBDA), 1969 does not mention brain stem death in its definition of death and hence for many years it has been felt that the RBDA required an amendment to include this. While the Government of India may take time to amend the law, other state governments may consider passing similar GOs to help clinicians overcome their dilemmas and fears.

Salient features of the Kerala GO on Guidelines for Brain Death Certification

• Brain stem death considered death under Registration of Births and Deaths Act (RBDA), 1969

It is clear from the scheme of the RBDA that the main purpose of the Act is to maintain and collect information about births and deaths, rather than prescribing how death should be determined. The Rules framed under the Act specify the format for the medical certificate of the cause of death (Form No. 4 under the Kerala Registration of Births and Deaths Rules, 1999). The form requires information about the immediate cause of death as well as other significant conditions of death. It is then clarified that: "This does not mean the mode of dying, e.g., heart failure, respiratory failure etc." The use of the term "etc" in this context is of significance. It suggests that there may be other modes of dying apart from heart failure or respiratory failure. One of these modes is brain stem death and therefore, brain stem death is also considered death under the RBDA, 1969.

• Role of panel of doctors

One doctor in the panel has to perform the test and it is mandatory that other panel members have to witness and interpret these tests. All the prescribed tests are required to be performed twice with the minimum interval of 6 hours between the tests "to ensure that there has been no observer error" and persistence of the clinical state can be documented with absolute degree of certainty. It is to be noted that the diagnosis is based only on the clinical examination.

• Role of ancillary testing

A neurophysiological or imaging study to prove the absence of electrical activity or blood flow should be carried out if the treating team or panel of doctors who are certifying are in doubt in the diagnosis of brain stem death. 

• Time of death

The time of death is the time the arterial pCO₂ reached the target value in the second apnoea test.

• Discontinuation of cardiorespiratory support

The family member/caregiver should be provided with brain stem death confirmation report signed by all the four members of the brain stem death certifying team. All treatment including cardiorespiratory support must be discontinued once brain stem death is pronounced.

Salient features of the Gujarat GO on Brain-Stem Death Declaration Guidelines

It is based primarily on the Kerala GO on Brain Death Certification. The significant differences are that the Gujarat GO does not comment on the RBDA, 1969, and while the Kerala GO makes no mention of organ donation in its algorithm, the Gujarat guidelines incorporate consent/no consent for organ donation. The guidelines state, ‘After grief time, the near relatives of the deceased person may ask for organ donation of brain stem dead person. If family agrees for organ donation and signs Form 8 (www.notto.gov.in), the cardiopulmonary support and end of life care must continue till the organ procurement procedure takes place. If family does not agree, all treatment including cardiorespiratory support must be discontinued once brain stem death is pronounced.’

Both GOs caution that rather than ordering ancillary tests, physicians may decide not to proceed with the declaration of brain stem death if clinical findings are unreliable.

The Kerala GO in its entirety is available at www.knos.org.in