Dr. Rahul Panwar MD Resident AIIMS Jodhpur

1. Brainstem death and its medico-
legal perspectives
BRAINSTEM DEATH AND ITS MEDICO-LEGAL
PERSPECTIVES
Dr. Rahul Panwar
MD Resident AIIMS jodhpur

2. INTRODUCTION
 BRAIN DEATH – Brain death is irreversible loss of cerebral and
cardiorespiratory function.
 There are three types of brain death:
 1.CORTICAL OR CEREBRAL DEATH
 2.BRAIN STEM DEATH
 3.WHOLE BRAIN DEATH

3. BRAINSTEM DEATH
 Cerebrum may be intact, though cut off functionally by stem lesion.
 Loss of vital centers that control respiration and the ascending reticular
activating system (RAS) that sustains consciousness.
 Patient irreversibly comatose and incapable of spontaneous breathing.

4. ANATOMICALAND PHYSIOLOGICAL BASIS OF
BRAINSTEM DEATH
 The brainstem – midbrain, pons and medulla.
 Contains the nuclei of last ten cranial nerves and ascending and
descending tracts.
 The RAS, provides the anatomical and physiological basis for wakeful
consciousness.

5.  The medullary RF – Heartbeat, breathing and circulation.
 The pontine RF – Coordination of acoustic, vestibular, respiratory and
cardiovascular processes.
 The midbrain – Visuospatial orientation and eating behavior.

6. Various Criteria for Determining Brain Death
 HARVARD CRITERIA (1968)
 PHILADELPHIA PROTOCOL (1969)
 MINNESOTA CRITERIA (1971)

9. HARVARD CRITERIA
1. Unreceptivity and unresponsivity
2. No movements
3. Apnoea
4. Absence of elicitable reflexes
5. Isoelectric EEG

10. 1.Unreceptivity and unresponsivity
 Total unawareness to external stimuli and inner need.
 Complete unresponsiveness to even most intense painful stimuli.

11. 2.No movements
 No spontaneous muscular movements in response to stimuli such as.
- Pain
- Touch
- Sound
- Light
 For at least 1 hour.

12. 3.Apnoea
 Absence of spontaneous breathing for at least one hour.
 PCO2 Rise above threshold (>60 mmHg)
 If patient on ventilator, total absence of spontaneous breathing is
established by turning off the respirator for 3 minutes and observing
whether there is any effort from the subject to breath spontaneously.

13. 4.Absence of elicitable reflexes
 Pupils should be fixed and dilated, does not respond to light
 Ocular, Vestibular movement and blinking absent (eg: Doll’s eye movement & Caloric test)
 No evidence of postural activity
 Corneal and pharyngeal reflexes absent
 Spinal reflexes are also absent

14. 5.Isoelectric EEG
 Confirmatory test

15.  All the test should be repeated after 24 hours
with no change in results.

16. DIAGNOSIS OF BRAINSTEM DEATH
 EXCLUSIONS
1.Patient may be under effect of drugs, eg:- therapeutic overdoses
2.Core temperature of body is below 35 degree C, hypothermia.
3.Severe metabolic or endocrine disturbances that may lead to severe
irreversible coma, eg:- diabetes.

17. PRECONDITIONS OF DIAGNOSIS
 Patient must be deeply comatose
 Patient must be maintained on a ventilator
 Cause of the coma must be known

18. PERSONNEL WHO SHOULD PERFORM THE
TESTS
 Must be performed by 2 medical practitioners
 Doctor involved should be experts
 Transplant surgeons under no circumstances can perform the test
 At least one of the doctor should be of consultant status, junior doctors are
not allowed
 Each doctor should perform the test twice

19. Team of four medical experts including
 Medical Administrator In charge of the hospital.
 Authorized Specialist.
 Authorized Neurologist/NeuroSurgeon.
 Medical Officer treating the patient.
PERSONNEL WHO SHOULD PERFORM THE
TESTS (INDIA) as per section 3(6) of THOTA

20. • Amendments in the THO Act (2011) -a surgeon/physician and an
anesthetist/intensivist, when approved neurosurgeon/ neurologist are
not available.
• None of the doctor's who participate in diagnosis of brain death should
have any interest in transplantation or organ removal from cadaver.

21. INDIAN CONTEXT AND MEDICO-LEGAL
ASPECTS
 Awareness about braindeath is extremely low in India.
 Various aspects of braindeath, its importance for organ donation and its
legality needs to be elaborated.
 India follows the UK concept of brainstem death.
[Wig N, Gupta P, Kailash S. Awareness of brain death and organ transplantation among select Indian population. J
Assoc Physicians India. 200351.455-8. [PubMed: 12974425]

22.  Transplantation of Human Organs Act (THOA) was passed by Indian
parliament in 1994 which legalized the Brainstem death.
 IN 1995, THO rules were laid down which describe brainstem death
certification procedure.
[Government of India. Ministry of Law, Justice and CompanyAffairs (Legislative Department) New Delhi. The Transplantation of Human Organs Act, 1994* Central Act 42 of
1994/2011
Transplantation of Human Organs Act

23. Highlights of this Act are:
1.Statutary sanction to the brain death concept.
2.Regulation of removal, storage and transplantation of human organs for
therapeutic purposes.
3.Commercial dealings in human organs prevented.

24.  The Act was initiated at the request of Maharashtra, Himachal
Pradesh and Goa (who therefore adopted it by default) and was
subsequently adopted by all states except Andhra Pradesh and Jammu
&Kashmir.
 The state of Maharashtra has passed a resolution making it
mandatory to declare and certify "braindeath”
Lows of Organ Donations in India !Laws Made Easy /www.organindia.org
Government of Maharashtra, Public Health Department,Government Resolution No.MAP2012/CR.289/AROGYA6. Mumbai: Mantralaya; 2012. Sep 13

25.  The Government Resolution underlines the responsibilities of
hospitals registered under THO Act 1994 & NTORCs.
 It is mandatory now for these hospitals to certify and notify the
brainstem death cases to Zonal Transplantation Coordination
committee.

26. Current Status of Organ Donation Act
 It is proposed to amend the THO Act by changing its name from
'Transplantation of Human Organs Act' to 'Transplantation of Human
Organs & Tissues Act’
 Law will broaden the definition of 'near relative' to include grandparents,
grandchildren, uncles and aunts.
 Also, not-so-close relatives who have stayed with the patient can donate
organs provided there is no commercial dealing.
'Transplantation of Human Organs & Tissues Act’ Directorate General of Health Services,DGHS.Org.in.Updated in 16-7-2020

27.  National human Organ and Tissues Removal and Storage Network and
National Registry for Transplant are to be established.
 Provision of Mandatory ‘Transplant Coordinator’ in all hospitals
registered under the act.
 Provision of Swap Donation included.
 'Transplantation of Human Organs & Tissues Act’ Directorate General of Health Services,DGHS.Org.in.Updated in 16-7-2020

28. National Organ Transplant Programme
 Government of India is implementing National Organ Transplant
Programme for carrying out the activities as per amendment Act.
 Hon'ble Prime Minister has highlighted the importance of organ donation
in the ‘Mann Ki Baat’ Programme broadcast in October and November
2015.
'Transplantation of Human Organs & Tissues Act’ Directorate General of Health Services,DGHS.Org.in.Updated in 16-7-2020

29.  Dedicated Institutional Mechanisms Under NOTP
1.SOTTO is an institutional mechanism to support States.
2.ROTTO are identified institutions which are champions field in to take care
of a group of states.
3.NOTTO at apex level.
'Transplantation of Human Organs & Tissues Act’ Directorate General of Health Services,DGHS.Org.in.Updated in 16-7-2020

30. 1.National Organ & Tissue Transplant Organization (NOTTO)
 An apex level organization, having components of National networking,
National Registry, National level Biomaterial centre.
 Facility of cadaver organ and tissue retrieval Operation theatre has been
established in the Safdarjung 'Hospital Campus, New Delhi under
Directorate General of Health Services.

31. 2.Regional Organ & Tissue Transplant Organization (ROTTO)
• Networking including allocation, where SOTTOs not functional

32. 3.State Organ & Tissue Transplant Organization (SOTTO)
• It is imagined to establish one SOTTO each state. So far following 12
SOTTOs have been sanctioned.

34. Organ Donation
 In case the family wishes to donate the organs/ tissue, medications are
usually continued until the time the patient is declared brain dead.
 These medications help to keep the blood pressure and heart rate under
control and some reduces swelling in brain.
 Legality of brainstem death in India needs to be highlighted.

36. Consent
 Almost everywhere organ donation is voluntary, Two voluntary systems
include
1.Opt In - Where the donor gives consent.
2.Opt Out - Where anyone who has not refused is considered as a donor.
» In India we have the Opt in system, while many western countries practice
the opt out system.

37.  Hospital Organ Donation Registry (HODR) coordinates the process of
cadaver organ donation.
 During lifetime, a person can pledge for organ donation by filling up a
donor form in the presence of two witnesses, one of who shall be a near
relative and send the same to HODR.
 The organ donor form could be obtained from HODR either personally or
through mail.
Organ Donation Algorithm

41.  The Procedure for Documentation of Drainstem Death is
as Follows:
1.To ensure that all data are entered in Form 10 of the Rules, 2014.
2. Ensure that all four doctors are signed and dated the Form 10.
3.Time of brainstem death is documented in the medical records .
4.After the completion of second apnea test the patient is declared
brainstem dead.
5.Informed the next kin of the results.
Certification of Brain Stem Death in India: Medico-Legal Perspectives Noble Gracious, Veena Roshan Jose1 Government Medical College, Thiruvananthapuram, Kerala, 1 Department of Law,
Dharmashastra National Law University, Jabalpur, Madhya Pradesh, India http://www.ajmonline.org.in .

42. Source of Organ for Transplant
1.Living Doner Transplant
 Near Relative donor (mother; father, son, daughter, brother, sister, spouse)
 Other than near relative donor: Such a donor can donate only for the reasons of affection
and attachment with the approval of the authorization committee.
2. Deceased donor Transplant
 Donor after Brain stem death: Organ Donation is practically possible in the
situation of Brain stem death e.g. a victim of road traffic accident etc.
 Donor after cardiac death(DCD): Practically in Indian scenario only tissues are
donated after cardiac death. But few center's like PGI Chandigarh has started DCD.

44.  There is a line of demarcation when the artificial aids should be
stopped so that the doctor may not get involved in the offence of
culpable homicide and negligence.
 Thus he should first consult with other doctors.
 Clinician should make it clear to the relatives that ventilation is not
being withdrawn to let the patient die but because continued ventilation
is immaterial for a patient who is already dead except in case of organ
transplant.
Removal of Life Supporting System

45. Punishment for Removal of Human Organ without
Authority.
 Punishable with imprisonment for a term which may extend to ten years and with fine
which may extend to twenty lakh rupees.
 Where any person convicted under sub-section (1) is a registered medical practitioner, his
name shall be reported to the respective State Medical Council for taking necessary action
including the removal of his name from the register of the Council for a period of two years
for the first offence and permanently for the subsequent offence.
 Punishment for commercial dealings in human organs.—imprisonment for a term
which shall not be less than five years but which may extend to ten years and shall be liable
to fine which shall not be less than twenty lakh rupees but may extend to one crore rupees.

46. »Heart: 4-6 hours
» Lungs: 4-6 hours
» Liver: 12 hours
» Pancreas: 12-18 hours
» Kidneys: 72 hours
» Small Intestines: 4-6 hours
Organ Preservation Time

47. Unwillingness to accept brain death
» Lack of understanding the concept.
» Special emotional attachment to the dead person.
» Loss of confidence in medical practice.
» Ethical questions related to earlier organ transplant procedure.
» Perceived insufficient participation of government and medical associations.

48. 22/02/2021

49. CONCLUSION
 Attention must be given to understanding the public and professional
perceptions of brain death and to educate both groups.
 Proper laws should be framed perhaps to assure legal and ethical
exemption for those who by reason of conscience cannot accept the
concept of brain death.

52. Thank you