Basic idea of how to diagnose brain death and other medicolegal aspect of organ transplantation.

1. TOPIC :MEDICOLEGAL ASPECT OF
HUMAN ORGAN TRANSPLANTATION
PRESENTER : DR. SOREINGAM RAGUI
MODERATOR : PROF. TH. BIJOY SINGH

2. HISTORY
 Comos and Damian
 Allotransplantation
(16 th century).
 Deacon Justinian was
amputated to treat a
cancerous lesion.
 The leg of a recently
slain Ethiopian Moor
gladiator.

3. First successful Bone
Graft(1668)
 First successful bone graft
documented by Job Van
Meekeren.
 Job van Meekeren (1635)
 He wrote a book, which gives a
good representation of the state
of the art of surgery in the 17th
century in Amsterdam.

4. 09/07/1905
First successful cornea
transplant by Eduard Zirm
(18 March 1863 - 15 March 1944),
was born in Vienna, Austria.
That day Zirm first met man blinded in both
eyes called Glogar.
At the same time, a boy was brought to his
clinic after an accident that left metal pieces
in his eyes. The attempts to save boy's eyes
were unsuccessful. Zirm enucleated them and
saved the corneas for transplantation into
Glogar's eyes.
Although complications affected one eye, the
other remained clear allowing Glogar to
return to work.

5. December 1954
First Kidney transplantation
Dr. Harrison, Joseph E.
Murray, John P. Merrill
Achieved the first
successful kidney
transplant,
between identical
twins

6. First operations in the World made by Demichov
1937 - THE FIRST ARTIFICIAL
HEART
1946 - THE FIRST HETEROTOPIC
HEART
TRANSPLANTATION
1946 - THE FIRST TRANSFER
COMPLEX HEART-LUNG
1947 - The first isolated lung transplantation
1948 - The first liver transplantation
1951 - The world's first orthotopic heart transplant
without the use of cardiopulmonary bypass
1952 - The world's first mammarno-coronary
bypass surgery (1988 - State Prize)

7.  Christiaan Neethling Barnard
(8 November 1922 – 2 September
2001) South African cardiac
surgeon who performed the
world's first successful human-to-
human heart transplant.
 Following the first successful
kidney transplant in 1953, in the
United States,
 Barnard performed the first
kidney transplant in South Africa
in October 1967. Christian
Barnard all his life considered
Demikhov his teacher

8. 1979
First successful
live-donor partial
pancreas
transplant by
David E
Sutherland

9. 2005
First successful ovarian
transplant by Dr P N
Mhatre (wadia hospital
mumbai,India)

10. 2008
First successful transplantation
of near total area (80%) of face,
(including palate, nose, cheeks,
and eyelid by Maria Siemionow
(Cleveland, USA

11. Introduction
Organ transplantation is a condition when
the human organ from one individual is
transplanted into the other human for the
use by other such individual who himself is
having his own such organ failed and non
functional.
Organ: not related to human
reproduction(e.g ova, sperm, ovaries,
testicles or embryos)
It also does not deal with blood or its
constituents for transfusion purpose

12. Types(medico legally)
REGENERATIVE TISSUE: blood,
semen, bone marrow, skin.
NON REGENERATIVE TISSUE:
cornea, heart, lungs, liver, kidney
Regenerative tissue has less problem
compare to non regenerative tissue
which are usually donated after the
death of the person.

13. SOURCES OF ORGANS
 Homologous donation : organ are relocated to the same
body(no legal implication)
 Heterologous donation : includes blood or bone marrow.
live heterologous donation extend to paired organ like
kidney.
 Cadaveric donation: only means of obtaining unpaired
organ for donation. Here the accurate diagnosis and
management of brain stem death is very essential,
because organ taken from beating hearth donor have
more chance of success.
 1: Beating Heart donor.
 2: Non heart beating donor.

14. According to Gortmaker et al(1996)
 Most common cause of death
spontaneous/traumatic ICH as a result of RTA.
Out of this potential donor death was mostly due to
1. Head injury(49%)
2. Cerebrovascular Event(33%)
But due to advancement in safety measures from
newer gadgets and life saving machine these death has
fell to 30%.

15. Type of donor(THOA 1994)
 First, it permits a near relative, defined as a
patients,spouse, parents, siblings, and children, to
donate a organs to the patient.
 Secondly, live donors who are not near relatives but
are willing to donate organs to the due to attachment
or any other reasons are permitted to do so,
 provided that the transplantations have the approval
of the Authorization Committee, established under
the Act.

16. Legal aspect
THOA 1994(Transplantation of Human Organ Act)
June 1994 - Indian Parliament
July 8,1994- president of India gave his assent
Feb 4,1995- Came in force by a gazette notification
Regulates the removal of organ from living as well as the death.
The principal matters covered are:
 Authority for the removal of human organ
 Regulation of hospitals
 Registration of hospitals
 Offences and penalties

17. 1.Aims at putting a stop to live
unrelated transplant.
2.In case of live transplant-
 The donor and recipient
(genetically related)
Or be approved by the Authorizing
committee(application made jointly
by (Recepient+Donor)

18. 3.It accepts the brain stem death criterion
“Brain-Stem death" Means the stage at which all
functions of the brain-stem have permanently and
irreversibly ceased and is so certified under sub-section (6)
of section 3
Brain death needs to be certified by a board of
doctors consisting of :
1. Registered Medical Practitioner (RMP) in charge of
hospital where brain death has occurred
2. An independent RMP – a specialist
3. A Neurologist / Neurosurgeon nominated by panel
4. RMP treating the patient
The patient must be examined by team of doctors at least
twice with a reasonable gap of time in between (at least 6
hours)

19. Causes: Brain Death
Normal Cerebral Hemorrhage

20. Normal
Cerebral
Anoxia

21. Normal Cerebral Trauma

22. DIAGNOSIS
(1) Clinical Evaluation (Prerequisites)
 Establish Known Irreversible Cause of Coma
 Exclusion of Potentially Reversible Conditions

23. (2) Clinical Evaluation (Neuro assessment)
 Establish Coma
 Establish Absence of Brain Stem Reflexes
 Establish Apnoea
 Absence of Respiration drive
(3) Ancillary Tests
(4) Documentation
 Time of death is the time the arterial PaCO2 reached
the target value OR
 When ancillary test officially interpreted

24. Brain Death
Neurologic Examination
Absent Brain Stem Reflexes
 Pupillary Reflex (absent)
 Eye Movements
Occulo-Cephalic ( Dolls Eye Movements)
Occulo-Vestibular (Cold Caloric test)
 Facial Sensation and Motor Response
 Pharyngeal (Gag) Reflex absent
Tracheal (Cough) Reflex Absent

25. Pupils dilated with no constriction to
bright light(2A,3E)

26. Occulo-Cephalic Response(A8,E3,5)
(No Dolls Eye Movements)

27. Occulo-Vestibular Response(A8,E3,5)
“Cold Caloric Testing”
Normal Response in Coma No Response in Brain Stem Death

28. Facial Sensations & Motor Response(A5,E7)
 Absent Corneal Reflex
 Absent Jaw reflex
 No response to
Supraorbital Or
Temporo-Mandibular
Pressure

29. Brain Death : Apnoea Test
 Pre-requisites
 Body Temperature > 36° C
 Systolic Blood Pressure ≥ 100 mm Hg
 Normal Electrolytes profile
 Normal PaCO2 (35-45 mm Hg)
 Pre-Oxygenation
 100% Oxygen via Tracheal Cannula for 10 min
 Achieve PaO2 = 200 mm Hg
 Monitor PaO2 with pulse oximetry

30.  Reduce Ventilation frequency to 10/min
 Reduce PEEP to 5 Cm H2O
 Take 1st Blood sample for Blood Gas analysis
 Disconnect Ventilator
 Deliver 100% O2 by catheter through ET tube
 @ 6 L/min
 Observe for Respiratory Movement
 Atleast for 8 – 10 min

31. Discontinue Testing
 If BP drops to < 90 mm Hg
 PaO2 drops to 85% by pulse Oxymetry for 30 Sec
If no respiratory drive observed after 08 min
 Take next Blood sample for Blood gas studies
 If respiratory movements are absent & arterial
PaCO2 is 60 mm Hg OR
20 mm Hg increase over a baseline normal PaCO2
The Apnea test result is POSITIVE
 Supports the clinical diagnosis of brain death

32. Brain Death
Ancillary Confirmatory Testing
Recommended when
 Proximate cause of coma is not known or
 When confounding clinical conditions limit clinical
examination
1. EEG
2. Cerebral Angiography
3. PET : Glucose Metabolic Studies
4. Dynamic Nuclear Scan
5. Somato-Sensory Evoked Potential

33. Brain Death
Confirmatory Testing
Normal
Electro-Cerebral Silence

34. Cerebral Angiography
Normal No Intra- Cranial Flow

35. PET
Glucose Metabolism Studies
Normal
“Hollow-skull sign”
of brain death
Cerebral metabolism
globally reduced ~50%

36. 5. In cases of unclaimed body( Hospitals,
prisons) organ claimed after 48 hrs.
6. Organ preserved according to current
scientific method.
7. Organ to be removed and used for
therapeutic purpose.
8.The act impose for compulsory
registration of hospital( Removal,
storage, transplantation)

37. 9.Central and state Govt empowered to appionting of
appropriate authority(AA)
The Appropriate Authority constituted by the State governments, is vested
with the following power:
• Inspect and Grant registration to the hospitals for transplant surgery.
• Enforce the required standards for hospitals.
• Conduct regular inspection of the hospitals to examine the quality of
transplantation and follow-up medical care of donors and recipients.
• Suspend or cancel the registrations or erring hospitals.
• Conduct investigation into complaints for breach of any provisions of
the Act.
• Hence the removal, storage and transplantation of human organs can
only be undertaken at hospitals licensed by the Appropriate Authority.
However, the removal of eyes from the dead body of a donor can be made
at other places.
AA can issue a license to a hospital only for a period of 5 years at a time.
It can renew the license once every five years.

38.  10. Govt also empowered to appoint Authoristion
Committee or committees.
• The ACs are of the respective States or Union
Territories is constituted to “approve” or "reject”
transplants between the recipient and unrelated
donors.
• The primary duty of the AC is to be able to establish
that the unrelated donors are not under any coercion
or undue influence by monetary consideration to
donate their organs
11. Act also provide provision for appeal
12. Punishments
RMP 1st offence: removal of name(2 yrs)
subsequent : permanently

39.  Any other person
Imprisonment -(2-5 years) and 3- 10 year
Fine : Rs 10,000 and 20 lakhs
Commercial dealing
Imprisonment 2 -7 yrs (5-10 yrs)and fine Rs. 10,000
to Rs. 20,000 (1 crore)
13. In case of MLC,or possible PME no organ should be
taken without the permission from the IO.

40. The Transplantation of Human Organs Act
(THOA) 2011 Amendments
i. Tissues have been included under the definition of organ
transplant
ii. SWAP organ transplant has been included
iii. Mandatory requirement of transplant coordinator in the
centre
iv. Mandatory information to a dead in ICU telling about
options for organ donation
v. Penalty has been increased to 20 lakhs.
vi. Diagnosis of Brain death made easy by including
anesthetist and intensivist in the category of neurologist.
vii. No organ donation from mentally challenged person
viii. Minors cannot donate
ix. Indian cannot donate to foreigners unless near relatives.
x. Eye enucleation can be done by trained technicians

41. Issue related to donor
 Voluntary refusal of life prolonging treatment by a competent adult
must be respected
 In untested body organ transplantation doctor must take every
precaution to ensure to rule out the risk of acquiring disease
 Doing/taking organ without the consent(>18 yrs) and that of
relative-Unethical
 For the benefit of guardian if consent is given-unethical
 Unethical to go ahead with organ transplant-if the donor is mentally
unsound
 Monster, anencephaly-unethical
 Marriage done for organs (kidney Marriage)-unethical
 Mutilating the foetus for benefit of others -unethical

42. Issue related to doctor
 Doctor should ensure that the organ removed should
be the one for which consent has been given
 Doctor should not be involved in any money
transaction.
 The doctor should not do the transplant if the donor
is related to him.
 Concerned specialist should not encourage organ
transplant for want of money.
 Failure to screen disease may lead to negligent act.

43. Issue related to recipient
Xenotransplant
Potential recipient and their
relative can be tempted or
pressured.
Blackmail or bribe of living
donor to donate

44.  Unethical to go ahead with the transplantation when
the deceased had not consented but after death the
relatives does.
 Surrogate mother: A possibility of that the fertilized
egg is reared as a foetus and infant for the purpose of
organ transplantation.
CAUSES OF SHORTAGE OF ORGAN
 Lack of awareness and will among most practicing
physician has result in high inadequate cadaver
donation.
 Failure to convert potential donors into actual donor
 Evolvement of better trauma management facilities
 consent: valuable lost of time

45. Issue related to organ procurement
Commercial trading of organ is an
offence
-kidney buyers
-kidney marriage
-human organ shop
-surrogate mother

46. Means to correct organ shortage
 More awareness for both the Govt and
health sector,doctors and NGO.
 General public should be told about organ
transplantation and should be given right to
choose before hand.
 Presumed consent should be followed in
every
country(egSpain,Australia,Belgium,Denmar
k,Finland)

47. THANK U