1. LEGAL ISSUES ORGAN
TRANSPLANT
BRAIN STEM DEATH
IDENTIFICATION, SCREENING
AND CERTIFICATION
Sandipan Dhar

2. THE TRANSPLANTATION OF HUMAN
ORGANS ACT, 1994
Regulates removal,storage and transplantation for
therapy
Prevention of commercial human organ dealing

3. THOA 1994
(Transplantation of Human Organ Act)
 1994 - Indian Parliament
 1995 - Maharashtra Government
1. Brain Stem death was legally recognized
2. Commercialization of transplant
punishable crime.

4. THOA 1994
Defined:
 Brain death
 Donor
 Human organ
 Near relatives
 Hospital
 Payment etc.

5. To implement THOA the Government had to
 Regulate living kidney donation
programme.
 Promote cadaver transplant programme.

6. THOA
 Authority for removal of human organs
before and after death
 Preservation of organs.
 Regulations of Hospital
 Registration of Hospitals
 Offences and penalties

7. Authorization sec.9
 State Appropriate Authority
 Authorization Committee

8. As per the Act Govt. of Maharashtra
appointed
 State Appropriate Authority – DHS dealing
with Cadaver Transplant Programme
 State Authorisation Committee consisting of
 DMER
 Dean J. J. Hospital
 Representative from DHS
Dealing with living donation

9. State Appropriate Authority
(SAA)
 Grants registration
 Renews ,suspends,cancels registration
 Enforces standards in hospitals
 Recognizes brain death committee of each
hospital.
 Investigates complaints
 Periodic inspection of hospitals

10. OFFENCES AND PENALTIES
 Removal without authority
Imprisonment upto 5 yrs and fine upto Rs.
10,000,information to Medical Council
 Commercial dealing
Imprisonment 2 -7 yrs and fine Rs. 10,000
to Rs. 20,000

11. BRAIN STEM DEATH
 Single largest source of transplantable organs.
 Physiological core of brain death.
 Diagnosis by clinical bedside means.
 No sophisticated investigations.
 3 Steps – UK code.
preconditions
exclude reversible causes
apnoea

12. PRECONDITIONS
 Deeply comatose.
 On a ventilator in ICU.
 Known cause of coma.
 All remedial measures taken.

15. EXCLUSIONS
 All reversible causes.
 Primary hypothermia < 35 degrees C.
 Drugs – intoxication , sedation , poisoning.
 Neuro muscular blocking agents – muscle
relaxants.
 Severe metabolic and endocrine disturbance
– hepatic , uraemic , diabetic coma.

16. WHEN ARE THE TESTS DONE?
 Preconditions and exclusion criteria
satisfied.
 Failed attempts at reversal.
 At least 12 hours of vigorous management
after admission.

17. WHAT ARE THE
CONFIRMATORY TESTS?
 Absent brain stem reflexes.
 Apnoea test.

18. RETESTING
 Test twice with 6 hours gap.
 Ensure persistance of non-functioning brain stem.
 Time gap utilised for counselling.
 Cardiac death usually within 72 hours of brain stem death.
 After second apnoea test inform relatives about death and
use of ventilator for organ perfusion only.
 Time of death is time of second apnoea test.
 Until family accepts reality of death do not approach for
organ donation.

19. IDENTIFICATION OF BSD
 Location :- patient in ICU on ventilator.
 Who identifies first ?

20. SCREENING POTENTIAL
DONORS
 All BSD not eligible for organ donation.
 Donor criteria :-
1. Age 3 – 65 years.
2. No long standing HT , DM , IV drug abuse , malignancy.
3. No primary organ disease or trauma.
4. Avoid occult sepsis – drowning , burns , more than 7 days
indwelling catheter.
5. Negative viral markers.
6. For kidneys – no acute / chronic renal failure, urinary tract infection.

21. CONTINUED
8. Normal LFT - liver.
9. Pancreas – no evidence of DM or abnormal
pancreatic function.
10. Lungs and heart – no visible infiltrate /
trauma to chest , normal ECG and cardiac
function , sputum negative gram stain ,
dopamine less than 10 mcg/kg/min.

22. UNACCEPTABLE ORGAN
DONOR
 History of trauma or diseased organs.
 Long standing DM , HT , CV.
 Malignancy.
 Untreated systemic bacterial , viral , fungal
infection.
 Prolonged hypotension , asystole.

23. MANAGEMENT OF
CADAVER DONOR
 Complicated challenge.
 Maintain SBP > 90 mm of Hg.
 CVP 8 – 12 cm of H2O.
 UO 40 – 80 ml/hr.
 Body temp. > 35 degree C.
 PaO2 > 100, pCO2 = 35 mm, pH > 7.2
 Correct hypotension with IV fluids,
dopamine/dobutamine/adrenaline.
 Keep electrolyte balance.

24. WHO TESTS AND CERTIFIES?
 BSD declaration by an authorised team –
independent of transplant team.
 Authorised team :-
1. Treating doctor.
2. Authorised specialist.
3. Neurosurgeon/neurophysician.
4. Medical administrator.
 Independent testing by all members twice.

25. ORGAN DONATION
 Kidneys.
 Liver.
 Pancreas.
 Intestine.
 Lungs.
 Heart.
 Limbs.
 Eyes and skin ( tissue ).

28. CONCLUSION
Potential organ donors should be :-
1. BSD certified.
2. Eligible.
3. In ICU.
4. Well maintained on ventilator.

33. Heart valves
Dura mater
Blood vessels Skin
Bone, ligaments,
tendons,
fascia lata,
cartilage