LEGAL ISSUES ORGAN

TRANSPLANT

BRAIN STEM DEATH

IDENTIFICATION, SCREENING

AND CERTIFICATION

Sandipan Dhar

THE TRANSPLANTATION OF HUMAN

ORGANS ACT, 1994

Regulates removal,storage and transplantation for

therapy

Prevention of commercial human organ dealing

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.

THOA 1994

Defined:

Brain death

Donor

Human organ

Near relatives

Hospital

Payment etc.

To implement THOA the Government had to

Regulate living kidney donation

programme.

Promote cadaver transplant programme.

T H O A

Authority for removal of human organs

before and after death

Preservation of organs.

Regulations of Hospital

Registration of Hospitals

Offences and penalties

Authorization sec.9

State Appropriate Authority

Authorization Committee

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

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

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

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

PRECONDITIONS

Deeply comatose.

On a ventilator in ICU.

Known cause of coma.

All remedial measures taken.

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.

WHEN ARE THE TESTS DONE?

Preconditions and exclusion criteria

satisfied.

Failed attempts at reversal.

At least 12 hours of vigorous management

after admission.

WHAT ARE THE

CONFIRMATORY TESTS?

Absent brain stem reflexes.

Apnoea test.

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.

IDENTIFICATION OF BSD

Location :- patient in ICU on ventilator.

Who identifies first ?

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.

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.

UNACCEPTABLE ORGAN

DONOR

History of trauma or diseased organs.

Long standing DM , HT , CV.

Malignancy.

Untreated systemic bacterial , viral , fungal

infection.

Prolonged hypotension , asystole.

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.

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.

ORGAN DONATION

Kidneys.

Liver.

Pancreas.

Intestine.

Lungs.

Heart.

Limbs.

Eyes and skin ( tissue ).

CONCLUSION

Potential organ donors should be :-

1. BSD certified.

2. Eligible.

3. In ICU.

4. Well maintained on ventilator.

Skin

Heart valvesDura mater

Blood vessels

Bone, ligaments,

tendons,

fascia lata,

cartilage