Legal issues organ transplant, brain stem death identification, screening and certification
LEGAL ISSUES ORGAN TRANSPLANT BRAIN STEM DEATHIDENTIFICATION, SCREENING AND CERTIFICATION Sandipan Dhar
THE TRANSPLANTATION OF HUMAN ORGANS ACT, 1994Regulates removal,storage and transplantation for therapyPrevention of commercial human organ dealing
THOA 1994 (Transplantation of Human Organ Act) 1994 - Indian Parliament 1995 - Maharashtra Government1. Brain Stem death was legally recognized2. Commercialization of transplant punishable crime.
THOA 1994Defined: 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.
THOA 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 DHSDealing 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.
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.
CONTINUED8. 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 ).
CONCLUSIONPotential organ donors should be :-1. BSD certified.2. Eligible.3. In ICU.4. Well maintained on ventilator.