brain death status 2013
DESCRIPTION
Status of Brain death in 2013 in IndiaTRANSCRIPT
Brain death Brain death certification and certification and cadaveric organ cadaveric organ
transplant : current transplant : current status in India status in India Dr. P alepu B Gopal, Dr. P alepu B Gopal, MD, FRCA, MD, FRCA,
CCST, FICCMCCST, FICCM
Consultant Consultant Critical Care MedicineCritical Care Medicine
Axon Anaesthesia Associates &Axon Anaesthesia Associates &Apollo Health City Apollo Health City
Hyderabad Hyderabad
DisclaimerDisclaimer
•I am not funded by any voluntary organization or NGO
for this lecture
•The opinions expressed are my interpretation of AP Law
and some judgments
•Brain death and Organ donation are subjects of state law
•Be compliant to your own state law when you indulge
in the above activity
Andreas Vesalius
1564 Vesalius in Spain1959 Coma depasse in France1965 Brain Death Renal Transplant1968 Harvard Criteria for Brain Death
American Neurological Associations1976 Conf. Of Royal Colleges,UK1980 President’s Commission on Ethics.US1994 ‘Transplantation of Human Organ act’
Govt of India,1995 Govt of Andhra Pradesh
Evolution of Brain Death Concept
THE TRANSPLANTATION OF HUMAN ORGANS ACT, 1994
Ministry of Law, Justice and Company Affairs
(Legislative Department)
New Delhi, the 11th July, 1994
The following Act of Parliament received the assent of the President on the 8th July,
1994 and is hereby published for general information:-
THE TRANSPLANTATION OF HUMAN ORGANS ACT, 1994
No.42 OF 1994
CHAPTER I - PRELIMINARY 1. (d) “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;(e) " deceased person" means a person in whom permanent disappearance of all evidence of life occurs, by reason of brain stem death or in a cardio pulmonary sense at any time after live birth has taken place;
CHAPTER III - REGULATION OF HOSPITALS 10.On and from the commencement of this Act:-1.No hospital, unless registered under this Act, shall conduct or associate with, or help in the removal, storage or transplantation of any human organ;
As per the Transplantation of Human Organ Act of 1994, to make adiagnosis of brainstem death requires a panel of four doctorsconsisting of the doctor in charge of the patient, the doctor in charge of the hospital where the patient was treated, an independent specialist of unspecified specialty and a neurologist or a neurosurgeon. The burden of proof rests with the specialist of the neurosciences, with the other members confirming the diagnosis. All the four doctors Sign each test done to document absence of brainstem function
Two interesting questions.
First, if the relatives refuse the donation of organs in a brainstem-dead
certified patient, can the life support systems be disconnected
and switched off ?
Second, if the relatives request more time to decide about organ
donation during which the cardiopulmonary function of the deceased
patient ceases, what time does one record as the time of death ?
Can one die more than once ? (first, when one’s brain dies and again later
when one’s heart stops).
Death
Cardiac ( Visceral ) Cerebral ( Brain )
Physical Social Personal
Definition of Death
Chambers Extinction or cessation of life.
Oxford The final cessation of vital functions in
an organism, the ending of life.
Brain Death
Chambers The cessation of function of brain, rather than
cessation of heart beat true indication of death.
Oxford
Irreversible brain damage causing the end of independent
respiration, regarded as
indicative of death.
Functions of Brain
Cognition Knowing,Perceiving and Conceiving
Sensory Feeling
Motor Protection
Autonomic Visceral control
Consequences of Brain Death
Loss of ‘Personhood’ or Self
Coma – Unresponsive state
Deregulation of Visceral function
• Automaticity Heart
• Functional arrest Lungs
• Flow dependency Kidneys etc
‘Your Heart can die without YOU dying,But if your Brain dies, YOU die’ DA Jones
Why ?
1. Neurons don’t multiply !
2. No extra-corporeal method to substitute for lost brain function !!
3. No brain Transplantation !!!
So, Brain death is irreversible
Brain Death time is official time
of Death
General Issues reg Brain Death
• Defining Death
• Deciding Specialists
• Reliable testing methods
Limiting Points in India
General Public
• Concept of Death
• Scandals of Transplant
• Transplant is a Rich Man’s Game
Limiting Points in India - Medical Professionals
• Text book definition of death
• Poor awareness of scientific aspects
• Apathy
• Fear of unknown and legal hassles
• Non-confidence in Transplant treatments
• Vested Interest
• Personal and Religious
• Non- differentiation between donor and transplant centres
Deceased organ Deceased organ donations in Indiadonations in India
Lack of awarenessLack of awareness Brain death declaration not Brain death declaration not
mandatorymandatory Absence of public private Absence of public private
partnershippartnership Lack of favourable legislationsLack of favourable legislations Government willGovernment will Evolving fieldEvolving field
Whole Brain Criteria All functions of the entire Brain are
determined to be entirely absent
Brain Stem CriteriaIrreversible loss of vital functions likecardiac and respiratory
Defining Brain DeathDefining Brain Death
Definitions in AP Law (1995)
Deceased Person A person in whom permanent disappearance of all evidence of life occurs by Brain stem Brain stem
DeathDeath or in cardiopulmonary sense.
Brain Stem Death All functions of the Brain stem have and
irreversibly ceased.
Who can Certify Brain Death ?
A Board consisting of :
Reg.Med Practitioner I/c of the Hospital
Independent Reg.Med Practitioner
A Neurologist or Neurosurgeon
Treating Reg.Med. Practitioner
Anaesthesiologist or Intensivist
Unanimous Certification
The TeamThe Team
THE TRANSPLANTATION OF HUMAN ORGANS (AMENDMENT) ACT, 2011MINISTRY OF LAW AND JUSTICE
New Delhi, 28th September, 2011/Asvina 6, 1933 (Saka) (No.16 of 2011) THE TRANSPLANTATION OF HUMAN ORGANS (AMENDMENT) ACT, 2011
Transplant Co-Ordination Organisations
USA UNOSUK UK TransplantsEU EU Trans.Co-ordin. CouncilAustralia Australian Trans.Registry
India MOHAN - TN, AP, MumbaiZTCC - MaharashtraFORTE - BangaloreORBO - New DelhiTN - Govt Ombudsman
Organ TransplantationOrgan Transplantation
Commonest Transplantation in the countryCommonest Transplantation in the country Growing incidence of Diabetes & Growing incidence of Diabetes &
HypertensionHypertension Availability of technologyAvailability of technology Technical expertiseTechnical expertise Shrinking family sizeShrinking family size Lack of “Donor organs”Lack of “Donor organs” Thriving “Organ Trade”Thriving “Organ Trade”
Organ DonationOrgan Donation
Concept of “Brain Death” not yet Concept of “Brain Death” not yet popularpopular
Lack of awareness among publicLack of awareness among public Hospital infrastructure still Hospital infrastructure still
inadequateinadequate Lack of trained human resourcesLack of trained human resources Favourable legislationsFavourable legislations
Driver’s Driver’s License with License with the clause on the clause on organ organ donationdonation
TRANSPLANTATION OF HUMAN TRANSPLANTATION OF HUMAN ORGANS ACT 1994 [THOA] & ORGANS ACT 1994 [THOA] &
AMENDMENT 2011AMENDMENT 2011
The legal framework The legal framework
TRANSPLANTATION OF HUMAN TRANSPLANTATION OF HUMAN ORGANS ACT 1994 [THOA]ORGANS ACT 1994 [THOA]
Chapter
Sections
Title
1 1-2 Preliminary
2 3-9 Authority for Removal of Human Organs
3 10-12 Regulation of Hospitals
4 13 Appropriate Authority
5 14-17 Registration of Hospitals
6 18-22 Offenses and Penalties
7 23-25 Miscellaneous
Key provisionsKey provisions
THOA Amendment 2011THOA Amendment 2011
Transplant Coordinator Transplant Coordinator
Section 2 - q : Definition and duties of tx coordinator
Section 3 -1- 14 : removal of organ by RMP in consultation with tx
coordinator
Section 14 – 4 : every transplant hospital to have a tx coordinator
Section 24 – ka : to define qualification and experience of a tx coordinator
Duties of an RMP Duties of an RMP (1994)(1994)
Duties of an RMP Duties of an RMP (2011) (2011)
THOA Rules 1995 THOA Rules 1995 Chapter Title
1 Short title
2 Definitions
3 Authority for Removal of Human Organ
4 Duties of medical practitioner
4 A Authorisation Committee
5 Preservation of Organs
6 (A-F) Composition of Authorisation Committee
7 Registration of Hospitals
8 Renewal Of Registrations
9 Conditions for grant of Registration
10 Appeal
RULES: How the THO RULES: How the THO Act works Act works
Forms - Deceased donation, live donation, hospital registration
Authorisation Committee - Composition
DutiesOperation/working
Appropriate Authority Hospital – Registration
Prerequisites
Appeal- Against Authorisation Committee
Against Appropriate Authority
Forms: Consent Forms Forms: Consent Forms Who signs Who collects Who keeps
Live donation
Form 1a Near relative Tx coordinator
Tx hospital
Form 1b Spouse Tx coordinator
Tx hospital
Form 1c Unrelated donor Tx coordinator
Tx hospital
Deceased Donation
Form 5 (donor card)
donor donor donor
Form 6 or Form 9 Person legally in possession of body
Tx coordinator Hospital
Forms: Live Forms: Live donationdonation
Form No. Who signs Who collects
Live related donor
Form 1a Related donor Tx coordinator
Form 2 (donor fitness) Treating RMP Tx coordinator
Form 3 (HLA Lab report)
Head of Laboratory (NABL certified)
Tx coordinator
Form 10 (joint application)
Donor and recipient
Tx coordinator
Forms: Live Forms: Live donation donation
Form No. Who signs Who collects
Live spouse donor
Form 1b Spouse Tx coordinator
Form 2 (donor fitness)
Treating RMP Tx coordinator
Form 10 (joint application)
Donor and recipient
Tx coordinator
Forms: Live Forms: Live donationdonation
Form No. Who signs Who collects
Live unrelated donor
Form 1c Unrelated donor
Tx coordinator
Form 2 (donor fitness)
Treating RMP Tx coordinator
Form 10 (joint application)
Donor and recipient
Tx coordinator
Forms: Deceased donationForms: Deceased donationForm No. Who signs Who collects
Form 6/9 Person legally in possession of body
Tx coordinator
Form 8 (Brain death certificate)
Certifying team of RMP
Tx coordinator
Special forms :Inquest requestForensic authorisation
As per state government protocols
Tx coordinator and investigating police officer
Forms: Forms: Hospital Hospital
registration registration
Form No. Who signs Who keeps
Form 11 (Request for registration)
Hospital RMO Appropriate authority
Form 12 (Transplant licence)
Appropriate authority
Hospital RMO
Form 13 (Renewal of registration)
Appropriate authority
Hospital RMO
Offences and Offences and penalties penalties
Offences and Offences and penalties penalties
Offences and Offences and penalties penalties
State Government OrdersState Government Orders
Tamil Nadu• 8 GOs 2008-2011 – BD declaration ,
Authorisation Comm. Appropriate Auth. , NTORC , Organ sharing
The legal framework The legal framework
Annual Transplant Data: Annual Transplant Data: IndiaIndia
OrganOrgan Requirement Requirement Transplants Transplants
Live donorLive donor CadavericCadaveric
KidneyKidney 100,000100,000 9500 9500 500 500
LiverLiver 20,00020,000 450 450 50 50
HeartHeart 50005000 - total 70 - total 70
LungsLungs -- - - - -
PancreasPancreas -- - - - -
Small bowelSmall bowel -- - - - -
Form 11Form 11
APPLICATION FOR REGISTRATION OF HOSPITAL TO CARRY APPLICATION FOR REGISTRATION OF HOSPITAL TO CARRY OUT ORGAN OUT ORGAN TRANSPLANTATIONTRANSPLANTATION
To To
The Appropriate Authority for organ The Appropriate Authority for organ
(State or Union Territory)(State or Union Territory)
We hereby apply to be recognized as an institution to We hereby apply to be recognized as an institution to carry out organ transplantation. The required data about the carry out organ transplantation. The required data about the facilities available in the hospital are as followsfacilities available in the hospital are as follows
HospitalHospital
1. Name__________________________________1. Name__________________________________
2. Location__________________________________2. Location__________________________________ ________________
__________________
Step 1: Approval for Organ Step 1: Approval for Organ Transplantation?Transplantation?
Approval for Organ Approval for Organ TransplantationTransplantation
Step 2: Brain Death Step 2: Brain Death CommitteeCommittee
Brain Death CommitteeBrain Death Committee
Step 3: Transplant Step 3: Transplant CoordinatorsCoordinators
Need to appoint 2 coordinatorsNeed to appoint 2 coordinators Leave reliefLeave relief TrainingTraining Awareness campaignAwareness campaign
Close contact with critical care teamClose contact with critical care team Morning and evening rounds of ICUMorning and evening rounds of ICU Nomenclature: ? PALNomenclature: ? PAL Identify potential donorIdentify potential donor
Form 8Form 8
We, the following members of the Board of medical experts after careful personal We, the following members of the Board of medical experts after careful personal examination hereby certify that Shri/Smt./Km ____________________________examination hereby certify that Shri/Smt./Km ____________________________aged about _________ s/o, d/o, w/o, Shri _________________________ resident of aged about _________ s/o, d/o, w/o, Shri _________________________ resident of _______________________________________________________ _______________________________________________________ ________________________________________________________________ is dead on account of ________________________________________________________________ is dead on account of permanent and irreversible cessation of all functions of the brain-stem. The tests permanent and irreversible cessation of all functions of the brain-stem. The tests carried out by us and the findings therein are recorded in the brain-stem death carried out by us and the findings therein are recorded in the brain-stem death certificate annexed hereto.certificate annexed hereto. Dated : ________________Dated : ________________ Signature _______________________Signature _______________________Place : ________________Place : ________________ 1. R.M.P. Incharge of the 1. R.M.P. Incharge of the 3. R.M.P., Nominated from the 3. R.M.P., Nominated from theHospital in which brain- Hospital in which brain- Panel of Names approved by Panel of Names approved byStem death has occurredStem death has occurred the Appropriate Authority the Appropriate Authority 2. Neurologist/Neuro-Surgeon2. Neurologist/Neuro-Surgeon 4. R.M.P. treating the 4. R.M.P. treating the Nominated from the panel ofNominated from the panel of aforesaid deceased person.aforesaid deceased person.Names approved by theNames approved by theAppropriate AuthorityAppropriate Authority
Form 6Form 6I,_____________________________ I,_____________________________ s/o, d/o, w/o Shris/o, d/o, w/o Shri__________________________________________
aged ___________ resident of _______________________________________ aged ___________ resident of _______________________________________ _________________________________________________________________________________ having lawful _________________________________________________________________________________ having lawful possession of the dead body of Shri/Smt/Km ___________________ s/o, d/o, w/o Shri ________________ possession of the dead body of Shri/Smt/Km ___________________ s/o, d/o, w/o Shri ________________ aged ___________ resident of _______________________________________ aged ___________ resident of _______________________________________ ________________________________________________________________ having known that the deceased ________________________________________________________________ having known that the deceased has not expressed any objection in his/her organ/organs being removed for therapeutic purposes has not expressed any objection in his/her organ/organs being removed for therapeutic purposes after his/her death and also having reasons to believe that no near relative of the said deceased after his/her death and also having reasons to believe that no near relative of the said deceased person has objection to any of his/her organs being used for therapeutic purposes, authorize person has objection to any of his/her organs being used for therapeutic purposes, authorize removal of his/her body organs, namely ________________________ removal of his/her body organs, namely ________________________ ____________________________________.____________________________________. Dated: __________________ Dated: __________________ Signature __________________Signature __________________ Place : __________________Place : __________________
Person in lawful possession of the dead body.Person in lawful possession of the dead body. Address: __________________________ Address: __________________________ ____________________________________________________________________________________________________________________________________________________________
Documents with Documents with CoordinatorCoordinator
File containingFile containing Approved Brain Death committeeApproved Brain Death committee Form 8Form 8 Form 6,7,9Form 6,7,9 Draft of all correspondence / certsDraft of all correspondence / certs
Police clearancePolice clearance Clearance from Post mortem authorityClearance from Post mortem authority Cert of organs removedCert of organs removed Handing taking over certificate Handing taking over certificate
Imp: have soft copy of all documents Imp: have soft copy of all documents ComputerComputer CD in an envelope: filedCD in an envelope: filed
Zonal Coordination Committee of Karnataka for Transplantatio
n (ZCCK)
Established by Government of
Karnataka on 13th April 2004
Statistics
20082008 0202
20092009 1111
20102010 1010
20112011 0606
2012 (till March)2012 (till March) 0606
Cadaver Organ Donors in Karnataka between 2008-2012
ChallengesChallenges
Lack of support by government hospitals in certification of Lack of support by government hospitals in certification of brain deathsbrain deaths
Need for more awareness programmes among medical Need for more awareness programmes among medical community and publiccommunity and public
Need for more supportive government orders on Deceased Need for more supportive government orders on Deceased Organ DonationOrgan Donation
NIMHANSNIMHANS - large number of accident and other neurological - large number of accident and other neurological cases reported to the hospital. An average of 20 brain deaths cases reported to the hospital. An average of 20 brain deaths every month but no brain death declaration or retrieval of every month but no brain death declaration or retrieval of organsorgans
Victoria Govt. HospitalVictoria Govt. Hospital – Similar situation – Similar situation
Zonal Transplant Coordination Center (ZTCC),
MumbaiEstablished 2000
Statistics
Number of patients listed/ registered on Number of patients listed/ registered on
the Mumbai city waiting list:the Mumbai city waiting list:
Kidneys:Kidneys: 21882188
Liver: Liver: 71 71
Lungs: Lungs: 5 5
Statistics
Year
2011
2012 (Jan-
Apr)
Total
Cadaver
donors
10
8
18
Liver
06
06
12
Kidney
20
15
35
Narmada Kidney Narmada Kidney FoundationFoundation
Founded in 1993Founded in 1993 NGO aimed to help people with NGO aimed to help people with
kidney diseaseskidney diseases Initiated several public & patient Initiated several public & patient
education programseducation programs Focus on prevention of kidney Focus on prevention of kidney
diseases and nutrition of patientsdiseases and nutrition of patients
Gujarat
Individual HospitalsIndividual Hospitals
NGO involvementNGO involvement
Statistics – IKDRC, Statistics – IKDRC, AhmedabadAhmedabad
YearYear
20052005
20062006
20072007
20082008
20092009
20102010
Deceased Deceased
DonorsDonors
1111
2525
1717
2121
2626
2323
KidneyKidney
2121
4545
3232
3838
4545
4242
LiverLiver
--
--
--
0202
0808
1414
Apollo Hospitals, Ahmedabad
Kidney transplant programme started in 2005Kidney transplant programme started in 2005
13 deceased organ transplants – kidney13 deceased organ transplants – kidney
3 deceased organ donations in 2012, out of 3 deceased organ donations in 2012, out of
which 2 livers and six kidneys have been used.which 2 livers and six kidneys have been used.
Muljibhai Patel Urological Hospital, Nadiad
13 cadaver kidney transplants performed 13 cadaver kidney transplants performed
between June 2000 – May 2010between June 2000 – May 2010
Shatayu
Non-profit organizationNon-profit organization
Public service initiative by Govindbhai C. Patel Public service initiative by Govindbhai C. Patel
Foundation, and supported by Ganesh Housing Foundation, and supported by Ganesh Housing
Corporation Limited. Corporation Limited.
Objectives:Objectives:
Increasing organ donation awarenessIncreasing organ donation awareness
Broadening people’s mindset regarding the gift Broadening people’s mindset regarding the gift
of life.of life.
Uttar PradeshUttar Pradesh
SGPGI, LucknowSGPGI, Lucknow
About 6-7 About 6-7 deceased deceased organ organ donations so donations so farfar
Kerala – God’s Own Kerala – God’s Own CountryCountry
SORT, CochinSORT, Cochin
Not for profit Not for profit organisationorganisation
Has initiated several Has initiated several public education public education programsprograms
Has had 10 multi Has had 10 multi organ donations so farorgan donations so far
2011 Statistics of deceased 2011 Statistics of deceased organ donations in Andhra organ donations in Andhra
PradeshPradesh
Heart Heart 0202 Liver Liver 1414 Kidneys Kidneys 2828 Heart valves Heart valves 2222 CorneasCorneas 8282 TotalTotal 148148
Statistics of deceased organ Statistics of deceased organ donations in Tamilnadudonations in Tamilnadu
20112011
Kidneys Kidneys 129129
LiverLiver 6464
HeartHeart 0808
LungsLungs 0202
Heart ValvesHeart Valves 8888
CorneasCorneas 7474
Total Donors Total Donors 8282
Heart Heart 16 16
Lung Lung 88
Liver Liver 7979
Kidney Kidney 148148
Heart Valves Heart Valves 76 76
Corneas Corneas 135135
20122012
KidneysKidneys 2121LiverLiver 1212HeartHeart 22EyesEyes 4646PancreasPancreas 11Heart ValvesHeart Valves 1010LungsLungs 11
Total DonationsTotal Donations 1313
Statistics of deceased organ Statistics of deceased organ donations in ?donations in ?
2012 Statistics of organ 2012 Statistics of organ donations in Delhidonations in Delhi
8-9 deceased organ 8-9 deceased organ donations last yeardonations last year
ORBOORBO AORTAAORTA
2012 Statistics of organ 2012 Statistics of organ donations in Chandigarhdonations in Chandigarh
8-9 deceased organ 8-9 deceased organ donations so far.donations so far.
PGIMER is a major PGIMER is a major playerplayer
Islands of Success
SummarySummary
Around 140 deceased organ donations Around 140 deceased organ donations nationwide in 2011nationwide in 2011
Southern & Western States active in Southern & Western States active in deceased donation programdeceased donation program
Central & State Governments need to Central & State Governments need to initiate advocacy programsinitiate advocacy programs
We should aim at doubling the numbers We should aim at doubling the numbers every yearevery year
Initiate program in States where it does Initiate program in States where it does not existnot exist