Brain death status 2013

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


Live spouse donor

Form 1b Spouse Tx coordinator

Form 2 (donor fitness)

Treating RMP Tx coordinator


Donor and recipient

Tx coordinator

Forms: Live Forms: Live donationdonation


Live unrelated donor

Form 1c Unrelated donor

Tx coordinator

Form 2 (donor fitness)

Treating RMP Tx coordinator


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

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

Brain death status 2013

Healthcare

Transcript of Brain death status 2013