Download MBBS Surgery Presentations 44 Organ Transplantation Lecture Notes

Download MBBS (Bachelor of Medicine, Bachelor of Surgery) 1st Year, 2nd Year, 3rd Year and Final year Surgery 44 Organ Transplantation PPT-Powerpoint Presentations and lecture notes






















THE TRANSPLANTATION OF

HUMAN ORGANS ACT, 1994

Dept of Surgery

PREDECESSORS

Eyes Act of 1982 and Ear Drums and Ear Bones Act

of 1982 (Union Territory of Delhi)
Maharashtra Kidney Transplantation Act 1982 and

Bombay Corneal Grafting Act,1957
Transplantation of Human Organs Bil , 1992 was

Introduced in Lok Sabha on 20 August 1992.
This Bil was assented by the President on 08 July

1994.

It became `The Transplantation of Human Organs

Act',1994(42 of 1994).








































































































Donor ?means a person , not less than 18 years of age,

who voluntarily authorises removal of any of his

organs for therapeutic purposes.
Hospital ? Nursing Home, Clinic, Medical Centre,

medical or teaching institution for therapeutic

purposes.
Near Relative ? Spouse, Son, Son, Daughter, Father,

Mother, Brother, Sister.
Registered Medical Practioner ? means a Medical

Practioner who possesses any recognized medical

qualifications as defined in Clause (H) of section 2 of

the Indian Medical Council Act, 1956 (102 of 1956)

and is enrol ed on a State Medical Council.

BOARD OF MEDICAL EXPERTS

Registered Medical Practioner, in charge of the

hospital in which brain-stem death occurred
An independent RMP, being a specialist nominated by

the RMP in clause (I) from the panel of names

approved by appropriate authority
A neurologist or a neurosurgeon nominated by the

RMP in clause (I) from the panel of names approved

by appropriate authority
RMP treating the person whose brain-stem death has

occurred

_ _ _ _ _ _ _ _

No authority can be granted in cases an inquest is

required
In unclaimed bodies (more than 48 hours) in a hospital

or prison, the authority may be given by the person in

charge of management of the hospital or prison or a

person authorised in this behalf by the incharge




















APPROPRIATE AUTHORITY

Central Govt. shal appoint ,by notification, one or

more officers as AA, and State Govt. for the

State.

Duties ?

To grant, renew, suspend and cancel registration

under sub-section(3) of that section.
To enforce standards as prescribed.
To investigate any breach of provisions of act.
To inspect hospitals for examination of the quality of

transplantation and fol ow-up care.

Registration of Hospitals ? apply to AA within

sixty days of commencement of Act
AA may reject the application, suspend or

cancel the Registration (with or without

notice)
Appeal within thirty days to Central/State

Govt against

Rejection/Suspension/Cancel ation














































OFFENCES AND PENALTIES

Removal of organs without authority :

Imprisonment upto five years and fine of ten

thousand rupees
RMP ? Removal of name from register of State

Medical Council for two years for first offence and

permanently for subsequent offence

Punishment for commercial dealings in human organs ?

Imprisonment for a term between two to seven years

and a fine of between Rs. 10000-20000

THE TRANSPLANTATION OF HUMAN

ORGAN RULES 1995

DUTIES OF MEDICAL PRACTIONER ?

Authorization in Form no. 1 by donor

Medical fitness certificate (Form no. 2)

If donor is a near relative then Form no. 3 is fil ed

after establishing relation

If donor is spouse then sign a certificate in Form no.

4
Donor had authorised in presence of two witnesses

authorised removal of organ from his body,in Form No.

5


























































There is lawful possession of dead body by a person

having signed a certificate as specified in Form 6 or 7

Board of experts has signed Form 8

Form 9 has been signed by either of parents in case

the deceased is less than 18 years of age

Form 10 to be fil ed for transplantation by live donor

other than near relative, to be signed by both

prospective donor and recipient with reason of

affection and attachment. This has to be approved by

Authorisation Committee.

CONDITIONS FOR GRANT OF

CERTIFICATE OF REGISTRATION

GENERAL REQUIREMENT-

SURGICAL STAFF
CARDIOLOGY STAFF
NURSING STAFF
COMMUNICATION SYSTEM
INTENSIVIST
MEDICAL SOCIAL WORKER
PERFUSIONIST
OPHTHALMOLOGIST






























NON TRANSPLANTATION PROGRAMME TEAM ?

NEUROLOGIST
NEUROSURGEON
MEDICAL SUPERINTENDENT
ANY OTHER HOSPITAL STAFF
EYE DONATION COUNSELLOR/GRIEF COUNSELLOR
CORNEAL SURGEONS

DEPARTMENTS ? 18 (Neurology,Microbiology,

Mycology,Pathology,Virology,Nephrology,

GI Surgery,Anaesthesiology,

Paediatrics,Physiotherapy,Immunology,Haematology,

Blood Bank, Imaging Services

ClinicalChemistry, Cardiology,Ophthalmology,Psychology)

BASIC EQUIPMENT ?

OPERATING ROOM FOR ROUTINE OPEN

HEART SURGERY WHICH INCLUDES HEART

LUNG MACHINE AND ACCESSORIES.

SLIT LAMP

SPECULAR MICROSCOPE

OPERATING MICROSCOPE

ADDITIONAL EQUIPMENT ?

CELL SAVER

ASSIST DEVICE LIKE IABP AND

CENTRIFUGAL PUMP

MOBILE C ARM














RADIOIMMUNOASSAY FOR MEASURING

CYCLOSPORIN LEVELS
LAB FACILITIES
AUTOCLAVE
UV LAMP
LAMINAR FLOW

RECENT ORGAN TRAFFICKING SCANDALS

NMC NOIDA IN 1998 ? Kidney Transplantation

Racket

KAKKAR HOSPITAL, AMRITSAR ? Kidney

Transplantation Racket

Kidney Transplantation Racket in five Hospitals of

Hyderabad In 1993




























In USA, a total of 97,179 patients were waiting for

a transplant as of September 17, 2007. Fol owing is a

list by type of transplant needed:

73,149 patients waiting for a kidney transplant

16,702 patients waiting for a liver transplant

1,640 patients waiting for a pancreas transplant

2,316 patients waiting for a kidney-pancreas transplant

209 patients waiting for an intestine transplant

2,626 patients waiting for a heart transplant

115 patients waiting for a heart-lung transplant

2,336 patients waiting for a lung transplant

97,179 TOTAL PATIENTS

WAITING* * Some patients are waiting for more than

one organ, therefore, the total number of patients is

less than the sum of patients waiting for each organ.


































Numbers of Transplants Performed During 2006

17,092 kidney transplants

6,650 liver transplants

463 pancreas transplants

954 kidney-pancreas transplants

175 intestine transplants

2,192 heart transplants

31 heart-lung transplants

1,405 lung transplants

28,932 TOTAL TRANSPLANTS PERFORMED*

? Based on data from the Organ Procurement and

Transplantation Network of the U.S. Department of

Health and Human Services, as of June 29, 2007 -- data

subject to change due to future submissions or

corrections.

THE REPORT

OF

TRANSPLANTATION OF HUMAN ORGANS ACT

REVIEW COMMITTEE

AS PER THE DELHI HIGH COURT JUDGEMENT

DATED 06.09.2004 IN W.P. NO.813/2004 TO

REVIEW THE PROVISIONS OF THE

TRANSPLANTATION OF HUMAN ORGANS ACT,

1994 AND THE TRANSPLANTATION OF HUMAN

ORGANS RULES,1995)






















































































BACKGROUND

A committee, hereinafter referred to as the THOA

review committee, was constituted in terms of the

judgement dated September 6, 2004 passed by

Hon'ble Mr. Justice Manmohan Sarin of High Court of

Delhi in WP(c) 813/2004 titled Balbir Singh vs. The

Authorisation Committee and others (Balbir Singh

Case) with direction to review the efficacy, relevance

and impact of the legal provisions
Contained in the transplantation of human organs act,

1994 (TOHO Act) And The Transplantation Of Human

Organs Rules, 1994 (TOHO Rules).

The review committee commenced its working under

the chairpersonship of Additional Secretary (Health)

to the Government of India and set out to objectively

and critical y appraise and analyse the practical

functional y of the provisions of the TOHO act and

the TOHO rules, as defined by the Hon'ble High Court

of Delhi in the Balbir Singh case.
























































Make its recommendations on the

composition of Authorisation Committees
Jurisdiction of the Authorisation

Committees should be enlarged by

bringing within its ambit the process of

certifying a "near relative" or the task

be assigned to another designated

authority
Develop a mechanism where al proposed

donors including `near relatives' should be

scrutinised by a committee (The

Authorization Committee)

Composition of hospital based authorisation committees :

(to be proposed by institution and notified by govt.)

The senior most person officiating as medical director /

medical superintendent of the hospital.

DM/ADM/SDM of the district which include the

officers holding equivalent post in hierarchy

irrespective of nomenclature of the designation. (To be

nominated by concerned State/UT GOVT.)

Two senior medical practitioners from the same hospital

who are not part of the transplant team.


















































































































Two members being persons of high integrity, social

standing and credibility, who have served in high

ranking government positions, such as in higher

judiciary, senior cadre of police service or who have

served as a reader or professor in UGC approved

university or are self-employed professionals of repute

such as lawyers, chartered accountants, writers,

journalists and doctors (of Indian Medical Association)

etc.
One medical practitioner working in a government

hospital to be nominated by the Central/State

government.
Composition of state/ district level Authorisation

Committees (to be constituted by Concerned state/UT

govt.)
A medical practitioner officiating as chief medical

officer or any other equivalent post in the main/major

government hospital of the district.

DM/ADM/SDM Of the district which include

the officers holding equivalent post in hierarchy

irrespective of nomenclature of the designation.



Two senior medical practitioners to be chosen

from the pool of such medical practitioners who

are residing in the concerned district and who

are not part of any transplant team.
Two senior citizens, non-medical background

(one lady) of high reputation and integrity to be

chosen from the pool of such citizens residing




























































in the same district, who have served in

high ranking government positions, such as

in higher judiciary, senior cadre of police

service or who

have served as a Reader

or Professor in UGC approved University

or are self-employed professionals of

repute such as lawyers, chartered

accountants, writers, journalists and

doctors (of Indian Medical Association)

etc.
One medical practitioner working in a

government hospital to be nominated by

the concerned state/UT government.

ADDITIONAL FORMS

FORM 1A

FORM 1B

FORM 1C

FORM-2:AMENDED

FORM-4:DELETED

FORM-7:DELETED AS IT IS IDENTICAL TO FORM

6
FORM-10:AMENDED


















































































































Where the proposed transplant is between persons

related genetical y, (e.g. Brother, sister, mother, father,

children above the age of 18 years)
The Authorisation committee must evaluate:-
Results of tissue typing and other basic tests.
Documentary evidence of relationship e.g. Relevant birth

certificates and marriage certificate, certificate from

sub-divisional magistrate/ metropolitan magistrate/or

Sarpanch of the Panchayat;
Documentary evidence of identity and residence of the

proposed donor e.g. Ration card/voters identity

card/passport/ driving license/ pan card/bank account

and family photograph depicting the proposed donor and

the proposed recipient along with another near relative.

If in its opinion, the relationship is not conclusively

established after evaluating the above evidence, it may in

its discretion direct further medical tests as prescribed

in rule 4(1).

b) Where the proposed transplant is between a

married couple:
The authorisation committee must evaluate al

available evidence to establish the fact and

duration of marriage and ensure that

documents such as marriage certificate,

marriage Photograph is placed before the

committee along with the information on the

number and age of children and a family

photograph depicting the entire immediate

family, birth certificate of children containing

particulars of parents.








































































































c) Where the proposed transplant is between persons

who are related genetical y but whose relationship

cannot be established in accordance with rules:-
Results of tissue typing and other tests with the name

of the HLA laboratory and if possible the statistical

estimation of the probability of a genetic relationship;
Documentary evidence of relationship
Ex. Relevant birth certificates and marriage

certificate,

certificate

from

sub-divisional

magistrate/ metropolitan magistrate/or Sarpanch of

the Panchayat; documentary evidence of identity and

residence of the proposed donor e.g. Ration

card/voters identity card/passport/ driving license/

pan card/bank account and family photograph

depicting the proposed donor and the proposed

recipient along with another near relative.

WHERE THE PROPOSED TRANSPLANT IS

BETWEEN INDIVIDUALS WHO ARE NOT

"NEAR RELATIVES"

The authorization committee must evaluate:-

That there is no commercial transaction between the

recipient and the donor. That no payment of money or

moneys worth as referred to in the sections of the act,

has been made to the donor or promised to be made to

the donor or any other person.
That the fol owing is specifical y assessed by the

authorisation committee :-
An explanation of the link between them and the

circumstances which led to the offer being made;


































































































































Reasons why the donor wishes to donate?
Documentary evidence of the link e.g. Proof that they

have lived together etc.
Old photographs showing the donor and the recipient

together.
That there is no middleman/tout involved;
That financial status of the donor and the recipient is

probed by asking them to give appropriate evidence of

their vocation and income for the previous three

financial years. Any gross disparity between the status

of the two, must be evaluated in the backdrop of the

objective of preventing commercial dealing.
That the donor is not a drug addict or a known person

with criminal record;

That the next of kin of the proposed unrelated

donor is interviewed regarding awareness

about his/her intention to donate an organ, the

authenticity of the link between the donor and

the recipient and the reasons for donation.

Any strong views/ disagreement/objection of

such kin may also be recorded and taken note

of.

E) When the proposed donor or the recipient or

both are foreigners:
A senior embassy official of the country of

origin has to certify the relationship between

the donor and the recipient or where they are

not related the reasons as to why the proposed

donor is desirous of donating his organ to the

proposed recipient.














































































































































Authorisation committee can examine the cases of

Indian donors consenting to donate organs to a foreign

national, including a foreign national of Indian origin,

with greater caution. This should be done rarely in

deserving cases only.
In case where the donor is a woman greater

precautions ought to be taken. Her identity and

independent consent should be confirmed/ verified by a

person other than the recipient. Any document with

regard to the proof of residence/ domicile and

particulars of parentage should be relatable to the

photo identity of the applicant in order to ensure that

the documents pertain to the same person, who is the

proposed donor and in the event of any inadequate or

doubtful information to this effect, the authorisation

committee may in its discretion seek such other

information or evidence as may be expedient and

desirable in the peculiar facts of the case.
In al cases of non-near relatives, the interview of the

donor should specifical y deal with the aspect of

affection/attachment/ other special reason, in order to

rule out commercial considerations.
Further al donors should specifical y be interviewed to

rule out any element of coercion, undue influence, fraud

or misrepresentation in the proposal of donation. The

authorization committee should state in writing its

reason for rejecting/approving the application of the

proposed donor and al approvals should be subject to

the fol owing conditions:-
















































































































































































That the approved proposed donor has been

and would mandatorily be subjected to al such

medical tests as required at the relevant

stages to determine his biological capacity and

compatibility to donate the organ in question

and further that the psychiatrist clearance

would also be mandatory to certify his mental

condition, awareness, absence of any overt or

latent psychiatric disease and ability to give

free consent. The committee also takes note of

the recent judgement of the Hon'ble Supreme

Court of India, where the "authorisation

committee" of Punjab was directed to examine

the donor and the recipient, while the

transplantation was to be carried out at

Chennai.

While an endeavour has been made to recommend the

enhanced jurisdiction of the authorisation committees

as envisaged in the judgement of Hon'ble Supreme Court

of India, yet it is felt that several aspects peculiar to

the attending ground realities were not brought to the

notice of the Hon'ble apex court. For instance what

happens if the donor and the recipient hail from

different states; what happens if one of them or both

hails from a state/states where there is/are no

"authorisation committee" and lastly it is not clear as to

whether the "authorisation committee" of the state

where transplantation is taking place, shal retain some

jurisdiction or wil be completely without jurisdiction

and if latter is the case then how wil the medical

evidence if required to be assessed, wil be assessed by

the domicile "authorisation committee" without

resulting in delays and without compromising the other

laudable objectives of the TOHO act.






































































Benefits for Live Donors

Comprehensive health care scheme may be evolved by

the government.

Life long free renal/liver checkup, fol ow-up and care

in hospital, (including its other branches, if any),

where organ donation has taken place.

To secure the donor against mortality risk due to

organ donation related reasons, a customized life

insurance policy of Rs. 2 Lakhs for 3 years with one

time premium to be paid by recepient.

Certificate of appreciation to al live donors by

state/local government with an identity card

Endorsing his eligibility to obtain and avail various

benefits recommended here. The card should

prominently display a slogan such as "thank you for

saving a life".
Compensation for any expenses / loss of income

incurred as specified in section 2 (k) of the THOA act.
50% concession in 2nd class by Indian railways.

Recommended procedure for medical tests for

establishing genetic relationship between the recipient

and "near relatives" are as fol ows:-

The tests for HLA, HLA-B al eles to be performed by

the serological and/or PCR based DNA methods.

Test for HLA-DR beta genes to be performed using the

pcr based DNA methods.

Test for HLA-DR beta genes to be performed using the

PCR based DNA








































































































































? Methods where the above two tests does not

establish a genetic relationship between the donor

and the recipient, the same tests to be performed on

both or at least one parent. If parents are not

available, same tests to be performed on such

relatives of donor and recipient as are available and

are wil ing to be tested.

? Where the tests referred to above do not establish a

genetic relationship between the donor and the

recipient,

Tests for DNA fingerprinting using single

locus/multilocus polymorphic probes to be performed.

The head of the testing laboratory should state in

writing whether or not he/she is satisfied that the

claimed genetic relationship between the donor and the

recipient is established

Promote Swap Operations:

Swap operations that is to say that two different wil ing

but incompatible `near relative' donors (vis-?-vis their

intended related recipient) are permitted to donate

their organs in exchange without any commercial

interest and only due to the reason that despite

wil ingness, their organ was not found medical y

compatible for their intended recipients. This would

greatly help patients who have `near relatives' wil ing to

donate but incompatible for their recipient. Swap

operations may be considered by authorization

committee on case to case basis and as per the existing

THOA act and rules.




Unrelated donors can donate `by reason of affection or

attachment' towards the recipient (Ch 2, Sect 9(3))

This requires obtaining prior approval from an

authorising committee.


EFFECTIVENESS OF ACT

"THE ACT HAS BECOME USELESS BECAUSE
IT HAS NOT HELPED STOP THE
COMMERCIALISATION OF ORGAN
DONATION. IN FACT, IT HAS INCREASED
OVER THE RECENT PAST."

[NEPHROLOGIST]

"I RECEIVED SOME MONEY FROM THE

RECEPIENT FOR DONATING MY KIDNEY AND
I DONATED IT BECAUSE OF MONEY.'"
[DONOR]


CONSTRAINTS

ON

IMPLEMENTATION

COMMERCIAL INTERESTS (MIDDLEMEN AND

SERVICE PROVIDERS):

" I paid my broker his due as i was wheeled into the operation

theatre. He didn't move away from the stretcher until i paid

because he was not sure of me coming back alive. He made sure

of getting paid for arranging a donor for me."





(RECEPIENT)

`...It is possible for us to cut corners and lower the norms

required for performing transplantation....... The lack of

standards and economic pressures means that people will cut

corners.'

(NEPHROLOGIST)

CONSTRAINTS

ON

IMPLEMENTATION

AMBIGUITIES AND LOOPHOLES IN THE ACT

`I was asked to pose for a photograph with the recipient

and act as his wife for a while. I was told that this

arrangement wil help me in escaping the rules and

regulations and wil also expedite payments to me.'

(DONOR)

` My second daughter soon after her marriage was advised

to undergo transplant surgery. Although my first

daughter was wil ing to donate her kidney, her husband

demanded a sum of money ... I helped out with my own

savings and we paid nearly Rs 100,000 US $2,298;

1,890] to my first son-in-law.'

(MOTHER OF RECIPIENT)


CONSTRAINTS ON IMPLEMENTATION- LOW

MONITORING CAPACITY OF REGULATORY

AUTHORITIES

`I was asked by the recipient and the middleman to

report a wrong address to the ac to escape police

inquiries later.'


(DONOR)

... It is not possible for us to go on checking this as we

have a large number of such applications to scrutinise

Every week. As such, we have no mechanism to police

this practice and the rules as they exist do not require

of us such monitoring.'

(MEMBER OF AC)



CONSTRAINTS ON IMPLEMENTATION PRESSURES

AND RESPONSIBILITIES EXERTED ON THE ACS

Imagine you are in need of a kidney and have been waiting

for a year or so. This is a life and death situation. What

can you do if you don't find a related donor? Is it

correct to stop a donor from giving his/her organ, even

though he/she may receive some money in return for his

organ? Is it correct to stop a patient receiving an

unrelated kidney from a donor?'

(FORMER MEMBER OF AC)




CONSTRAINTS ON IMPLEMENTATION



We too are human beings and we cannot easily say `no' to

applicants seeking our approval for receiving unrelated

kidneys, even when we strongly suspect monetary

transactions between them. It is very difficult to

disapprove them especial y when they are in tears crying

for our help and have been suffering from want of a

kidney for several months. We tend to give in especial y

when patients undergo transplant surgery for the second

time, which is not uncommon.'

(FORMER GOVT OFFICIAL)

Summing up, commercialisation is widely acknowledged to

exist.

Factors that explain failure of THOA

Key commercial interests (notably middlemen/brokers

and service providers)

The ambiguities and loopholes in the act,

The low monitoring capacity of regulatory authorities

The pressures and responsibilities exerted on the ACs








ETHICS

" Ethics does not treat the world. Ethics must be a

condition of the world, like logic."

WITTGENSTEIN

Ethical issues related to the donor's family.
Relation between brain death & organ donation.
Decision maker in the family.
Incentives
Religious issues
Medico-legal case
Conditions / choice regarding recepients.

ETHICAL ISSUES FACED AT THE HOSPITAL LEVEL

ROLE CLARIFICATION & AUTHORITY IN TEAM
PRESSURE FROM TRANSPLANT TEAM
COMFORTABILITY

FACTOR

IN

NON-

NEUROLOGISTS & SURGEONS.
RELATION BETWEEN BRAIN DEATH & ORGAN

DONATION.




LEGAL ASPECTS

No actual penalization of people involved in organ

rackets til date.

Al ows brain death to be recognized in only selected

recognized organizations.

GLOBAL ETHICAL ISSUES

INTERNET SOLICITING
DIFF. SOURCES OF ORGANS
"ORGAN MARKET": IMPACT ON CADAVER

TRANSPLANT.




RECOMMENDATIONS / POSSIBLE SOLUTIONS

NO MATTER WHAT THE SITUATION, THE

SOLUTIONS PROPOSED, "THE DIGNITY OF THE

LIVING & THE DYING REMAINS AT STAKE &

MUST BE FACTORED INTO THE EQUATION."

POSSIBLE BIOLOGICAL SOLUTIONS

XENO-TRANSPLANTATION
CLONING
DEVELOPING ARTIFICIAL ORGANS.
DEVELOPING ORGANS FROM PATIENT'S STEM

CELLS.




SOCIETAL / GLOBAL SOLUTIONS

ROLE OF MEDIA TO INCREASE AWARENESS OF

ORGAN DONATION.
PROMOTE ORGAN DONATION IN ALL

COMMUNITIES.

STATE LEVEL SOLUTIONS

REQUIRED CHANGES / MODIFICATIONS IN

EXISTING LAW IN INDIA.
CONSENT: INFORMED V/S PRESUMED.
MANDATED CHOICE OR REQUIRED RESPONSE

POLICY.
PROVISION OF REQUIRED FACILITIES.




INSTITUTIONAL LEVEL SOLUTIONS

COUNSELING AT HOSPITAL LEVEL.
APPROACHING EVERY BRAIN DEAD PATIENT.
MULTI-DIMENSIONAL APPROACH TO MEET

PHYSICAL,

PSYCHOLOGICAL,

SOCIAL

&

SPIRITUAL NEEDS.

INDIVIDUAL ACTIONS AS SOLUTIONS

DONOR CARDS / ADVANCE DIRECTIVES
MOTIVATING ONESELF AND OTHERS
MEDICAL

PROFESSIONALS

TO

PROMOTE

UNDERSTANDING OF BRAIN DEATH & ORGAN

DONATION




Possible Policy Options
Tighten Wording Of Act.
Remove Provisions For Spouse And `Affection And

Attachment'
Mandate 3rd Party Tissue Testing
Promote Cadaveric Program

What is truly distinctive about transplantation is not

technology but ethics. Transplantation is the only

area in all health care that cannot exist without the

participation of the public. It is the individual citizen

who while alive or after death makes organs and

tissues available for transplantation. If there were no

gifts of organs or tissues, transplantation would come

to a grinding halt.

Arthur Caplan,

Bioethicist



Thank you

This post was last modified on 08 April 2022