Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_1739_Библиотеки_им_академика_М_И_Перельмана.pdf
134
A Simple Introduction to Organ Transplant
Dr Gopi Ayyaswamy
Act and the rules made there under, grant to the applicants approval
for the removal and transplantation of the human organ.
f. If, after the inquiry and after giving an opportunity to the applicants
of being heard, the Authorisation Committee is satised that the
applicants have not complied with the requirements of this Act and
the rules made thereunder, it shall, for reasons to be recorded in
writing, reject the application for approval.
4. Regulation of hospitals conducting the removal, storage or transplan-
tation of human organs
On and from the commencement of this Act:
a. No hospital, unless registered under this Act, shall conduct, or
associate with, or help in, the removal, storage, or transplantation
of any human organ;
b. No medical practitioner or any other person shall conduct, or
cause to be conducted, or aid in conducting by himself or through
any other person, any activity relating to the removal, storage or
transplantation of any human organ at a place other than a place
registered under this Act; and
c. No place including a hospital registered under Sub-section (1) of
Section 15 shall be used or cause to be used by any person for the
removal, storage or transplantation of any human organ except for
therapeutic purposes.
d. Notwithstanding anything contained in Sub-section (1), the eyes or
the ears may be removed at any place from the dead body of any
donor, for therapeutic purposes, by a registered medical practitioner.
Explanation: For the purposes of this sub-section, “ears” includes ear
drums and ear bones.
5. Prohibition of removal or transplantation of human organs for any
purpose other than therapeutic purposes: No donor and no person
empowered to give authority for the removal of any human organ shall
authorise the removal of any human organ for any purpose other than
therapeutic purposes.
Legal Aspects
135
Dr Gopi Ayyaswamy
6. Explaining effects, etc., to donor and recipient: No registered medical
practitioner shall undertake the removal or transplantation of any human
organ unless he has explained, in such manner as may be prescribed, all
possible effects, complications and hazards connected with the removal
and transplantation to the donor and the recipient respectively.
7. Appropriate Authority
a. The Central Government shall appoint, by notication, one or more
ofcers as Appropriate Authorities for each of the union territories
for the purposes of this Act.
b. The State Government shall appoint, by notication, one or more
ofcers as Appropriate Authorities for the purposes of this Act.
c. The Appropriate Authority shall perform the following functions,
namely:
I. To grant registration under Sub-section (1) of Section 15 or renew
registration under sub-section of that section;
II. To suspend or cancel registration under Sub-section (2) of
Section 16;
III. To enforce such standards, as may be prescribed, for hospitals
engaged in the removal, storage or transplantation of any human
organ;
IV. To investigate any complaint of breach of any of the provisions of
this Act or any of the rules made thereunder and take appropriate
action
V. To inspect hospitals periodically for examination of the quality of
transplantation and the follow-up medical care to persons who
have undergone transplantation and the persons from whom
organs are removed; and
VI. To undertake such other measures may be prescribed.
The Transplantation of Human Organs Act (THOA) in India stands
as a pivotal legal framework aimed at regulating organ donation and
transplantation practices in the country. With its inception, THOA has not
only provided a structured mechanism for the procurement and allocation
136
A Simple Introduction to Organ Transplant
Dr Gopi Ayyaswamy
of organs but has also sought to prevent the exploitation of vulnerable
individuals in the organ trade. Through stringent provisions and ethical
guidelines, THOA ensures that organ transplantation procedures adhere
to the principles of equity, transparency, and informed consent.
The signicance of THOA is evident that its impact extends beyond
mere legislative enforcement. The Act has fostered a culture of altruism
and compassion, inspiring countless individuals to consider the noble
act of organ donation as a means of saving lives. Moreover, THOA has
facilitated advancements in medical science by promoting research and
innovation in the eld of organ transplantation, thereby offering hope to
countless patients in need of life-saving interventions.
However, amidst its achievements, challenges persist in the effective
implementation and enforcement of THOA across the diverse landscape
of India. Addressing issues such as organ trafficking, black-market
exploitation, and disparities in access to transplantation services remains
imperative to uphold the principles enshrined in the Act. Furthermore,
raising awareness and promoting education about organ donation and
transplantation are essential steps towards fostering a culture of ethical
and voluntary organ donation in the country.
In conclusion, the Transplantation of Human Organs Act (THOA)
stands as a testament to India’s commitment to promoting the well-being
of its citizens and upholding the sanctity of human life. As we continue
to navigate the complexities of organ transplantation in the modern era,
let us remain steadfast in our dedication to advancing the principles of
justice, compassion, and solidarity embedded within THOA. Together,
let us strive towards a future where every individual has equitable access
to life-saving organ transplantation, and where the gift of organ donation
serves as a beacon of hope for those in need.
Dr Gopi Ayyaswamy
Contents
1. Denition of brain stem death as per THOA 1994.
2. Identication of brain stem death
3. Determination of brain stem death
4. Certication of brain stem death
5. Brain stem death Checklist
6. Form 8 model
7. Difference between coma and brain stem death
Definition
Brain stem death as dened by the Transplantation of Human Organs Act,
1994 Act No. 42 of 1994 dated 8th July, 1994 states that:
“Brain stem death” means the stage at which all functions of the brain-
stem have permanently and irreversibly ceased and is so certied under
Sub-section (6) of Section 3;
Brain stem death—“the stage at which all functions of the brain stem have
permanently and irreversibly ceased” (THOA)—is recognized as death in
most countries of the world, the THOA is the only legislation in India that
conrms it as legal death, and provides a procedure for certifying it.
Brain Stem Death Can Occur in Patients
• Who have sustained injuries to the brain resulting from traumatic causes
such as road accidents, falls, blows to the head
Transplant of Human
Organs Act
16
138
A Simple Introduction to Organ Transplant
Dr Gopi Ayyaswamy
• Non-traumatic causes like spontaneous bleeding from high blood
pressure,
• Bursting of brain aneurysm,
• Drowning
• Carbon-monoxide poisoning during which time the brain is deprived
of blood and oxygen.
Identification of Brain Stem Death
Preliminary Criteria
Patients who meet the following criteria must be examined for establishing
the diagnosis of brain stem death.
a. Apparent coma
b. Lack of brain stem reexes
c. Not breathing without the ventilator
Pre-requisites for Declaration of Brain Dead
A denite, known and demonstrably irreversible cause of brain injury/
damage
i. Precise clinical or imaging evidence of an acute CNS (central nervous
system) catastrophe that is compatible with the clinical diagnosis of
brain stem death.
ii. No confounders that may hamper the clinical assessment. (For
example, medical conditions like severe electrolyte/acid–base
imbalance, endocrine disturbance, drug intoxication or poisoning,
neuromuscular blockade, hypotension [<100 mmHg] and hypothermia
[core temperature <36°C])
Components of a standard DNC (Death by Neurological Criteria
Examination)
Following are the three components of a standard DNC (death by
neurological criteria examination), performed on the patient to arrive at
the clinical diagnosis of brain stem death.
• Coma: No response to painful stimuli
Transplant of Human Organs Act
139
Dr Gopi Ayyaswamy
• Absence of brain stem reexes
• An appropriately done apnoea test
Note: It should also be understood that no permission is required from the family to perform clinical
examination and apnoea test. It is considered a part of the examination to which all patients in the
hospital are subjected to.
Exclusion/Correction of Complicating and Co-existing Medical
Conditions that may Confound Clinical Assessment
The approach to the patient who is being evaluated for death should be to
ensure that there is not a confounding issue that could render the diagnosis
false. This is clearly the job of the physician. Following is a brief account
of confounders which need to be carefully addressed during the process
of determination of brain stem death.
1. Intoxications/medications
2. Homeostatic abnormalities
• Hypotension
• Hyponatremia
• Hypercalcemia
• Severe acidosis
• Hyper- or hypoglycaemia
• Hepatic insufciency
• Severe renal failure (high BUN [blood urea nitrogen] and creatinine)
• Occasionally, endocrine abnormalities such as Addison’s hypocor-
tisolism and thyroid disease can affect mental status.
1. Hypothermia
2. Cardiac arrest with return of spontaneous circulation (ROSC) after
resuscitation.
Neurological Determination of Death
Mandatory Points to be Noted
• The consultant physician and/or neurologist/neurosurgeon should
conduct a thorough and methodical clinical examination of the
neurological status and functioning of the patient.
140
A Simple Introduction to Organ Transplant
Dr Gopi Ayyaswamy
• The examination should remain consistent with prescribed brain stem
death guidelines throughout the observation and testing period.
• Two tests are necessary; they should be separated by no less than 6 hours
in adults.
• Once a time interval has been set for the second test, it must be carried
out within that interval, either by the examining physician or by a
suitable designated medical practitioner.
• In children, age is important in considering time intervals between two
tests: 1 week to 2 months, 48 hours; 2 months to 1 year, 24 hours; >1
year, 12 hours
Neurological Assessments
1. Evaluation of coma: Response to painful stimuli
2. Cranial nerve examination: Eliciting brain stem reexes
• Pupil response test
• Corneal examination
• Oculocephalic tests
• Oculovestibular tests
• Gag tests
1. Evaluation of Coma: Response to Painful Stimuli
There should be complete loss of consciousness, loss of motor response
to pain, accid tone and absence of spontaneous or induced movements.
Technique: By applying pressure on the trapezius muscle, nger nail bed,
supraorbital ridge or temporomandibular joint.
Steps:
• Pinch trapezius muscle or apply nail bed pressure in hand or pressure
on supraorbital ridge or temporomandibular joint
• Examine for abnormal movements/grimacing
• Repeat on opposite side
Interpretation: Presence of brain stem function: Voluntary movements/
posturing/grimacing. Absence of brain stem function: Patient must be
without any type of response to verbal/painful stimuli
Transplant of Human Organs Act
141
Dr Gopi Ayyaswamy
Note: Spinal reexes and various spontaneous movements may be present in brain stem dead
patients and should not be confused with evidence of brain stem function.
2. Cranial Nerve Examination
Eliciting brain stem reexes: The cranial nerve examination conrms the
absence of reex arcs that require brain stem function but do not require
cortex function.
• Pupil response test
• Corneal examination
• Oculocephalic test
• Oculovestibular test
• Gag test
Note: All the above tests are performed on both the sides of the patient.
Pupil Response Test
The reex arc of 2nd and 3rd cranial nerves is tested by observing the
response to light
Technique: Shining light (torch) into each eye sequentially by sweeping
the torch from lateral (close to the ear) to medial.
Steps
• Both eyes should be open (response is observed in both eyes)
• Sweep light in the left eye from lateral to medial
• Observe response in left eye (direct reex) and right eye (indirect/
consensual reex)
• Repeat on opposite side after a minute
Interpretation
• Presence of brain stem function: Pupils constrict
• Absence of brain stem function: No pupil response
Corneal Examination
The reex arc of 5th and 7th cranial nerves is tested by observing the blink
response.
142
A Simple Introduction to Organ Transplant
Dr Gopi Ayyaswamy
Technique: A wisp of cotton is rubbed against the cornea, taking care not
to injure the cornea.
Steps
• Take a cotton swab and pull out some threads at the end to make a
wisp.
• Approach the patient laterally so that he cannot see you coming.
• Gently place the wisp on the cornea at the junction where iris and sclera
meet and brush it laterally.
• Repeat on opposite side.
Interpretation
• Presence of brain stem function: Blinking of the eyelids
• Absence of brain stem function: No blink response
Oculocephalic Tests (Doll’s Eyes)
The reex arc of 3rd, 4th, 6th, 8th and 11th cranial nerves is tested by
observing the movement of patient’s eyeballs while moving the head.
Technique: Test is performed by holding the eyes open and moving the
head back and forth. The endotracheal tube is held in place.
Note: Do not perform this test on patients with unstable spine fractures
Steps
• Hold patient’s eyes open and hold the endotracheal tube also in place,
so that it does not get dislodged.
• Briskly turn the head (with a bit of jerk) one way and then the other.
Interpretation
• Presence of brain stem function: The eyes x their gaze in one point in
the space and the eyes move in the head as the head is moved to keep
looking at the same place
• Absence of brain stem function: The eyes are xed in the head and the
eyes will move with the head, regardless of how the head is positioned.
Transplant of Human Organs Act
143
Dr Gopi Ayyaswamy
Oculovestibular Tests
The reex arc of 3rd, 6th and 8th cranial nerves is tested by administering
cold water into the ear canal and observing eye movements.
Technique: The purpose is to cool the tympanic membrane and it is done
by cold water irrigation into the ears.
Note: Do not perform this test on patients with a ruptured tympanic membrane; Also responses
can be absent if there is blood/cerumen in the auditory canal. This can be avoided by an otoscopic
examination prior to the test.
Steps: Inspect the auditory canal for ruptured tympanic membrane/
blood/wax in the canal
• Elevate the head to 30 degrees
• Place a small basin below the ear
• Hold the eyes open.
Use a 30 or 60 cc syringe with buttery tubing (needle cut off) to slowly
ush 30–60 ml of ice water into the ear.
Repeat on the opposite side after waiting for a warm up period of 5 minutes.
Interpretation
• Presence of brain stem function:
– Awake patient: Eyes deviate towards cold water stimulus and rapid
phase of nystagmus in the opposite direction.
– Comatose patient: Eyes deviate towards cold water stimulus usually
with nystagmus.
• Absence of brain stem function: No ocular response
Gag Test
The reex arc of 9th and 10th cranial nerves is tested by stimulating the
posterior pharynx and observing the gag reexes.
Technique: The gag test is done by visually inspecting the oral cavity as
the posterior pharynx is mildly stimulated.
Steps:
• Open the mouth and shine light on the posterior pharyngeal membrane