To Err is Human: Post Mortem of the recent Max controversy
Dr KK Aggarwal
National
President IMA
“A premature (22 weeks) newborn was allegedly declared
dead. While being taken for the funeral, the newborn was discovered to be
alive, put on life support system, and died after 5 days. His twin was
stillborn.”
This was a ‘medical error’ caused due to wrong diagnosis
and declaring a newborn dead in the presence of hypothermia. This amounts to
professional incompetency and it is for the MCI or State Medical Council to
take necessary action against the concerned doctors.
Clinical death vs permanent death is a concept that
started after the introduction of CPR in the country. A similar mistake
occurred in Safdarjung hospital in June 2017, that of terming clinical death as
brain death. In clinical death, the person may have no signs of life, but the
brain remains alive for 10 minutes in routine deaths and for few hours in
hypothermia. CPR during this period can revive the heart.
There is always opportunity in adversity and the same is
true for this incident as well. Measuring rectal temperature in newborn is not
currently the practice. However, in view of this incident, measuring rectal
temperature should now become part of the protocol adopted before declaring a
newborn dead. This will ensure that no patient is declared dead under
conditions of hypothermia.
Mistakes or errors are a part of clinical practice. They
should be accepted as there is always a lesson in them. However, with
knowledge, we can learn more about how to avoid them.
This was, however, not a case of criminal negligence.
For this incidence to be called criminal negligence and
to apply Section 308, there should have been an intention to declare an living
baby dead or the knowledge that the baby was alive. According to me, the doctor
on duty was unaware that the baby was alive.
Even today, not everyone knows that in hypothermia, the
brain can remain alive for few hours.
I personally feel such mistakes will continue to happen
until widespread dissemination of this knowledge is undertaken.
Are medical errors common?
The Institute of Medicine released their landmark
report To Err Is Human in 1999 according to which 98,000
people die in US hospitals every year from preventable medical errors.
In 2013, there were about 400,000 deaths from
preventable medical errors. Today, 1.7
million Americans are victims of preventable medical errors, which lead to as
many as 440,000 deaths annually. In India, the number is likely to be higher.
Was this mistake avoidable?
I feel mistakes occurred at every level. The first one
was by the first junior doctor, second by nurse, third by the senior nurse, and
lastly by the consultant. If the child was alive, at least one of them could
have noticed.
It’s clear that the child had no heart beat and hence the
error in judgment.
Also, the very fact that all concerned missed the
diagnosis of alive brain indicates the level of ignorance and absence of
established protocols in the medical society.
IMA has since issued an advisory to make sure that all
practitioners are aware of this fact. It is also creating guidelines regarding
declaring death in hypothermia cases.
Doctors and nurses also make mistakes as a part of their
learning curve. Only bad doctors sexually molesting patients,
stealing drugs, or making a wrong diagnosis with no insight need
to be punished.
Definition of abortion
As per the Medical Termination of Pregnancy Act, termination
of a pregnancy at 20 weeks is an abortion and delivery
after 20 weeks and before 37 weeks is a premature delivery.
What is prematurity?
Prematurity is defined as a birth that occurs before the
completion of 37 weeks (less than 259 days) of gestation. It is associated with
approximately one-third of all infant deaths and accounts for about 45%
of children with cerebral palsy, 35% of children with vision impairment, and
25% of children with cognitive or hearing impairment.
The risk of complications increases with increasing
immaturity. Thus, infants who are extremely preterm (EPT), born at or
before 25 weeks of gestation, have the highest mortality rate (approximately
50%) and if they survive, they are at the greatest risk for severe impairment.
What is fetal viability?
A fetus delivered after 28 weeks or one with a weight
> 900 gram is a viable fetus; no consent is required for active
resuscitation (surfactant and ventilator if required)
What about 20-28 weeks?
Today 20-28 weeks means extreme prematurity. The fetus
must be put on warmer and symptomatic therapy. It is a norm to not put the
fetus on ventilator. However, if the parents insist on placing the
22-week-old baby on ventilator, the doctors can find it extremely hard to
refuse. The process should then be carried out only after informed consent. In
cases the patient cannot afford, he or she must be transferred by the private
hospital under supervision to a government hospital with nursery facility.
Classification of prematurity
Preterm infants can be classified
according to gestational age (GA) as follows.
· Late preterm birth: GA between 34
and 37 weeks
· Very preterm birth: GA less than
32 weeks
· Extremely preterm birth: GA at or
below 28 weeks
Preterm infants are also classified by birth weight.
· Low birth weight (LBW): Less than
2500 g
· Very low birth weight (VLBW):
Less than 1500 g
· Extremely low birth weight
(ELBW): Less than 1000 g
When to declare death?
No death to be declared in presence of hypothermia.
What is hypothermia?
A core body temperature of 90-95°F (32 to 35°C) is
mild hypothermia, 82 to 90°F (28 to 32°C) is moderate hypothermia,
and below 82°F (28°C) is severe hypothermia.
In about 14% of premature babies, core body temperature
below 35°C is common.
Can a fetus appear dead when it is not?
In severe hypothermia, cold slows or stops the metabolic
machinery underlying body function. The metabolism slows by approximately 6%
for each 1°C (1.8°F) decrease in body temperature, such that at 28°C (82°F),
the basal metabolic rate is approximately half of normal. At this temperature,
all body systems begin to fail including circulation, ventilation, and the
central nervous system. Patients often lose consciousness and vital signs may
be absent. Muscle rigidity without shivering can be mistaken for rigor mortis.
The absence of shivering and presence of stupor, skin flushing, muscle
rigidity, hypoventilation, and circulatory failure means very cold patients
often appear dead rather than hypothermic. This may partly explain why
many severely cold patients are pronounced dead without consideration of
hypothermia.
However, in this stage of severe hypothermia (core
temperature <28°C or 82°F), a suspended metabolism may protect against
hypoxia. There have been cases of patients surviving anoxia for 12 to 18
minutes at 28°C (82°F) and up to 60 minutes or more at 20°C (68°F). Intact
recovery has been reported after submersion for up to 66 minutes, after hours
of arrest without cardiopulmonary resuscitation (CPR), after CPR for as long as
six and a half hours, and with total resuscitation times up to nine hours.
Thus, recognition of hypothermia in such patients may
sometimes permit successful recovery
despite prolonged arrest. Only with such recognition can the patient benefit
from rapid, effective rewarming, and vigorous support.
How a doctor from Oxford, ‘Dr Amit Gupta’, would have
managed a 22-week-old baby?
A 22-week preterm birth is not viable for life
Firstly, as a neonatologist, I would not expect to be
called in to attend the delivery of babies that are preterm.
To put it in context, when a mother carries her baby for
9 months, it is a 40-week gestation period. Survival at 22 weeks gestation is
only about 3% in the UK and 5% in the US.
These babies, weighing anywhere between 250 grams and 500
grams, are extremely fragile and have such severely immature organ systems that
current technology struggles to transition them to full maturity. It is
accepted practice to not offer resuscitation at 22 weeks. This may change in
the future, but for now, the prognosis is grim for babies born at 22 weeks.
I would talk to parents and explain.
Before delivery, however, our obstetric staff would
counsel the parents on the abysmal outcome of babies born so prematurely. Many
would not even survive the process of labor. However, if they did, parents
would be offered support and may choose to hold the babies, to stay with them,
and take their time to say their prayers and goodbyes.
For a baby born alive, the parents would be explained
that the babies might continue to show signs of life for several minutes or
even hours.
Though it may sound shocking, we do come across cases
where the heart rate is so faint after birth, the breathing so shallow and
intermittent, that the doctor attending the delivery presumed that the baby is
dead.
So, while it is crucial that the healthcare professional
is 100% sure before death is pronounced, there have been cases where death has
been falsely presumed.
Should babies be handed over in a plastic bag?
No. This reflects a poor attitude towards human dignity
and the lack of empathy towards the enormous tragedy befalling the parents.
Even if parents consider the death of a baby at 22 weeks as a miscarriage and
choose to not carry out final rites, the body should be handed over respectfully.
However, in this case, the plastic bag probably provided the warmth needed to
revive the baby.
What is the answer?
The answer to such situations is: Fix the 'culture'.
· Communicate, communicate, and communicate
· Compassion should be demonstrated in practice as much as
in feeling. Health care is compassion and everything else stems from it. A
compassionate attitude of staff in clinical medicine is more important than all
the brilliant CVs, flashing monitors, and state-of-the-art equipment put
together. The poor/inconsiderate/
· Call relatives, meet them if they are willing, and then
listen to them. When you think you have listened enough, listen some more (and
switch your mobile phone off when you do!). Apologize for the pain they have
undergone. Don't indulge in non-apology. An apology is not an admission of
guilt, but an acknowledgment of the pain they have been through. And
tell them what you would do so that other parents don't go through this
experience.
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