Memorandum by Mrs Clare Bowen (PS 79)
PATIENT SAFETY
INTRODUCTION
Bethany Bowen had a hereditary blood condition
(spherocytosis) that resulted in anaemia and significant swelling
of the spleen. She was healthy and normal in every other way,
and was able to attend school, interact with other children and
engage in play. Visible symptoms were a slightly yellow skin,
and the appearance of an enlarged stomach (due to the swelling
of the spleen). Her condition required monitoring, but she was
coping well with it at the time of the operation even with the
complication of three small gallstones. The operation was necessary
at some point in her childhood as existing alternatives are inadequate.
The operation is normally straightforward and
comparatively risk free.
The procedure consented to by the parents:
Laparoscopic surgery would be employed to mobilise
the spleen. The spleen would then be dropped into the pelvic area,
where it would be removed via a bikini-line incision. Following
splenic removal, the gall bladder would be opened and gall stones
removed.
The procedure carried out:
Laparoscopic surgery was employed to mobilise
the spleen. A morcellator was employed to break up the spleen
inside an endoscopic bag, inside the body cavity. The morcellator
blade was applied to the spleen via a small opening in the abdominal
wall. Collapse occurred during this process and the rest of the
operation had to be abandoned. Beth died in theatre never recovering
from initial collapse.
KEY CRITICISMS
The following points are based on information
gathered from letters, reports, and audio recordings of meetings
held at the John Radcliffe Hospital and the inquest at Oxford
Coroners Court.
— The proposed procedure for spleen removal
was changed after the consent forms were signed by the parents.
— The parents were not informed of this
change, or of any additional risks this entailed.
— No reason was given as to why the proposed
procedure was changed at the last minute.
— The new procedure involved the use of
a morcellator, which carried considerably more risk to the patient.
The risks associated with the morcellator significantly outweighed
the benefits.
— The new procedure was a training exercise.
— The doctor operating the morcellator
was a trainee, and had never operated the tool before or heard
of the procedure before that morning.
— The surgeon directly supervising him
had never seen or operated the tool before.
— A third surgeon, believed to have some
experience (but not in the UK and a number of years ago), was
present in the room but not watching the tool in operation.
— This is considered by both the Trust
and the surgeons as a perfectly acceptable definition of conducting
an operation using trained staff.
— Evidence was destroyed: including the
bag containing the spleen; the swabs; all the disposable parts
of the morcellator including the blade; the bag applicator, and
all the blood collected.
— Poor record keeping: an independent anesthetist
examined some of the medical notes and found them to be completely
inadequate, in terms of insufficient detail, and numerous omissions.
— Post mortem examination revealed Bethany's
Aorta to have two complete cuts, approximately 1cm apart. (It
should be noted that the diameter of the morcellator blade is
approximately 1cm.)
— With regard to the cuts, the testimony
by the surgeons present in the operating theatre shifted from:
| (a) | July 2006 (following Bethany's death): blood vessel accidentally cut with morcellator resulting in major blood loss and death. To,
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| (b) | January 2007 (Recorded meeting): Aorta cut in two places, probably with the morcellator, but the resulting blood loss was not significant. Cause of death unclear. To,
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| (c) | November 2007 (Inquest): Aorta certainly not damaged by the morcellator, and the two cuts found have no explanation. Blood loss from the cuts insignificant, and cause of death unclear.
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— Cuts were found to her large intestine and stomach,
in addition to those found in the aorta. No explanation was given
as to the cause of these cuts.
— The doctors have dismissed all suggestion they caused
her death either through their actions or inaction, but have not
presented any alternative explanation.
— The Trust failed to satisfactorily investigate the
events surrounding Bethany's death, and pursued a strategy of
misinformation and obfuscation, including circulation of documents
containing gross inaccuracies relating to the family. The only
actions that could be seen as proactive on their behalf were failed
attempts to find a pre-existing medical condition in the family.
— The family were forced to appoint a solicitor in an
effort to overcome difficulties in dealing with the Trust and
to fight for a full inquest.
— Sixteen months after Bethany's death the Trust admitted
liability for not gaining adequate consent, and for not having
proper training procedures. However, a number of surgeons, when
giving evidence at the coroners inquest, refuted the suggestion
relating to inadequate consent, and stated that the training was
sufficient.
— Instructions laid down by the manufacturer of the
endo bag, which specifically state that a morcellator should not
be used with this bag on the grounds of safety, were ignored by
the surgeons operating on Beth. This was not acknowledged as an
error of judgment. On the contrary, the need to comply with the
manufacturers instructions was disputed in the coroner's court.
— Training in the UK is offered and indeed recommended
by the supplier of the morcellator (both at an external training
centre, and on site at the hospital) but was not undertaken. The
surgeons believe the morcellator is too simple a piece of equipment
to require such training.
— Consultant surgeons are not required to log or record
any of their training or experience. They are able to say to a
hospital "I am trained on this piece of equipment" and
that is usually considered sufficient. They do not have to prove
it or show any records before carrying out the procedure.
— First indication from the anaesthetist of Bethany's
collapse occurred at 1615. The circulating nurse was told to leave
at 1630. This instruction was unprecedented in his experience.
A senior staff nurse took over as circulating nurse, and observed
the doctors having a discussion about what to do next. They were
not attempting CPR at that point. Attempts were made to release
the other circulating nurse at 1645, but she resisted. She was
relieved from duty at 1710.
— It has been stated that 1630 was the scheduled end
of the nurses' shift. This does not satisfactorily explain why
a senior member of staff attempted to enforce a shift change during
a medical emergency. Indeed, it is astonishing.
— A report into what happened to Bethany and what procedural
changes would be made was promised by the JR Trust following her
death. At the time of writing, two years, three and a half months
have passed since Bethany's death and the family have received
plenty of excuses, but no report.
POSSIBLE CONCLUSIONS
1. Bethany's death is a mystery. It occurred due to a
symptomless pre-existing medical condition that was not diagnosed,
not detected at post-mortem, and manifested itself simultaneously
with cuts appearing in the aorta, leading to a stopping of the
heart. The actions of the surgeons did not cause her death.
2. Bethany's death has a scientific explanation. This
would almost certainly have been established had
(i) all the above-mentioned evidence been safeguarded,
(ii) cameras been fitted to the walls of the operating theatre
and their data verifiably protected.
(iii) Data gathered by heart function and other vital organ
monitoring equipment been recorded automatically, in real time,
and protected with tamper seals.
(iv) a national and independently appointed investigation
team been brought in whenever an incident such as this takes place.
This team should consist of people with an investigative background
(eg former police officers), as well as medically trained members.
The verdict from the inquest stated that Bethany's aorta
was damaged by an unspecified surgical instrument. No attempt
was made to hold any surgeon responsible for their actions, and
no recommendations were made by the coroner.
Recommendations:
The time has to come to acknowledge that medical staff may
not always be forthcoming with all the facts following the death
of a patient that they were directly involved with. To do so could
damage or even terminate their career, and implicate colleagues
with whom they work closely.
It should also be recognised that it is not in the interests
of the NHS Trust to publish information that reveals human error
and serious shortcomings in procedure. They have a reputation
to protect.
This may seem obvious, but the experience of the witness
both in the 16 months prior to the inquest and during the inquest
itself, is that the testimony of the doctors is ultimately
decisive in determining the facts.
It is the key recommendation of this report that the only
way to prevent a repeat of this accident, reduce the level of
similar incidents, and safeguard against cover-up, is to introduce
all the points listed in 2. i to iv above and to set up a regulatory
body (either within or outside the NHS) that monitors and records
all doctors training with new procedures, ensuring they are fully
assessed and documented rather than the "lets have a go"
approach used in Beth's case.
Also, it is common knowledge that clinicians close ranks,
feeling they are under siege, when things go wrong. It would have
taken a brave doctor or nurse to speak out after Bethany's death.
The railway industry has a reporting system known as CIRAS.
This stands for "Confidential Incident Reporting and Analysis
System".
"CIRAS is an alternative way for rail industry staff
to report safety concerns that they feel unable to report through
company safety channels. It is a completely independent and confidential
way to report safety concerns without fear of recrimination."
[www.ciras.org.uk]
CIRAS has been in place for many years—the work has
already been done—the government need only liaise and adopt
this system for the NHS. We strongly recommend they do this.
TREATMENT OF
THE FAMILY
BY THE
HOSPITAL AFTER
THE DEATH
OF BETHANY—WRITTEN
BY HER
MOTHER CLARE
We were informed of her death by the surgical team, whilst
on the ward in front of other patients and visitors, and were
not taken somewhere more private. Following disclosure of this
devastating news, we were left to leave the ward and walk out
of the hospital via the main entrance unaided and unaccompanied
by any hospital staff. We were not asked as to our means of getting
home, and we were not in a fit state to drive. By chance, other
family members were available to drive us, but the hospital did
not know this.
The hospital contacted us the following day, and arranged
for a bereavement services appointment. However, the hospital
later cancelled this visit, and offered no explanation.
No information was given to us unless we asked the right
question, and even after we asked if all of the information had
been given to us they produced new photos and slides at the inquest.
We spent a very long time talking to the hospital about Beth
and what had happened, but all new information we received was
because of questions we asked, they never volunteered information
and they were always very closed and defensive towards us.
They never said sorry other than in a letter from their solicitors
after the inquest when they admitted liability. [N.B. Liability
admitted by the Trust; the surgeons remained in denial.]
None of them saw Beth as a little girl only a patient to
practice on, another patient to wheel through the theatre.
If any of the operating team had stopped to question each
other on what they were doing, or had been made, by procedure,
to discuss options then I believe Beth would still be alive today,
why did no one say,
— Is it not better to remove a broken bag than leave
a child under anesthetic for an extra 45 minutes?
— Is it not better to get some retraining as you have
not used this equipment for 3 to 4 years?
— Is it not better for the trained doctor to be hands
on rather than outside the operational field watching a screen
where the manufacturers [of the endo bag] believe you would not
be able to see anything if it did go wrong?
— Is it not right to inform the parents we have altered
the operation plan?
— This piece of equipment is not made specifically for
paediatrics and had never been used in UK for splenectomy before.
Do we not need more than a conversation on the morning of the
operation before we go ahead and use it?
Why is it in the field of surgery that doctors training and
experience allows them the right to make decisions without question
and without fear of being held to account?
When I signed the consent form I believed a doctor who had
relevant training was operating on Beth. This was not the case.
Would you get onto an aeroplane with a pilot who did not know
how to fly, with a copilot who had had it explained but never
seen it done and a cabin crew who said they had done it three
to four years ago, this is comparatively what situation they put
Beth into.
THE MORCELLATOR
The Gynecare morcellator has a nose (or barrel) of approximately
20cm in length with a rotating blade protruding at the tip, in
order to reach and cut tough material in parts of the body difficult
to access by any other means. It has been specifically designed
for use in gynaecology, where it is often used in hysterectomies.
It had not been used to break up a spleen inside an endo
bag, laparoscopically, in paediatric surgery before, either at
the JR, or anywhere else in the UK. The following are some of
the risks associated with this new type of surgery:
1. The blade is capable of 1000rpm (although the surgeons
who operated on Bethany state they used it on the lowest speed
setting).
2. Located at the tip, the blade cannot be seen as it cuts
into the spleen, which is inside an endoscopic bag within the
abdomen.
3. The nose (or barrel) is too long for this type of operation.
The surgeons stated at the inquest that they applied the tip no
more than 2 or 3 centimetres into the abdomen. However, it is
difficult to know precisely how far the device had been pushed
in, without any gradations or marking to give an indication. An
extra one or two centimeters could result in cutting through the
bag and causing injury, and some point of reference is clearly
essential—especially when the operator has no experience.
To reiterate: they could not see the blade, and were relying on
a best guess as to how deep it had penetrated.
4. A laparoscopic (or keyhole) camera was used, which gave
a limited view of the bag inside the abdomen. During the inquest
the court heard that the field of view was very restricted, showing
only one side of the bag. Had the blade penetrated the other side,
this would not be visible on the monitor screen.
5. The inquest heard of an incident which occurred in the
USA in 2006, when a morcellator was used on a woman patient, to
cut up the spleen inside an endo bag. The morcellator went through
the bag, cut her aorta, and the patient died.
6. When used with inadequate training, (for whatever procedure)
it is potentially dangerous. The representative from [Johnson
and Johnson] stated, "I would not advise anyone to use the
morcellator without first attending our training course, where
the user practices on a cows tongue."
Why would a Morcellator be used in this type of operation?
The lead surgeon cited the following advantages:
"You can remove the spleen piecemeal, not the total spleen,
but partly remove it piecemeal to make it more softer [sic] and
then remove it with the forceps."
In addition, the morcellator will, in theory, speed up the
process of spleen removal, which was of some relevance in Bethany's
operation because the surgeons had intended to proceed to remove
gall stones, after the splenectomy. However, had time been a critical
factor in this operation, it should be noted that the surgeons
lost 45 minutes in the early stages in attempting to place the
spleen into a damaged bag, before abandoning it and using a replacement
bag. They cited the cost of wasting a disposable bag as the reason
for their 45 minutes of perseverance. Safety to the patient, and
time lost, was not a factor that seemed important during that
part of the procedure.
It should also be noted that there are safer, proven, alternative
techniques for breaking up the spleen inside a bag, which make
use of blunt instruments.
OTHER FACTORS
IN ELECTING
TO CHOOSE
THE MORCELLATOR
As a new technique it is attractive to surgeons. As surgeons
they are "hands on", and there is clearly a degree of
excitement about pioneering a new technique. Individual surgeons
gain recognition within their profession and in the media for
being the first to introduce new methods and embrace new technologies,
that go on to become adopted by the profession at large.
CONCERNS
The difficulty is that there are no systems in place to hold
them back. They are able to make spur-of-the-moment decisions
that radically alter the risks to the patient. They are not compelled
to comply with manufacturer's safety instructions. A representative
of the manufacturer of the endo bag, whilst giving evidence stated:
"We've, in our experiments and in our research, discovered
the bag is fantastic for keeping soft tissue and protecting wounds,
wound edges, it's not intended for use in conjunction with very
sharp devices…"
"My experience is we've always said do not use the morcellator
and I know that we have had experience either at the research
stage, or early on in the use of the product which would suggest
that the morcellator is not a good thing to do, in the bag, as
you saw there it is very difficult to see what is going on in
the structure when you can only see one face of it laparoscopically.
The comment was 'You can't see either behind or below'".
The instructions for use that accompany the retrieval bag
specifically state that a morcellator should not be used in conjunction
with it: "We stop people from doing it", he said.
The surgeons do not have to attend training courses if they
consider they have sufficient experience in the theatre. The point
is—they decide. When things do go wrong, they are not held
to account. This is evident from the outcome of the inquest, which
stated that Bethany's aorta was damaged by an unspecified surgical
instrument. No attempt was made to hold any surgeon responsible
for their actions, and no recommendations were made by the coroner.
RECORD KEEPING
Blood loss was recorded as not significant, but no attempt
made to quantify, where quantification was possible. Records were
omitted; an independent anaesthetist at a meeting stated, "There
are boxes to be filled in [she proceeds to list various categories]
it's just completely blank".
The batch number and lot number of morcellator components
was not logged. During a meeting with the Trust, Bethany's father,
Richard, noted, "Potentially you've got a box full of faulty
parts in your hospital ready to use on somebody else." This
was in the context of a suggestion by the Trust that an electrical
fault in the morcellator may have been the cause.
Her weight was incorrect on the notes, and this was not queried
by the anaesthetist, who said that she had assumed figures had
been transposed.
Given the magnitude of error that occurred on the day Bethany
died, it is easy to lose sight of other, lesser systemic and procedural
failings which, had the morcellator not been used, could have
lead to other types of adverse event.
HUMAN FACTORS
A great deal of the testimony of the doctors was in the third
person, using phrases that repeatedly referred to how a given
procedure would be carried out, should be carried out, or had
to be carried out, but very rarely (if at all) said what they
actually did on the day Bethany died.
Bethany's father Richard, who tragically died from heart
disease brought on by the stress of losing his daughter and the
painful circumstances that followed, had this to say,
"Until the NHS is called to account for taking these
risks they will simply go on killing our children… We have
little faith that lessons will be learned until there is an independent
body that monitors surgical training in the NHS. The risks that
were taken by the Trust during the operation on Bethany were simply
incredible and the attitude of the Trust was truly appalling."
November 2008
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