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Probe follows baby Molly inquest
28.11.07
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THE Irish Medicines
Board (IMB) is investigating claims it tested the
wrong batch of cardiac valves after the death of a
baby heart patient in Co Donegal. The IMB also
confirmed yesterday that the cardiac implants,
manufactured by Shelhigh Inc., - a US company
currently under investigation by the American Food
and Drug Administration (FDA) - are still certified
for use in Europe. |
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However, the board said
the Shelhigh implants have not been used in Ireland
since 2001. The IMB came in for severe criticism
last week at the inquest into the death of six-month
old Molly Markey from Redcastle, Co Donegal, where
the jury returned a verdict of death by medical
misadventure.
Molly Markey was born in May 2005 at Altnagelvin
Hospital, Derry, |
with a rare heart
defect and was fitted with a Shelhigh porcine valve
at the Royal Victoria Hospital, Belfast, in July of
that year. The operation was deemed a success and
this was confirmed at a check-up in October.
However, Molly became very ill on the morning of
November 9, 2005 and died an hour later in her
mother's arms. She had suffered a large ventricular
aneurysm.
An autopsy undertaken by consultant histopathologist
Dr. Michael McDermott at Our Lady's Hospital for
Sick Children, Dublin, found there was a
micro-bacterial infection within the implanted
pulmonary valve. Dr. McDermott said the infection
"most likely" developed because the valve was not
sterile at the time of implantation.
However, as a pathologist and not a cardiologist, he
was unable to definitively conclude that the
micro-bacterial infection directly caused the baby's
death.
IMB medical devices department director, Ms. Ann
O'Connor told the inquest that after the baby's
death was reported, a full and detailed review was
undertaken involving the IMB, its Spanish
counterparts, an EU working group and Shelhigh Inc.
At the end of the review which included sterility
test results from Shelhigh, the IMB was satisfied
the product was sterile when it left the
manufacturing plant. The IMB and the EU working
group concluded that the certification mark was
issued correctly and that it remained valid.
It emerged during the inquest, however, that the lot
number of the device implanted into Molly Markey's
heart appeared not to correspond with the lot number
inspected afterwards by the IMB and the EU working
group.
Raymond Bradley, solicitor for the family put it to
Ms. O'Connor that the IMB's system for inspecting
devices for safety on behalf of the Irish public was
"fundamentally flawed". "You are accepting what the
medical device manufacturer is saying to you," he
said.
Asked yesterday how it appeared to have investigated
the wrong batch, the IMB said in a statement: "Each
device has an individual serial number, a device lot
number and a sterility lot number associated with
it.
"The IMB did not have direct access to the patient
files from which a number was quoted at the
coroner’s court and therefore we do not know which
of the three numbers are recorded on the file and
which was quoted. "While the IMB is investigating
the matter, it can state that the device lot number
was the number provided by the IMB in court last
Friday."
Asked if the IMB had failed in its duty of care to
the public by not issuing a warning notice about
Shelhigh implants until May 2007, the statement
continued: "The IMB have been informed that Shelhigh
cardiac devices have not been distributed in Ireland
since 2001. The IMB issued a safety statement in
2007 to update healthcare professionals of the
situation in the US in relation to this device."
To read more from the inquest
click here
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