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Probe follows baby Molly inquest 28.11.07

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.
Baby Molly Markey 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 coronerís 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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