Organ transplant solution was tainted

The head of organ transplantation at Beaumont Hospital has criticised the Irish Medicines Board for failing to tell the hospital that a solution for transplanting organs had been quarantined because it was contaminated.

According to David Hickey, director of transplantation at Beaumont Hospital, three patients had organs implanted which had been stored in a batch of viaspan that has been quarantined by IMB.

While he said those three patients had not suffered any problems, he said it was an “extraordinary oversight” by IMB and the manufacturers, Bristol-Myers Squibb, not to tell Beaumont about the contamination.

“We found out about this in Beaumont on Friday when St Vincent’s rang us to tell us they had tried to replenish their stocks and they had been told the solution was no longer available,” Mr Hickey said.

“There is a worldwide ban on it for the moment but we found out only because Vincent’s called us. We would have used stock we had if we had not been informed.

“Myself and our chief pharmacist managed to source another solution through Denmark which is pretty much similar. We were able to get that in on Saturday and we have been using that solution for the donors we have now.”

Viaspan preserves the kidney, liver, pancreas and bowel, and is often used when organs are transported around the country.

Tests have found the presence of a bacteria, Bacillus cereus, in the solution. Bacillus cereus is most well known for producing a toxin in food that causes food poisoning.

Symptoms of the poisoning include diarrhoea — which may be bloody and severe — nausea, vomiting, and stomach cramps.

Mr Hickey said it was “correct and careful” on the IMB’s part to quarantine the batch and he said the contamination would probably be resolved without any problems to anybody.

“But the extraordinary thing is that this is done and the people who are responsible for procuring organs and donors were not informed either by the IMB or by Bristol-Myers Squibb,” said Mr Hickey.

“IMB pulls a product but does not inform the people it impacts on.

“It is an extraordinary oversight by both bodies.”

Bristol-Myers Squibb said it took its responsibility for patient safety “extremely seriously”.

“We routinely monitor our manufacturing lines to confirm that our products conform to the highest quality standards required by the regulatory authorities,” it said. “During one such routine test we received notification from the third-party manufacturer of potential contamination on the production line.

“Following this notification, we have taken the precautionary measure of recalling all batches of viaspan.

“BMS has notified all health authorities in countries where the product is distributed and will provide further updates as the investigation progresses.”