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Tests on organs fluid continue

Tests are being carried out on a liquid used in organ donations in case bacteria has contaminated it
Tests are being carried out on a liquid used in organ donations in case bacteria has contaminated it

Tests are continuing into whether a faulty pressure gauge is behind a bacteria outbreak on the production line for the UK's main donor organ solution.

Pharmaceutical firm Bristol-Myers Squibb is investigating a small leak that could have led to the bacteria Bacillus cereus appearing on the line for Viaspan solution.

Viaspan preserves the kidney, liver, pancreas and bowel, and is often used when organs are transported around the country. Its main use is to preserve kidneys, of which around 1,500 transplant operations are carried out every year in the UK.

Bristol-Myers Squibb issued a worldwide recall of Viaspan on Thursday night after the bacteria was found at a facility in Austria.

A spokeswoman for the firm said inspectors became aware of a problem earlier this month when routine testing of the line revealed some cloudiness.

In order to test the line's sterility, production of Viaspan is stopped and another solution is run through the system. It is this test solution that was found to contain Bacillus cereus. Tests are now being carried out on stocks of Viaspan itself.

The spokeswoman said: "They believe, potentially, that the issue is a faulty pressure gauge on the production line that's been found to have a small leak. An urgent investigation is being carried out and everything is being tested."

The Government and the Medicines and Healthcare products Regulatory Agency (MHRA) are working to secure alternative liquids for transplants. Until then, Viaspan will still be used in the UK and patients can be prescribed an antibiotic in case the bug is present.

Bacillus cereus is most well known for producing a toxin in food which causes food poisoning. Symptoms of the poisoning include diarrhoea - which may be bloody and severe - nausea, vomiting and stomach cramps.

Chief medical officer, Professor Dame Sally Davies, said: "Our priority is to ensure patients are safe. There is currently no evidence of any problems in patients who have recently had transplants where Viaspan has been used. If we were to recall the product immediately it is clear that patients would suffer and some may die."

Press Association


From Belfast Telegraph