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The British government has confirmed that there had been a global recall of the fluid used to store most of its donor organs over fears it may have become contaminated.
The bacteria Bacillus cereus was found in the production line of Viaspan, the world's "gold standard" organ storage fluid, a spokesman for Britain's Medicines and Healthcare products Regulatory Agency (MHRA) said.
US manufacturer Bristol-Myers Squibb (BMS) confirmed it had issued a global recall after tests found bacteria in the solution used to monitor the sterility of the storage fluid.
No patients affected yet
"We are urgently investigating the cause of this issue," the company said. "BMS has notified all health authorities in countries where the product is distributed and will provide further updates as the investigation progresses."
The British government stressed that no patients had reported any adverse reactions following transplants, and that it would still use organs currently stored in the fluid.
"Our priority is to ensure patients are safe," said Sally Davies, the government's top health advisor. "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."
The last production-line tests were carried out in July, so any fluid produced since then is at risk of contamination.
The results of ongoing tests on batches on Viaspan are due within two weeks, according to the British health spokesman.
Viaspan preserves the liver, bowel and pancreas and is often used when organs are transported.
The bacteria can cause diarrhoea, nausea, vomiting and stomach cramps, but patients can be prescribed antibiotics before their operation as a precautionary measure. - (AP, March 2012)
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