The Department of Health in England says that Viaspan, a manufactured fluid used to preserve some donor organs when they are moved, could have been contaminated with the bacterium, Bacillus cereus since last July.
Viaspan is a sterile, cold solution that is widely used for storing and transporting abdominal organs such as the liver, pancreas and bowel.
Bristol Myers-Squibb, the manufacturer of Viaspan, have issued a worldwide recall of their product because they found “potential contamination on the product line” at their Austrian factory, reports The Telegraph.
A BBC report says that tests found Bacillus cereus in the solution used to test the sterility of Viaspan, and investigations are now in progress to establish if the preservative fluid itself is affected.
Results are expected in the next two weeks.
In the meantime, doctors are advised to continue using Viaspan until an alternative is found.
Chief Medical Officer Professor Dame Sally Davies said the priority was 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,” she said, according to BBC News.
“If we were to recall the product immediately it is clear that patients would suffer and some may die,” she added.
Bacillus cereus is well known for producing a toxin that causes food poisoning, symptoms of which include diarrhoea, which can be severe and bloody; nausea; vomiting and stomach cramps.
Infection with the bacterium responds to antibiotic treatment.
No transplant centres in the UK have reported any adverse events that could be linked to possible contamination.
The Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health are looking for alternative liquids for abdominal organs, in case there is a temporary shortage of Viaspan.
On Thursday, the MHRA authorized two products, neither of which carries a “kite mark” in the UK, for human use: Celsior and HTK.
Written by Catharine Paddock PhD