A solution that is manufactured for Bristol Myers-Squibb by a third party and used to preserve some donor organs could be contaminated with bacteria.
Fiona McMillan, corporate and brand communications manager at BM-S’s UK headquarters in Uxbridge, says the bacteria Bacillus cereus was found in the Caso bouillon solution used to test the sterility of Viaspan in a media fill test carried out in February at Fresenius Kabi’s plant in Austria.
The contamination was pinpointed to a faulty pressure gauge on the filling line, which had created a small leak. A previous test carried out in July 2011 did not detect any problems.
BM-S stopped production of Viaspan and issued a worldwide recall as a precautionary action as soon as the microbiological tests had been completed in late March.
The firm is continuing to investigate this issue and is monitoring the quality of all products, and will make any changes necessary to ensure the safety and efficacy of its medicines.
“This is the first time we have encountered this type of issue with Fresenius, and once we know the cause of the problem, we will work appropriately with this supplier to manage any changes in procedures that may be required,” says McMillan.
“Fresenius will finalise its investigation and put actions in place so that we anticipate supply should be restored by June.” The firm is also investigating whether Viapsan has also been contaminated, but doctors are still being advised to continue using it until alternatives can be found.
BM-S says the final tests on the product were all satisfactory at the time Viaspan was introduced to the market and the investigation to date has not found any evidence that batches have been affected.
Professor Sir Kent Woods, chief executive of the UK’s Medicines and Healthcare products Regualtory Agency, said: “There is no evidence from transplant centres that patients who have had transplants using this solution are experiencing any related healthcare problems.
“We have acted quickly to protect patients and we have alerted transplant centres and surgeons immediately about this contamination and precautionary recall by the manufacturer.
“We are working closely with the NHS to make alternative products available for transplant operations. We support the decision to use Viaspan if it is clinically appropriate for patients and there are no alternatives available.
“Situations like this are very rare. If transplant patients have any questions, they should speak to their doctor.”