Bristol Myers-Squibb recalls Viaspan over potential Bacillus contamination

The bacterium, Bacillus cereus as cultivated on sheep blood agar 

Credits: CDC/ Courtesy of Larry Stauffer, Oregon State Public Health Laboratory

March 30, 2012

Pharmaceutical giant, Bristol Myers-Squibb (BMS) announced Thursday a global recall of the sterile organ storage fluid, Viaspan after bacterial contamination was discovered on the production line at a manufacturing facility in Austria.

The bacterium, Bacillus cereus was found in fluid used to test the sterility of the Viaspan production line. Batches of Viaspan are now being tested for contamination.

Viaspan is a fluid used to preserve organs, primarily the liver, pancreas and bowel, after removal from the donor until transplant into the organ recipient.

The recall applies to 10 countries where there are alternative storage solutions: Australia, Italy, Estonia, Slovenia, Argentina, Chile, Germany, France, Ireland, and the United Kingdom.

BMS is also working with health officials in 11 other European countries and New Zealand that use Viaspan but do not have alternative solutions.

Viaspan is not sold in the United States or Asia.

The Belfast Telegraph reports that BMS is performing tests to determine where the leak in the production line is located. A faulty pressure gauge is thought to be the problem.

In the UK, where there are about 800 liver, 250 pancreas and 30 to 40 bowel transplants each year, they will continue to use Viaspan as there is currently no evidence of any problems in patients who have recently had transplants where Viaspan has been used according to Chief Medical Officer Professor Dame Sally Davies.

Patients that did present with an infection with Bacillus cereus could be treated with antibiotics.

Bacillus cereus is an aerobic, spore-forming bacterium found in the soil and the environment worldwide.

The organism is a well-recognized and common cause of food poisoning worldwide.

Bacillus cereus made the news last year when alcohol pads produced by the Triad Group were found to be contaminated with the spore-forming bacteria. The contaminated pads were implicated in the death of a 2-year-old boy.

Source