“Transplant organ fluid 'contaminated',” BBC News reported today, saying that bacteria could have come into contact with the product viaspan. Viaspan is a liquid used in the transportation of donor organs prior to transplant. Tests have found bacteria in the solution used to test and monitor the sterility of viaspan.
Bristol-Myers Squibb, the manufacturer of viaspan, has announced a "precautionary recall" across Europe after tests showed it may have been contaminated since last July.
The problem was detected on March 19 at a manufacturing facility in Austria, and the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), was notified on March 23. The MHRA issued its advice today, alerting transplant centres and surgeons. However, the MHRA supports the use of viaspan if it is clinically appropriate and there are no alternatives available. Patients can be prescribed an antibiotic as a precaution.
So far, no evidence of contamination of viaspan itself has been found. There is currently no evidence of any problems in patients who have recently had transplants where viaspan has been used, and no transplant centres have reported any adverse effects. The recall measures are described as precautionary.
The recall applies to Australia, Italy, Estonia, Slovenia, Argentina, Chile, Germany, France, Ireland and the UK, where there are alternative products available.
What is this fluid used for?
Viaspan preserves donated organs such as the liver, pancreas and bowel when these organs are transported prior to transplant. It is designed to mimic the conditions inside cells and contains a balance of inert substances; starch to prevent oedema (swelling of the tissue); and other substances, such as steroids and insulin.
In the UK, a special health authority, NHS Blood and Transplant (NHSBT), co-ordinates organ donations. NHSBT has agreed with the decision to continue to use available stocks of viaspan until suitable alternative products are available. This is necessary, they say, so that the transplant programme is not affected by this product recall.
Fluids used in the transport of organs are meant to be sterile, cold solutions, and the sterility of manufacturing plants is regularly tested and monitored. The MHRA has confirmed that the solution used to test viaspan could have been contaminated since July 8–9 2011.
What is the bacteria and what are its effects?
The bacteria has been identified as Bacillus cereus – a cause of food poisoning that lives in soil. The usual sources of Bacillus cereus food poisoning are cooked foods that have been left to cool, especially rice dishes, but also meat or vegetable dishes, dairy products, soups, sauces or sweet pastry products.
Typical symptoms include vomiting in the first 1–5 hours and then diarrhoea from 8 to 16 hours. Stomach cramps can also occur.
How many people may be affected?
There are about 700–800 liver, 250 pancreas and 30–40 bowel transplants in the UK each year. As the bug has not been detected in the UK it seems unlikely that anyone here will be affected.
What are the risks to people who have had a transplant?
The Department of Health has said: "there is currently no evidence of any problems in patients who have recently had transplants where viaspan has been used".
What are the alternatives?
If viaspan were recalled immediately, potentially life-saving operations might have to be cancelled, according to the Department of Health. It says that Bristol-Myers Squibb has said that, where necessary, viaspan can continue to be used until transplant teams have stocks of alternative products. Patients can be prescribed an antibiotic known to be effective against the possible contaminant as a precaution.
The authorities are trying to source alternatives, to avoid using viaspan. The three potential alternatives being looked at are:
- Soltran (also known as Marshall's Solution)
All three of these alternatives are now authorised for use by the MHRA.