The NHS should continue with organ transplantations despite fears that the fluid used to transport organs may be contaminated, according to England’s chief medical officer (CMO).
Professor Dame Sally Davies said that despite concerns over the Viaspan fluid, which is used to transport abdominal organs such as the liver, pancreas, kidney and bowel around the UK, transportation should continue.
Tests have found bacteria – Bacillus cereus – in the solution used to test the sterility of Viaspan, which is produced by Bristol Myers-Squibb, but further tests are being carried out to see if the Viaspan itself is contaminated. The company has instigated a precautionary recall of the product.
Professor Davies said: “Our priority is 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. If we were to recall the product immediately it is clear that patients would suffer and some may die.
“The manufacturer has advised that where necessary, Viaspan can continue to be used until transplant teams have stocks of alternative products and patients can be prescribed an antibiotic known to be effective against the contaminant as a precaution.
“We are now working urgently to source alternative products. The MHRA is working closely with the manufacturers and tests are ongoing.”
The CMO will also write to all transplant centres with further advice.
Professor Sir Kent Woods, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said the agency had contacted all transplant centres and surgeons to alert them about the situation.
“There is no evidence from transplant centres that patients who have had transplants using this solution are experiencing any related healthcare problems,” said Professor Woods.
“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.”
NHS Blood and Transplant, which coordinates organ donations across the UK, also endorsed the decision to continue to use Viaspan until suitable alternative products were available.
Its medical and research director Lorna Williamson said: “This is necessary, if the transplant programme is not to be affected by this product recall. We are reassured that no adverse events have been reported related to this product.
“We are working with the MHRA and the transplant centres to ensure that the vital transplant programme continues. We are liaising with DH over supplies of alternative products and are ready to offer transport assistance if needed.”