Blood bags 'had no quality guarantee'

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The Independent Online
The first batch of Tuta blood bags imported to England in June last year did not carry the certificate of guarantee to show they complied with National Blood Authority standards, according to documents obtained by the Independent.

The documents show that the quality of the Australian-made Tuta bags, which were withdrawn on Tuesday after a contamination scare, alarmed some blood transfusion staff from the start. They criticised the failure to carry out a national validation of the bags. According to the report by the Mersey and North Wales Blood Service, some batches were labelled with the wrong information; one box had handwritten amendments to its code number and there was concern about the amount of air in the packs.

The row over the bags continued yesterday as the authority confirmed that a Swindon man critically ill with blood-poisoning had received blood on Monday from a Tuta bag belonging to a high-risk batch first identified last week.

The authority has been criticised for mishandling the recall of the bags after the Princess Margaret Hospital in Swindon said it was not told to withdraw any batches of bags, and that blood from Tuta bags could be used if hand and eye tests showed they were intact. A preliminary hospital investigation has failed to rule out the bag as a cause of blood poisoning. A spokesman for the Sydney-based manufacturer said "human error" had affected the production process leading to leaking seals in some bags supplied to England, Wales, and Scotland.

Dr Vanessa Martlew, director of the Mersey and North Wales Blood Service which evaluated the bags, confirmed that no certificates of conformance were received with the first consignment. Tuta Laboratories agreed to send it out immediately, but delays persisted in receipt of batch documentation.The report was considered by the NBA but the problems not thought serious enough for a recall.

Sue Cunningham, of the NBA, said the Mersey and North Wales evaluation was an interim report only and that all "initial teething problems" had been quickly resolved by Tuta. The NBA has been criticised for contracting with Tuta to provide bags in a deal aimed at saving it pounds 700,000.

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