§ Lord Clement-Jonesasked Her Majesty's Government:
Further to the Written Answer by the Baroness Andrews on 4 April (WA 154), why a recent case of transfusion-related acute lung injury (TRALI) was settled by the National Blood Service out of court; and how many other cases of TRALI have been settled and at what total cost to the Department of Health; and [HL3486]
Further to the Written Answer by the Baroness Andrews on 4 April (WA 154), how the provision for future compensation claims relating to transfusion-related acute lung injury (TRALI) will be reconciled with the continuing risk to patients of serious illness or death from fresh frozen plasma transfusions. [HL3487]
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)The National Blood Authority (NBA) is a special health authority. In this case of transfusion-related acute lung injury (TRALI) the NBA admitted liability; It was advised, therefore that liability should be admitted and a settlement negotiated. This is a matter for the NBA.
The reduction of incidents of TRALI continues to be a high priority. We have not undertaken an assessment on the cost of possible compensation claims for TRALI.
§ Lord Clement-Jonesasked Her Majesty's Government:
Why they are not funding a commercially available fresh frozen plasma which is treated in such a way that there is no risk of SARS, or other unknown, potentially fatal emerging (lipid-enveloped) viruses, being transmitted; and [HL3488]
Why they will not consider funding a pharmaceutically licensed, virally inactivated, pooled, fresh frozen plasma, which could eliminate the risk to patients of transfusion-related acute lung injury (TRALI) and the risk of infections such as HIV, hepatitis B and hepatitis C. [HL3491]
§ Lord WarnerThe safety of blood and blood products used in the National Health Service is of paramount importance. Although most United Kingdom fresh frozen plasma (FFP) is not virally inactivated, high levels of safety are achieved by using single unit, as opposed to pooled plasma, by screening out potential high risk donors and by testing every unit of donated blood for the presence of infections such as HIV, hepatitis B, hepatitis C before it is released to hospitals. In addition, the National Blood Service is conducting an options appraisal of means to minimise the risk of transfusion-related acute lung injury from FFP.
The decision taken to import FFP from the United States for young babies and children born after 1 January 1996 will provide additional protection to the most vulnerable group who will not have been exposed to bovine spongiform encephalopathy through the 152WA food chain. The National Blood Authority is currently involved in negotiating for supplies of FFP for this group of patients and plans to have it available later this year. A commercially produced FFP product, sourced from the United States, is also available for the National Health Service to purchase.
The Government's Advisory Committee on the Microbiological Safety of Blood and Tissue for Transplantation will continue to review the risk of new emerging viruses such as severe acute respiratory syndrome (SARS) on the blood supply. There is no evidence that SARS can be transmitted by blood transfusion.
§ Lord Clement-Jonesasked Her Majesty's Government:
Further to the Written Answer by the Baroness Andrews on 1 May (WA 126–27), why they do not think that high levels of safety are achieved through pooled plasma products, despite them being virally inactivated; and what evidence they have against pooled products to support this view; and [HL3490]
Why they have recommended a virally inactivated fresh frozen plasma for specific sub-groups of transfusion patients when a licensed. virally inactivated product is commercially available; and [HL3524]
Further to the Written Answer by the Baroness Andrews on 1 April (WA 123–24), what scientific evidence they have to support the belief that non-virally inactivated single unit plasma (which is currently used in the United Kingdom) is preferable to virally inactivated pooled plasma.[HL3525]
§ Lord WarnerUnited Kingdom single unit fresh frozen plasma (FFP) is already a very safe product. To minimise the risk from viruses, it is made only from previously tested blood donors. Since the year 2000, an additional test for hepatitis C has been added. As a result the risk from a single unit of FFP is estimated to be one in 5 million for HIV and lower than one in 1 million for hepatitis C. As a precautionary measure all FFP from UK blood donors has been leucodepleted to remove the white cells which evidence suggests may carry the greatest risk of transmitting variant Creutzfeldt-Jakob disease. The decision taken to import virally inactivated single unit FFP from the United States for young babies and children born after 1 January 1996 was made to provide additional protection to this most vulnerable group who have not been exposed to bovine spongiform encephalopathy through the food chain. Over 300,000 units of FFP are issued annually and it is only given in life-threatening situations to prevent or stop haemorrhage associated with abnormal blood clotting.
Virally inactivated pooled FFP is subjected to a single virus reduction step. Two viruses (hepatitis A and parvovirus) are not susceptible to this form of inactivation. It is also possible that a new virus could appear that is not susceptible to the inactivation treatment and could spread to those transfused via the pooling of many donations.
153WAThe Government's expert Advisory Committee on the Microbiological Safety of Blood and Tissue for Transplantation has considered the relative risks and safety of the different types of fresh frozen plasma available and has recommended the use of UK single unit FFP but clinicians are free to choose which product to use.