Report of the Irish Medicines Board to the Minister for Health and Children on the Blood Transfusion Service Board for the year 1998
First parMr Brian Cowen T.D., Minister for Health and Children today ( 9 September 1999) published the report of the Irish Medicines Board (IMB) on the Blood Transfusion Service Board (BTSB) in respect of the year ending 31 December 1998. This the second annual report prepared by the IMB on foot of a recommendation of the Tribunal of Inquiry chaired by Mr Justice Finlay.
The report notes that the BTSB is undergoing a period of rapid change with many positive new developments underway which will help to assure the safety of the blood supply. These include the construction of a new National Headquarters on the campus of St James’s Hospital, the modernisation of the Components Processing Area at the Munster Centre, the appointment of a new Chief Executive Officer, Donor Services Manager and IT Manager, the installation of Progesa, a state of the art IT system, the introduction of additional virus safety measures, the planned introduction of HCV PCR testing which will facilitate the detection of Hepatitis C or other viruses at very low levels and the planned introduction of leucodepletion to guard against the possible transmission of nv CJD.
During 1998, the IMB identified a number of areas where the desired standard of Good Manufacturing Practice (GMP) had not yet been achieved. The IMB considered that the status and resources available to Quality Assurance was not sufficient to meet the requirements of GMP; it expresses concern at the rate of progress in relation to the maintenance, upgrading and validation of the existing computer system; it notes that a comprehensive GMP training programme was not in place and states that the absence of technical contracts between the BTSB and outside testing laboratories is not in compliance with GMP.
The Minister said that he and his Department will continue to work with the BTSB and the IMB towards the achievement of the highest possible standards of product quality and patient safety.
“The opening later this year of the new BTSB Headquarters at St James’s Hospital, which will be one of the most modern and best equipped blood transfusion centres in the world, will be a major milestone in the development of a world class transfusion medicine service in this country.” said the Minister.