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The Medicines Inspectorate began its inspection of BPL and concluded that planning for essential improvements should begin immediately and called for urgent action. It observed the current position was not a recent situation.

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Following the redevelopment of BPL, an increase in plasma supplies and factor concentrate production occurred.

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The Northern Regional Health Authority was offered increased capital and the West Midlands Regional Health Authority was offered an increased revenue allocation in order to produce the plasma required.

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In considering what needs the Department of Health should plan for, a review of blood and blood products in 1976 noted that there was little information to show whether current practices represented optimal use of products or whether figures were misleading due to wasteful practices.

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Thomas Dutton identified that the customary method of financing the NBTS was not conducive to the development of such a partnership and this was probably the biggest factor that led to the delay in mounting the AHG (Factor 8) concentrate production programme.

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The introduction of component therapy on a large scale reduced the need for independent, self-sufficient regional units.

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Thomas Dutton stated that devising and effectively managing a balanced programme for the preparation and distribution of blood components including clotting factors as "probably the most urgent task facing the NBTS" and he spoke of the need to fractionate something approaching one million donations annually.

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The 1975 target of 350,000 donor units was met, but Thomas Dutton stated that this target had long since been recognised as too low.

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Thomas Dutton observed that the Development of the NBTS Trends Report essentially said no more about Factor 8 requirements than some experts had been saying for years, which had now become generally accepted.

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Dr Waiter stated that it was accepted that in order to meet the anticipated demand for principal plasma fractions, a new plant in addition to that already available in the UK must be acquired.

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A pilot study conducted by Dr Robinson's team using the new Haemonetics v50 machine became a turning point in the UK, showing it enabled plasmapheresis more efficiently and more safely.

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No existing factory building could be found to accommodate BPL, even with adaptations.

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A lack of ministerial decision, ministerial uncertainty, and the absence of long-term management arrangements were issues identified by Mr Smart as hampering the work done by the Policy Steering Group for the re-development of BPL.

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Manual plasmapheresis started to fall out of favour compared to machine plasmapheresis. The Mersey Regional BTS opted against manual plasmapheresis due to problems associated with the need for a continuous supervisor, the time needed to complete a procedure and the need for temperature-controlled centrifuges. This was despite the use of machines.

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In a written parliamentary answer, Kenneth Clarke, Minister of State for Health, stated that the Government decided in 1982 that self-sufficiency in all blood products should be achieved and the BPL at Elstree should be rebuilt to provide capacity to manufacture blood products needed by the NHS in England and Wales. It was said to be on time for completion in January 1986.

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Results from a pilot study for large-scale plasma procurement using automated plasmapheresis showed that it could safely and economically produce high-quality plasma, necessary for national self-sufficiency.

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Investigations in relation to upgrading BPL showed that no British firm had the necessary expertise in the manufacture of blood products and only foreign firms had approached the Department with a view to processing British plasma on the existing basis and to process and re-export plasma from overseas.

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In December 1979, a submission was made to ministers on the future of BPL and the problems the department faced in terms of the present and future operation of this facility.

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Ministers were asked to consider and agree whether: that there should be a short-term upgrade to BPL even though it would fall short of recommendations of the Medicines Inspectorate; a decision in principle to rebuild BPL but without commitment to method or timing; and to conduct a further exploration of options for rebuilding within the NHS or in collaboration with industry.

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Despite the decision to waive Crown immunity, there was some flexibility for NHS facilities. Although manufacturing licenses were not mandated by statute for NHS manufacturing facilities, the policy was that they should still comply with the standards which the Medicines Division would require from commercial firms.

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