Transfusion Medicine. 1992. 2, 65-68
REPORT OF M E E T I N G
Transfusion medicine: fact and fiction* H. H. Gunson,
National Director. National Blood Transfusion Sernice, Manchesrer,
U.K.
Receirvd 20 Ocroher 1991
niques with increasing sophistication for their detection. This could be described as the era of blood group serology. The discovery by Cohn of the alcohol fractionation of plasma during the 1950s led to the preparation of albumin and other products available in a relatively purified form. This work was fundamentally important and still has applications today. It was supplemented by the finding by Pool and her co-workers that cryoprecipitation of plasma yields high concentrations of factor VIII in the precipitate and led the way for the treatment of patients suffering from haemophilia A with factor VIII deficient in their blood. It is now possible, with increasing technological developments, to obtain this factor in a high state of purity. During the 1950sand 1960s most blood transfusions were of whole blood, although some anaemic patients received concentrated red cells. During the 1970s the replacement of the glass bottle with the plastic bag enabled the cellular and plasma components of the donation of whole blood to be separated and the concept of component therapy evolved, i.e. the patient received the blood or plasma component for which they were deficient. Since 1970, the applications of blood transfusion have increased: transplantation immunology requires a laboratory testing service akin to blood group serology; haemapheresis, started in the 196Os, is used to harvest plasma with high titres of specific antibodies and to treat patients with high levels of certain atypical antibodies or proteins; and the prevention of Rh haemolytic disease of the new-born by passive immunization are a few examples. The 1980s have been dominated by the AIDS epidemic and the transmission of HIV infection by transfusion of blood and blood products. Blood transfusion services have given much consideration to increasing the safety of the blood supply and of fractionated plasma products, a process which began with tests for syphilis in the 1940s, and for hepatitis B in the late 1960s and early 1970s. Towards the end of the 1980s, biotechnology has begun to have an effect on the work of blood transfusion services.
The various aspects of this intriguing subject were considered in four sessions. The contents of these sessions were: general considerations, regulatory and legal, educational and historical and future perspectives. It is not intended, in this review, to summarize the contents of the presentations during the meeting. To do so would not make interesting reading nor would it attempt to answer the two questions which were paramount in the Symposium; what is transfusion medicine and how much is fact and how much is fiction? DEVELOPMENT OF T H E C O N C E P T OF TRANSFUSION MEDICINE Modern blood transfusion has a history going back for nine decades with the discovery of the ABO blood groups by Landsteiner in 1900. C. F. Hogman (Sweden) reviewed the landmarks from the era of direct transfusion, usually performed by surgeons. The discovery of anticoagulation using citrate compounds provided the impetus for the needs of the Second World War. The discovery that blood could be stored using an acidified glucose citrate medium. enabled blood donations to be collected, and stored in ‘blood banks’ before transportation to the place where the patient was to be transfused. Coincidentally, the discovery of the Rh groups in 1940, by Landsteiner and Wiener, and their association with haemolytic disease of the new-born, was the beginning of the extraordinary development of blood group serology which dominated the science of transfusion during the 1940s and 1950s. Many contributed during this period to the better understanding of the nature of blood group antigens, their inheritance, their distribution world-wide and the development of tech* Report of the 16th International Symposium organized by Dr C. Th. Smit-Sibinga. Director of the Red Cross Blood Bank. Groningen-Drenthe, The Netherlands, 9-1 I October 1991.
Correspondence: National Directorate, NBTS, North Western Regional Health Authority, Gateway House. Piccadilly South, Manchester M 6 0 7LP. U.K.
65
66
H . H. Gunson
For the last 15 years, those trained in clinical specialities have begun to work in transfusion centres to provide a clinical interface. The Council of Europe, through its Committee of Experts in Blood Transfusion and Immunohaematology, created a coordinated research group in the early 1980s to consider training and education for medical graduates wishing to pursue a career in ‘Transfusion Medicine’. A report on training programmes, published in 1984 and adopted by the Council of Ministers in 1985, embraced all the areas of work carried out by blood centres from the collection of the blood, testing and processing to involvement with the treatment of the patient. Thus, the concept of the speciality of transfusion medicine was conceived, together with a postgraduate educational programme which would enable medical workers in this speciality to have a status on a par with those working in other recognized specialities. Whether this concept has general agreement, is a fact or a fiction, will be discussed later in the report. CONTROLS I N BLOOD T R A N S F U S I O N MEDICINE If one accepts, for the present, that transfusion medicine embraces all theevents which take place from the blood donor giving blood to the transfusion of the products of this donation to the patient, it can be appreciated that controls must be applied. These have two aspects. Legisfutiue. The objectives of legislation are to provide protection for both the donor and the patient. Thise are not specific for blood transfusion but apply also to organ transplantation. Professor J. K. M . Gevens (Netherlands) considered that the law had an important part to play in the maintenance of adequate standards in all aspects of blood transfusion medicine. It is difficult, however, to legislate other than generally as developments in this field are too complex and too fast for legislation in detail to be effective. Laws establishing codes of ethics, embracing principles such as those given in the Council of Europe’s Recommendations on the responsibilities of health authorities in the field of blood transfusion, and for the international exchanges of blood products (which calls for a degree of harmonization), could exert a beneficial effect on regulating the working practices of blood transfusion services. In addition, legislation is required to cover liability, which in the European Community (EC) was established by the Directive EC 85/374. This defined blood and blood products with other goods for which any person has the right to expect quality and could apply for redress if this quality was not achieved.
Mr J. Evans (U.K.) examined the consequences of this EC Directive on blood services in that the producer is liable to the consumer for damage caused by a defect in its products unless there is a valid defence. Within these terms, however, there was considerable debate about who, for instance, was the producer in relation to the products of a donation of blood and even to the product itself. Should this be interpreted as a product manufactured from the blood or the blood itself? In more recent proposals by the EC, currently under consideration, both the contractor and the supplier may have liabilities. Significantly in this Directive there is no clear demarcation between a service and a product; the consumer has the responsibility to prove that the service or product has caused damage but the supplier has to prove absence of fault. The EC Directive 89/38 1 brings fractionated plasma products under similar controls to other pharmaceutical products with respect to safety, quality and efficacy. This directive, because of its other provisions which will be discussed Iater, will, in the view of Professor J. D. Cash (U.K.), have a profound effect on the operations of blood services in the present decade. Professor R. W. Beal (LRCS), speaking on behalf of the Council of Europe, considers that the effect of the Directive would be felt, not only in Europe, but in many other countries throughout the World. Regulations and regulatory mechanisms. Dr J. S . Epstein (USA) described the procedures which were in force in the U.S.A. to regulate the safety and efficacy of blood and blood products to protect the public health. The Federal Drugs Administration (FDA), a federal agency, has the legal authority to create and enforce regulations. Blood and blood products have been included since 1972. Licences and annual inspections by the FDA are required for blood service establishments and their activities are regulated from donor selection, the testing of the blood collected to the labelling of the product. It requires reports on errors and accidents. The FDA focuses principally on the manufacturer and close attention is paid to process validation and adherence to Good Manufacturing Practice (GMP) and performance of the products in clinical trials prior to licensing. This closely regulated system for all blood products is not evident in European countries as the cellular products from a blood donation are not licensed. Nevertheless, as a result of product liability and inevitably due to 89/381/EC, blood centres have had to introduce quality systems. Dr W. Wagstaff (U.K.) outlined the typical areas of operation in a blood centre where quality assurance was applied. In truth no activity can be excluded and attention must be paid to specification of materials and operations (GM P),
Transfusion medicine:fact andfiction
documentation (standard operating procedures), records (from the donor to the patient) and the creation of a product master file (including the documentation, records and the results of quality control tests). Dr C. T h Smit-Sibinga (Netherlands) emphasized these principles and considered that they play a part in the educational aspects which are so vitally important in transfusion medicine. When one considers the legislation and regulations which are being applied increasingly to the products of the blood donation, doubts emerge about whether the concept that speciality of transfusion medicine embraces the entire activity of blood services, from the donor to the patient, is a fact or a fiction. In the view of Dr D. Goldfinger (U.S.A.) this concept is a fiction. He contends that the laws and regulations create restrictions in the doctor-patient relationship. This should be based on clinical judgement and guidelines rather than regulations. In his stimulating and provocative presentation he drew attention to several examples to substantiate his argument. For instance, with predeposit autologous donations some donors are excluded because of their health, yet the surgeon is willing to operate and the anaesthetist to anaesthetize such patients. Blood has been collected from dedicated donors with successful outcomes at haematocrit levels lower than those acceptable for blood donors. Goldfinger suggest that physicians who treat patients with infectious diseases are not experts in the manufacture of antibiotics, although it was pointed out, in discussion, that there is considerable medical involvement in the manufacture of antibiotics. Dr Goldfinger, with some, but not universal, support from the meeting considers that transfusion medicine is a composite of two specialities, those who manage blood centres, including medical and nonmedical management [an aspect presented by Mr B. T. Teague (U.S.A.)] and the clinical management of pa tien ts.
T H E FUTURE O F TRANSFUSION MEDICINE This was discussed under several headings. Educa t ionaI
Education should begin at an undergraduate level and Professor G. Makes (Germany) outlined courses for both undergraduates in their third and fourth years of their academic course whilst postgraduate education is incorporated in a 5-year training programme. Dr S. Urbaniak (U.K.) stressed the need for formal
61
recognition of training posts and programmes. Proof of competence is normally achieved by examination. Such persons are probably at their peak of both theoretical and practical knowledge; thereafter progress can be variable. A system of medical audit is an essential feature of continuing appraisal. This can be a source of conflict but it is important that standards are met and maintained. Confidentiality is safeguarded but effective peer review performed by professionals should encourage the raising of standards. Dr C. Th. Smit-Sibinga (Netherlands) stressed that a major educational aspect was in the standards, inspection and accreditation mechanisms. Once such standards have been set they must be implemented. Education should not be restricted to medical graduates entering the speciality. D r A. P. M. Los (Netherlands) stressed the need for education within the community. Transfusion services are reliant on their donors; donor motivation and retention are, therefore, essential elements of continual education. Finally, research and development (R&D) are important for transfusion medicine to meet new challenges. The factors which encourage success in this field are management, long-term planning, commitment and allocation of resources. Dr J. E. Menitore (U.S .A.) differentiated be tween research workers (independent, resenting authority and difficult to manage who require a supervisor with credentials) from development staff (who respond to the needs of customers and require financial compensation through patents). Technological
Major advances have been made during recent years with the impact of biotechnology on transfusion medicine. Dr H. G . Klein (U.S.A.) reviewed the variety of growth factors that are now becoming available from recombinant technology; erythropoetin, cytokines, which stimulate myelopoeisis, and the potential for gene transfer by lymphocytes and possibly monocytes. Dr B. Habibi (France) addressed the problem of the management of the transition to the products derived from biotechnology. These include factor VIII and possibly factor VII and anti-D. Blood centres with their expertise in cell collection, separation and storage, cryopreservation and quality assurance will play an important role in these evolving techniques.
Blood and hlooti product usage The optimum use of blood products is not easy to define. Economy in usage may not indicate good clinical practice. The Sanguis project addresses this
68 H . H . Gunson
matter in 10 EC countries and asks such questions as how much, how many and why? The analysis of the results should create useful guidelines for the future. Seljk@ ciency
0
0
Dr B. Habibi (France) considered that a challenge for transfusion medicine was to achieve self-sufficiency for products derived from blood by the use of voluntary, unpaid donors. The Directive 89/38 I/EC embodies the WHO recommendation that member states should achieve such self-sufficiency. As this Directive will be incorporated in the laws of each member state of the EC, the recommendation becomes a requirement for the future. This means, as pointed out by Professr J. D. Cash (U.K.), that such a proposal could have farreaching affects for the future. Governments will inevitably be involved with respect to the supply and demand of blood products.
0
0
0
0
Transfusion medicine in deceloping countries
Dr Hu Chung-Li (WHO) outlined the work of the WHO programme Global Blood Safety Initiative (GBSI), launched in 1988 as a co-operative venture with ISBT, LRCS and other organizations. The objectives are to achieve a safe, adequate and effective blood supply for those persons in need. Throughout the developing countries in general the organization of transfusion medicine is poor. However, outside the developed countries, progress is now being made in 23 countries and it is hoped that by 1995 that each WHO region should have a blood donor organizer and that less than 5% should have paid donors. The early achievements are satisfactory but there is much work still to be done. WHO have established local training programmes and have facilitated the organization of training courses. Dr W. N. Gibbs (WHO) stated that the main areas where this need existed was in blood donation, collection, processing of blood donations, appropriate use and management. GBST have developed guidelines, in-service training (although many countries have scant resources), training overseas when appropriate and regional training centres.
0
It is fiction that: 0
0
0
0
0 0
TRANSFUSION MEDICINE-FACT FICTION
AND
However one defines medicine there are, undoubtedly. facts and fictions. It is a fact that: 0
this speciality over the 90 years of its modern
development has had, and is increasingly having, a significant effect on medical and surgical practice it has become one of the most regulated specialities in medical practice both through legislation, licensing and other regulations it has had to adapt to the demand for safer products and to take measures to increase safety, quality and efficacy there are many young persons, both medical and non-medical, entering the speciality of transfusion medicine who are capable of managing both procedures in blood centres and have the expertise to treat patients. research and development are producing facts out of fiction (some may say ‘science fiction’) from only a few years ago the WHO, operating under considerable difficulties are, through GBSI, attempting to increase the safety of blood transfusion world-wide the WHO, through their foresight and recommendations with respect to voluntary, unpaid donations and self-sufficiency, are influencing decisions taken by the EC for the 1990s self-sufficiency with respect to blood products from voluntary unpaid donors will be a challenge for many countries in the 1990s.
0
there is agreement over what constitutes the speciality transfusion medicine. One view is that this embraces all activities from blood collection to the administration of products to the patient. Others, however, consider that operational activities in blood centres do not need medical input and that transfusion medicine is the clinical treatment of the patient there is such a thing as a safe blood transfusion (i.e. no risk) although there are many countries with legislation concerning transfusion medicine, these are adequately monitored and implemented unless guidelines, regulations and legislation facilitate cross-boundary flow within EC countries, selfsufficiency in Europe will occur regulations are applied equally in all countries the training programmes proposed by the Council of Europe have fulfilled expectations blood transfusion medicine is of a uniform standard throughout the World.
The last word should rest with Professor J. D. Cash (U.K.) who said that transfusion medicine was at a watershed. Much has been achieved but there is still much more to do.
REPORT OF M E E T I N G
Transfusion medicine: fact and fiction* H. H. Gunson,
National Director. National Blood Transfusion Sernice, Manchesrer,
U.K.
Receirvd 20 Ocroher 1991
niques with increasing sophistication for their detection. This could be described as the era of blood group serology. The discovery by Cohn of the alcohol fractionation of plasma during the 1950s led to the preparation of albumin and other products available in a relatively purified form. This work was fundamentally important and still has applications today. It was supplemented by the finding by Pool and her co-workers that cryoprecipitation of plasma yields high concentrations of factor VIII in the precipitate and led the way for the treatment of patients suffering from haemophilia A with factor VIII deficient in their blood. It is now possible, with increasing technological developments, to obtain this factor in a high state of purity. During the 1950sand 1960s most blood transfusions were of whole blood, although some anaemic patients received concentrated red cells. During the 1970s the replacement of the glass bottle with the plastic bag enabled the cellular and plasma components of the donation of whole blood to be separated and the concept of component therapy evolved, i.e. the patient received the blood or plasma component for which they were deficient. Since 1970, the applications of blood transfusion have increased: transplantation immunology requires a laboratory testing service akin to blood group serology; haemapheresis, started in the 196Os, is used to harvest plasma with high titres of specific antibodies and to treat patients with high levels of certain atypical antibodies or proteins; and the prevention of Rh haemolytic disease of the new-born by passive immunization are a few examples. The 1980s have been dominated by the AIDS epidemic and the transmission of HIV infection by transfusion of blood and blood products. Blood transfusion services have given much consideration to increasing the safety of the blood supply and of fractionated plasma products, a process which began with tests for syphilis in the 1940s, and for hepatitis B in the late 1960s and early 1970s. Towards the end of the 1980s, biotechnology has begun to have an effect on the work of blood transfusion services.
The various aspects of this intriguing subject were considered in four sessions. The contents of these sessions were: general considerations, regulatory and legal, educational and historical and future perspectives. It is not intended, in this review, to summarize the contents of the presentations during the meeting. To do so would not make interesting reading nor would it attempt to answer the two questions which were paramount in the Symposium; what is transfusion medicine and how much is fact and how much is fiction? DEVELOPMENT OF T H E C O N C E P T OF TRANSFUSION MEDICINE Modern blood transfusion has a history going back for nine decades with the discovery of the ABO blood groups by Landsteiner in 1900. C. F. Hogman (Sweden) reviewed the landmarks from the era of direct transfusion, usually performed by surgeons. The discovery of anticoagulation using citrate compounds provided the impetus for the needs of the Second World War. The discovery that blood could be stored using an acidified glucose citrate medium. enabled blood donations to be collected, and stored in ‘blood banks’ before transportation to the place where the patient was to be transfused. Coincidentally, the discovery of the Rh groups in 1940, by Landsteiner and Wiener, and their association with haemolytic disease of the new-born, was the beginning of the extraordinary development of blood group serology which dominated the science of transfusion during the 1940s and 1950s. Many contributed during this period to the better understanding of the nature of blood group antigens, their inheritance, their distribution world-wide and the development of tech* Report of the 16th International Symposium organized by Dr C. Th. Smit-Sibinga. Director of the Red Cross Blood Bank. Groningen-Drenthe, The Netherlands, 9-1 I October 1991.
Correspondence: National Directorate, NBTS, North Western Regional Health Authority, Gateway House. Piccadilly South, Manchester M 6 0 7LP. U.K.
65
66
H . H. Gunson
For the last 15 years, those trained in clinical specialities have begun to work in transfusion centres to provide a clinical interface. The Council of Europe, through its Committee of Experts in Blood Transfusion and Immunohaematology, created a coordinated research group in the early 1980s to consider training and education for medical graduates wishing to pursue a career in ‘Transfusion Medicine’. A report on training programmes, published in 1984 and adopted by the Council of Ministers in 1985, embraced all the areas of work carried out by blood centres from the collection of the blood, testing and processing to involvement with the treatment of the patient. Thus, the concept of the speciality of transfusion medicine was conceived, together with a postgraduate educational programme which would enable medical workers in this speciality to have a status on a par with those working in other recognized specialities. Whether this concept has general agreement, is a fact or a fiction, will be discussed later in the report. CONTROLS I N BLOOD T R A N S F U S I O N MEDICINE If one accepts, for the present, that transfusion medicine embraces all theevents which take place from the blood donor giving blood to the transfusion of the products of this donation to the patient, it can be appreciated that controls must be applied. These have two aspects. Legisfutiue. The objectives of legislation are to provide protection for both the donor and the patient. Thise are not specific for blood transfusion but apply also to organ transplantation. Professor J. K. M . Gevens (Netherlands) considered that the law had an important part to play in the maintenance of adequate standards in all aspects of blood transfusion medicine. It is difficult, however, to legislate other than generally as developments in this field are too complex and too fast for legislation in detail to be effective. Laws establishing codes of ethics, embracing principles such as those given in the Council of Europe’s Recommendations on the responsibilities of health authorities in the field of blood transfusion, and for the international exchanges of blood products (which calls for a degree of harmonization), could exert a beneficial effect on regulating the working practices of blood transfusion services. In addition, legislation is required to cover liability, which in the European Community (EC) was established by the Directive EC 85/374. This defined blood and blood products with other goods for which any person has the right to expect quality and could apply for redress if this quality was not achieved.
Mr J. Evans (U.K.) examined the consequences of this EC Directive on blood services in that the producer is liable to the consumer for damage caused by a defect in its products unless there is a valid defence. Within these terms, however, there was considerable debate about who, for instance, was the producer in relation to the products of a donation of blood and even to the product itself. Should this be interpreted as a product manufactured from the blood or the blood itself? In more recent proposals by the EC, currently under consideration, both the contractor and the supplier may have liabilities. Significantly in this Directive there is no clear demarcation between a service and a product; the consumer has the responsibility to prove that the service or product has caused damage but the supplier has to prove absence of fault. The EC Directive 89/38 1 brings fractionated plasma products under similar controls to other pharmaceutical products with respect to safety, quality and efficacy. This directive, because of its other provisions which will be discussed Iater, will, in the view of Professor J. D. Cash (U.K.), have a profound effect on the operations of blood services in the present decade. Professor R. W. Beal (LRCS), speaking on behalf of the Council of Europe, considers that the effect of the Directive would be felt, not only in Europe, but in many other countries throughout the World. Regulations and regulatory mechanisms. Dr J. S . Epstein (USA) described the procedures which were in force in the U.S.A. to regulate the safety and efficacy of blood and blood products to protect the public health. The Federal Drugs Administration (FDA), a federal agency, has the legal authority to create and enforce regulations. Blood and blood products have been included since 1972. Licences and annual inspections by the FDA are required for blood service establishments and their activities are regulated from donor selection, the testing of the blood collected to the labelling of the product. It requires reports on errors and accidents. The FDA focuses principally on the manufacturer and close attention is paid to process validation and adherence to Good Manufacturing Practice (GMP) and performance of the products in clinical trials prior to licensing. This closely regulated system for all blood products is not evident in European countries as the cellular products from a blood donation are not licensed. Nevertheless, as a result of product liability and inevitably due to 89/381/EC, blood centres have had to introduce quality systems. Dr W. Wagstaff (U.K.) outlined the typical areas of operation in a blood centre where quality assurance was applied. In truth no activity can be excluded and attention must be paid to specification of materials and operations (GM P),
Transfusion medicine:fact andfiction
documentation (standard operating procedures), records (from the donor to the patient) and the creation of a product master file (including the documentation, records and the results of quality control tests). Dr C. T h Smit-Sibinga (Netherlands) emphasized these principles and considered that they play a part in the educational aspects which are so vitally important in transfusion medicine. When one considers the legislation and regulations which are being applied increasingly to the products of the blood donation, doubts emerge about whether the concept that speciality of transfusion medicine embraces the entire activity of blood services, from the donor to the patient, is a fact or a fiction. In the view of Dr D. Goldfinger (U.S.A.) this concept is a fiction. He contends that the laws and regulations create restrictions in the doctor-patient relationship. This should be based on clinical judgement and guidelines rather than regulations. In his stimulating and provocative presentation he drew attention to several examples to substantiate his argument. For instance, with predeposit autologous donations some donors are excluded because of their health, yet the surgeon is willing to operate and the anaesthetist to anaesthetize such patients. Blood has been collected from dedicated donors with successful outcomes at haematocrit levels lower than those acceptable for blood donors. Goldfinger suggest that physicians who treat patients with infectious diseases are not experts in the manufacture of antibiotics, although it was pointed out, in discussion, that there is considerable medical involvement in the manufacture of antibiotics. Dr Goldfinger, with some, but not universal, support from the meeting considers that transfusion medicine is a composite of two specialities, those who manage blood centres, including medical and nonmedical management [an aspect presented by Mr B. T. Teague (U.S.A.)] and the clinical management of pa tien ts.
T H E FUTURE O F TRANSFUSION MEDICINE This was discussed under several headings. Educa t ionaI
Education should begin at an undergraduate level and Professor G. Makes (Germany) outlined courses for both undergraduates in their third and fourth years of their academic course whilst postgraduate education is incorporated in a 5-year training programme. Dr S. Urbaniak (U.K.) stressed the need for formal
61
recognition of training posts and programmes. Proof of competence is normally achieved by examination. Such persons are probably at their peak of both theoretical and practical knowledge; thereafter progress can be variable. A system of medical audit is an essential feature of continuing appraisal. This can be a source of conflict but it is important that standards are met and maintained. Confidentiality is safeguarded but effective peer review performed by professionals should encourage the raising of standards. Dr C. Th. Smit-Sibinga (Netherlands) stressed that a major educational aspect was in the standards, inspection and accreditation mechanisms. Once such standards have been set they must be implemented. Education should not be restricted to medical graduates entering the speciality. D r A. P. M. Los (Netherlands) stressed the need for education within the community. Transfusion services are reliant on their donors; donor motivation and retention are, therefore, essential elements of continual education. Finally, research and development (R&D) are important for transfusion medicine to meet new challenges. The factors which encourage success in this field are management, long-term planning, commitment and allocation of resources. Dr J. E. Menitore (U.S .A.) differentiated be tween research workers (independent, resenting authority and difficult to manage who require a supervisor with credentials) from development staff (who respond to the needs of customers and require financial compensation through patents). Technological
Major advances have been made during recent years with the impact of biotechnology on transfusion medicine. Dr H. G . Klein (U.S.A.) reviewed the variety of growth factors that are now becoming available from recombinant technology; erythropoetin, cytokines, which stimulate myelopoeisis, and the potential for gene transfer by lymphocytes and possibly monocytes. Dr B. Habibi (France) addressed the problem of the management of the transition to the products derived from biotechnology. These include factor VIII and possibly factor VII and anti-D. Blood centres with their expertise in cell collection, separation and storage, cryopreservation and quality assurance will play an important role in these evolving techniques.
Blood and hlooti product usage The optimum use of blood products is not easy to define. Economy in usage may not indicate good clinical practice. The Sanguis project addresses this
68 H . H . Gunson
matter in 10 EC countries and asks such questions as how much, how many and why? The analysis of the results should create useful guidelines for the future. Seljk@ ciency
0
0
Dr B. Habibi (France) considered that a challenge for transfusion medicine was to achieve self-sufficiency for products derived from blood by the use of voluntary, unpaid donors. The Directive 89/38 I/EC embodies the WHO recommendation that member states should achieve such self-sufficiency. As this Directive will be incorporated in the laws of each member state of the EC, the recommendation becomes a requirement for the future. This means, as pointed out by Professr J. D. Cash (U.K.), that such a proposal could have farreaching affects for the future. Governments will inevitably be involved with respect to the supply and demand of blood products.
0
0
0
0
Transfusion medicine in deceloping countries
Dr Hu Chung-Li (WHO) outlined the work of the WHO programme Global Blood Safety Initiative (GBSI), launched in 1988 as a co-operative venture with ISBT, LRCS and other organizations. The objectives are to achieve a safe, adequate and effective blood supply for those persons in need. Throughout the developing countries in general the organization of transfusion medicine is poor. However, outside the developed countries, progress is now being made in 23 countries and it is hoped that by 1995 that each WHO region should have a blood donor organizer and that less than 5% should have paid donors. The early achievements are satisfactory but there is much work still to be done. WHO have established local training programmes and have facilitated the organization of training courses. Dr W. N. Gibbs (WHO) stated that the main areas where this need existed was in blood donation, collection, processing of blood donations, appropriate use and management. GBST have developed guidelines, in-service training (although many countries have scant resources), training overseas when appropriate and regional training centres.
0
It is fiction that: 0
0
0
0
0 0
TRANSFUSION MEDICINE-FACT FICTION
AND
However one defines medicine there are, undoubtedly. facts and fictions. It is a fact that: 0
this speciality over the 90 years of its modern
development has had, and is increasingly having, a significant effect on medical and surgical practice it has become one of the most regulated specialities in medical practice both through legislation, licensing and other regulations it has had to adapt to the demand for safer products and to take measures to increase safety, quality and efficacy there are many young persons, both medical and non-medical, entering the speciality of transfusion medicine who are capable of managing both procedures in blood centres and have the expertise to treat patients. research and development are producing facts out of fiction (some may say ‘science fiction’) from only a few years ago the WHO, operating under considerable difficulties are, through GBSI, attempting to increase the safety of blood transfusion world-wide the WHO, through their foresight and recommendations with respect to voluntary, unpaid donations and self-sufficiency, are influencing decisions taken by the EC for the 1990s self-sufficiency with respect to blood products from voluntary unpaid donors will be a challenge for many countries in the 1990s.
0
there is agreement over what constitutes the speciality transfusion medicine. One view is that this embraces all activities from blood collection to the administration of products to the patient. Others, however, consider that operational activities in blood centres do not need medical input and that transfusion medicine is the clinical treatment of the patient there is such a thing as a safe blood transfusion (i.e. no risk) although there are many countries with legislation concerning transfusion medicine, these are adequately monitored and implemented unless guidelines, regulations and legislation facilitate cross-boundary flow within EC countries, selfsufficiency in Europe will occur regulations are applied equally in all countries the training programmes proposed by the Council of Europe have fulfilled expectations blood transfusion medicine is of a uniform standard throughout the World.
The last word should rest with Professor J. D. Cash (U.K.) who said that transfusion medicine was at a watershed. Much has been achieved but there is still much more to do.
