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欧洲的输血:输血医学初始培训与持续培训的基本原则:实现欧洲协调统一的方法

Blood transfusion in Europe: basic principles for initial and continuous training in transfusion medicine: an approach to an European harmonisation.

作者信息

Mueller M M, Seifried E

机构信息

Institute for Transfusion Medicine and Immunohaematology, Clinics of the Johann Wolfgang Goethe-University, Frankfurt/Main, Germany.

出版信息

Transfus Clin Biol. 2006 Nov;13(5):282-5; quiz 286-9. doi: 10.1016/j.tracli.2006.11.004. Epub 2006 Dec 29.

Abstract

Over the past few decades, transfusion medicine and haemotherapy have evolved into complex medical disciplines comprising a broad field of subspecialties such as immunohaematology, blood component production, haemapheresis and haemostaseology. Transfusion medicine is thus an important qualification at the interfaces of analytical laboratory medicine, pharmaceutical production and clinical disciplines such as internal medicine, anaesthesiology or surgery. Physicians specialising in transfusion medicine are valuable and competent partners for these related disciplines when it comes to safe, effective and tailored haemotherapy. Why has transfusion medicine become so complex? On the one hand, one can discern problems such as infectious diseases like the HIV disaster in the past century, resulting in guidelines, directives and laws such as the transfusion law in Germany. Thereby, we now enjoy the highest level of blood product safety ever regarding viral transmission thanks to the broad implementation of PCR testing. On the other hand, there are numerous positive reasons for the increasing complexity of transfusion medicine: Modern medical therapies like stem cell transplantation, cellular therapy, transplantation of solid organs, regenerative medicine and surgery cannot exist without a safe supply of blood products and high quality standard as well as special blood products and laboratory services provided by blood banks and transfusion medicine specialists. Good laboratory practice (GLP), good manufacturing practice (GMP), quality management systems and quality control on the pharmaceutical manufacturer's level are only few examples of the standards in today's blood banking. European directives in the field of blood products, stem cell preparations and tissue have led to higher uniform quality standards for biological preparations in a unified Europe, which is the desired outcome, but which also increases the complexity of this field. In contrast, directives 93/16/EEC and 2001/19/EC, the directives of the European Parliament and of the Council on the mutual recognition of professional qualifications of European doctors currently in force, as well as the impending directive 2005/36/EC, which has to be translated into national law until October 2007, do not include transfusion medicine, blood transfusion or immunohaematology at all. Other medical specialities, which like our field, are not common to all member states of the European Union, are listed in the above mentioned directives with the minimum length of training and minimal requirements for the qualifications. Examples include clinical biology, biological haematology, microbiology-bacteriology, biological chemistry, immunology, thoracic, paediatric or vascular surgery as well as physiotherapy, stomatology, neuro-psychiatry, dermato-venerology, occupational medicine, allergology, geriatrics, gastro-enterological surgery, community medicine, nuclear medicine, pharmacology, accident and emergency medicine or tropical medicine. Most of the above are medical specialities in some member states, but not in all. A concerted initiative inaugurated by the European Network of Transfusion Medicine Societies (EuroNet-TMS) and the European Blood Alliance (EBA) aims to compile the situation of the transfusion medicine speciality throughout Europe. A preliminary summary of the current situation in 15 European states was prepared in 2005 after a first set of questions, which was sent out by us via the EBA platform. The authors appreciate Clair Watts' compilation of the answers provided by the 15 European colleagues. A summary of these answers is depicted in Table 1. However, the initiative aims at a more complex analysis of the different requirements and constituent parts of the qualification in transfusion medicine in different countries. A long-term objective of this initiative might be to introduce the transfusion medicine specialisation into the above mentioned EC directives in order to facilitate mutual recognition of transfusion medicine qualifications throughout Europe.

摘要

在过去几十年里,输血医学和血液疗法已发展成为复杂的医学学科,涵盖了广泛的亚专业领域,如免疫血液学、血液成分生产、血液单采术和止血学。因此,输血医学在分析检验医学、药品生产以及内科、麻醉学或外科等临床学科的交叉领域中是一项重要的资质。在安全、有效且个性化的血液疗法方面,专门从事输血医学的医生对于这些相关学科而言是宝贵且称职的合作伙伴。

为何输血医学变得如此复杂?一方面,可以识别出一些问题,比如过去世纪像艾滋病灾难这样的传染病,这导致了诸如德国输血法等指导方针、指令和法律的出台。由此,由于聚合酶链反应(PCR)检测的广泛应用,我们现在在血液制品病毒传播方面享有前所未有的最高安全水平。另一方面,输血医学日益复杂有诸多积极原因:现代医学疗法,如干细胞移植、细胞治疗、实体器官移植、再生医学和外科手术,如果没有安全的血液制品供应、高质量标准以及血库和输血医学专家提供的特殊血液制品和实验室服务,便无法存在。药品生产厂家层面的良好实验室规范(GLP)、良好生产规范(GMP)、质量管理体系和质量控制,只是当今血库标准的几个例子。欧盟在血液制品、干细胞制剂和组织领域的指令,在统一的欧洲导致了生物制剂更高的统一质量标准,这是期望的结果,但也增加了该领域的复杂性。相比之下,目前有效的欧洲议会和理事会关于欧洲医生专业资格互认的93/16/EEC和2001/19/EC指令,以及即将在2007年10月前转化为国内法的2005/36/EC指令,根本不包括输血医学、输血或免疫血液学。其他医学专业,像我们这个领域一样,并非欧盟所有成员国都有,在上述指令中列出了其最短培训时长和最低资质要求。例子包括临床生物学、生物血液学、微生物学 - 细菌学、生物化学、免疫学、胸外科、儿科或血管外科,以及物理治疗、口腔医学、神经精神病学、皮肤性病学、职业医学、变态反应学、老年医学、胃肠外科、社区医学、核医学、药理学、急诊医学或热带医学。上述大多数在一些成员国是医学专业,但并非所有成员国都有。由欧洲输血医学学会网络(EuroNet - TMS)和欧洲血液联盟(EBA)发起的一项协同倡议旨在汇总全欧洲输血医学专业的情况。在我们通过EBA平台发出第一组问题后,2005年对15个欧洲国家的现状进行了初步总结。作者感谢克莱尔·瓦茨对15位欧洲同事提供答案的整理。这些答案的总结见表1。然而,该倡议旨在对不同国家输血医学资质的不同要求和组成部分进行更复杂的分析。这项倡议的一个长期目标可能是将输血医学专业纳入上述欧盟指令,以便在全欧洲促进输血医学资质的互认。

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