荷兰一家骨科骨库的设计与管理
Design and management of an orthopaedic bone bank in The Netherlands.
作者信息
Zwitser Eline W, Jiya Timothy U, George Licher H, van Royen Barend J
机构信息
Department of Orthopaedic Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
出版信息
Cell Tissue Bank. 2012 Mar;13(1):63-9. doi: 10.1007/s10561-010-9230-4. Epub 2010 Nov 13.
The design and management of an orthopaedic bone bank is a complex process in which medical organisation and legislation intertwine. Neither in the Netherlands, nor in any other European country, there are official guidelines for the organisation and management of an orthopaedic bone bank. In the Netherlands, the recently modified 'law of security and quality for using human materials' (WVKL) dictates requirements for technical and organisational aspects for the use of human tissue and cells. The bone bank procedures include a thorough questionnaire for donor selection, extensive serological, bacteriological and histopathological examination, as well as standard procedures for registration, processing, preservation, storage and distribution of bone allografts. This article describes the organisation of an accredited bone bank and can be used as a proposition for an official guideline or can be useful as an example for other orthopaedic bone banks in Europe.
骨科骨库的设计与管理是一个复杂的过程，涉及医学组织与立法的交织。在荷兰以及任何其他欧洲国家，均不存在关于骨科骨库组织与管理的官方指南。在荷兰，最近修订的“人类材料使用安全与质量法”（WVKL）规定了使用人体组织和细胞的技术及组织方面的要求。骨库程序包括一份用于供体选择的详尽问卷、广泛的血清学、细菌学和组织病理学检查，以及同种异体骨移植的登记、处理、保存、存储和分发的标准程序。本文描述了一个获得认证的骨库的组织情况，可作为官方指南的提案，也可为欧洲其他骨科骨库提供范例。
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