van Wijk Marja J, van Geyt Caroline, Laven Audrey B H, Beele Hilde, Bokhorst Arlinke G
BISLIFE Foundation, P.O. Box 309, 2300 AH Leiden, The Netherlands.
Cell Tissue Bank. 2012 Dec;13(4):547-63. doi: 10.1007/s10561-011-9270-4. Epub 2011 Aug 24.
To identify critical elements of physical examination (PE) of potential tissue donors that could help to improve the safety of tissue transplantation. Physical signs were identified that can indicate the presence of a contraindication mentioned in EU Directive 2006/17/EC and that can theoretically be detected at PE. A risk assessment was designed, according to the Failure Mode and Effects Analysis model. Signs were scored on several aspects, taking into account various control measures, either required in the EU Directive or additional non-required measures. 106 signs associated with general and tissue-specific contraindications were identified. Signs of advanced infection with HIV, hepatitis B/C and syphilis (n = 13, 12.3%) can be omitted, since these contraindications will be detected by the required serological testing. With the required control measures, risk priorities are unacceptably "high" for 17.3% of the signs. For 64.5% of the signs, additional control measures are possible, which result in acceptable risk priorities for all signs. This risk management procedure identified the minimal necessary content of PE in potential tissue donors. Furthermore, risks associated with tissue donation were elucidated and possible risk control measures were identified as well as their impact on the safety of tissue transplantation.
为确定潜在组织供体体格检查（PE）的关键要素，以帮助提高组织移植的安全性。识别出可表明存在欧盟指令2006/17/EC中提及的禁忌症且理论上可在体格检查时检测到的体征。根据失效模式与效应分析模型设计了风险评估。考虑到欧盟指令要求的各种控制措施或额外的非要求措施，从多个方面对体征进行评分。识别出106个与一般和组织特异性禁忌症相关的体征。可省略与HIV、乙型/丙型肝炎和梅毒晚期感染相关的体征（n = 13，12.3%），因为这些禁忌症将通过要求的血清学检测来发现。采取要求的控制措施后，17.3%的体征的风险优先级“高”得令人无法接受。对于64.5%的体征，可采取额外的控制措施，这会使所有体征的风险优先级都可接受。这种风险管理程序确定了潜在组织供体体格检查的最低必要内容。此外，阐明了与组织捐赠相关的风险，确定了可能的风险控制措施及其对组织移植安全性的影响。
