Abstract
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.
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References
Beele H, Van Wijk M, Bokhorst A, Van Geyt C (2009) Physical examination of the potential tissue donor, what does literature tell us? Cell Tissue Bank 10:253–257
Caliendo C, Armstrong ML, Roberts AE (2005) Self-reported characteristics of women and men with intimate body piercings. J Adv Nurs 49:474–484
Commission (EU) Directive 2006/17/EC (2006) Technical requirements for donation, procurement and testing of human tissues and cells. Off J Eur Union. 8 Feb 2006
European Commission Eudralex (2008) The rules governing medicinal products in the European Union. Volume 4. Good Manufacturing Practice (GMP) Guidelines. Part III. GMP related documents. Q9 Quality Risk Management. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002873.pdf. Accessed July 2011
Kasper DL, Braunwald E, Hauser S, Longo D, Jameson JL, Fauci AS (2004) Harrison’s principles of internal medicine, 16th edn. McGraw-Hill, New York
Mandell GL, Bennett JE, Dolin R (2004) Mandell’s principles and practice of infectious diseases, 6th edn. Churchill Livingstone, Philidelphia
Schmidt RM, Middleman AB, Torchia MM, Armstrong ML (2009) Tattooing and body piercing. UpToDate 2009. http://www.uptodate.com. Accessed 2010
The Royal College of Pathologists (2002, Sept) Guidelines on autopsy practice. Report of a working group of The Royal College of Pathologists. http://www.rcpath.org/index.asp?PageID=240. Accessed Mar 2011
Van Geyt C, Van Wijk M, Bokhorst A, Beele H (2010) Physical examination of the potential tissue donor, what do European tissue banks do? Clin Transpl 24:259–264
Van Wijk MJ, Visser L, Bokhorst AG (2008) Evaluation of the autopsy report before releasing musculoskeletal tissue donors; what is the benefit? Cell Tissue Bank 9:329–335
Visser L, Holsboer E, Bokhorst AG, Van Wijk MJ (2010) The value of autopsy and other histological examinations for the safety of tissue transplantation. Cell Tissue Bank. doi:10.1007/s10561-010-9221-5
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van Wijk, M.J., van Geyt, C., Laven, A.B.H. et al. Physical examination of potential tissue donors: results of a risk management procedure to identify the critical elements of the physical examination. Cell Tissue Bank 13, 547–563 (2012). https://doi.org/10.1007/s10561-011-9270-4
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DOI: https://doi.org/10.1007/s10561-011-9270-4