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van Wijk M.J.,BISLIFE Foundation | Beele H.,Ghent University | Brubaker S.A.,American Association of Tissue Banks | Navarro A.,Banc de Sang I Teixits | And 2 more authors.
Cell and Tissue Banking | Year: 2015

The European Association of Tissue Banks (EATB) Donor Case Workshop is a forum held within the program of the EATB Annual Congress. The workshop offers an opportunity to discuss and evaluate approaches taken to challenging donor selection and donation ethics, and it strengthens networking between tissue banking professionals. The workshops actively engage participants from a wide array of international expertise, in an informal, secure and enjoyable setting in which learning from peers and finding potential solutions for submitted cases are facilitated. This report reflects some of the discussion at the Donor Case Workshop during the EATB Annual Congress in Brussels in 2013. The presented cases demonstrate that the findings, their interpretation, the resulting actions and preventive measures in the different tissue facilities are not always predictable. The varied responses from participants and lack of consensus corroborate this and clearly indicate that operating procedures do not comprehensively cover or prepare for all eventualities. For many of the issues raised there is no relevant information in the published literature. By publication of a summary of the discussions we hope to reach a wider audience, to provide information gathered at the workshop and to stimulate individuals and institutions to undertake further literature reviews or to undertake research in order to gather evidence concerning the discussed topics. © 2014, Springer Science+Business Media Dordrecht.

Olender E.,Medical University of Warsaw | Brubaker S.,American Association of Tissue Banks | Uhrynowska-Tyszkiewicz I.,Medical University of Warsaw | Wojtowicz A.,Medical University of Warsaw | Kaminski A.,Medical University of Warsaw
Transplantation Proceedings | Year: 2014

Background. The idea of cell treatment of various diseases and medical conditions has become very popular. Some procedures are well established, as is autologous chondrocyte implantation, whereas others are still in the process of early development, laboratory experiments, and some clinical trials.Methods. This report is devoted to an example of an emerging cell treatment: bone augmentation with the use of autologous cells and its legal and technical background. Various requirements set by law must be met by tissue banks performing cell seeding of grafts. In Europe, the requirements are described in directives 2004/23/EC, 2006/17/EC, 2006/86/EC, and in the regulation 2007/1394/EC.Results. Revitalization of biostatic allografts gives new, promising tools for creation of functional parts of organs; brings the methodology used in tissue banks closer to tissue engineering; places the enterprise in the mainstream of advanced biotechnology; allows the full potential of tissue allografts; and opens a new, large area for clinical and laboratory research. Cell and tissue processing also have a financial impact on the treatment: it produces additional expenditures.Conclusions. Clinical effectiveness will be the most decisive factor of whether this innovative treatment will be applied in a particular type of medical condition. From a tissue establishment perspective, the most important issue is to develop a procedure that ensures safety for the patient in graft quality terms. © 2014 Elsevier Inc. All rights reserved.

Podzemny C.E.,LABs Inc. | Brenton M.D.,LABs Inc. | Brubaker S.A.,American Association of Tissue Banks | Marians R.C.,LABs Inc.
Cells Tissues Organs | Year: 2013

A country-to-country analysis of infectious disease screening requirements for donated tissues or cells reveals they are not often harmonized. Transmission of one such infectious disease, human T-lymphotropic virus (HTLV), is related to the transfer of HTLV-infected, viable leukocytes of sufficient number. The ability to characterize allograft tissue as being absent of leukocytes, or containing relatively few leukocytes, by using a specific test has not been previously investigated. A quantitative polymerase chain reaction (qPCR) test was developed to interrogate protein tyrosine phosphatase, receptor type C (PTPRC) gene expression in tissue samples and was able to determine the number of leukocytes present in a tissue. The impact of a qualified leukocyte tissue testing method should be significant and lead to changes in donor eligibility regulations in certain countries. Human leukapheresis samples were used as a control to establish the amount of PTPRC in leukocytes. That value was used as a comparator to determine the number of leukocyte equivalents in tissues of interest. The qPCR test measured tissue leukocyte equivalents and the results were consistent with the relative abundance of leukocytes predicted for each tissue. Using qPCR to calculate leukocyte equivalents based upon PTPRC gene expression can be successfully employed to estimate the number of leukocytes in a tissue or allograft. This method could be used as a screen to rule out tissues that do not meet the criteria of being leukocyte rich and, therefore, do not need direct HTLV testing. © 2013 S. Karger AG, Basel.

Wood A.,Center for Nursing Practice | Brubaker S.A.,American Association of Tissue Banks | Spruce L.,Center for Nursing Practice
AORN Journal | Year: 2015

Update on perioperative Ebola precautions. Key words: Ebola, PPE, airborne, droplet, respirator.Contaminated rigid sterilization containers. Key words: rigid sterilization containers, filters, valves, latches, gaskets.Requirements for storing autologous tissue. Key words: tissue bank, autologous tissue, US Food and Drug Administration, human cells, delayed replantation or autotransplantation.Storing autologous human vein autografts. Key words: autografts, storage media, Tiprotec®, X-Vivo 10®, American Association of Tissue Banks.Dropped autografts. Key words: autograft, pulse lavage, wound classification, dropped grafts, cranial bone graft.Antimicrobial and fluid barrier fabrics. Key words: antimicrobial fabrics, fluid barrier fabrics, surgical site infections, scrub attire, surgical attire. © 2015 AORN, Inc.

Cox M.A.,Danish Medicines Agency | Brubaker S.A.,American Association of Tissue Banks
Cell and Tissue Banking | Year: 2012

In the context of the EU Directives for human tissues and cells (2004/23/EC, 2006/17/EC and 2006/86/EC) further interest has arisen on the practical application of a few clauses. One such aspect, for the evaluation phase of a potential donor, is the interpretation of the exclusion criterion "transplantation with xenografts." This article outlines the consensus viewpoints regarding the earlier evaluation of the risks related to xenotransplantation and describes the current status of the terminology and recommendations/laws in several healthcare sectors. The application of uniform terminology is encouraged within the healthcare sectors at the international level. © 2011 Springer Science+Business Media B.V.

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