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Objective: We present the operational organization and daily workflow of our Hamburg model and the results of the years 2007-2011 concerning donation of corneas, musculoskeletal and, since 2010, cardiovascular tissues. Methods: Each of the about 3,600 deceased every year undergoes an evaluation process by two coordinators on duty, the tissue coordinator and the family coordinator. All donation connected issues are carried out within the standardized protocols of a quality management system and documented in a special data base. Two catamnestic surveys evaluated the satisfaction of donor families retrospectively. The inclusion rate for cornea donation was 23% and for musculoskeletal donation 10%, with a decrease after the 75 years age restriction of musculoskeletal donors in 2011 defined by the contracting tissue bank German Institute for Cell and Tissue Replacement gGmbH (DIZG), Berlin. Results: Since 2007 1,268 corneas were explanted altogether, reflecting an increasing explantation rate from 156 (University Medical Center Hamburg-Eppendorf (UMC: 9) in 2007 up to 304 (UMC: 52) in 2011. Overall 173 musculoskeletal donors (5 years) and 11 cardiovascular donors (2 years) spent tissues. The consent rate was much higher. The evaluation of the families reflected a positive feedback for the guiding of the donation process. Conclusion: Forensic institutes can act as an interface between donors and recipients without neglecting forensic investigations. They are uniquely positioned to recognize potential donors. In addition, the contact with a physician of the forensic institute may help families during the mourning phase. [ABSTRACT FROM AUTHOR]

Objective: According to EU regulations (EU directive 2006/17/EC), blood specimens for virologic testing in the context of post-mortal tissue donation must be taken not later than 24 h post mortem. Methods: To verify validity of NAT in blood specimens collected later, viral nucleic acid concentrations were monitored in blood samples of deceased persons infected with HIV (n = 7), HBV (n = 5), and HCV (n = 17) taken upon admission and at 12 h, 24 h, 36 h and 48 h post mortem. HIV and HCV RNA were quantified using Cobas TaqMan (Roche), HBV DNA was measured by in-house PCR. Results: A more than 10-fold decrease of viral load in samples taken 36 h or 48 h post mortem was seen in one HIV-infected patient only. For all other patients tested the decrease of viral load in 36hour or 48-hour post-mortal samples was less pronounced. Specimens of 3 HIV- and 2 HBV-infected patients taken 24 h post mortem or later were even found to have increased concentrations (>10-fold), possibly due to post-mortem liberation of virus from particular cells or tissues. Conclusion: Our preliminary data indicate that the time point of blood collection for HIV, HBV and HCV testing by PCR may be extended to 36 h or even 48 h post mortem and thus improve availability of tissue donations. [ABSTRACT FROM AUTHOR]

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Background and Objective: The European consortium project TRANSPOSE (TRANSfusion and transplantation: PrOtection and SElection of donors) aimed to assess and evaluate the risks to donors of Substances of Human Origin (SoHO), and to identify gaps between current donor vigilance systems and perceived risks., Materials and Methods: National and local data from participating organizations on serious and non-serious adverse reactions in donors were collected from 2014 to 2017. Following this, a survey was performed among participants to identify risks not included in the data sets. Finally, participants rated the risks according to severity, level of evidence and prevalence., Results: Significant discrepancies between anticipated donor risks and the collected data were found. Furthermore, many participants reported that national data on adverse reactions in donors of stem cells, gametes, embryos and tissues were not routinely collected and/or available., Conclusions: These findings indicate that there is a need to further develop and standardize donor vigilance in Europe and to include long-term risks to donors, which are currently underreported, ensuring donor health and securing the future supply of SoHO., (© 2020 International Society of Blood Transfusion.)

Background and Objective: Donor selection criteria (DSC) are a vital link in the chain of supply of Substances of Human Origin (SoHO) but are also subject to controversy and differences of opinion. Traditionally, DSC have been based on application of the precautionary principle., Materials and Methods: From 2017 to 2020, TRANSPOSE (TRANSfusion and transplantation PrOtection and SElection of donors), a European research project, aimed to identify discrepancies between current DSC by proposing a standardized risk assessment method for all SoHO (solid organs excluded) and all levels of evidence., Results: The current DSC were assessed using a modified risk assessment method based on the Alliance of Blood Operators' Risk-based decision-making framework for blood safety. It was found that with limited or diverging scientific evidence, it was difficult to reach consensus and an international standardized method for decision-making was lacking. Furthermore, participants found it hard to disregard their local guidelines when providing expert opinion, which resulted in substantial influence on the consensus-based decision-making process., Conclusions: While the field of donation-safety research is expanding rapidly, there is an urgent need to formalize the decision-making process regarding DSC. This includes the need for standardized methods to increase transparency in the international decision-making process and to ensure that this is performed consistently. Our framework provides an easy-to-implement approach for standardizing risk assessments, especially in the context of limited scientific evidence., (© 2020 International Society of Blood Transfusion.)

Unlabelled: The authors present data from 36 musculoskeletal donors. Talking to the next of kin plays a key role in the consenting process for tissue donation. We give an overview of our fundamental thoughts and the guidelines developed for the contact with the family and present the results of a catamnestic review., Methods: One year after procurement, we contacted the consenting persons by telephone for an interview using a semi-standardized questionnaire to evaluate the information given on tissue donation and the emotional processing of the death., Results: 8-18 months after the donation, 26 (72.2 %) consenting persons could be reached and gave a positive feedback with regard to the information and support provided and the consent given by them at that time., Discussion: The telephone contact of physicians from an Institute of Legal Medicine with the family of a deceased is perceived as being helpful in an acute stress situation caused by a sudden death and as an accepted way to ascertain the deceased's last will with regard to a potential musculoskeletal donation. According to the German Transplantation Act asking for musculoskeletal donations is the duty of every physician. Our data show that this does not constitute an additional burden for the relatives, if the question is asked in an appropriate way.