BISLIFE Foundation

Leiden, Netherlands

BISLIFE Foundation

Leiden, Netherlands

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Van Wijk M.J.,BISLIFE Foundation | Hogema B.M.,Sanquin Blood Supply Foundation | Maas D.W.,BISLIFE Foundation | Bokhorst A.G.,BISLIFE Foundation
Transfusion Medicine and Hemotherapy | Year: 2011

Background: Emerging infectious diseases can compromise the safety of tissues for transplantations. A recent outbreak of Q fever, a zoonosis caused by the bacterium Coxiella burnetii, in the Netherlands compelled the Dutch tissue banks to assess the risk of Q fever transmission through tissue transplantation in order to maintain optimal safety. Methods: This article describes the systematic approach that was followed in the Netherlands. This approach included a review of the literature, a qualitative risk assessment, expert opinion gathering and investigations for specific strategies that can help to maintain the balance between tissue safety and availability. Results: This resulted in a specific donor selection policy and in development of further research to fill in gaps in knowledge about Q fever in tissue transplantation. Conclusion: The strategy described in this article may be useful for tissue bankers facing similar outbreaks of emerging infections or may be useful for development of future guidelines or assessment strategies for tissue banking. © 2011 S. Karger AG, Basel.


Van Wijk M.J.,BISLIFE Foundation | Maas D.W.,BISLIFE Foundation | Renders N.H.M.,Robert Bosch GmbH | Hermans M.H.A.,Robert Bosch GmbH | And 2 more authors.
BMC Infectious Diseases | Year: 2014

Background: After the largest outbreaks of Q fever ever recorded in history occurred in the Netherlands, concern arose that Coxiella may be transmitted via donated tissues of latent or chronically infected donors. The Dutch Health Council recently advised to screen tissue donors, donating high risk tissues, for Coxiella infection.Methods: After validation of an enzyme immunoassay (EIA) test for IgG antibodies against phase 2 of C. burnetii for use on post-mortem samples, serum samples of 1033 consecutive Dutch post-mortem tissue donors were tested for IgG antibodies against phase 2 of C. burnetii. Confirmation of reactive results was done by immunofluorescence assay (IFA). All available tissues (corneas, heart valves, skin and bone marrow) from donors with IgG reactivity were tested for presence of Coxiella DNA by PCR. Risk factors for IgG reactivity were investigated.Results: After validation of the tests for use on post-mortem samples, 50/1033 donors (4.8%) screened positive for phase 2 anti-Coxiella IgG by EIA, and 31 were confirmed by IFA (3.0%). One donor showed a serological profile compatible with chronic infection. All tested tissues (25 corneas, 6 heart valves, 4 skin and 3 bone marrow) from donors with IgG reactivity tested negative for the presence of Coxiella DNA. Except for living in a postal code area with a high number of Q fever notifications, no risk factors for IgG reactivity were found.Conclusions: The strong correlation between notifications and seroprevalence confirms that the used assays are sufficiently specific for use on post-mortem samples, although one has to be aware of differences between batches. Thus, this study provides a validated method for screening tissue donors for infection with Coxiella burnetii that can be used in future outbreaks. © 2014 van Wijk et al.; licensee BioMed Central Ltd.


PubMed | BISLIFE Foundation, Tissue Bank, Ghent University, Dutch Transplant Organisation and Institute of Legal Medicine
Type: Journal Article | Journal: Cell and tissue banking | Year: 2016

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 possible approaches taken to challenging situations regarding donor selection. Donor case workshops actively engage participants with diverging background and experience in an informal, secure and enjoyable setting. The resulting discussion with peers promotes consensus development in deciding tissue donor acceptability, especially when donor health issues are not conclusively addressed in standards and regulations. Finally the workshop serves to strengthen the professional tissue banking networks across Europe and beyond. This report reflects some of the discussion at the workshop during the annual congress in Lund, Sweden, in 2014. The cases presented demonstrate that the implications of various donor illnesses, physical findings and behaviours on the safety of tissue transplantation, may be interpreted in a different way by medical directors and other professionals of different tissue facilities. This will also result in diverging preventive measures and decisions taken by the tissue facilities. Some of the donor cases illustrate varied responses from participants and demonstrate that operating procedures, regulations and standards cannot comprehensively cover all tissue donor illnesses, medical histories and circumstances surrounding the cause of death. For many of the issues raised, there is a lack of published scientific evidence. In those cases, tissue bank medical director judgement is critical to guarantee transplantation safety. This judgement should be based on a proper and documented risk assessment case by case. Conditions or parameters taken into account for risk assessment are amongst others, the type of tissue, the type of processing, the characteristics of the final product, and the availability of an adequate sterilisation methodology. By publishing these difficult donor suitability cases, and the resulting discussions, we provide information for future similar cases and we identify needs for future literature review and scientific research. In this way the donor case workshops play a role in optimizing the quality and security of tissue donation.


Bosma S.,Ghent University | Van Wijk M.J.,BISLIFE Foundation | Richters C.D.,Euro Tissue Bank | Beele H.,Ghent University
Cell and Tissue Banking | Year: 2015

According to the European Union Tissues and Cells Directives donation of tissue is contraindicated in the presence of or a previous history of malignant disease, with the exception of cutaneous basal cell carcinoma. Skin cancer is the most common cancer. Due to ultraviolet light exposure and increasing life expectancy an increasing prevalence of malignant or premalignant skin lesions is observed, which may result in a decline of the availability of skin for transplantation. A risk assessment based on published studies and expert opinion was performed in order to investigate the risk of transmitting malignant or premalignant skin lesions through tissue transplantation, and more particular through skin transplantation. The scarcity of data concerning cancer transmission in tissue transplantation was challenging. Circumstantial evidence, available for organ transplantation, was used to develop the following policy proposal for skin transplantation and cutaneous tumours. Malignant melanoma is an absolute contraindication for the donation of skin and also of other tissues, whereas, non-lesional skin and other tissues of a donor with non-melanoma skin cancer (basal cell and squamous cell carcinoma) or with a premalignant skin lesion can be considered for transplantation. The above mentioned protocol proposal might serve as a prototype for analogous protocols for non-cutaneous malignancies. © 2015, Springer Science+Business Media Dordrecht.


Van Wijk M.J.,BISLIFE Foundation | Van Geyt C.,Ghent University | Laven A.B.H.,BISLIFE Foundation | Beele H.,Ghent University | Bokhorst A.G.,BISLIFE Foundation
Cell and Tissue Banking | Year: 2012

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 tissuespecific 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. © Springer Science+Business Media B.V. 2011.


Van Wijk M.J.,BISLIFE Foundation | Van Den Bogaerdt A.,Erasmus Medical Center | Bokhorst A.G.,BISLIFE Foundation
Cell and Tissue Banking | Year: 2013

The study aim was to identify risk factors for morphological rejection of aortic and pulmonary valves for transplantation that could be used to optimize donor selection. The files of all Dutch heart valve donors, donating in a 2.5 years period, whose hearts were processed at Heart Valve Bank Rotterdam, were reviewed for all factors that could be relevant for valve rejection and related to outcome of morphological assessment of the valves. Valves were retrieved from 813 deceased Dutch donors, 24.1% also donating organs. For 797 aortic and 767 pulmonary valves, who met retrieval criteria, morphological assessment was done. 69.5% of aortic and 37.5% of pulmonary valves were considered unsuitable for transplantation at morphological assessment. Backward stepwise multivariate logistic regression analysis, showed age, cardiac cause of death, cerebrovascular accident as cause of death or in medical history, and number of cardiovascular risk factors in a donor to be independent risk factors for morphological rejection of aortic valves. Age, sex, weight >100 kg and ruptured aortic aneurysm as cause of death were independent risk factors for morphological rejection of pulmonary valves. Being an organ donor was an independent predictor of morphological approval of aortic and pulmonary valves, while hypertension was an independent predictor for morphological approval of aortic valves. Thus, independent factors were identified that are associated with morphological rejection of aortic and pulmonary valves for transplantation, and that could be used to optimize donor selection by preventing unnecessary retrievals, limiting costs, while improving yield per donor with minimal compromise for availability. © 2011 Springer Science+Business Media B.V.


PubMed | BISLIFE Foundation
Type: Journal Article | Journal: Cell and tissue banking | Year: 2012

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.


PubMed | BISLIFE Foundation
Type: | Journal: BMC infectious diseases | Year: 2014

After the largest outbreaks of Q fever ever recorded in history occurred in the Netherlands, concern arose that Coxiella may be transmitted via donated tissues of latent or chronically infected donors. The Dutch Health Council recently advised to screen tissue donors, donating high risk tissues, for Coxiella infection.After validation of an enzyme immunoassay (EIA) test for IgG antibodies against phase 2 of C. burnetii for use on post-mortem samples, serum samples of 1033 consecutive Dutch post-mortem tissue donors were tested for IgG antibodies against phase 2 of C. burnetii. Confirmation of reactive results was done by immunofluorescence assay (IFA). All available tissues (corneas, heart valves, skin and bone marrow) from donors with IgG reactivity were tested for presence of Coxiella DNA by PCR. Risk factors for IgG reactivity were investigated.After validation of the tests for use on post-mortem samples, 50/1033 donors (4.8%) screened positive for phase 2 anti-Coxiella IgG by EIA, and 31 were confirmed by IFA (3.0%). One donor showed a serological profile compatible with chronic infection. All tested tissues (25 corneas, 6 heart valves, 4 skin and 3 bone marrow) from donors with IgG reactivity tested negative for the presence of Coxiella DNA. Except for living in a postal code area with a high number of Q fever notifications, no risk factors for IgG reactivity were found.The strong correlation between notifications and seroprevalence confirms that the used assays are sufficiently specific for use on post-mortem samples, although one has to be aware of differences between batches. Thus, this study provides a validated method for screening tissue donors for infection with Coxiella burnetii that can be used in future outbreaks.


PubMed | BISLIFE Foundation
Type: Congresses | Journal: 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.


PubMed | BISLIFE Foundation
Type: Journal Article | Journal: Cell and tissue banking | Year: 2013

The study aim was to identify risk factors for morphological rejection of aortic and pulmonary valves for transplantation that could be used to optimize donor selection. The files of all Dutch heart valve donors, donating in a 2.5 years period, whose hearts were processed at Heart Valve Bank Rotterdam, were reviewed for all factors that could be relevant for valve rejection and related to outcome of morphological assessment of the valves. Valves were retrieved from 813 deceased Dutch donors, 24.1% also donating organs. For 797 aortic and 767 pulmonary valves, who met retrieval criteria, morphological assessment was done. 69.5% of aortic and 37.5% of pulmonary valves were considered unsuitable for transplantation at morphological assessment. Backward stepwise multivariate logistic regression analysis, showed age, cardiac cause of death, cerebrovascular accident as cause of death or in medical history, and number of cardiovascular risk factors in a donor to be independent risk factors for morphological rejection of aortic valves. Age, sex, weight >100 kg and ruptured aortic aneurysm as cause of death were independent risk factors for morphological rejection of pulmonary valves. Being an organ donor was an independent predictor of morphological approval of aortic and pulmonary valves, while hypertension was an independent predictor for morphological approval of aortic valves. Thus, independent factors were identified that are associated with morphological rejection of aortic and pulmonary valves for transplantation, and that could be used to optimize donor selection by preventing unnecessary retrievals, limiting costs, while improving yield per donor with minimal compromise for availability.

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