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Patricia López-Chicón,1,2,* Maria Luisa Pérez,1,3,* Cristina Castells-Sala,1,2,* Rita A Piteria,1,2,* Oscar Fariñas,1,2 Jaime Tabera,1,2 Anna Vilarrodona1,3 1Barcelona Tissue Bank (BTB), Banc de Sang i Teixits (BST), Barcelona, Spain; 2Biomedical Research Institute (IIB-Sant Pau; SGR1113), Barcelona, Spain; 3Vall Hebron Institute of Research (VHIR), Barcelona, Spain*These authors contributed equally to this workCorrespondence: Maria Luisa Pérez, Barcelona Tissue Bank (BTB), Banc de Sang i Teixits (BST, GenCAT), Passeig Taulat 116, Barcelona, E-08005, Spain, Tel +34 935 57 35 00, Email mlperez@bst.catBackground: The activities of tissue establishments are constantly and rapidly evolving. The development of a new type of allograft, full-thickness acellular dermal matrix, with high mechanical properties to be used in tendon repair surgeries and abdominal wall reconstruction, has determined the need for quality by design process in order to assess evidence of quality, safety and efficacy. The EuroGTPII methodologies were specifically tailored to perform the risk assessment, identify and suggest tests in order to mitigate the potential risk consequences of a novel tissue preparation implementation.Methods: The new allograft and associated preparation processes were assessed using the EuroGTP methodologies and characterized to properly evaluate the novelty (Step 1), identify and quantify the potential risks and risk consequences (Step 2), and define the extent of pre-clinical and clinical assessments required to mitigate the risks identified in the assessment (Step 3).Results: Four risk consequences associated with the preparation process were identified: (i) implant failure related with tissue procurement and the reagents used during the decellularization protocol; (ii) unwanted immunogenicity related with the processing; (iii) disease transmission linked with the processing, reagents used, reduction in the reliability of microbiology testing and the storage conditions; and (iv) toxicity related to the reagents used and handling of the tissue during clinical application. The outcome of the risk assessment was a low level of risk. Nevertheless, it determined the need for a series of risk mitigation strategies proposed to reduce each individual risk and to provide additional evidence of the safety and efficacy of full-thickness acellular dermal matrix grafts.Conclusion: EuroGTPII methodologies allow us to identify the risks and ensure the correct definition of pre-clinical assessments required to address and mitigate the potential risk consequences, before proceeding with clinical use of the new allografts in patients.Graphical Abstract: Keywords: EuroGTPII methodology, acellular dermis, risk assessment, quality, safety

Since the start of the pandemic, the tissue donation in Catalonia (Spain) has decreased drastically. At the beginning of the lockdown (from March to May 2020) there was a drop of around 70% in donation of corneas and of approximately 90% in donation of placentas. Despite the fast updating of standard operating procedures, we had big difficulties in different points. For instance, in the availability of the transplant coordinator for the donor detection and evaluation, in obtaining the necessary PPE (personal protective equipment), or in the resources available in the quality control laboratories for screening. This, added to the collapse that hospitals suffered due to the large number of patients hospitalized each day, made donation levels slowly rebound.In order to provide solutions to all patients, we tried to adapt quickly to these emerging changes.In the case of corneas, we found a scenario that we had never had before. Although the cornea transplant plummeted at the beginning of the confinement (decreased by 60% compared to 2019), we run out of corneas -even for emergency situations- at the end of March.This situation led us to develop a new type of therapeutic solution in our Eye Bank. The cryopreserved cornea for tectonic purposes is a tissue that is kept frozen at -196°C and can be preserved for up to 5 years. Therefore, it is a tissue that allows us to respond to possible emergencies in subsequent similar situations.Regarding amniotic membrane for ocular care indications, the strategy was completely different. For this kind of tissue, we carried out an adaptation of our processing with two different purposes. On the one hand, to make sure that we could inactivate the SARS-CoV-2 virus, if it was there. On the other hand, to increase the donation of placentas. For this, changes in the transport medium and in the antibiotic cocktail were performed. In addition, an irradiation step was added to the final product.Little by little, it seems that the donations of corneas and placentas have been recovering. However, it is necessary to think about future contingency strategies in case a stop in donation is repeated., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Swab cultures are the most usual method to detect graft contamination; nevertheless it has been confirmed his limited sensibility. We have studied the relationship between blood cultures, swab surface cultures and cultures of entirely samples of cancellous bone., Material and Methods: We have evaluated 5 donors with positive blood culture, from 70 multiorganic donors during 2002. Blood samples were obtained prior the heart arrest. The bone procurement was done just after the organ recovery under aseptic conditions, and surface cultures were performed of each bone. After storage at -80 degrees C, cancellous samples were obtained by trephine and were completely cultured., Results: In one case, the same microorganism grown in blood culture, in 2 of 9 surface cultures, and in 15 of 26 samples of cancellous bone., Conclusion: We conclude that to guarantee allograft's safety it is recommended to add donor's blood culture to the habitual surface swab culture if secondary sterilisation is not performed.