Static cold package for transporting organs for transplants: a validation method and pilot test
Keywords:
Product packaging, Transplants, Validation study, Static cold package, Transport, Logistics, Organ transplantation, Transplantation, Validation methodAbstract
BACKGROUND: Logistic and temperature challenges contribute to organ loss during transplantation. Ensuring the safety of static cold packaging for organ transport is essential to improve patient access to transplants. This study aimed to verify a method for validating the packaging used to transport organs for transplantation.
DESIGN AND SETTING: Validation study and pilot test using experimental surgery on porcine organs.
METHODS: Data collection considered the variables related to organ integrity before and after transportation, including temperature (measured thrice with three instruments per organ), macroscopic evaluation (based on photographic and observational assessments), histology (structural analysis of the collected samples), and packaging contamination (triple-swab sampling for microorganism growth). Data analysis was performed using descriptive statistics, visual assessment, histological processing, and microbiological evaluation.
RESULTS: By the end of transportation, all the organs reached the ideal temperature range for transplantation. The similarity in swine weight and size enabled macroscopic comparisons. Histological analysis revealed no significant injuries or morphological changes. Regarding packaging, environmental microorganisms predominate, with sustainable post-transport differences.
CONCLUSION: The method developed to validate the package used for transporting organs for transplantation was successfully verified. Furthermore, this method addresses the existing gap in the process of documenting a robust validation method for packaging intended for organ transportation.
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Dimensionamento dos transplantes no Brasil e em cada Estado (2016–2023). Regist Bras Transpantes (RBT). 2023 [cited 2024 Jul 11];30(4) Available from: https://site.abto.org.br/wp-content/uploads/2024/03/RBT_2023-Populacao_Atualizado.pdf.
Roza BA, Schuantes-Paim SM, Oliveira PC, et al. Reasons for organ and tissue donation refusal and opposition: a scoping review. Rev Panam Salud Publica. 2024;48:e115. https://doi.org/10.26633/RPSP.2024.115.
Instituto Brasileiro de Geografia e Estatística (IBGE). Atlas escolas. Brasília (DF): IBGE; 2023 [cited 2024 Jul 11]. Available from: https://atlasescolar.ibge.gov.br.
Brasil. Ministério da Saúde. Agência Nacional de Vigilância Sanitária. Diretoria Colegiada. Resolução RDC nº 504, de 27 de maio de 2021. Dispõe sobre as Boas Práticas para o transporte de material biológico humano. Diário Oficial da União [Internet]. 2021 May 27 [cited 2025 Aug 20];101.1:126. Disponível em: https://pncq.org.br/wp-content/uploads/2021/06/RDC-504_27-mai-2021.pdf.
Copeland H, Hayanga JWA, Neyrinck A, et al. Donor heart and lung procurement: a consensus statement. J Heart Lung Transplant. 2020;39(6):501–17. https://doi.org/10.1016/j.healun.2020.03.020. Erratum in: J Heart Lung Transplant. 2020;39(7):734. PMID: 32650882; https://doi.org/10.1016/j.healun.2020.06.001.
Pereira WA, Fernandes RC, Soler WV, editors. Basic guidelines for retrieving multiple organs and tissues from the Brazilian Transplantation Society (ABTO). Brazil: Brazilian Transplantation Society; 2009.
Tripathy S, Das SK. Strategies for organ preservation: current prospective and challenges. Cell Biol Int. 2023;47(3):520–38. PMID: 36626269; https://doi.org/10.1002/cbin.11984.
Instituto Nacional de Meteorologia (Inmet). Clima. Anomalias de temperaturas medias, jul. 2025. [cited 2024 Jul 11]. Available from: https://clima.inmet.gov.br/temp.
The scientific basis of climate change. Contribution from the Working Group 1 to the first national assessment report of the Brazilian Panel on Climate Change (GT1 RAN1 PBMC). Brasília (DF): Painel Brasileiro de Mudanças Climáticas (PBMC); 2013 [cited 2024 Jul 11]. Available from: http://www.pbmc.coppe.ufrj.br/index.php/en/publications/reports-pbmc/item/executive-summary-the-scientific-basis-of-climate-change?category_id=16.
Carrier AN, Verma A, Mohiuddin M, et al. Xenotransplantation: a new era. Front Immunol. 2022;13:900594. PMID: 35757701; https://doi.org/10.3389/fimmu.2022.900594.
Tierie EL, Roodnat JI, Dor FJMF. Systematic surgical assessment of deceased-donor kidneys as a predictor of short-term transplant outcomes. Eur Surg Res. 2019;60(3–4):97–105. PMID: 31480061; https://doi.org/10.1159/000501602.
Dare AJ, Pettigrew GJ, Saeb-Parsy K. Preoperative assessment of the deceased-donor kidney: from macroscopic appearance to molecular biomarkers. Transplantation. 2014;97(8):797–807. PMID: 24553618; https://doi.org/10.1097/01.TP.0000441361.34103.53.
Dabare D, Hodson J, Nath J, et al. Macroscopic assessment of the quality of cold perfusion after deceased-donor kidney procurement: A United Kingdom population-based cohort study. Clin Transplant. 2021;35(5):e14272. PMID: 33638883; https://doi.org/10.1111/ctr.14272.
Kulu Y, Khajeh E, Ghamarnejad O, et al. Expanding pancreas donor pool by evaluation of unallocated organs after brain death: Study Protocol Clinical Trial (SPIRIT Compliant). Med (Baltim). 2020;99(10):e19335.
Nicholson ML, Hosgood SA. Organ retrieval and preservation. Surgery (Oxf). 2023;41(9):559–65.
Eixerés-Esteve A, Pérez-De la Sota E, Cortina-Romero JM. Preservation methods: beyond the icebox. Cir Cardiovasc. 2022;29(6):323–31.
Abbas SH, Friend PJ. Principles and current status of abdominal organ preservation for transplantation. Surg Pract Sci. 2020;3:100020.
Smith TB, Nicholson ML, Hosgood SA. Advances in hypothermic and normothermic perfusion in kidney transplantation. Transplantology. 2021;2(4):460–77.
D’Alessandro AM, Southard JH, Love RB, Belzer FO. Organ preservation. Surg Clin North Am. 1994;74(5):1083–95. PMID: 7940062.
Lechiancole A, Sponga S, Benedetti G, et al. Graft preservation in heart transplantation: current approaches. Front Cardiovasc Med. 2023;10:1253579. PMID: 37636303; https://doi.org/10.3389/fcvm.2023.1253579.
Schlegel A, Muller X, Dutkowski P. Machine perfusion strategies in liver transplantation. Hepatobiliary Surg Nutr. 2019;8(5):490–501. PMID: 31673538; https://doi.org/10.21037/hbsn.2019.04.04.
Evagorou M, Erduran S, Mäntylä T. The role of visual representations in scientific practices: from conceptual understanding and knowledge generation to “seeing” how science works. IJ Stem Ed. 2015;2(1).
Magaki S, Hojat SA, Wei B, So A, Yong WH. An introduction to the performance of immunohistochemistry. Methods Mol Biol. 2019;1897:289–98. PMID: 30539453; https://doi.org/10.1007/978-1-4939-8935-5_25.
Erbasan F. Brain abscess caused by Micrococcus luteus in a patient with systemic lupus erythematosus: case-based review. Rheumatol Int. 2018;38(12):2323–8. PMID: 30374688; https://doi.org/10.1007/s00296-018-4182-2.
Zhu M, Zhu Q, Yang Z, Liang Z. Clinical characteristics of patients with Micrococcus luteus bloodstream infection in a Chinese tertiary-care hospital. Pol J Microbiol. 2021;70(3):321–6. PMID: 34584526; https://doi.org/10.33073/pjm-2021-030.
Karam BRS, Ribeiro PMAP. Staphylococcus warneri: brief literature review. Braz J Hea Rev. 2022;5(2):4358–64.
Corynebacterium imitans LMG 19048 is an aerobe, mesophilic bacterium that was isolated from human throat. BacDive Database. 2025; 2022 [cited 2024 Jul 11]. Available from: https://www.bacdive.dsmz.de/strain/3162.
Yadav AN, Verma P, Kumar V, et al. Biodiversity of the Genus Penicillium in different habitats. In: Gupta VK, Couto-Rodriguez S, editors. New and future developments in microbial biotechnology and bioengineering. Elsevier; 2018. p. 3–18.
McAnulty JF. Hypothermic organ preservation by static storage methods: current status and a view to the future. Cryobiology. 2010;60(3) Suppl:S13–9. PMID: 19538951; https://doi.org/10.1016/j.cryobiol.2009.06.004.
Ohkawara H, Kitagawa T, Fukushima N, et al. A newly developed container for safe, easy, and cost-effective overnight transportation of tissues and organs by electrically keeping tissue or organ temperature at 3 to 6°C. Transplant Proc. 2012 May;44(4):855–8. PMID: 22564566; https://doi.org/10.1016/j.transproceed.2012.02.023.
Gómez KM, Camacaro FT, Vargas DS, et al. How are organs transported for transplantation in Chile? an exploratory study. Transplant Proc. 2023;55(1):49–52. PMID: 36599731; https://doi.org/10.1016/j.transproceed.2022.10.060.
Cobos M, Trunzo L, Vogt MV, et al. Sterility and safety validation for transport packaging of organs and tissues. Transplant Proc. 2018;50(2):416–7. PMID: 29579817; https://doi.org/10.1016/j.transproceed.2017.12.050.
Bellotti HB, Francoso MT. System for transporting human organs. Case Studies on Transport Policy. 2021;9(2):431–42.
Axelrod DA, Shah S, Guarrera J, et al. Improving safety in organ recovery transportation: report from the ASTS/UNOS/AST/AOPO transportation safety summit. Am J Transplant. 2020;20(8):2001–8.
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