Latin America's First Active and Intelligent Packaging for Organ Transportation
Sibele Maria Schuantes‐Paim, Renata Fabiana Leite, Victor Arayama Cruz, Vanessa Ayres Carneiro Gonçalves, Júlia Karini da Silva Araujo, Karoline Sabrina de Carvalho Gomes, Luciana Chelotti Cardim Perillo, Graciana Maria de Moraes Coutinho, Eliana Cavalari Teraoka, Adriana Aparecida Carbonel, José Homero Soares, Manuel de Jesus Simões, Selma Ferrer, Ari Nelson Rodrigues Costa, Ana Paula Reis Nolêtto, Leandro Moriyama Konatu, Murched Omar Taha, André Ibrahim David, Janine Schirmer, Bartira de Aguiar RozaABSTRACT
This study aimed to present and validate the Autonomous and Intelligent Packaging for the Cold Chain in Health Systems (EMAIS‐SR) for organ transport through an experimental model using porcine organs. To do so, Landrace porcine hearts, livers, pancreases and kidneys were transported using either EMAIS‐SR or traditional ice‐filled coolers. Following transport, organs were assessed after 2 h through collected data that included temperature monitoring, macroscopic evaluation, histological analysis and microbiological testing. Prototypes at different technology readiness levels (TRL6 and TRL7) were evaluated. Regarding the findings, EMAIS‐SR maintained organ temperatures predominantly within the recommended 2°C–8°C range. In the adjusted analysis, the TRL7 prototype achieved significantly lower post‐transport temperatures than TRL6 (adjusted difference: 2.91°C; 95% CI, 1.32–4.50; p = 0.0006), indicating improved thermal performance after system refinements. Additionally, minor macroscopic changes were observed in some samples, but without histological correlation. Histological analysis showed better tissue preservation in EMAIS‐SR samples, particularly in nuclei morphology and cytoplasmic structure. Furthermore, microbiological results indicated equivalent or lower contamination in EMAIS‐SR compared to the control, especially in later tests. Overall, EMAIS‐SR demonstrated effective thermal control, preservation of tissue integrity and biological safety in a structured preclinical model using porcine organs. Consequently, these findings validate EMAIS‐SR as a robust and clinically promising alternative to conventional organ transport systems.