Static cold package for transporting organs for transplants: a validation method and pilot test

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.

Validation study and pilot test using experimental surgery on porcine organs.

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.

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.

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.