Principles of transportation of donor organs and tissues for transplantation
https://doi.org/10.20340/vmi-rvz.2025.3.PROT.1
Abstract
Objective: to develop a comprehensive protocol for the transportation of donor organs and tissues for transplantation, taking into account modern international standards, Russian legislation requirements, and identified legal conflicts.
Materials and methods. An analysis of current Russian and international legislation in the field of biological materials transportation, IATA standards, aviation security requirements, and practical experience of leading transplantation centers was conducted. Regulatory documents from the Ministry of Health of Russia, Ministry of Transport of Russia, Roszdravnadzor, and customs authorities were studied.
Results. A protocol has been developed that includes requirements for couriers, packaging of biomaterials according to IATA P650 standard, donor organ labeling, documentation workflow, and incident management. Significant legal conflicts were identified: contradiction between the requirement of Ministry of Health Order No. 567n regarding the use of special signals and the prohibition of their use in the absence of a patient; exceeding the volume of liquid in organ packaging beyond the established aviation regulations (100 ml); non-compliance of container sizes with airline hand luggage requirements.
Conclusions. Modern donor organ transportation requires a comprehensive interdisciplinary approach involving medical professionals, aviators, and regulatory authorities. It is necessary to eliminate the identified legal conflicts, develop special agreements with airlines, and create unified standards to ensure efficient and safe delivery of vital biomaterials.
Practical significance. The protocol can be used by transplantation centers to organize donor organ transportation, while the identified legal conflicts require attention from legislators to improve the regulatory framework.
Keywords
About the Authors
O. Yu. VerbaRussian Federation
Ol'ga Yu. Verba - Dr. Sci. (Med.), Professor of the Department of Aviation and Space Medicine; President
Author's contribution: preparation of the protocol text.
2/1, Barrikadnaya str., building 1, Moscow, 125993;
Ivankovskoe shosse, 7, Moscow, 125367
Competing Interests:
The authors declare no competing interests. B.I. Yaremin is the executive secretary of the editorial board of the journal. I did not take part in the decision to publish the work.
B. I. Yaremin
Russian Federation
Boris I. Yaremin - Cand. Sci. (Med.), surgeon and researcher of the Liver Transplant Center; Associate Professor, Head of the Academic Department of the Department of Transplantology and Artificial Organs; Head of the Department for Coordination of Organ and/or Tissue Donation; Head of the Department of Surgical Diseases of the Moscow Medical University "Reaviz".
Author contribution: preparation of the protocol text.
3, Bolshaya Sukharevskaya Square, Moscow, 129090;
1, Ostrovityanova St., Moscow, 117513;
23, Kashirskoe shosse, Moscow, 115522
Competing Interests:
The authors declare no competing interests. B.I. Yaremin is the executive secretary of the editorial board of the journal. I did not take part in the decision to publish the work.
K. K. Gubarev
Russian Federation
Konstantin K. Gubarev - Head of the Surgical Department for Coordination of Human Organ and (or) Tissue Donation
Author contribution: preparation of the protocol text.
23 Marshal Novikov St., Moscow, 123098
Competing Interests:
The authors declare no competing interests. B.I. Yaremin is the executive secretary of the editorial board of the journal. I did not take part in the decision to publish the work.
R. P. Lavrinyuk
Belarus
Rostislav P. Lavrinyuk - Head of the Department for Coordination of Organ and Tissue Collection for Transplantation
Author contribution: preparation of the protocol text.
7, Meditsinskaya St., Brest, 224027
Competing Interests:
The authors declare no competing interests. B.I. Yaremin is the executive secretary of the editorial board of the journal. I did not take part in the decision to publish the work.
O. S. Pokrovskaya
Russian Federation
Ol'ga S. Pokrovskaya - Cand. Sci. (Med.), Head of the Department of Pre-Transplant Preparation, Hematologist
Author's contribution: preparation of the protocol text.
4, Novy Zykovsky Ave., Moscow, 125167
Competing Interests:
The authors declare no competing interests. B.I. Yaremin is the executive secretary of the editorial board of the journal. I did not take part in the decision to publish the work.
K. V. Grozovskiy
Israel
Kirill V. Grozovsky - Transplantation coordinator, National Center for Transplant Coordination
Author's contribution: preparation of the protocol text.
Kiryat Hadassah, Jerusalem, 91120
Competing Interests:
The authors declare no competing interests. B.I. Yaremin is the executive secretary of the editorial board of the journal. I did not take part in the decision to publish the work.
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Review
For citations:
Verba O.Yu., Yaremin B.I., Gubarev K.K., Lavrinyuk R.P., Pokrovskaya O.S., Grozovskiy K.V. Principles of transportation of donor organs and tissues for transplantation. Bulletin of the Medical Institute "REAVIZ" (REHABILITATION, DOCTOR AND HEALTH). 2025;15(3):238-256. (In Russ.) https://doi.org/10.20340/vmi-rvz.2025.3.PROT.1