Раздел медицины:
Биотехнологии и биоматериалы

Implementation of EU requirements for tissue and cell banking in Poland

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Целью работы стало описание статуса тканевых банков Польши. Выполнение стандартов ЕС по безопасности и качеству тканей и клеток, используемых для трансплантации, было достигнуто путем планирования и организации учебных курсов для работников здравоохранения. Все действия учитывали создание системы наблюдения деятельности тканевых и клеточных банков в Польше и приспосабливали их к стандартам и директивам ЕС.

Aim. The aim of this work is to describe the status of tissue banking in Poland. Currently, there are 22 tissue and cell banks active in Poland: 4 multi-tissue banks, 9 mono-tissue banks and 9 stem cell banks. 15 of them are public, the remaining 7 are non-public.

Materials and methods. In January 2004, the Polish Minister of Health established the National Centre of Tissue and Cell Banking, using the manpower and infrastructure of the Central Tissue Bank in Warsaw for institutional control of tissue banks in Poland to implement Directive 2004/23/EC of the European Parliament and of a Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

Results. Implementation of EU standards on the safety and quality of tissues and cells used for transplantation was accomplished by planning and organisation of training courses for health professionals iengaged in tissue banking activities, creation of inspection system of tissue establishments, involvement in national and international activities in tissue banking field, creation of a software for tissue banking activities, implementation of tissue grafts coding system for its traceability and reporting system of Severe Adverse Reaction and Events, upgrading of tissue bank facilities to reach sanitary and epidemiological protection conditions.

Discussion. All the activities regarding implementation of the Directive 2004/23/ EC were financially supported by Transition Facility 2004, 2006 and National Public Health Transplantation Programme - POLGRAFT 2006-2009. Public tissue and cell establishments were not able to afford all the expences arising from new european and national law requirements.

Conclusion. All mentioned activities allowed for creation of the surveillance system of tissue banking activities in Poland and to adjust tissue and cell banks to EU standards and Directives.

Kaminski A., Uhrynowska-Tyszkiewicz I., Olender E.
National Centre of Tissue and Cell Banking, Department of Transplantology & Central Tissue Bank, Medical University of Warsaw, Warsaw, Poland

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