Tissue establishment as a necessary institution within the country health care system: importance, requirements and stru

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Tissue establishment as a necessary institution within the country health care system: importance, requirements and structure Jorge Morales Pedraza

Received: 15 July 2015 / Accepted: 10 September 2015 / Published online: 14 September 2015  Springer Science+Business Media Dordrecht 2015

Abstract A tissue establishment is a unit or service, inside or outside of a public or private hospital, generally operated by public or non-profit-making bodies or in some countries by private profit-making institutions that procure, process, sterilise, store, and distribute sterilised human tissues to private or public hospitals to be used in certain medical treatments. Each tissue establishment should adopt the best possible structure, hired the necessary well-trained staff, according to the level of its activities, and should establish the necessary internal committees to ensure the highest quality of its operation. In addition, the tissue establishment should adopt a quality management system in order to reduce the risk and maximize the benefits of the transplantation process. Keywords Tissue establishments  Human tissues  Code of ethics  Code of practice  Quality control system  Standard operating procedures

A tissue establishment is a unit or service, inside or outside of a public or private hospital, generally operated by public or non-profit-making bodies or in some countries by private profit-making bodies that

J. Morales Pedraza (&) Univ. Diploma Mathematics and Economics, Vienna, Austria e-mail: [email protected]

procure, process, sterilise, store, and distribute sterilised human tissues to private and/or public hospitals to be used in certain medical treatments. However, due its specific characteristics, a tissue establishment should be created only where a real need exists and the population is ready to donate tissues. For this reason, before a decision is adopted to create a tissue establishment, due considerations should be given to the real demand of human tissues, the readiness of public and private hospitals and other medical facilities to use sterilised human tissues in certain medical treatments or research activities involving human tissues, and to the public opinion on human tissue donation. It is also indispensable to have a space built properly for the operation of the tissue establishment, the possibility to hire well-trained staff, the purchase of the necessary equipment to ensure the correct processing of the human tissues procured by the tissue establishment, the adoption of a code of ethics, a code of practice and a quality management system, and fulfil other relevant practical operational requirements for providing safe, reliable, and biologically useful human tissues. Screening of potential tissue donors is one of the most important activities that should be carried by a tissue establishment in closed cooperation with hospitals and other medical facilities. Taking into account the importance of screening of potential tissue donors, this activity requires specific training to learn the bes