The decellularized dermis distributed by FBTV is a flap of dermal tissue, generally harvested from the
back. The decellularized dermis is cleared of cellular and nuclear material while preserving the
structure of the extracellular matrix.
The clinical use of human tissue offers important benefits for recipients. Like any product of human origin, their use is not without risks, although these are rare. A control system is needed to ensure traceability and identification of the tissue at any stage of the process, from donation to recipient. Each tissue is identified with a unique code to allow traceability from origin to destination. Once the tissue is transplanted the code must be attached to the recipient’s medical history. FBTV must be informed when the tissue has been transplanted, through the completion of the “Traceability Card” attached to the tissue. The bank must be informed if the tissue has not been implanted.
If there is suspicion or evidence of a serious adverse reaction or an effect in the recipient possibly related to the safety and quality of the transplanted tissue, the physician should contact immediately and complete the ‘Rapid Notification of Suspected Serious Adverse Events of Suspected Serious Adverse Events” or “Rapid Notification of Suspected Serious Adverse Reactions”.
FBTV is registered on the list of Tissue Banks accredited by the National Transplant Centre; regulated activities include donation, collection, evaluation, preparation, preservation and distribution of homologous tissues. It operates in compliance with international standard ISO 9001:2015 and has a certification process in place to certify that tissues meet predefined safety, traceability and morphological requirements. Homologous tissues procured, processed, stored and distributed meet the requirements of Italian legislation (Law 91/99, Legislative Decree 191/97, Legislative Decree 15/11/2016, Legislative Decree 256 16/12/2016, State/Regions Agreement 66/CSR 8/3/2018) and European Directive 2004/23 and Directives 2006/17/EC, 2006/86/EC, 2012/39/EU, 2015/565/EU, 2015/566/EU. FBTV follows the standards of the main scientific associations: European Association of Tissue Banks (EATB), American Association of Tissue Banks (AATB), and the recommendations of: Good Tissue Practices (Euro-GTP) and the Council of Europe EDQM Guide to the quality and safety of tissues and cells for human application.
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