The Amniotic Membrane supplied by FBTV comes in patches of different sizes, the patch is placed on a support material that indicates its direction. Specifically, its stromal side is adherent to the filtrino and the epithelial side is towards the operator.
Used in many specialities in cases of:
The human amniotic membrane is a unique, thin, collagenous membrane derived from the submucosa of the placenta, t h e area where the human foetus grows and develops. It is made up of layers of collagen including: basement membrane and stromal matrix. The amniotic membranes used for clinical applications come from placentas harvested only from elective caesarean sections following careful selection of the d o n o r , who has consented to the donation, in accordance with tissue quality and safety regulations. In addition to standard screening including: Ac anti-HIV 1/HIV 2, Ac anti-HCV, HBsAg, Ac anti-HBc, Ac anti-HBs, Ac anti-Treponema pallidum, Ac anti-HTLVI/HTLVII, HBV-DNA, HCV-RNA, HIV- 1 RNA, additional Ac anti-Toxo IgG and IgM and Ac anti-CMV IgG and IgM tests are performed. Microbiological screening and, if deemed necessary, additional tests are also performed on each donor and tissue.
The patch amniotic membrane is cryopreserved at -160°C, after immersion in a solution containing a cryoprotectant (10% DMSO), in order to minimise tissue damage due to water crystallisation during freezing, a process that is carried out by means of a computer- controlled temperature descent. It is then stored in nitrogen vapour with continuous temperature monitoring for up to 5 years.
The fabric is sent frozen in a container with dry ice, athermic, certified to ensure temperature maintenance during transport. The expiry date for tissues distributed and kept at a temperature of -70°C/-80°C is 90 days from the date of shipment, once thawed they must be used within 7 days. The Bank guarantees proper storage until receipt of the tissue; in the event of any problems occurring during transport, the user must immediately report it to FBTV.
All tissues distributed to implantation centres are accompanied by documentation describing: suitability of the donor, origin and characteristics of the tissue, expiry date, serological and microbiological tests performed, method of preservation, specific instructions for preservation and implantation, documentation for follow- up of the implanted tissue.
Each tissue must be used for a single patient.
The results obtained to date show that the amnio- tic membrane, thanks to the processing techniques, retains its original properties and can be considered a material of choice. All preparation, handling and storage operations are carried out in an environment with facilities in accordance
to national regulations. Laboratory activities take place in environments classified as grade A according to the European Guide to Good Manufacturing Practice (GMP), the classification of the environments is verified with continuous checks in order to minimise the risk of contamination. Access to classified environments requires specific clothing to minimise possible contamination from outside and to safeguard the safety of personnel. Entrance to processing rooms is strictly limited to persons involved in the process or visitors accompanied by internal staff.
The processing of the amniotic membrane includes:
Vancomycin, Meropenem
cryoprotective containing 10% DMSO
quality controls performed are reviewed and approved. Quality assurance and safety are performed:
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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