title: Current trends in safety assurance for tissue grafts used in burn treatment.
abstract: The author presents a summary of current safety standards for allogeneic and xenogeneic biological skin grafts. The fundamental document relevant to allogeneic transplants, establishing the minimal level of safety guaranteed in European Union states, is the European Parliament and Council Directive (2004/23/EC) from March 31st 2004. This Directive determines that grafts will be prepared by a licensed or accredited tissue bank, and that this arrangement must be put in place by the member states within 2 years. In the Czech Republic licensing of tissue banks took place immediately after issuance of the Directive. Licensing was also a condition for product reimbursement by insurance companies. To gain a licence, tissue banks had to fulfil many safety criteria associated with screening of living or deceased donors for health suitability, providing traceability of the donor-recipient route, prevention of secondary and cross-contamination during processing and storage of the harvested tissues, proof of product microbiology check up, and cold chain control. The Tissue Bank of the Faculty Hospital in Hradec Králové is one of the two tissue banks that gained the broader type of 'multifunctional' licence and was granted registration number MTB 006. Obtaining the licence was facilitated by completion of a new workplace project conceived as a combination of cryogenic and clean-room technology. Currently, this tissue bank prepares cryopreserved dermoepidermal and dermal grafts as well as amnion and chorioamnion grafts. All tissue banks will have to renew their licences again according to the conditions established by a new law about human tissues and cells which is currently in preparation. Neither the Directive of the European Parliament nor the Transplantation Law of the Czech Republic regulates the issue of xenografts. Since availability of allogeneic biological covers is limited, it is significant that the WHO perspective on the use of xenogeneic biological covers, as established in 2005, is positive. This attitude should also be taken in the Czech Republic. The directives of the European Union pertinent to medical devices of biological origins can be applied only to devitalized tissues--and moreover, the domestic pig is not on the risk animal list. The author presumes that to guarantee safe use of viable xenografts it is necessary to follow the general principles of quality control as applied in the workplace for many years, as well as general medicinal product safety principles, including strict veterinary control of breed of animals whose tissues are used for the preparation of xenografts.
authors.affiliation: Tissue Bank, Faculty Hospital Hradec Králové, Czech Republic. mericka@fnhk.cz
authors.forename: P
authors.initials: P
authors.lastname: Mericka
mesh_terms: D002056:Burns / Q000601:surgery*; D018153:Czech Republic; D033161:Government Regulation; D006801:Humans; D017751:Safety Management / Q000331:legislation & jurisprudence*; D016038:Skin Transplantation; D014015:Tissue Banks / Q000331:legislation & jurisprudence*