Share

IIR document

The impact of the European Union legislation on the practices of cell and tissue banks in the Czech Republic.

Author(s) : MERICKA P., STRAKOVÁ H., STÁRKOVÁ D., et al.

Summary

The quality and safety requirements on cell and tissue transplants were set recently by the European Parliament and Council Directive 2004/23/EC and precised in the European Commission Directives 2006/17/EC and 2006/86/EC. The principles of voluntary and unpaid donation were already included in the National Transplantation Act; a proposal of a special new Act setting the safety and quality norms is now undergoing the standard parliamentary process. As an immediate action the system of tissue bank licensure was established by the Ministry of Health, and the total of 19 institutions were licensed in 2004. Changes of the system of the work of a tissue bank are demonstrated on work experience of the Tissue Bank of the University Hospital Hradec Králové, designed and rebuilt as a combination of cryogenic and clean-room technology. The system of secondary contamination prevention is based on processing in the environment of the grade A with the background of grade B, regularly validated by an authorised company. The validation results showed maintaining of the grade A in the critical processing area both at rest and at operation conditions. The non-compliance rate of aseptically prepared cell and tissue grafts with the quality criteria set by the tissue bank management in specifications of individual products varied between 0.73% in peripheral blood progenitor cells concentrates and 6.4% in minimally manipulated solid tissue grafts (bone, cartilage ligaments, fascia lata) used for reconstructive operations in orthopaedics, traumatology and neurosurgery.

Available documents

Format PDF

Pages: ICR07-C1-1451

Available

  • Public price

    20 €

  • Member price*

    Free

* Best rate depending on membership category (see the detailed benefits of individual and corporate memberships).

Details

  • Original title: The impact of the European Union legislation on the practices of cell and tissue banks in the Czech Republic.
  • Record ID : 2007-2866
  • Languages: English
  • Subject: Regulation
  • Source: ICR 2007. Refrigeration Creates the Future. Proceedings of the 22nd IIR International Congress of Refrigeration.
  • Publication date: 2007/08/21

Links


See other articles from the proceedings (839)
See the conference proceedings

Indexing