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Storage preparation of human heart valves for implants generally includes incubation in an antimicrobial disinfection solution and cryopreservation. Changes in patterns of microorganisms susceptibility to antibiotics is a variable process of that promote its inefficiency. The aim of this study has been an evaluation of in vitro susceptibility of high virulence microorganisms isolated in our tissue bank for 14 years in order to evaluate the efficiency, and to promote changes for further antibiotics mixtures as well. Data presented in this study show that microorganisms isolates in valve banking display susceptibility patterns similar to those shown in other clinical circumstances, and the most commonly used antibiotics regimes are useful to date. An antibiotic cocktail containing aminoglicoside in addition to ciprofloxacin and vancomycin is an efficient mixture to be used in valve banking. Further studies will be necessary for monitoring patterns changes of in vitro susceptibility of microbiological isolates in tissue banking.

The recent introduction as a minimum test required in The Guide to Safety and Quality Assurance for Organs, Tissues and Cells (Council Europe) and the Directive 2004/23/EC applied to donation, procurement, testing, processing, preservation, storage and distribution of human cells and tissues make necessary the implementation of these markers in all European Tissue Establishments. In this study we have analyzed the impact in tissues discard by introducing anti-HBc in a European Tissue Establishment in a country with a high prevalence of HBV infection. The adoption of this exclusion criteria in this region results in acceptably rejection rates among tissue donors, although some studies are needed on basis a risk assessment to determine the eligibility for clinical use.

In order to guarantee the required level of quality for our Bone &Tissue Banking, we evaluated a new CE marked container (CELLFLEX MacoPharma), for packing, transport, processing and storage of bones for therapeutic use. The use of CE marked containers is mandatory for organ and tissue containers (Medical Device Directive 93/42). We carried out a three-phase study: (1)Evaluation, (2) Implementation, (3)Audit The product was evaluated for the following criteria:Dash mechanical resistance, Dash air tightness, Dash fragility, Dash capacity. No damage was observed after the storage period, even after immersion in liquid nitrogen. No breakages were observed after provoked impact tests (pots dropped onto the floor). The pot capacity evaluation showed that the inner pot volume (approximately 500 ml) permits adequate storage of tendons and the majority of bone allografts. In conclusion, this evaluation has shown that the CELLFLEX kit is suitable for long duration preservation of bone allografts even at very low temperature conditions (vapour phase nitrogen). Its format and structure permit preservation of most bone allografts.