Gema Fornés

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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 fortherapeutic use. The use of CE marked containers is mandatory for organ and tissue containers (Medical Device Directive 93/42). We carried out a(More)
Quality control and standardized preservation methods are essential in the field of transplantation. The International Organization for Standardization (ISO) has established a common set of manufacturing, trade and communications standards that are applicable worldwide and that provide the basis of a quality plan for Tissuebreak Banks. The Sectorial Tissue(More)
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(More)
Specular microscopy can provide a non-invasive morphological analysis of the cornea endothelial cell layer. A variety of analysis programs are available to determine corneal endothelial quality. The flex-center endothelial analysis method (Konan Inc) is a newer technique including the outermost digitized cells and thus increases the number of cells for(More)
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(More)
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