Abstract:
: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 Banking (STB) of the Regional Blood Transfusion Center (RBTC) of Córdoba (Spain) is a non-profit-making tissue bank, established in 1992 to provide tissues for surgical procedures to the hospitals in a regional area. In 1998, the STB as a part of the RBTC embarked upon the path of becoming ISO-certified: after two years of the implementation of the project, STB attained ISO 9002 certification, thus becoming one of the first tissue banks in Europe to achieve this qualification. In this paper we describe the process of becoming ISO-certified, to demonstrate the positive impact that it has had on our entire organization.The assistance of an outside consultant who provided the necessary information for implementing an ISO quality management system was required. The initial improvement was: a well-defined quality manual to address all elements of the ISO 9002 standard, an improved document control system, detailed standard operating procedures (SOPs) and improved employees training processes. A quality committee team and developed quality indicators were created. The internal quality auditing program was established by the selection of employees from a cross-section of the organization, who were trained in internal auditing processes. A formal corrective action system was developed and implemented to facilitate process improvement. The consultant conducted a pre-certification audit, and one month later the certification audit was performed.In conclusion, the implementation of an ISO quality program in the STB has helped our center to establish a control process in the manufacturing of products and services to meet the expectations of our customers, by providing components and services that comply with the national regulatory standards and requirements.
journal_name
Cell Tissue Bankjournal_title
Cell and tissue bankingauthors
Villalba R,Eisman M,Fornés G,Mesa A,De Torres P,Ariza MJ,Gutierrez Guzmán A,Gómez Villagrán JLdoi
10.1023/A:1011576332362keywords:
subject
Has Abstractpub_date
2001-01-01 00:00:00pages
45-49issue
1eissn
1389-9333issn
1573-6814pii
337556journal_volume
2pub_type
杂志文章abstract::Recovered human and animal tissues are used extensively in surgery for wound repair and reconstruction. In preparation for the validation of chemical disinfection and radiation sterilization processes, studies were performed on the development and validation of quantitative bioburden recovery methods for human bone an...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-010-9238-9
更新日期:2012-03-01 00:00:00
abstract::The present experiment was conducted to evaluate the effect of kinetin on ram semen quality during cold storage. Ejaculates were collected using an artificial vagina from five Qezel rams. Ejaculates which met the criteria (volume of 0.75-2 ml; minimum spermatozoa concentration of 2.5 × 109 spermatozoa/ml and forward p...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-016-9604-3
更新日期:2018-03-01 00:00:00
abstract:BACKGROUND:The role of bone and tissue banking is well known to meet the ever-growing need of bone and soft tissue allografts. Strict guidelines have been established to ensure high standard and minimize complications related to bone transplantation. METHODS:The Bone Bank in King Faisal Specialist Hospital and Researc...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-020-09868-7
更新日期:2020-10-04 00:00:00
abstract::The regulatory framework of tissue banking introduces a number of requirements for monitoring cleanrooms for processing tissue or cell grafts. Although a number of requirements were clearly defined, some requirements are open for interpretation. This study aims to contribute to the interpretation of GMP or GTP guideli...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-012-9355-8
更新日期:2013-12-01 00:00:00
abstract::In Malaysia, tissue banking activities began in Universiti Sains Malaysia (USM) Tissue Bank in early 1990s. Since then a few other bone banks have been set up in other government hospitals and institutions. However, these banks are not governed by the national authority. In addition there is no requirement set by the ...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-010-9188-2
更新日期:2010-11-01 00:00:00
abstract::In order to solve some of the problems that are affecting tissue banking activities in the world, a new program/project proposal could be prepared by the IAEA and interested Member States in order to implement it in 2009. The main objective of the new program/project proposal could be the following: To consolidate tis...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-008-9092-1
更新日期:2009-05-01 00:00:00
abstract::Freeze-dried dura mater allograft (FDDMA) was evaluated as a cost-effective collagenous barrier using an experimental animal model to determine its biocompatibility and 'cell-occlusivity' potential. The FDDMA was processed at the Civil Hospital Ahmedabad, in accordance with the guidelines provided by the South-Eastern...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1023/B:CATB.0000007039.98845.bd
更新日期:2003-01-01 00:00:00
abstract::This study aimed to optimise methods of cryopreserving human articular cartilage (AC) tissue for the isolation of late chondrocytes. Human AC specimens from osteoarthritis patients who had undergone total knee replacement were used to optimise the chondrocyte isolation process and the choice of cryoprotective agent (C...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-012-9328-y
更新日期:2013-06-01 00:00:00
abstract::Osteochondral defects can degenerate into osteoarthritis and currently there are no good treatment alternatives available to most Orthopaedic surgeons. Osteochondral allografting can restore damaged joint surfaces but its clinical use is limited by poor access to high quality tissue. Vitrification of osteochondral tis...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-006-9023-y
更新日期:2007-01-01 00:00:00
abstract::Recently Bulgarian Bone Marrow Donors Registry (BBMDR) has been established and since August 2005 it has been a member of Bone Marrow Donors Worldwide. Currently the number of healthy donors included in the BBMDR is relatively low. All donors included in the BBMDR are typed for HLA-A, -B, -DRB loci. Phylogenetic analy...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-007-9046-z
更新日期:2008-12-01 00:00:00
abstract::Human epidermal melanocytes can be induced to form melanocyte spheroids and revert to immature characteristics by long-term trypsinization (LTT). To further explore the biological characteristics of melanocytes after LTT and to study the underlying mechanism. Melanocytes were subjected to long-term (2 h) trypsinizatio...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-020-09866-9
更新日期:2020-09-25 00:00:00
abstract::Mesenchymal stem cells (MSCs) are used for tissue regeneration in several pathological conditions, including autoimmune diseases. However, the optimal sources and culture requirements for these cells are still under investigation. Here, we compared mRNA expression in dermal MSCs (DMSCs) at passage (P) 3 and P5 to prov...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-017-9672-z
更新日期:2018-09-01 00:00:00
abstract::Human skin allografts can be preserved by different methods. In our clinical practice, human skin allografts are harvested on multi-organ and tissue donors, transferred at +4°C in Ringer Lactate, cryopreserved with 15% Glycerol and held in the vapor phase of a liquid nitrogen freezer until delivery to the burn center....
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-011-9239-3
更新日期:2012-03-01 00:00:00
abstract::Since there is no upper age limit for general organ donation, unlike heart valve donation, and since a quarter of all organ donors are 65 years and older, we examined whether the heart valves from these donors are suitable as allografts. In the period 1999-2004 the aortic valve and pulmonary valve of 100 organ donors ...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-007-9052-1
更新日期:2008-03-01 00:00:00
abstract::Demineralized freeze-dried bone allograft (DFDBA) has been used extensively in periodontal therapy. Questions have been raised however, about the osteogenic potential of the variety of grafts available. In India the cost factor is another important consideration. The aim of this study therefore was to evaluate the cli...
journal_title:Cell and tissue banking
pub_type: 杂志文章,随机对照试验
doi:10.1007/s10561-014-9481-6
更新日期:2015-09-01 00:00:00
abstract::Perivascular cells are known to be ancestors of mesenchymal stem cells (MSCs) and can be obtained from heart, skin, bone marrow, eye, placenta and umbilical cord (UC). However detailed characterization of perivascular cells around the human UC vein and comparative analysis of them with MSCs haven't been done yet. In t...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-015-9542-5
更新日期:2016-06-01 00:00:00
abstract::Autologous chondrocyte implantation has been shown to be a promising method for treatment of deep articular cartilage defects. The hyaline cartilage formed by implanted autologous chondrocytes has biomechanical properties similar to those of natural articular cartilage. Between June 2006 and September 2008 we performe...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-009-9163-y
更新日期:2010-05-01 00:00:00
abstract::The goal of periodontal therapy is to prevent periodontal disease progression and to regenerate lost periodontal tissues. Various bone grafts are used alone or in combination with other treatment modalities for periodontal therapy. In literature no reports are presented with block allografts in the treatment of intrab...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-018-09744-5
更新日期:2019-02-11 00:00:00
abstract::The Central Tissue Bank in Warsaw was established in 1963 and since then ionising radiation has been routinely applied to sterilise tissue grafts. Connective tissue grafts such as bone, cartilage, tendons, sclera, pericardium, skin, acellular dermis and amnion irradiated with a dose of 35 kGy in a (60)Co source and/or...
journal_title:Cell and tissue banking
pub_type: 杂志文章,评审
doi:10.1007/s10561-005-0338-x
更新日期:2005-01-01 00:00:00
abstract::To compare the quality of the repair tissue in three-dimensional co-culture of human chondrocytes implanted in an in vivo model. Six cadaveric and five live human donors were included. Osteochondral biopsies from the donor knees were harvested for chondrocyte isolation. Fifty percent of cadaveric chondrocytes were exp...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-017-9635-4
更新日期:2017-09-01 00:00:00
abstract::We describe a rapid and easy technique for the preparation of pre-stripped Descemet membrane (DM) endothelial keratoplasty (DMEK) tissue in the eye bank, without the use of dye or trephining by the eye bank technician. After drawing 2 radial marks 90° apart on the scleral rim of the cornea, a circumferential incision ...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-019-09771-w
更新日期:2019-06-01 00:00:00
abstract::The use of glycosaminoglycans (GAGs) as the second macromolecular component with collagen for the membrane preparation is based on the idea to create a biodegradable scaffold for new tissue. A hybrid collagen/hyaluronan membrane with specific bubble macrostructure was designed to serve as a synthetic dermal substitute...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1023/a:1010181925236
更新日期:2000-01-01 00:00:00
abstract::Tissue engineering using human cells and tissue has one of the greatest scientific and economical potential in the coming years. There are public concerns during the ongoing discussion about future trends in life sciences and if ethic boundaries might be respected sufficiently in the course of striving for industrial ...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1023/A:1026392429112
更新日期:2003-01-01 00:00:00
abstract::Rheumatoid arthritis (RA) is the most common degenerative arthritic cartilage and represents a disease where the prospect of stem cell therapy offers considerable hope. Currently, bone marrow (BM) represents the major source of mesenchymal stem cells (MSCs) for cell therapy. In the pathology of RA, the pro-inflammator...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-012-9354-9
更新日期:2013-12-01 00:00:00
abstract::This is a report of a workshop held on the establishment of human research tissue banking which was held in Levi, Finland 21-24 March 2002. There were 21 participants from 7 European countries. This meeting was attended by representatives from academia, research tissue banks and from the Biotech and Pharmaceutical Ind...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1023/A:1022811232250
更新日期:2002-01-01 00:00:00
abstract::Although allografts for anterior cruciate ligament (ACL) replacement have shown advantages compared to autografts, their use is limited due to the risk of disease transmission and the limitations of available sterilization methods. Gamma sterilization has shown detrimental effects on graft properties at the high doses...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-011-9289-6
更新日期:2012-08-01 00:00:00
abstract::Tissue and organ transplantation is one of the most promising treatments for some incurable diseases. Nowadays, transplantation is the common therapy in many countries. Unfortunately, availability of donated tissues and organs is limited. There are several factors which may affect donation rate for instance; social fa...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-014-9473-6
更新日期:2015-06-01 00:00:00
abstract::Blood samples collected from deceased tissue donors for mandatory transfusion microbiology testing may be taken either at the time of tissue donation, or residual samples may be retrieved from hospital laboratories where they were originally used for ante-mortem tests. In the latter case, sample labelling may not conf...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-008-9071-6
更新日期:2008-12-01 00:00:00
abstract::The Israel National Skin Bank (INSB) was founded jointly by the Israel Defense Forces (IDF) Medical Corps and the Ministry of Health in 1986. The prime purpose of the Skin Bank is to treat burn victims incurred at war or during mass casualty incidences. The INSB Protocol is comprised of international skin bank protoco...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1023/A:1010183719662
更新日期:2000-01-01 00:00:00
abstract::Mesenchymal stem cells (MSCs) though multipotent exhibit limited lifespan in vitro, with progressive reduction in capacity for self-renewal leading to irreversible arrest of cell division, which limits their use for therapeutic purposes. Human umbilical cord wall MSCs are easy to process and proliferate rapidly in cul...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-015-9525-6
更新日期:2016-03-01 00:00:00