2012, Number 5
<< Back
Acta Ortop Mex 2012; 26 (5)
Musculoskeletal tissue banks in Mexico: behavior, management and recommendations on their activities
Álvarez-San Martín R
Language: Spanish
References: 41
Page: 332-339
PDF size: 69.80 Kb.
ABSTRACT
Tissue banks currently warrant an interdisciplinary management leading to detect and address pressure conflicts taking into account ethical aspects, the safety and quality of the tissues provided, behavior under the principles of altruism, solidarity and equity, and the procurement of deceased donor tissues. This review article intends to inform about the main work-related and coordination aspects of the departments in tissue banks, and recognize their instances of sanitary responsibility and the bodies issuing recommendations to maintain clinical safety from the perspective of infection prevention and transmission of diseases related with musculoskeletal grafts.
REFERENCES
Ethical Aspects of Human Tissue Banking: Opinion of the European Group on Ethics in Science and New Technologies to the European Comission, 1998.
Fehily D, Dziedzic-Goclawska A, Kaminski A: Module 5. Quality assurance-quality control. Subject 1. Tissue banking: general organization. International On-Line Tissue Banking Course 2010; IL3.
Convention for the Protection of Human Rights and dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Article 1 Council of Europe, 1997.
Schulz-Baldes A, Biller-Adorno N, Capron AM: International perspectives on ethics and regulation of human cell and tissue transplantation. Bulletin of the World Health Organization 2007; 85: 941-8.
Explanatory Report of the Additional Protocol to the convention for Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine Concerning Transplantation of Organs and Tissues of Human Origin. 1997: 123.
U.S. Department of Health and Human Services. Food and Drug Administration: Guidance for Industry. Elegibility Determination for Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). Center for Biologics Evaluation and Research; 2007.
Directive 2004/23/EC of the European Parliament and of the Council of 31 march 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Official Journal L 2004; 102,7.4: 48-58.
Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23 as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. Official Journal L 2006; 38/40,9.2.
Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23 as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells. Official Journal L 2006; 294/32.
International Organization for Standardization [Internet]. ISO standards [última consulta: 2012, Enero 3]. Available in: http://www.iso.org/iso/iso_catalogue/management_and_leadership_standards/quality_management/iso_9000_essentials.htm.
European Directive 2004/23/EC Chapter IV. Provisions on the quality and safety of tissues and cells. Article 16, Quality Management. Tissue and Cell Directive– Directive 2004/23/EC of the European Parliament and the Council of 31 March 2004 on setting standards of the quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells. Official Journal of the European Union L.102/55.
Ley General de Salud Título XIV, Capítulo I: Disposiciones Comunes. Artículo 316 (DOF11-06-2009).
European Directive 2004/23/EC Chapter IV. Provisions on the quality and safety of tissues and cells. Article 17, Responsible Person. Tissue and Cell Directive – Directive 2004/23/EC of the European Parliament and the Council of 31 March 2004 on setting standards of the quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells. Official Journal of the European Union L.102/55.
Reglamento de Insumos Título Cuarto Establecimientos. Capítulo III: Responsables Sanitarios (últimas reformas DOF 5-08-2008).
Ley General de Salud Título XIV Donación, Trasplantes y Pérdida de la Vida. Capítulo I: Disposiciones Comunes, Artículo 315 (últimas reformas DOF 11-06.2009).
Ley General de Salud Título XIV Donación, Trasplantes y Pérdida de la Vida. Capítulo I: Disposiciones Comunes, Artículo 316 (últimas reformas DOF 11-06.2009).
European Directive 2004/23/EC Chapter IV. Provisions on the quality and safety of tissues and cells. Article 24, Relations between tissue establishment and third parties. Tissue and Cell Directive– Directive 2004/23/EC of the European Parliament and the Council of 31 March 2004 on setting standards of the quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells. Official Journal of the European Union L.102/56.
Ley General de Salud Título XIV: Donación, Trasplantes y Pérdida de la Vida. Capítulo III: Trasplante, Artículo 337 (últimas reformas DOF 11-06.2009).
Álvarez SMR: Los tejidos musculoesqueléticos con fines de trasplante en México. Análisis de la organización, regulación y manejo del banco de tejidos hospitalario y las recomendaciones sobre la disposición de tejidos musculoesqueléticos considerados como insumos para la salud. [Tesina del Diplomado de Coordinación de Donación de Órganos y Tejidos con Fines de Trasplante]. México, D.F. Centro Nacional de Trasplantes, CENATRA-Universidad Nacional Autónoma de México, UNAM; 2010.
Transplant Services Foundation (TSF): Quiénes somos. Servicio Coordinación de Trasplantes. Disponible en: www.tsf.cat
Joyce MJ, Greenwald AS, Boden S, et al: Musculoskeletal tissue allograft safety. Committee on Biological Tissue Implants Working Group. AAOS 75th Annual Meeting., San Francisco California; 2008.
Centers for Disease Control and Prevention: About tissue transplants 2006 [Internet]. Available in: http://www.cdc.gov/ncidod/dhqp/tissueTransplantsFAQ.html.
Nemzek JA, Swenson CL, Arnoczky SP: Retroviral transmission by the transplantation of connective tissue allografts. An experimental study. J Bone Joint Surg Am 1994; 76: 1036-41.
Vangsness CT Jr, García IA, Mills CR, et al: Allograft transplantation in the knee: tissue regulation, procurement, processing, and sterilization. Am J Sports Med 2003; 31: 474-81.
AOSSM 2006: Orthopaedic surgical procedure survey on allografts. naperville (IL). Leever Research Services; 2006.
McAllister DR, Joyce MJ, Mann BJ, et al: Allograft update: the current status of tissue regulation, procurement, processing and sterilization. Am J Sports Med 2007; 35(12): 2148-58.
Centers for Disease Control and Prevention (CDC): Epidemiologic notes and reports transmission of HIV through bone transplantation: case report and public health recommendations. MMWR Morb Mortal Wkly Rep 1988; 37(39): 597-9.
Asselmeier MA, Caspari RB, Bottenfield S: A review of allograft processing and sterilization techniques and their role in transmission of the human immunodeficiency virus. Am J Sports Med 1993; 21: 170-5.
Simonds RJ, Holmberg SD, Hurwitz RL, et al: Transmission of human immunodeficiency virus type 1 from a seronegative organ and tissue donor. N Engl J Med 1992; 326: 726-32.
Simonds RJ: HIV transmission by organ and tissue transplantation. AIDS 1993; 7(Suppl 2): S35-8.
Li CM, Ho YR, Liu YC: Transmission of human immunodeficiency virus through bone transplantation: a case report. J Formos Med Assoc 2001; 100(5): 350-1.
Sanzen L, Carlsson A: Transmission of human T-cell lymphotrophic virus type 1 by a deep-frozen bone allograft. Acta Orthop Scand 1997; 68: 72-4.
Centers for Disease Control and Prevention (CDC): Hepatitis C virus transmission from an antibody-negative organ and tissue donor–United States, 2000-2002. MMWR Morb Mortal Wkly Rep 2003; 52: 273-4, 276.
Septic arthritis following anterior cruciate ligament reconstruction using tendon allografts– Florida and Louisiana, 2000. Morb Mortal Wkly Rep 2001; 50(48): 81-3.
Centers for Disease Control and Prevention (CDC): Update: Allograft-associated bacterial infections-United States, 2002. MMWR Morb Mortal Wkly Rep 2002; (51): 207-10.
Centers for Disease Control and Prevention (CDC): Invasive Streptococcus pyogenes after allograft implantation– Colorado, 2003. MMWR Morb Mortal Wkly Rep 2003; (52): 1173-6.
Barriga A, Díaz-de Rada P, Barroso JL, et al: Frozen cancellous bone allografts: positive cultures of implanted grafts in posterior fusions of the spine. Europ Spine J 2004; 13(2): 152-6.
Martínez-Pardo M, Hernández L, Reyes-Frías M, Luna Zaragoza D: Coding and Traceability used by tissue Banks in Mexico. Cell Tiss Bank 2010; 11(4): 393-5.
Kalter ES: Tissue banking programmes in Europe. Brit Med Bull 1997; 53(4): 798-816.
Alabat: Taller de buenas prácticas en procesamiento y producción en bancos de tejidos. Proyecto RLA/6/062 ARCAL CVIII. Anexo III. Disponible en: http://www.alabat.org/index.php?option=com_content&view=section&layout=blog&id=9&Itemid=72
Organización Mundial de la Salud: Consejo Ejecutivo de la CXXIIIª Reunión. Anexo del documento EB123/5. Principios rectores de la OMS sobre trasplante de células, tejidos y órganos humanos; 2008.