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Órgano Oficial del Colegio Mexicano de Ortopedia y Traumatología

2012, Number 2

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Acta Ortop Mex 2012; 26 (2)

Musculoskeletal Tissue Banks in Mexico. Part I. Regulation and Organization

Álvarez-San Martín R

Language: Spanish
References: 50
Page: 130-136
PDF size: 48.13 Kb.


ABSTRACT

Although Tissue Banks and their activities are not new in Mexico, the specific regulations for the activities of tissue banks and musculoskeletal tissues considered as health supplies are still under development. This review paper intends to provide information on the national situation of musculoskeletal tissue banks, major aspects concerning their regulation and organization, and the recognition of the national instances pertaining to the Coordination for Organ and Tissue Donation for Transplant Purposes for the obtention of (musculoskeletal) tissues from deceased donors.


REFERENCES

  1. Galván RM, Álvarez LE, Briseño RAN: Banco de hueso y tejidos en México. Rev Mex Ortop Ped 2005; 7(1): 5-8.

  2. Martínez-Pardo ME, Morales-Pedraza J, Sánchez-Ramírez O: The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Mexico. Cell Tiss Bank 2009; 10(2): 157-65.

  3. 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.

  4. Martínez-Pardo M, Reyes-Frías M: The Tissue Bank at the National Nuclear Research Institute in Mexico. Cell Tiss Bank 2003; 4(2-4): 163-8.

  5. Morales PJ: The advances in tissue banking. The International Atomic Energy Agency (IAEA) program on radiation and tissue banking: a successful program for developing countries. Cell Tiss Bank 2006; 7(4): 237-58.

  6. Figueroa A: El IMSS pondrá en funcionamiento su primer banco de hueso; al menos 5 mil cirugías al año requieren de un injerto. Boletín de Salud 2009. Comunicado de Prensa. En: http://www.cronica.com.mx/especial.php?id_tema=1232&id_nota=420266

  7. Luna-Zaragoza D, Reyes-Frías M: Donation transplants and tissue banking in Mexico. Cell Tiss Bank 2001; 2(4): 255-9.

  8. CENATRA: Establecimientos Autorizados. 23 de Diciembre del 2010. Centro Nacional de Trasplantes CENATRA. Disponible en: www.cenatra.salud.gob.mx. Abril 26, 2011.

  9. Ley General de Salud. Título XIV: Donación trasplante y pérdida de la vida. Capítulo I. Disposiciones comunes. Artículo 314 Fracción X. (Últimas reformas DOF 11-06-2009).

  10. Ley General de Salud. Título XIV: Donación Trasplante y Pérdida de la vida: Capítulo I. Disposiciones Comunes. Artículo 314 Fracción XIII. (Últimas reformas DOF 11-06-2009).

  11. Ley General de Salud. Título XIV: Donación trasplante y pérdida de la vida: Capítulo I. Disposiciones comunes. Artículo 314 Fracción XVII. (Últimas reformas DOF 11-06-2009).

  12. Ley General de Salud. Título XII: Control sanitario de productos y servicios de su importación y exportación: Capítulo I. Disposiciones Comunes. Artículo 194 Bis. (Últimas reformas DOF 11-06-2009).

  13. Ley General de Salud. Título XII Control Sanitario de productos y servicios de su importación y exportación: Capítulo VIII. Equipos médicos, prótesis, ortesis, ayudas funcionales, agentes de diagnóstico, insumos de uso odontológico, materiales quirúrgicos, de curación y productos higiénicos. Artículo 262 Fracción VI. (Últimas reformas DOF 11-06-2009).

  14. Reglamento de Insumos. Título segundo: insumos: Capítulo I. Disposiciones Comunes. Sección 1ª-Sección 6ª. (Últimas reformas DOF 5-08-2008).

  15. Comisión Federal para la Protección contra Riesgos Sanitarios COFEPRIS: Página Web: www.cofepris.gob.mx 2011. Junio 28.

  16. Ley General de Salud. Título XII: Control Sanitario de Productos y Servicios de su Importación y Exportación: Capítulo I. Disposiciones Comunes. Artículo 197. Vigente al 24 de Octubre 2011.

  17. Reglamento de Insumos Título segundo: Capítulo I. Disposiciones comunes. Sección Primera: Características y condiciones sanitarias. (Últimas reformas DOF 5-08-2008).

  18. Reglamento de Insumos. Título segundo: Capítulo I. Disposiciones comunes. Sección Segunda envasado y etiquetado. (Últimas reformas DOF 5-08-2008).

  19. Reglamento de Insumos. Título segundo: Capítulo I. Disposiciones comunes. Sección tercera Prescripción. (Últimas Reformas DOF 5-08-2008).

  20. Reglamento de Insumos. Título segundo: Capítulo I. Disposiciones Comunes. Sección Cuarta venta o suministro. (Últimas reformas DOF 5-08-2008).

  21. Reglamento de Insumos. Título segundo: Capítulo I. Disposiciones comunes. Sección quinta Investigación y suspensión de actividades. (Últimas reformas DOF 5-08-2008).

  22. Reglamento de Insumos. Título segundo: Capítulo I. Disposiciones comunes. Sección sexta Destrucción de insumos. (Últimas reformas DOF 5-08-2008).

  23. Commission Directive 2004/23/EC: European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Official Journal of the European Union: 48-58.

  24. Commission Directive 2004/23/EC: European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Official Journal of the European Union: 58. Annex. Information to be provided on the donation of cells and/or tissues.

  25. Commission Directive 2006/17/EC: Implementing directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. Official Journal of the European Union: 40-42.

  26. Commission Directive 2006/17/EC: Implementing directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. Official Journal of the European Union: 43-44. Annex I. Selection criteria for donors of tissues and/or cells (except donors of reproductive cells) as referred to in Article 3(a).

  27. Commission Directive 2006/17/EC: Implementing directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. Official Journal of the European Union: 45-46. Annex II. Laboratory tests required for donors (except donors for reproductive cells) as referred to in Article 4(1).

  28. Commission Directive 2006/17/EC: Implementing directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. Official Journal of the European Union: 47-48. Annex III. Selection criteria and laboratory tests required for donors of reproductive cells as referred to in Article 3(b) and Article 4(2).

  29. Commission Directive 2006/17/EC: Implementing directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. Official Journal of the European Union: 49-52. Annex IV. Cell and/or tissue donation and procurement procedures and reception at the tissue establishment as referred to in Article 5.

  30. Commission Directive 2006/86/EC: European Parliament and of the Council 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 of the European Union: 32-36.

  31. Commission Directive 2006/86/EC: European Parliament and of the Council 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 of the European Union: 37-40. Annex I. Requirements for accreditation, designation, authorization or licensing of tissue establishments as referred to in Article 3.

  32. Commission Directive 2006/86/EC: European Parliament and of the Council 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 of the European Union: 41-43. Annex II. Requirements for the authorization of tissue and cell preparation processes at the tissue establishments as referred to in Article 4.

  33. Commission Directive 2006/86/EC: European Parliament and of the Council 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 of the European Union: 44. Annex III. Notification of Serious Adverse Reactions Part A & Part B.

  34. Commission Directive 2006/86/EC: European Parliament and of the Council 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 of the European Union: 46. Annex IV. Notification of Serious Adverse Events Part A & Part B.

  35. Commission Directive 2006/86/EC: European Parliament and of the Council 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 of the European Union: 47-48. Annex V. Annual Notification Format Part A & Part B.

  36. Commission Directive 2006/86/EC: European Parliament and of the Council 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 of the European Union: 49. Annex VI. Information on the minimum donor/recipient data set to be kept as required in Article 9. Part A & Part B..

  37. Commission Directive 2006/86/EC: European Parliament and of the Council 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 of the European Union: 45. Annex VII. Information contained in the European Coding System.

  38. European Directive 2004/23/EC: Chapter IV. Provisions on the quality and safety of tissues and cells. Article 16, Quality Management. Official Journal of the European Union. 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. L.102/55.

  39. European Directive 2004/23/EC: Chapter IV. Provisions on the quality and safety of tissues and cells. Article 17, Responsible Person. Official Journal of the European Union. 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. L.102/55.

  40. Commission Directive 1– Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells.

  41. Commission Directive 2 – Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and the Council 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. 2006, Octubre 25.

  42. Guidance for Industry: Elegibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). U.S. Department of Health and Human Services. Food and Drug Administration. Center for Biologics Evaluation and Research 2007.

  43. LABAT: Taller de buenas prácticas en procesamiento y producción en bancos de tejidos. Proyecto RLA/6/062 ARCAL CVIII. Anexo III. Disponible en: www.alabat.org

  44. Álvarez San Martín R: 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.

  45. El modelo español. Organización Nacional de Trasplantes ONT. Gobierno de España. Ministerio de Sanidad, Política Social e Igualdad. www.ont.es/informacion/Paginas/Trasplante.aspx Consultado Enero 3, 2012.

  46. Ley General de Salud: Título XIV. Donación Trasplantes y Pérdida de la Vida. Capítulo I. Disposiciones comunes Artículo 314. Fracción XV. (Última reforma DOF 16-11-2011).

  47. Fehily D, Dziedzic-Goclawska A, Kaminski A: Quality assurance-quality control. Subject 1. Module 5. In: Tissue banking: general organization. In: International On-Line Tissue Banking Course IL-3 Manual, 2010: 1-20.

  48. European Directive 2004/23/EC: Chapter IV. Provisions on the quality and safety of tissues and cells. Article 18, Personnel. Official Journal of the European Union 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. L.102/55.

  49. European Directive 2004/23/EC: Chapter IV. Provisions on the quality and safety of tissues and cells. Article 24. Relations between establishments and third parties. Official Journal of the European Union. 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. L.102/56.

  50. American Association Tissue Bank Standards 1997.




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