2012, Número 2
Bancos de tejidos musculoesqueléticos en México. Parte I. Regulación y organización
Idioma: Español
Referencias bibliográficas: 50
Paginas: 130-136
Archivo PDF: 48.13 Kb.
RESUMEN
Aunque en México los Bancos de Tejidos y sus actividades no son nuevos, las regulaciones específicas sobre las actividades de los bancos de tejidos y los tejidos musculoesqueléticos como insumos para la salud están en desarrollo. Este artículo de revisión tiene por objetivo informar acerca del panorama nacional de los bancos de tejidos musculoesqueléticos, los principales aspectos de regulación y organización de éstos, así como el reconocimiento de las figuras nacionales de la Coordinación de Donación de Órganos y Tejidos con Fines de Trasplante para la obtención de tejidos (musculoesqueléticos) de donante cadavérico.REFERENCIAS (EN ESTE ARTÍCULO)
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).
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.
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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..
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.
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.
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.
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.
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.
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.
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.