The Tissue Bank at the National Nuclear Research Institute in Mexico

Martínez-Pardo, María Esther; Reyes-Frías, Ma. Lourdes

doi:10.1023/b:catb.0000007038.09698.c2

Cited by 7 publications

(1 citation statement)

References 1 publication

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“…Moreover, the exact number of tissue banks using gamma radiation for terminal sterilization, and their doses, remains unknown (Vangsness et al 2003). Many banks (Alvarez et al 2003;Bryce and Journeaux 1996;Campbell and Oakeshott 1995;Erkol et al 2003;Farrington et al 1998;Gajiwala 2003;Grieb et al 2005;Ireland and McKelvie 2003;Lindeque et al 2005;Loty et al 1990;Martinez-Pardo and Reyes-Frias 2003;Navas and Soto 2003;Fig. 1 The bacterial contamination rate of bone allografts Sommerville et al 2000;USTC 2005;Vajaradul 2000) follow the International Atomic Energy Agency (IAEA) recommendation (IAEA 1967a(IAEA , 1973(IAEA , 1990) of using 25 kGy as the standard dose.…”

Section: Selection Of Radiation Dose and Its Application In Tissue Banksmentioning

confidence: 99%

Sterilization of Allograft Bone: is 25 kGy the Gold Standard for Gamma Irradiation?

Nguyen

Morgan

Forwood

2006

Cell Tissue Banking

140

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For several decades, a dose of 25 kGy of gamma irradiation has been recommended for terminal sterilization of medical products, including bone allografts. Practically, the application of a given gamma dose varies from tissue bank to tissue bank. While many banks use 25 kGy, some have adopted a higher dose, while some choose lower doses, and others do not use irradiation for terminal sterilization. A revolution in quality control in the tissue banking industry has occurred in line with development of quality assurance standards. These have resulted in significant reductions in the risk of contamination by microorganisms of final graft products. In light of these developments, there is sufficient rationale to re-establish a new standard dose, sufficient enough to sterilize allograft bone, while minimizing the adverse effects of gamma radiation on tissue properties. Using valid modifications, several authors have applied ISO standards to establish a radiation dose for bone allografts that is specific to systems employed in bone banking. These standards, and their verification, suggest that the actual dose could be significantly reduced from 25 kGy, while maintaining a valid sterility assurance level (SAL) of 10(-6). The current paper reviews the methods that have been used to develop radiation doses for terminal sterilization of medical products, and the current trend for selection of a specific dose for tissue banks.

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Section: Selection Of Radiation Dose and Its Application In Tissue Banksmentioning

confidence: 99%

Sterilization of Allograft Bone: is 25 kGy the Gold Standard for Gamma Irradiation?

Nguyen

Morgan

Forwood

2006

Cell Tissue Banking

140

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The tissue bank at the Instituto Nacional de Investigaciones Nucleares: ISO 9001:2000 certification of its quality management system

Martínez-Pardo

Mariano-Magaña

2007

Cell Tissue Banking

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Tissue banking is a complex operation concerned with the organisation and coordination of all the steps, that is, from donor selection up to storage and distribution of the final products for therapeutic, diagnostic, instruction and research purposes. An appropriate quality framework should be established in order to cover all the specific methodology as well as the general aspects of quality management, such as research and development, design, instruction and training, specific documentation, traceability, corrective action, client satisfaction, and the like. Such a framework can be obtained by developing a quality management system (QMS) in accordance with a suitable international standard: ISO 9001

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The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Mexico

Martínez-Pardo

Pedraza²,

Ramírez

2008

Cell Tissue Bank

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Tissue banking started in Mexico in 1948-1949, when two bone banks were established, one at the Infantile Hospital of Mexico and other at the Central Military Hospital. Mexico has benefited for the implementation of the IAEA program since through it has been able to settle down and to consolidate the Tissue Bank at the Instituto Nacional de Investigaciones Nucleares ININ (National Institute for Nuclear Research). This is the only bank in Latin America that has a Quality Management System in force, certified under ISO 9001:2000 since August 1, 2003. The first tissue processed was amnion. The main products of the BTR are amnion and pig skin. Both are biological tissues which their main use is as a wound dressing in patients with burns, scars, diabetic ulcers, epidermolysis bullosa, damaged ocular surface, etc. The General Health Law, published in 1984 and reformed in June 19, 2007, describes the procedure for the disposal of organs, tissues and human cadavers in its fourteenth title and in the Regulation for Sanitary Control. During the period 2001-2005, the ININ Tissue Bank produced 292 sterilised tissues (amnion, 86,668 cm(2), and frozen pig skin, 164,220 cm(2), at an estimated cost of 1,012,668 Mexican pesos. Until 2006, one hundred eighty five (185) patients have been treated with the use of sterilised tissues produced by the ININ Tissue Bank. The radiation source used for sterilisation of tissues is an industrial Cobalt-60 irradiator model JS-6500 AECL, which belongs to ININ. This equipment is located in other building, close to the BTR, in the Centro Nuclear de México "Dr. Nabor Carrillo Flores" (Nuclear Center of Mexico). Until 2006, six hospitals use in a routine way the sterilised tissues produced by the ININ Tissue Bank, for the treatment of burns originated by diverse agents like flame, electricity, liquids in boil, chemical reagents, as well as for the reconstruction of the ocular surface. Two of these hospitals treat patients of very low economic incomes, mainly needy individuals, who cannot afford to pay this type of treatments in other hospitals due to their high cost. The results obtained up to now are highly promising.

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The Tissue Bank at the National Nuclear Research Institute in Mexico

Cited by 7 publications

References 1 publication

Sterilization of Allograft Bone: is 25 kGy the Gold Standard for Gamma Irradiation?

Sterilization of Allograft Bone: is 25 kGy the Gold Standard for Gamma Irradiation?

The tissue bank at the Instituto Nacional de Investigaciones Nucleares: ISO 9001:2000 certification of its quality management system

The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Mexico

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