The Colombian Experience in Tissue Banking: The Bone and Tissue Bank of the Cosmos and Damian Foundation, Bogota

Navas, José Miguel Mestre; Soto, Camilo

doi:10.1023/b:catb.0000007037.42773.47

Cited by 3 publications

(2 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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%

“…Therefore, there is a general trend to minimize the dose, aiming for between 15 and 20 kGy (BTC 2005;Jinno et al 2000). Because gamma irradiation at any dose can reduce bone allograft biomechanics and degrade the protein component of bone matrix (Virolainen et al 2003), there are some tissue banks that do not apply radiation for terminal sterilization of their products (Deijkers et al 1997;Hou et al 2005;Navas and Soto 2003;Sutherland et al 1997;Virolainen et al 2003).…”

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

confidence: 99%

See 1 more Smart Citation

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

Nguyen

Morgan

Forwood

2006

Cell Tissue Banking

141

View full text Add to dashboard Cite

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.

show abstract