Surgeons will be familiar with many sterilisation techniques used to decontaminate surgical instruments, medical devices, etc. Some of these (eg high temperature sterilisation) are not suitable for tissues. Research scientists within Tissue Services have carried out comprehensive evaluations of sterilisation techniques to determine which are suitable for which tissues. The tissues have subsequently been validated to ensure that essential biological and biomechanical properties have not been adversely affected, and that the graft remains biocompatible.
Various model systems using bacterial spores and viruses have been used to simulate worst-case scenarios. In addition, the sterilisation procedure complies with European Standards ISO 11137 and it is titled Sterilisation of healthcare products where appropriate.
For viable (living grafts), banked using cryopreservation techniques, the application of a 'sterilisation' method would not be appropriate as this would also kill the tissue cells. In these cases we have developed disinfection methods that kill bacteria without compromising donor cell viability. Where appropriate, validation studies have been published in peer reviewed journals (see references below).
We believe that the use of validated decontamination procedures minimises the risk of disease transmission and enhances the safety of tissue allografts.
|Evaluation of ethylene oxide sterilisation of tissue implants||J N Kearney, V C Franklin V Agurregoicoa||Journal of Hospital Infection 13: 71-80||1989|
|Effects of antifungals on the viability of heart valve cusp derived fibroblasts||V Agurregoicoa, J N KearneyG A Davies, G Gowland||Cardiovascular Research 23(12): 1058-1061||1989|
|Evaluation of NaOH treatment of human dura mater implants to obviate Creutzfeldt-Jakob Disease transmission||J N Kearney, C Johnson||Biomaterials 12: 431-432||1991|
|Ethylene oxide sterilisation of allogeneic bone implants||J N Kearney, R BojarK T Holland||Clinical Materials 12: 129-135||1993|
|Sterilisation of human tissue implants||J N Kearney||Tissue & Cell Report 4 (1): 33-36||1996|
|Application of a high-level peracetic acid disinfecton protocol to re-process antibiotic disinfected skin allografts||R J Lomas, Q Huang, D E Pegg, J N Kearney||Cell and Tissue Banking5: 23-36||2004|
|Use of peracetic acid to sterilise human donor skin for production of acellular dermal matrices for clinical use||Huang Q, Dawson R A, Pegg D E, Kearney J N, MacNeil S||Wound Repair and Regeneration 12: 276-287||2004|
|Effects of a peracetic acid disinfection protocol on the biocompatibility and biomechanical properties of human patellar tendon allografts||Lomas R J, Jennings L M, Fisher J, Kearney J N||Cell and Tissue Banking 5: 149-160||2004|
|Validation of radiation dose received by frozen unprocessed and processed bone during terminal sterilisation||M.J.Eagle, P.Rooney, R.Lomas, J N Kearney||Cell and Tissue Banking6 (3) 221-230||2005|
|Development of a bacteriophage model system to investigate virus inactivation methods used in the treatment of bone allografts||C.Bienek, L.MacKay, G.Scott, A.Jones, R.Lomas, J.N.Kearney, G.Galea||Cell Tissue Banking||2006|
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