Sterilisation
And Disinfection

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.

References

Title Author Journal Details Year
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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