Sterilisation of implantable devices

Abstract

The pathogenesis and rates of infection associated with the use of a wide variety of implantable devices are described. The multi-factorial nature of post-operative periprosthetic infection is outlined and the role of sterilisation of devices is explained. The resistance of bacterial spores is highlighted as a problem and a full description is given of the processes of sterilisation by heat, steam, ethylene oxide, low temperature steam and formaldehyde, ionising radiation and liquid glutaraldehyde. Sterility assurance and validation are discussed in the context of biological indicators and physical/chemical indicators. Adverse effects upon the material composition of devices and problems of process control are listed. Finally, possible optimisations of the ethylene oxide process and their potential significance to the field of sterilisation of implants is explored.