Human pathogens, nosocomial infections, heat-sensitive textile implants, and an innovative approach to deal with them.

Implantable polymers, as used for biomedical applications, inherently have to be sterile. Nonetheless, most implants, particularly those comprised of biomaterials developed in recent years for tissue engineering, are heat sensitive. Therefore, use of hazardous (radio)chemicals--due to lack of alternative methods--is still state of the art for sterilization processes. The drawbacks of these techniques, both drastic and well known, lead to the demand for an alternative sterilization method, which is equally obvious and urgent. High-pressure fluid treatment is a low-temperature technique that is already in use for pasteurization of liquid food products. This paper explores inactivation of vegetative microorganisms, spores, and endotoxins adherent to solid surfaces using compressed CO(2). Pressures ranging from 50 to 100 bar and temperatures from 25 °C to 50 °C were explored to investigate liquid, gaseous or supercritical state. Analysis of variance (ANOVA) and statistical modeling were used to identify the optimum parameter settings for inactivation of pathogenic bacteria and fungi (Candida albicans, Staphylococcus aureus). The addition of small amounts of ozone ensures inactivation of persistent spores (Bacillus stearothermophilus, B. subtilis) up to 10(6) cfu/ml, while endotoxins remain in practically unchanged concentration on the polymer surface. We then discuss environmental issues of the process and inactivation mechanisms. The replacement of conventional chemicals with nonpersistent ones resolves organizational and safety-related issues and protects natural resources as well as handling staff. The pressurized-fluid-based method exhibits mild treatment parameters, thus protecting sensitive textures. Finally, an outlook on possible applications of this innovative technique is presented.