New hygiene services in medical device cleaning and reprocessing by the use ofliquid carbon dioxide and extremophile enzymes
IGF 32 EN
Current and, to a much higher extend, future medical devices like flexible endoscopes and implants are very sensitive and thermolabile. Thus they can’t be disinfected and sterilized by the established and safe thermal procedures. The state of the art procedures, which relay on chemo-thermal or chemical disinfection and sterilization, have many disadvantages such as e.g. lower process safety, residual chemicals, material damage.
Within the project an innovative procedure for the cleaning and disinfection of geometrically complex and thermo-labile medical device was developed. Process challenging devices for flexible endoscopes served as surrogate model system. The procedure applied incubation in liquid and supercritical CO2 at temperatures <40 °C. Within a process times of 15 minutes a high antimicrobial activity against bacteria, fungi, viruses and bacterial endospores was obtained, comparable to established low-temperature sterilization procedures that are assumed to exhibit the risk of toxic residues. The cleaning efficacy of the new procedure could be improved by the application of special enzymes. Under application of specific proteases a procedure was developed using the process challenging device of Appendix 8 and 9 of the actual guideline of DGKH, DGSV, DGVS, DEGEA and AKI. Residual protein content was below the acceptance level. With regard to the test of the overall process performance microbial inactivation rates of RF>9 (E. faecium) were measured. The process time was about 1 hour, processed objects are obtained dry. The new procedure overcomes conventional chemo- and chemo-thermal procedures with regard to the spectrum of affected microbes, inactivation rates and harmlessness of applied substances.
Due to the developed new enzyme-improved liquid/supercritical-CO2-procedure an innovative reprocessing procedure for geometrically complex and thermo-labile medical devices is available for professional service provider companies and manufacturers of medical devices. The number of potential facilities that can apply the procedure consists of approx. 30,000 hospitals and numberless medical practices as well as some thousand manufacturers of thermo-labile medical devices within the EC.
The IGF-project 32 EN of the research association Europäische Forschungsgemeinschaft Reinigungs- und Hygienetechnologie e.V., Campus Fichtenhain 11, D-47807 Krefeld, was supported via the AiF within the funding programme „Industrielle Gemeinschaftsforschung und –entwicklung (IGF)“ by the Federal Ministry of Economic Affairs and Technology (BMWi) due to a decision of the German Parliament.
The research report is available on request from FRT.