EFFECTIVENESS OF HOSPITAL CENTRAL STERILIZATION PROCESSING VS. CLINIC-BASED STERILIZATION PROTOCOLS: A NON-INFERIORITY TRIAL

Abstract

Purpose: .The purpose of the study was to determine if clinic-based sterilization is non-inferior to hospital-based central sterilization. Methods: This study was a blinded and standardized, direct comparison of commonly used sterilization methods. Clinic-based sterilization was compared with hospital-based central sterilization for usage with non-complex surgical instruments. Instruments (n=1264) were randomly assigned to 1 of 5 groups as either test groups (Groups A, B, C) or negative control groups (Groups D, E). Groups A, B and C were artificially inoculated using vital strain of E. faecalis and S. aureus, Groups D and E were non-inoculated negative controls. Test Groups B and C (n=593 and n=584) were sterilized using either a clinic based sterilization protocol or hospital-based central sterilization protocol, whereas Group A was used to determine the viability of methods used. All groups were then incubated at 37 degrees Celsius in a validated culture medium (Tryptic-soy broth) for 72 hours and checked for bacterial growth (turbidity) by a single blinded observer. Results: Group B (clinic-based sterilization) the rate of successful sterilization was 99.8314% (592/593) and for Group C (hospital-based sterilization) the rate was 100% (584/584). Groups A, D, and E were used to determine the validity of the results. Statistical analyses of all variables failed to identify significant differences between test Groups B and C at a 95% confidence interval. Conclusion: From this study we can conclude that for non-complex surgical instruments, centrally-based sterilization protocols and clinic based sterilization protocols are equivalent in sterilization. Thus, other factors should be considered when determining which sterilization method is appropriate for each specific department within a hospital setting.