775 COST UTILITY ANALYSIS COMPARING DUODENOSCOPE REPROCESSING/STERILIZATION, NOVEL DUODENOSCOPES WITH DISPOSABLE ENDCAPS AND FULLY DISPOSABLE DUODENOSCOPES

Abstract

Transmission of multi-drug resistant organisms by duodenoscopes used during ERCP is problematical. The FDA (Food & Drug Administration) recently issued a communique recommending transition away from reusable fixed endcap duodenoscopes to those with newer design features that facilitate or eliminate the need for reprocessing. Duodenoscopes with disposable endcap and fully disposable duodenoscopes have now been developed This analysis evaluates the relative cost of different approaches to minimizing infection risk, taking into account the cost associated with duodenoscope-transmitted infection. We developed a Monte Carlo analysis model in R to assess the cost-effectiveness of various approaches: (1) Single High Level Disinfection (HLD), (2) Double HLD, (3) Ethylene oxide (EtO) sterilization, (4) Culture & hold, (5) Duodenoscope with disposable endcap and (6) Disposable duodenoscope. This model utilizes a multi-state trial framework and institutional cost estimates (Table 1). We assumed a triangular distribution with 3 parameters: minimum, maximum and most probable infection rate (MPIR), which vary across the six options. Using these values, we simulated quality adjusted life years (QALY) lost by duodenoscope-transmitted infection and factored this into the average cost for each approach. Our model’s simulated cost for each approach at variable rates of MPIR is depicted in Figure 1. At all rates of infection transmission below 1%, the duodenoscope with disposable endcap was the most cost-effective approach (Figure 1). The fully disposable duodenoscope eliminates the potential for infection transmission and is more cost effective than single/double HLD at all infection transmission rates, more cost effective than EtO for MPIR <0.22%, and more cost effective than culture & hold for MPIR <0.49%. Single and double HLD are the two most costly approaches at all potential infection transmission rates. The next two most costly approaches: EtO and culture & hold, require more duodenoscopes and costly transport/institutional infrastructure. Our model indicates that novel duodenoscopes with a disposable endcap represent the most cost-effective option performing ERCP, with an anticipated very low infection transmission rate and disposable element costing approximately 1/5th that of the fully disposable duodenoscope. Limitations of this model include necessary assumptions and the potential lack of generalizability to lower volume community facilities. These data underscore the importance of cost calculations which account for the potential for infection transmission and associated patient morbidity/mortality associated with each approach. Institution-specific cost analyses will become increasingly relevant as the FDA recommendation for transitioning to duodenoscopes with newer design features gains momentum.Figure 1Simulated cost for each duodenoscope-associated infection minimization approach at variable rates of ‘most probable infection rate.’View Large Image Figure ViewerDownload Hi-res image Download (PPT)