Cost utility analysis of strategies for minimizing risk of duodenoscope-related infections.

BACKGROUND AND AIMS: Transmission of multidrug-resistant organisms by duodenoscopes during ERCP is problematical. The U.S. Food and Drug Administration recently recommended transitioning away from reusable fixed-endcap duodenoscopes to those with innovative device designs that make reprocessing easier, more effective, or unnecessary. Partially disposable (PD) duodenoscopes with disposable endcaps and fully disposable (FD) duodenoscopes are now available. We assessed the relative cost of approaches to minimizing infection transmission, taking into account duodenoscope-transmitted infection cost.

METHODS

We developed a Monte Carlo analysis model in R (R Foundation for Statistical Computing, Vienna, Austria) with a multistate trial framework to assess the cost utility of various approaches: single high-level disinfection (HLD), double HLD, ethylene oxide (EtO) sterilization, culture and hold, PD duodenoscopes, and FD duodenoscopes. We simulated quality-adjusted life years (QALYs) lost by duodenoscope-transmitted infection and factored this into the average cost for each approach.

RESULTS

At infection transmission rates <1%, PD duodenoscopes were most favorable from a cost utility standpoint in our base model. The FD duodenoscope minimizes the potential for infection transmission and is more favorable from a cost utility standpoint than use of reprocessable duodenoscopes after single or double HLD at all infection rates, EtO sterilization for infection rates >.32%, and culture and hold for infection rates >.56%. Accounting for alternate scenarios of variation in hospital volume, QALY value, post-ERCP lifespan, and environmental cost shifted cost utility profiles.

CONCLUSIONS

Our model indicates that PD duodenoscopes represent the most favorable option from a cost utility standpoint for ERCP, with anticipated very low infection transmission rates and a low-cost disposable element. These data underscore the importance of cost calculations that account for the potential for infection transmission and associated patient morbidity/mortality.