Background: The choice between reusable and single-use devices for ERCP depends on various medical and economic criteria. This study evaluated the reliability and the safety (risk of cross-contamination) of reusable devices. A cost analysis of the use of reusable devices also was conducted.
Methods: All patients referred for ERCP that required use of a sphincterotome or a retrieval basket were eligible for inclusion in a clinical study of 4 different devices (3 types of sphincterotome, 1 type of retrieval basket). All devices were steam sterilized. Before each use, each device was subjected to bacteriologic and virologic tests (hepatitis C virus, hepatitis B virus markers). Devices were examined before and after each procedure. The numbers of safe and efficient procedures that could be performed with each device were assessed. Three strategies were compared in a cost analysis: internal reprocessing (strategy 1), external reprocessing (strategy 2), and single-use (strategy 3). Inputs used were the results of the clinical study, hospital data for 1 year of endoscopic activity, and market prices.
Results: A total of 342 patients underwent the following procedures: sphincterotomy (248 patients), stent insertion (59 patients), use of basket without sphincterotomy (14 patients), and diagnostic ERCP/unsuccessful cannulation (21 patients). At the time of ERCP, 36 patients had viral or bacterial infection. Fifty instruments were used (20 single-lumen sphincterotomes, 10 double lumen sphincterotomes, 20 retrieval baskets). Overall, the median number of efficient uses per device was 10. The median number of efficient uses by each type of device was the following: single-lumen sphincterotome, 12; double-lumen sphincterotome, 8; and, retrieval baskets, 10. All virologic and bacteriologic tests for all instruments were negative. The cost-optimization analysis found that strategy 1 is cost effective (euro37,283/y) compared with strategy 2 (euro40,101/y) and especially with Strategy 3 (euro115,210/y).
Conclusions: Reuse of the sphincterotomes and baskets evaluated in this study during ERCP is safe in terms of infectious hazards. Because they endure numerous uses, reusable instruments are cost effective, especially when compared with single-use accessories.