A prospective study of the repeated use of sterilized papillotomes and retrieval baskets for ERCP: Quality and cost analysis

Purpose: To analyze the consequences of the practice of sterilizing and reusing ERCP accessories instead of following a single-use policy. Methods: 15 new papillotomes (Olympus KD21) and 10 new retrieval baskets (Olympus FG23) were labeled with autoclave resistant colored tape. For each use, accessories were evaluated by the staff gastroenterologist with respect to their function for the intended task, on a scale of 1 (useless) to 10 (excellent). The staff was blinded as to the number of prior uses. The fellow recorded the date of use, the quality rating, and the task undertaken: cannulation, sphincterotomy; stent retrieval; or negative, simple, or difficult stone extraction. All instruments underwent routine manual cleaning and ethylene oxide gas sterilization. All discarded instruments were sterilized one final time and sent to the microbiology lab for bacterial and viral culture to confirm that no transmissible agents could be detected after sterilization. Cost estimates per use (US$) were based on the purchase price of accessories ($175/papillotome; $375/basket) and the additional cost of cleaning and sterilization ($1.70/papillotome; $1.93/basket), which included labor, supplies, and equipment maintenance costs. Results: The 15 papillotomes have been used a total of 119 times (median 7; mean 7.9), including 42 sphincterotomies (35%) To date, 7 papillotomes have been discarded after a mean of 5.3 uses (median 3), the usual reason being damage to the wire. 10 retrieval baskets have been used a total of 90 times (median 8; mean 9). These included 25 uses for difficult stone extractions. 2 baskets were destroyed in order to perform mechanical lithotripsy, and another was lost in processing. Kaplan-Meier curves established that the median survival of both papillotomes and baskets before dropping to below a rating of 6 was 8 uses. There have been no complications attributable to the use of suboptimal reused equipment. All cultures of sterilized instruments were negative. Cost Analysis: 80 of these papillotomes and 36 of these baskets are purchased annually in our unit. Using an estimate of 8 uses per accessory, our projected yearly cost savings of multiple use versus single use of these new instruments is $97,048 for papillotomes and $94,019 for retrieval baskets, a 7.5 and 7.7 fold reduction in cost, respectively. If disposable papillotomes ($120) were used instead, the savings would be $61,848. Conclusion: Papillotomes and retrieval baskets may be reused reliably multiple times after sterilization. Unless the price of disposable instruments is considerably lowered, multiple reuse of instruments will remain the more cost-effective practice alternative.