In vitro and in vivo evaluation of a reusable double-channel sphincterotome

Background: To date, one reusable, double-channel sphincterotome has been a pproved by the Food and Drug Administration in the United States. Whether t his device can be reprocessed easily and whether it is more durable than cu rrently manufactured disposable sphincterotomes are uncertain. Methods: Thirty double-channel, 20 mm, braided-wire sphincterotomes approve d for multiple uses were studied in vitro/in vivo with regard to durability and sterilization. A cost analysis of reusable, disposable, and reprocesse d disposable sphincterotomes was also carried out. Results: Three of 10 sphincterotomes evaluated in vitro broke after 3, 4, a nd 8 uses. Electrical integrity was preserved after 10 uses in the remainin g sphincterotomes. Nine sphincterotomes remained functional for at least 3 uses, five for 6 uses, and one for 10 uses. Culture results after inoculati on demonstrated contamination with surviving organisms after manual cleanin g and no growth after ethylene oxide sterilization. Sixty-one procedures we re performed in vivo using 20 sphincterotomes (mean number of uses 3.1). No evidence of procedurally related infection occurred with reuse. Cost per u se of this reusable sphincterotome was calculated to be $62.98; it became c ost effective after 2.2 and 7.9 uses when compared with disposable and repr ocessed, disposable sphincterotomes, respectively. Conclusions: This reusable sphincterotome proved to be safe, easily sterili zed, and electrically intact after repeated use. In vivo, however, a progre ssive loss of function limited the mean number of uses to 3.1. In settings that preclude reuse of reprocessed disposable accessories, this reusable sp hincterotome may provide a means to decrease costs associated with endoscop ic retrograde cholangiopancreatography.