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

Background and Study Aims: Therapeutic endoscopic retrograde cholangiopancr eatography (ERCP) has been deemed to be a "cost-prohibitive" procedure, bas ed upon the cumulative costs of one-time-use accessories and current reimbu rsement plans, One-time-use sphincterotomes comprise a significant componen t of that cost and, accordingly, we evaluated the disability and clinical u sefulness of a recently introduced reusable double-channel sphincterotome, Materials and Methods: We studied a reusable 6-Fr sphincterotome at baselin e and following contamination with 10(6) Bacillus stearothermophilus, Repro cessing included a unique 30-minute ultrasonic cleaning step in lieu of man ual cleaning, followed by steam sterilization, Parameters evaluated include d sphincterotome function, electrical integrity, and our ability to sterili ze the devices for three in vitro trials, In vivo studies included patient demographics and outcomes, procedural findings, and success rates, and the mean number of times the sphincterotome was used, functional grading at Results: Ten out of ten sphincterotomes maintained form, function, and elec trical integrity in vitro, and all cultures were negative after sterilizati on, In the initial in vivo study, ten sphincterotomes were used in 50 patie nts (mean, 5 uses) with a 94% success rate, Reasons for sphincterotome fail ure included leak or breakage of the accessory port in 70%, wire fracture i n 10%, incorrect wire bow in 10%, and dogged injection port in 10%, Followi ng reconfiguration of the insertion-port polymer, an additional ten sphinct erotomes were used in 110 patients (mean, ii uses), Mechanical failure occu rred primarily at the wire-insertion port, resulting in progressive frictio n with reuse, There were neither electrical nor infectious complications as sociated with reuse, Conclusions: A reusable double-channel sphincterotome is available which ca n theoretically be reprocessed and sterilized without the manual cleaning s tep of the reprocessing process, Contingent upon both provider and patient, multiple reuse can be anticipated, and contingent upon purchase price and reprocessing costs, the potential for procedural cost savings is significan t.