| In vitro study and in vivo application of a reusable double-channel sphincterotome. | |
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MedLine Citation:
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PMID: 11396756 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND AND STUDY AIMS: Therapeutic endoscopic retrograde cholangiopancreatography (ERCP) has been deemed to be a "cost-prohibitive" procedure, based upon the cumulative costs of one-time-use accessories and current reimbursement plans. One-time-use sphincterotomes comprise a significant component of that cost and, accordingly, we evaluated the disability and clinical usefulness of a recently introduced reusable double-channel sphincterotome. MATERIALS AND METHODS: We studied a reusable 6-Fr sphincterotome at baseline and following contamination with 10(6) Bacillus stearothermophilus. Reprocessing included a unique 30-minute ultrasonic cleaning step in lieu of manual cleaning, followed by steam sterilization. Parameters evaluated included sphincterotome function, electrical integrity, and our ability to sterilize 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 time of use, and reasons for sphincterotome malfunction. RESULTS: Ten out of ten sphincterotomes maintained form, function, and electrical integrity in vitro, and all cultures were negative after sterilization. In the initial in vivo study, ten sphincterotomes were used in 50 patients (mean, 5 uses) with a 94% success rate. Reasons for sphincterotome failure included leak or breakage of the accessory port in 70%, wire fracture in 10%, incorrect wire bow in 10%, and clogged injection port in 10%. Following reconfiguration of the insertion-port polymer, an additional ten sphincterotomes were used in 110 patients (mean, 11 uses). Mechanical failure occurred primarily at the wire-insertion port, resulting in progressive friction with reuse. There were neither electrical nor infectious complications associated with reuse. CONCLUSIONS: A reusable double-channel sphincterotome is available which can theoretically be reprocessed and sterilized without the manual cleaning step 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 significant. |
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Authors:
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R A Kozarek; S L Raltz; J J Brandabur; D J Patterson; T J Ball; M G Gluck; S E Sumida; S K Roach; D E Drajpuch; D L Irizarry |
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Publication Detail:
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Type: Clinical Trial; In Vitro; Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Endoscopy Volume: 33 ISSN: 0013-726X ISO Abbreviation: Endoscopy Publication Date: 2001 May |
Date Detail:
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Created Date: 2001-06-08 Completed Date: 2001-10-25 Revised Date: 2009-11-19 |
Medline Journal Info:
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Nlm Unique ID: 0215166 Medline TA: Endoscopy Country: Germany |
Other Details:
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Languages: eng Pagination: 401-4 Citation Subset: IM |
Affiliation:
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Section of Gastroenterology, Virginia Mason Medical Center, Seattle, Washington 98111, USA. gasrak@vmmc.org |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Cholangiopancreatography, Endoscopic Retrograde
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economics,
instrumentation* Cholestasis / pathology* Equipment Contamination Equipment Failure Analysis Equipment Reuse / economics Female Geobacillus stearothermophilus / growth & development Humans Male Middle Aged Prospective Studies Sphincterotomy, Endoscopic / economics, instrumentation* Sterilization / economics |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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