IN-VITRO EVALUATION OF WIRE INTEGRITY AND ABILITY TO REPROCESS SINGLE-USE SPHINCTEROTOMES

Background: Sphincterotomes are currently marketed as one-time-use ite ms and constitute considerable cumulative expense in a busy endoscopy unit. It is uncertain whether these accessories can be safely reproces sed without loss of form and function. Methods: We studied disposable sphincterotomes (five 5F, five 6F) in vitro as to their durability, el ectrical integrity, and ability to be adequately cleaned both manually and with ethylene oxide after contamination with 10(5) to 10(6) Mycob acterium chelonei. Results: Seven of the 10 sphincterotomes withstood the rigors of reuse; three 6F sphincterotomes developed wire fracture between four and eight uses. Electrical integrity, as measured by an e lectrosurgical analyzer, remained intact up to time of breakage in ail sphincterotomes. Manual cleaning followed by glutaraldehyde soak resu lted in residual mycobacterial colonies in five 6F sphincterotomes and a single 5F sphincterotome. No instrument had residual organisms cult ured following manual cleaning and ethylene oxide sterilization. Concl usions: The authors conclude that one-time-use sphincterotomes have th e potential for safe reuse.