In vitro evaluation of wire integrity and ability to reprocess single-use sphincterotomes

Background: Sphincterotomes are currently marketed as one-time-use items and constitute considerable cumulative expense in a busy endoscopy unit. It is uncertain whether these accessories can be safely reprocessed without loss of form and function. Methods: We studied disposable sphincterotomes (five 5F, five 6F) in vitro as to their durability, electrical integrity, and ability to be adequately cleaned both manually and with ethylene oxide after contamination with 10(5) to 10(6) Mycobacterium 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 electrosurgical analyzer, remained intact up to time of breakage in ail sphincterotomes. Manual cleaning followed by glutaraldehyde soak resulted in residual mycobacterial colonies in five 6F sphincterotomes and a single 5F sphincterotome. No instrument had residual organisms cultured following manual cleaning and ethylene oxide sterilization. Conclusions: The authors conclude that one-time-use sphincterotomes have the potential for safe reuse.