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In vitro evaluation of wire integrity and ability to reprocess single-use sphincterotomes
R A Kozarek1, S E Sumida, S L Raltz
1Section of Gastroenterology, Virginia Mason Medical Center, Seattle 98111, USA.
Gastrointestinal Endoscopy
|February 1, 1997
Summary
Disposable sphincterotomes may be safely reused after reprocessing. Ethylene oxide sterilization effectively eliminated bacteria, though some mechanical wear occurred with repeated use.
Area of Science:
- Gastroenterology
- Medical Device Reprocessing
- Infectious Disease Control
Background:
- Disposable sphincterotomes represent a significant cost in high-volume endoscopy units.
- The safety and efficacy of reprocessing single-use sphincterotomes are not well-established.
Purpose of the Study:
- To evaluate the durability, electrical integrity, and cleaning effectiveness of disposable sphincterotomes after simulated reprocessing.
- To assess the potential for safe reuse of these medical devices.
Main Methods:
- Ten disposable sphincterotomes (5F and 6F) were subjected to in vitro testing.
- Devices were contaminated with Mycobacterium chelonei and cleaned manually or with ethylene oxide.
- Durability, electrical integrity, and microbial contamination were assessed after multiple uses.
Main Results:
- Seven of ten sphincterotomes survived repeated use; three 6F devices showed wire fracture between 4-8 uses.
- Electrical integrity was maintained until mechanical failure.
- Ethylene oxide sterilization rendered all instruments sterile, while manual cleaning with glutaraldehyde left residual bacteria in some devices.
Conclusions:
- Disposable sphincterotomes demonstrate potential for safe reuse.
- Ethylene oxide sterilization is effective in eliminating microbial contamination.
- Further investigation into mechanical durability is warranted for specific device types.