一次性使用括约肌切开刀金属丝完整性及再处理能力的体外评估

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

作者信息

Kozarek R A, Sumida S E, Raltz S L, Merriam L D, Irizarry D C

机构信息

Section of Gastroenterology, Virginia Mason Medical Center, Seattle 98111, USA.

出版信息

Gastrointest Endosc. 1997 Feb;45(2):117-21. doi: 10.1016/s0016-5107(97)70232-3.

DOI:10.1016/s0016-5107(97)70232-3

PMID:9040994

Abstract

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 all 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.

摘要

背景

目前，括约肌切开刀作为一次性使用物品销售，在繁忙的内镜检查科室构成了相当大的累积费用。尚不确定这些附件在不失其形状和功能的情况下能否安全地重新处理。

方法

我们对一次性使用的括约肌切开刀（五把5F、五把6F）进行了体外研究，观察其耐用性、电气完整性以及在被10⁵至10⁶龟分枝杆菌污染后手动和用环氧乙烷充分清洁的能力。

结果

10把括约肌切开刀中有7把经受住了重复使用的考验；三把6F括约肌切开刀在使用四至八次后出现导线断裂。通过电外科分析仪测量，所有括约肌切开刀在断裂前电气完整性均保持完好。手动清洁后用戊二醛浸泡，五把6F括约肌切开刀和一把5F括约肌切开刀中出现了残留的分枝杆菌菌落。手动清洁和环氧乙烷灭菌后，没有器械培养出残留微生物。