Lee R M, Vida F, Kozarek R A, Raltz S L, Ball T J, Patterson D J, Brandabur J J, Gluck M, Tomas A, Sumida S E, Irizarry D, Jane C
Department of Internal Medicine, Section of Gastroenterology, Department of Microbiology, Department of Biomedical Engineering, Virginia Mason Medical Center, Seattle, Washington, USA.
Gastrointest Endosc. 1999 Apr;49(4 Pt 1):477-82. doi: 10.1016/s0016-5107(99)70046-5.
To date, one reusable, double-channel sphincterotome has been approved by the Food and Drug Administration in the United States. Whether this device can be reprocessed easily and whether it is more durable than currently manufactured disposable sphincterotomes are uncertain.
Thirty double-channel, 20 mm, braided-wire sphincterotomes approved for multiple uses were studied in vitro/in vivo with regard to durability and sterilization. A cost analysis of reusable, disposable, and reprocessed disposable sphincterotomes was also carried out.
Three of 10 sphincterotomes evaluated in vitro broke after 3, 4, and 8 uses. Electrical integrity was preserved after 10 uses in the remaining sphincterotomes. Nine sphincterotomes remained functional for at least 3 uses, five for 6 uses, and one for 10 uses. Culture results after inoculation demonstrated contamination with surviving organisms after manual cleaning and no growth after ethylene oxide sterilization. Sixty-one procedures were performed in vivo using 20 sphincterotomes (mean number of uses 3.1). No evidence of procedurally related infection occurred with reuse. Cost per use of this reusable sphincterotome was calculated to be $62.98; it became cost effective after 2.2 and 7.9 uses when compared with disposable and reprocessed, disposable sphincterotomes, respectively.
This reusable sphincterotome proved to be safe, easily sterilized, and electrically intact after repeated use. In vivo, however, a progressive loss of function limited the mean number of uses to 3.1. In settings that preclude reuse of reprocessed disposable accessories, this reusable sphincterotome may provide a means to decrease costs associated with endoscopic retrograde cholangiopancreatography.
迄今为止，美国食品药品监督管理局已批准一种可重复使用的双通道括约肌切开刀。该设备是否易于再处理，以及是否比目前生产的一次性括约肌切开刀更耐用尚不确定。
对30把经批准可多次使用的20毫米双通道编织线括约肌切开刀进行了体外/体内耐久性和灭菌研究。还对可重复使用、一次性使用和再处理的一次性括约肌切开刀进行了成本分析。
在体外评估的10把括约肌切开刀中，有3把在使用3次、4次和8次后损坏。其余括约肌切开刀在使用10次后仍保持电气完整性。9把括约肌切开刀至少可使用3次，5把可使用6次，1把可使用10次。接种后的培养结果显示，手工清洁后有存活微生物污染，环氧乙烷灭菌后无生长。使用20把括约肌切开刀进行了61例体内手术（平均使用次数3.1次）。重复使用未出现与手术相关的感染迹象。这种可重复使用的括约肌切开刀每次使用成本计算为62.98美元；与一次性和再处理的一次性括约肌切开刀相比，分别在使用2.2次和7.9次后具有成本效益。
这种可重复使用的括约肌切开刀经反复使用后证明是安全的，易于灭菌，且电气性能完好。然而，在体内，功能的逐渐丧失将平均使用次数限制在3.1次。在不允许重复使用再处理的一次性附件的情况下，这种可重复使用的括约肌切开刀可能提供一种降低与内镜逆行胰胆管造影相关成本的方法。
