Baker K H, Chaput M P, Clavet C R, Varney G W, To T M, Lytle C D
U.S. Food and Drug Administration Center for Devices and Radiological Health, Rockville, Maryland 20852, USA.
Laryngoscope. 1999 Apr;109(4):636-9. doi: 10.1097/00005537-199904000-00022.
Evaluate ENT endoscope sheaths as barriers to virus passage.
"Defective" sheaths covering an endoscope were challenged with virus to determine how many virus particles could be recovered from the endoscope.
Sheaths with small laser-drilled holes (2 to 30 microm) were challenged with high-titer virus suspensions (10(8) viruses/mL). The inside of the sheath and the endoscope were separately rinsed to recover any virus that penetrated through the hole in the sheath. In an attempt to assess the possible importance of holes in the sheaths, a sequential test was conducted with an initial virus challenge outside a defective sheath (30-micron hole in the sheath), after which the possibly contaminated endoscope was removed and inserted into a second defective sheath (with a 20-micron hole at the same location) to determine whether the contaminating virus would pass outward through the second sheath.
Small volumes of virus-containing fluid penetrated through the hole, e.g., 500 virus particles passed through one of three 30-microm holes. A significant fraction of those virus particles was occasionally found on the endoscope after removal from the sheath. Similar results were obtained with sheaths that had small tears (34-84 microm in length, from punctures with fine wires). Although some virus penetration could occur during the initial challenge contaminating the endoscope, no virus was detected passing outward through the second sheath.
Use of a sheath combined with intermediate level disinfection should provide a safe instrument for ENT endoscopy.
评估耳鼻喉科内窥镜护套作为病毒传播屏障的效果。
用病毒攻击覆盖在内窥镜上的“有缺陷”护套,以确定能从内窥镜上回收多少病毒颗粒。
用高滴度病毒悬液(10⁸病毒/毫升)攻击带有小激光钻孔(2至30微米)的护套。分别冲洗护套内部和内窥镜,以回收任何穿过护套上孔的病毒。为了评估护套上孔的可能重要性,进行了一项序贯试验,首先在有缺陷的护套(护套上有30微米的孔)外进行病毒攻击,之后取出可能被污染的内窥镜并插入第二个有缺陷的护套(在同一位置有20微米的孔),以确定污染病毒是否会向外穿过第二个护套。
少量含病毒液体穿过孔,例如,500个病毒颗粒穿过三个30微米孔中的一个。从护套中取出后,在内窥镜上偶尔会发现相当一部分这些病毒颗粒。对于有小裂口(长度为34 - 84微米,由细金属丝穿刺造成)的护套也得到了类似结果。尽管在最初攻击污染内窥镜期间可能会发生一些病毒穿透,但未检测到病毒向外穿过第二个护套。
使用护套并结合中等水平消毒应为耳鼻喉科内窥镜检查提供一种安全的器械。