Bathina M N, Mickelsen S, Brooks C, Jaramillo J, Hepton T, Kusumoto F M
Department of Medicine, University of New Mexico Health Sciences Center, Albuquerque, USA.
J Am Coll Cardiol. 1998 Nov;32(5):1384-8. doi: 10.1016/s0735-1097(98)00401-x.
The purpose of this study was to evaluate a new technique for sterilizing nonlumen electrophysiology catheters that uses hydrogen peroxide gas plasma.
The reuse of electrophysiology catheters may potentially result in a significant cost savings. While ethylene oxide sterilization appears to be safe and effective from a clinical standpoint, toxic ethylene oxide residuals, which exceed Food and Drug Administration standards, have been reported.
Ten nonlumen electrophysiology catheters were extensively evaluated. Each catheter was used five times and resterilized after each use with hydrogen peroxide gas plasma. Tests for sterility, mechanical and electrical integrity, chemical residuals and standard and electron microscopic inspection were performed.
Loss of electrical integrity or mechanical integrity was not observed in any catheter. No evidence of microbial contamination was found. Surface integrity was preserved except for one ablation catheter that exhibited fraying of the insulation at the insulation-electrode interface. Surface inspection using standard magnification and electron microscopy revealed no significant change in surface characteristics associated with the sterilization process. Hydrogen peroxide was the only chemical residual noted, with an average concentration of 0.22% by weight, which is within accepted American Association for the Advancement of Medical Instrumentation limits. The cost for a standard electrophysiology catheter ranges from $200 to $800, and one sterilization cycle costs $10. If electrophysiology catheters are used five times, resterilization could potentially result in a savings of $2,000 per catheter, or $9,000 for five ablation procedures.
Hydrogen peroxide gas plasma sterilization may provide a cost-effective means of sterilizing nonlumen electrophysiology catheters without the problem of potentially harmful chemical residuals. However, careful visual inspection of catheters, particularly at the insulation-electrode interface, is required if catheter reuse is performed.
本研究的目的是评估一种使用过氧化氢气体等离子体对非腔内心电生理导管进行消毒的新技术。
心电生理导管的重复使用可能会显著节省成本。虽然从临床角度来看，环氧乙烷消毒似乎是安全有效的，但已报告有毒的环氧乙烷残留量超过了食品药品监督管理局的标准。
对10根非腔内心电生理导管进行了广泛评估。每根导管使用5次，每次使用后用过氧化氢气体等离子体重新消毒。进行了无菌、机械和电气完整性、化学残留以及标准和电子显微镜检查。
在任何导管中均未观察到电气完整性或机械完整性丧失。未发现微生物污染的证据。除一根消融导管在绝缘-电极界面处出现绝缘层磨损外，表面完整性得以保留。使用标准放大倍数和电子显微镜进行的表面检查显示，与消毒过程相关的表面特征没有显著变化。仅检测到过氧化氢为化学残留，平均重量浓度为0.22%，在医疗仪器促进协会认可的限值范围内。一根标准的心电生理导管成本在200美元至800美元之间，一次消毒周期成本为10美元。如果心电生理导管使用5次，重新消毒每根导管可能节省2000美元，或为5次消融手术节省9000美元。
过氧化氢气体等离子体消毒可能为非腔内心电生理导管消毒提供一种具有成本效益的方法，且不存在潜在有害化学残留的问题。然而，如果进行导管重复使用，需要对导管进行仔细的目视检查，尤其是在绝缘-电极界面处。
