Lerouge S, Guignot C, Tabrizian M, Ferrier D, Yagoubi N, Yahia L
Biomedical Engineering Institute, Ecole Polytechnique, PO Box 6079, Montréal, Quebec H3C 3A7, Canada.
J Biomed Mater Res. 2000 Dec 15;52(4):774-82. doi: 10.1002/1097-4636(20001215)52:4<774::aid-jbm23>3.0.co;2-o.
Plasma-based sterilization is a promising alternative to ethylene oxide (EO) for reprocessing of electrophysiology catheters. To assess its safety in terms of material damage, modifications of surface and bulk properties as well as hydrolytic stability of sterilized catheters were evaluated. Polyurethane (PU) single-use electrophysiology catheters were subjected to one, five, and ten sterilization cycles by Sterrad-100S and Plazlyte, as well as by pure EO for comparison. Surface analysis techniques (ATR-FTIR, XPS, DCA) showed oxidation limited to the near-surface layer induced by both plasma-based sterilizers, whereas EO induced slight but deeper alkylation. Using bulk analysis techniques (RP-HPLC, SEC), oligomer alteration was observed after all three sterilization techniques, without modification of molecular weights. Hydrolytic stability of catheters was slightly changed by plasma-based sterilization, with a small increase in released oligomers. Finally, although Plazlyte and Sterrad are both plasma-based techniques, they induced different impacts on catheters, such as the degradation of an additive with Sterrad, and a clear difference in coloration with Plazlyte.
基于等离子体的灭菌是用于电生理导管再处理的环氧乙烷（EO）的一种有前景的替代方法。为了评估其在材料损伤方面的安全性，对灭菌导管的表面和本体性能的改变以及水解稳定性进行了评估。将聚氨酯（PU）一次性使用的电生理导管通过Sterrad - 100S和Plazlyte进行一、五和十次灭菌循环，以及通过纯EO进行灭菌以作比较。表面分析技术（衰减全反射傅里叶变换红外光谱法、X射线光电子能谱、动态接触角）表明，两种基于等离子体的灭菌器诱导的氧化仅限于近表面层，而EO诱导了轻微但更深的烷基化。使用本体分析技术（反相高效液相色谱法、尺寸排阻色谱法），在所有三种灭菌技术后均观察到低聚物的改变，但分子量未发生变化。基于等离子体的灭菌使导管的水解稳定性略有改变，释放的低聚物略有增加。最后，尽管Plazlyte和Sterrad都是基于等离子体的技术，但它们对导管产生了不同的影响，例如Sterrad使一种添加剂降解，而Plazlyte使颜色有明显差异。
