Grimandi G, Sellal O, Grimandi F, Crochet D
Department of Medicochirurgical Supplies, University Hospital, Nantes, France.
Cathet Cardiovasc Diagn. 1996 Jun;38(2):123-30; discussion 131-2. doi: 10.1002/(SICI)1097-0304(199606)38:2<123::AID-CCD1>3.0.CO;2-B.
This experimental study was conducted to evaluate the microbiological and mechanical risks of reusing angioplasty catheters after decontamination and resterilization. The catheters studied were decontaminated in an ultrasound chamber, rinsed, dried, wrapped, and resterilized at 25 or 35 Kgray. Sterility checks performed on catheters cut into three segments concerned bacteria, mushrooms, yeasts, and pyrogens. The surface condition of the balloons was studied by scanning electron microscopy. The mechanical properties analyzed were balloon diameter and bursting pressure and the mean resistance of the catheter body to breakage. Seventy angioplasty catheters of three different types (rapid exchange, coaxial, and on-wire balloon catheter) were tested. Decontamination proved insufficient owing to the persistence of cellular elements on the balloon surface and the presence of pyrogens. Sterility of the material was not ensured with an irradiation of 25 Kgray. It was probable but not certain with 35 Kgray, since an inhibitory effect on micro-organism growth was noted. Mechanical properties were not modified significantly. Our results do not favor the reuse of coronary angioplasty catheters. Better decontamination is desirable but difficult to obtain because of the adhesion of cellular elements to the polymers composing the catheters. Although our results are not necessarily applicable to all resterilization protocols, they indicate that teams desiring to reuse angioplasty material should first test the validity of their procedure for decontamination and resterilization.
本实验研究旨在评估血管成形术导管去污和再灭菌后微生物和机械方面的风险。所研究的导管在超声清洗室进行去污、冲洗、干燥、包装，然后在25或35千戈瑞剂量下进行再灭菌。对切成三段的导管进行的无菌检查涉及细菌、霉菌、酵母和热原。通过扫描电子显微镜研究球囊的表面状况。分析的机械性能包括球囊直径、爆破压力以及导管主体的平均抗破损性。测试了三种不同类型（快速交换型、同轴型和导丝球囊导管）的70根血管成形术导管。由于球囊表面细胞成分的残留和热原的存在，去污被证明是不充分的。25千戈瑞的辐照剂量无法确保材料无菌。35千戈瑞剂量可能有效但不确定，因为观察到对微生物生长有抑制作用。机械性能没有显著改变。我们的结果不支持重复使用冠状动脉血管成形术导管。更好的去污是可取的，但由于细胞成分与构成导管的聚合物的粘附，很难实现。尽管我们的结果不一定适用于所有再灭菌方案，但它们表明，希望重复使用血管成形术材料的团队应首先测试其去污和再灭菌程序的有效性。
