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Risks of reusing coronary angioplasty catheters: Results of an experimental study

✍ Scribed by Grimandi, Gael ;Sellal, Olivier ;Grimandi, Florence ;Crochet, Dominique


Publisher
John Wiley and Sons
Year
1996
Tongue
English
Weight
831 KB
Volume
38
Category
Article
ISSN
0098-6569

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✦ Synopsis


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 dlameter 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 persistance 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 microorganism 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. c 19% Wiley-Liss.


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titate the amount of pyrogen present in this setting. Of greatest importance is an evaluation of how much pyrogen is present, rather than its absolute presence or absence. Acceptable levels of pyrogen in medical devices have been defined. According to United States Pharmacopeia guidelines, catheters