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

Abstract

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 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. © 1996 Wiley‐Liss, Inc.

Is it possible to re-use mini-implants for orthodontic anchorage? Results of an in vitro study

“…However, economic factors have caused some clinicians to re-use implants or other medical devices that are meant to be disposable, like pacemakers, intra-aortic balloons, haemodialysis membranes, coronary angioplasty catheters and orthodontic brackets and wires [8][9][10] . In case of re-use, it is mandatory to ensure the sterility and mechanical qualities of the device 11 . Not all implants can be re-used, but metal implants, like those made from titanium may be more amenable to re-use because they can be mechanically and chemically cleaned and re-sterilized with potentially little or no loss of form or function 8 .…”

Functional properties and performance of new and reprocessed coronary angioplasty balloon catheters

“…Although safeness and effectiveness of reused angioplasty catheters are debated,8–12 the practice of their reprocessing is actually of large extent in western countries 13, 14. To assure the safety of restored devices, the conformity to the intended use, and the equivalence of performance between new and reprocessed devices, both hygienic and technical requirements must be satisfied 5, 15–17. Possible modifications of catheter materials and functional properties that might occur during decontamination and cleaning with chemical aggressive agents or during sterilization must be carefully examined 18.…”

Aufbereitung und Wiederverwendung medizinischer Einmalprodukte in der Radiologie

“…Trotz Dekontamination und Resterilisierung können allerdings organisches Material und Pyrogene auf der Oberfläche von Ballons zurückbleiben. Den Beweis dafür haben u. a. Untersuchungen mit dem Scanner-ElektronenMikroskop geliefert [13,14]. Auch das Risiko der Virusübertra-gung ist nicht zu vernachlässigen.…”