We sought to evaluate the performance of angioplasty catheters, restored under a strict manufacturing process, in patients with coronary artery disease.
Most countries outside the United States routinely reuse disposable medical equipment, resulting in significant cost savings.
Because of quality and legal concerns, reuse in the United States has been limited.
We investigated the reuse of percutaneous transluminal coronary angioplasty (PTCA) balloon catheters, restored by a process strictly controlled for bioburden and sterility, in patients undergoing PTCA.
Used PTCA balloon catheters were shipped to a central facility and were decontaminated, cleaned and tested for endotoxin using the limulus amebocyte lystate (LAL) gel clot method.
Physical testing and quality assurance were performed.
The products were packaged and sterilized with ethylene oxide.
Catheter performance was assessed in a pilot study powered to detect a 5% difference in the angiographic failure rates of new and reused balloons (beta 0.8).
The study enrolled 107 patients.
The indication for PTCA was stable angina pectoris in 69 patients, unstable angina in 22 and acute myocardial infarction in 16.
Of the 107 patients enrolled, 106 had a successful laboratory outcome, and 1 required coronary artery bypass graft surgery after failed rescue stenting. (...)
Mots-clés Pascal : Dilatation instrumentale, Artère coronaire, Cathéter, Réutilisation, Etats Unis, Amérique du Nord, Amérique, Analyse coût, Economie santé, Traitement, Pronostic, Homme, Traitement instrumental
Mots-clés Pascal anglais : Instrumental dilatation, Coronary artery, Catheter, Reuse, United States, North America, America, Cost analysis, Health economy, Treatment, Prognosis, Human, Instrumentation therapy
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0033451
Code Inist : 002B26E. Création : 17/04/1998.