title: Efficiency in endotoxin removal by a reprocessing protocol for electrophysiology catheters based on hydrogen peroxide plasma sterilization.
abstract: Electrophysiology and ablation cardiac catheters, which come in contact with blood during clinical use, are required to be non-pyrogenic (<20 endotoxin units (EU)/device). This study aimed to quantify the residual endotoxin load in reprocessed devices as a mandatory step to guarantee safe reuse. We monitored the pyrogenic status of the device (n=61) in three fundamental steps of the reprocessing protocol: after clinical use, after decontamination-cleaning treatments and after complete reprocessing, including sterilization by hydrogen peroxide gas plasma. Finally, a depyrogenation test was produced for evaluating the depyrogenation efficiency of the sole hydrogen peroxide sterilization treatment. Results showed that standard clinical use did not represent a source for endotoxin contamination, while the use of tap water and manual cleaning processing could increase the pyrogenic load in a significant way. The introduction of the sterilization by hydrogen peroxide gas plasma resulted in effective reduction of the endotoxin contamination and in safe reprocessing of 15 of 15 clinically used catheters. In addition, tests conducted on in vitro spiked catheters showed that initial pyrogenic loads of 40, 80, 200EU/device were reduced to less than 11EU/device. Depyrogenation testing demonstrated efficiency in endotoxin reduction of more than 62 times (1.8log). These results show the determining role of hydrogen peroxide gas-plasma sterilization in the reduction of pyrogenic load on medical devices. Considering actual hygienic requirements at single-use device reprocessing, hydrogen peroxide gas-plasma sterilization can be considered as an efficient treatment at non-lumen cardiac electrophysiology catheter reprocessing.
authors.affiliation: Department of Materials Engineering and Industrial Technologies, University of Trento,Via Mesiano 77, 38050 Trento, Italy. tessaro@science.unitn.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Tessarolo
authors.forename: Iole
authors.initials: I
authors.lastname: Caola
authors.forename: Giandomenico
authors.initials: G
authors.lastname: Nollo
authors.forename: Renzo
authors.initials: R
authors.lastname: Antolini
authors.forename: Giovanni M
authors.initials: GM
authors.lastname: Guarrera
authors.forename: Patrizio
authors.initials: P
authors.lastname: Caciagli
mesh_terms: D000891:Anti-Infective Agents, Local / Q000494:pharmacology*; D006328:Cardiac Catheterization / Q000295:instrumentation*; D002713:Chlorine / Q000494:pharmacology; D003666:Decontamination / Q000379:methods; D004594:Electrophysiology / Q000295:instrumentation*; D004731:Endotoxins / Q000032:analysis*; D017743:Equipment Reuse; D006801:Humans; D006861:Hydrogen Peroxide / Q000494:pharmacology*; D013242:Sterilization / Q000295:instrumentation / Q000379:methods*
chemical_list: D000891:Anti-Infective Agents, Local; D004731:Endotoxins; D002713:Chlorine; D006861:Hydrogen Peroxide