title: Safety of plasma-based sterilization: surface modifications of polymeric medical devices induced by Sterrad and Plazlyte processes.
abstract: Plasma-based sterilization is a promising alternative to the use of pure ethylene oxide (EO), for low-temperature clinical sterilization of medical instruments and devices. However, few studies have been published that evaluate its safety in terms of possible damage to materials, particularly polymers. The objective of this work was to evaluate polymer surface modifications induced by commercial plasma-based sterilizers, in comparison with pure EO: Samples from 5 polymer-based devices were subjected to 1, 5, and 10 sterilization cycles by Sterrad-100, Plazlyte, and pure EO. Surface analysis was carried out by X-ray photoelectron spectroscopy (XPS), dynamic contact angle measurements (DCA), and scanning electron microscopy (SEM). Surface oxidation and wettability changes were observed on all samples sterilized by plasma-based techniques, the degree of modifications depending on the sterilizer (Sterrad, Plazlyte) and the type of polymer. Drastic changes of surface appearance were also observed by SEM on PVC samples sterilized by Plazlyte and by pure EO. Possible repercussions on safety are discussed.
authors.affiliation: Biomedical Engineering Institute, Ecole Polytechnique, Station "Centre-Ville", PO Box 6079, Montreal, Quebec H3C 3A7, Canada.
authors.forename: S
authors.initials: S
authors.lastname: Lerouge
authors.forename: M
authors.initials: M
authors.lastname: Tabrizian
authors.forename: M R
authors.initials: MR
authors.lastname: Wertheimer
authors.forename: R
authors.initials: R
authors.lastname: Marchand
authors.forename: L'H
authors.initials: L
authors.lastname: Yahia
mesh_terms: D000327:Adsorption; D001792:Blood Platelets / Q000378:metabolism; D002404:Catheterization; D004202:Disinfectants; D004577:Electron Probe Microanalysis; D017743:Equipment Reuse; D005027:Ethylene Oxide / Q000737:chemistry*; D006801:Humans; D008422:Materials Testing; D008855:Microscopy, Electron, Scanning; D010100:Oxygen / Q000378:metabolism; D010949:Plasma / Q000378:metabolism; D011108:Polymers / Q000737:chemistry*; D011140:Polyurethanes / Q000737:chemistry*; D011143:Polyvinyl Chloride / Q000737:chemistry; D013242:Sterilization / Q000295:instrumentation / Q000379:methods*; D013499:Surface Properties
chemical_list: D004202:Disinfectants; D011108:Polymers; D011140:Polyurethanes; D011143:Polyvinyl Chloride; D005027:Ethylene Oxide; D010100:Oxygen