Safety of plasma‐based sterilization: Surface modifications of polymeric medical devices induced by Sterrad^® and Plazlyte™ processes

Article type: Research Article

Authors: Lerouge, S. | Tabrizian, M. | Wertheimer, M.R. | Marchand, R. | Yahia, L'H.^;

Affiliations: Biomedical Engineering Institute, École Polytechnique, Station “Centre‐Ville”, PO Box 6079, Montreal, Quebec H3C 3A7, Canada | Department of Engineering Physics and Materials Engineering, École Polytechnique, Station “Centre‐Ville”, PO Box 6079, Montreal, Quebec H3C 3A7, Canada | Montreal Heart Institute, 5000 Belanger, Montreal, Quebec H1T 1C8, Canada

Note: [] Corresponding author: L'Hocine Yahia, Biomedical Engineering Institute, École Polytechnique, Station “Centre Ville”, PO Box 6079, Montreal, Quebec H3C 3A7, Canada. Tel.: +1 514 340 4711, ext. 4378; Fax: +1 514 340 4611; E‐mail: [email protected].

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.

Keywords: Plasma‐based sterilization, safety, polymer‐based medical device, surface modification, oxidation

Journal: Bio-Medical Materials and Engineering, vol. 12, no. 1, pp. 3-13, 2002