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

Safety of plasma-based sterilization: Surface modifications of polymeric medical devices induced... 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. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Bio-Medical Materials and Engineering IOS Press

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

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Publisher
IOS Press
Copyright
Copyright © 2002 by IOS Press, Inc
ISSN
0959-2989
eISSN
1878-3619
Publisher site
See Article on Publisher Site

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.

Journal

Bio-Medical Materials and EngineeringIOS Press

Published: Jan 1, 2002

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