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Related Experiment Videos

Plasma-based sterilization: effect on surface and bulk properties and hydrolytic stability of reprocessed

S Lerouge1, C Guignot, M Tabrizian

  • 1Biomedical Engineering Institute, Ecole Polytechnique, PO Box 6079, Montréal, Quebec H3C 3A7, Canada.

Journal of Biomedical Materials Research
|October 18, 2000
PubMed
Summary
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Plasma sterilization offers a safe alternative for reprocessing electrophysiology catheters, showing minimal material damage compared to ethylene oxide (EO). Both plasma methods and EO caused minor surface and bulk changes, with slight impacts on hydrolytic stability.

Area of Science:

  • Biomaterials Science
  • Medical Device Reprocessing
  • Sterilization Technologies

Background:

  • Ethylene oxide (EO) sterilization is standard for electrophysiology catheters but raises safety concerns.
  • Plasma-based sterilization presents a promising, potentially safer alternative.
  • Evaluating material integrity after sterilization is crucial for device safety and efficacy.

Purpose of the Study:

  • To assess the safety of plasma-based sterilization methods (Sterrad-100S, Plazlyte) for polyurethane (PU) electrophysiology catheters.
  • To compare the effects of plasma sterilization with conventional ethylene oxide (EO) sterilization on catheter material properties.
  • To evaluate modifications in surface, bulk properties, and hydrolytic stability of catheters after multiple sterilization cycles.

Main Methods:

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  • Polyurethane (PU) electrophysiology catheters were subjected to 1, 5, and 10 sterilization cycles using Sterrad-100S, Plazlyte, and ethylene oxide (EO).
  • Surface properties were analyzed using Attenuated Total Reflectance Fourier-Transform Infrared Spectroscopy (ATR-FTIR), X-ray Photoelectron Spectroscopy (XPS), and Differential Scanning Calorimetry (DSC).
  • Bulk properties and hydrolytic stability were assessed via Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC), Size Exclusion Chromatography (SEC), and analysis of released oligomers.

Main Results:

  • Plasma sterilization induced near-surface oxidation, while EO caused slight, deeper alkylation.
  • Oligomer alteration was observed across all sterilization methods, but molecular weights remained unchanged.
  • Plasma sterilization slightly affected hydrolytic stability, increasing released oligomers.
  • Sterrad and Plazlyte exhibited distinct impacts, including additive degradation (Sterrad) and coloration changes (Plazlyte).

Conclusions:

  • Plasma-based sterilization is a viable alternative to EO for electrophysiology catheters, causing limited material damage.
  • While both plasma methods and EO alter catheter properties, the changes are generally minor and confined to the surface or oligomers.
  • Differences exist between plasma sterilization systems, necessitating specific evaluations for each technology.