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Oxidation and oxidation potential in contemporary packaging for polyethylene total joint replacement components
Luigi Costa1, Pierangiola Bracco, Elena Maria Brach del Prever
1Department of I.F.M. Chemistry and NIS Center of Excellence, University of Turin, Via Giuria 7, 10125 Italy.
Journal of Biomedical Materials Research. Part B, Applied Biomaterials
|February 14, 2006
Summary
Packaging significantly impacts the chemical stability of medical-grade polyethylene (PE) components. Gamma-sterilized PE in certain polymer-barrier packaging shows higher oxidation and hydroperoxide levels.
Area of Science:
- Orthopedic biomaterials science
- Polymer chemistry
- Medical device packaging
Background:
- Clinical use of polyethylene (PE) components requires assessment of their chemical stability.
- Sterilization methods and packaging materials can influence PE degradation.
Purpose of the Study:
- To analyze the chemical stability of conventional and highly crosslinked polyethylene (PE) components used clinically in Italy.
- To investigate the impact of packaging on PE component degradation post-sterilization.
Main Methods:
- Fourier-transform infrared spectroscopy (FTIR) was used to characterize hydroperoxide, oxidation, and trans-vinylene levels.
- 100 sterilized PE components from 18 orthopedic manufacturers were analyzed.
Main Results:
- Gas-sterilized PE components showed no detectable free radicals, hydroperoxide, or oxidation.
- Radiation-sterilized PE components exhibited higher oxidation and hydroperoxide levels when packaged in gas-permeable and polymer-barrier materials.
Conclusions:
- The study identifies a link between specific polymeric barrier packaging and increased oxidation/hydroperoxide content in gamma-sterilized PE components.
- Packaging choice is critical for maintaining the chemical integrity of radiation-sterilized polyethylene implants.