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Methods of Sterilization I: Physical Methods01:29

Methods of Sterilization I: Physical Methods

As used in a healthcare facility, sterilization destroys all microorganisms through physical or chemical methods. The physical method includes steam, dry heat, boiling water, and radiation.
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In healthcare, the chemical method of sterilization uses chemical sterilants to treat surgical instruments and medical supplies to help prevent the transmission of infectious pathogens to patients. Due to heat sensitivity, most medical supplies and equipment should not be exposed to high temperatures. These parts include rubber, plastic, glass, and other similar elements.
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Gamma-irradiation sterilization in an inert environment: a partial solution.

Daniel J Berry1, Barbara H Currier, Michael B Mayor

  • 1Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, USA.

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Gamma-inert sterilization prevented shelf oxidation but not in vivo oxidation in UHMWPE tibial inserts. Fatigue damage increased with in vivo oxidation, becoming more likely after 11-14 years, especially in active patients.

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Area of Science:

  • Biomaterials science
  • Orthopedic surgery
  • Materials engineering

Background:

  • Manufacturers shifted from gamma-air to gamma-inert sterilization for UHMWPE bearings to reduce oxidation and fatigue.
  • Gamma-inert sterilization aimed to prevent pre-implantation oxidation but did not eliminate in vivo oxidation.

Purpose of the Study:

  • To determine if gamma-inert sterilization prevented shelf oxidation leading to early fatigue in gamma-air-sterilized tibial inserts.
  • To assess if gamma-inert sterilization prevented fatigue caused by in vivo oxidation.

Main Methods:

  • Retrieved 183 gamma-air and 175 gamma-inert sterilized tibial inserts for fatigue damage assessment.
  • Analyzed 132 gamma-air and 174 gamma-inert inserts for oxidation using Fourier transform infrared spectroscopy.

Main Results:

  • Shelf-aged gamma-air inserts showed decreased mechanical properties due to oxidation.
  • Gamma-inert inserts with barrier packaging avoided shelf oxidation.
  • Both gamma-air and gamma-inert inserts oxidized in vivo, with increased fatigue damage correlating with longer implantation times, higher oxidation levels, and more use cycles.

Conclusions:

  • Published projections indicate gamma-inert inserts may reach critical oxidation levels for fatigue onset between 11-14 years post-implantation.
  • Observed retrieval data align with oxidation projections.
  • Increased oxidation directly correlates with a higher frequency of fatigue damage in UHMWPE tibial inserts.