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Personal protective equipment (PPE) is unique clothing or equipment worn by an employee to minimize or prevent exposure to infectious agents. PPE creates a barrier between the employee and the infectious materials. PPE must be readily available in the patient care area. PPE includes gloves, gowns and aprons, masks and respirators, goggles, face shields, shoes, and headcovers:
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Electron beam technology for Re-processing of personal protective equipment.

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Summary

Electron beam (eBeam) sterilization is not suitable for reprocessing N95 respirators and medical gowns due to significant mechanical degradation. While face shields showed no damage, the filtration efficiency of N95 respirators decreased, indicating limitations for critical personal protective equipment (PPE).

Keywords:
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Area of Science:

  • Biomedical Engineering
  • Materials Science
  • Infectious Disease Control

Background:

  • The COVID-19 pandemic severely disrupted the supply chain for essential Personal Protective Equipment (PPE), including N95 respirators, surgical masks, and medical gowns.
  • Emerging variants and unpredictable demand necessitate exploring methods for reprocessing used PPE to ensure adequate protection for healthcare personnel.
  • Electron beam (eBeam) sterilization, an FDA-approved technology, is investigated as a potential solution for decontaminating and reusing critical PPE.

Purpose of the Study:

  • To evaluate the efficacy and viability of using FDA-approved electron beam (eBeam) sterilization technology (ISO 11137) for reprocessing used N95 respirators, medical gowns, and face shields.
  • To assess the impact of eBeam irradiation on the surface properties, mechanical integrity, filtration efficiency, and liquid barrier performance of various PPE materials.
  • To determine the maximum permissible radiation dose for reprocessing different types of PPE without compromising their essential protective functions.

Main Methods:

  • N95 respirators, medical gowns (Proxima Sirus), and face shields were subjected to eBeam irradiation in air and argon across a dose range of 0-200 kGy.
  • Post-irradiation, comprehensive testing was conducted, including surface property analysis, mechanical property evaluation, filtration efficiency measurements, and liquid barrier performance tests.
  • Specific tests included assessing discoloration, mechanical degradation after multiple donning/doffing cycles for face shields, and filtration efficiency reduction in N95 respirators.

Main Results:

  • N95 respirators experienced a significant reduction in filtration efficiency to approximately 63.6%, although charge regeneration might offer potential for recovery.
  • Proxima Sirus medical gowns exhibited mechanical degradation that increased with radiation dose, becoming significant above 25 kGy.
  • Face shields demonstrated no mechanical degradation after 10 donning and doffing cycles, but N95 respirators and gowns showed substantial mechanical weakening at sterilization doses (>25 kGy).

Conclusions:

  • Electron beam (eBeam) sterilization is not suitable for reprocessing N95 respirators and Proxima Sirus medical gowns due to unacceptable levels of mechanical degradation and reduced filtration efficiency.
  • While face shields appear resilient to eBeam reprocessing, the material integrity issues with respirators and gowns preclude their reuse via this method.
  • Further research into charge regeneration for N95 respirators is warranted, but overall, eBeam technology presents significant limitations for reprocessing critical PPE during health emergencies.