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[Reevaluating the shelf life of sterilized packaged items via a risk-analysis study].

L Tourvieilhe1, A Guillermet1, H Hida1

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PubMed
Summary

Reprocessed reusable medical devices (RMD) shelf life was reevaluated. A risk analysis identified packaging, transport, and storage issues, extending RMD shelf life to 6 months for containers and 4 months for pouches.

Keywords:
Analyse de risquesDurée de péremptionRisk analysisShelf lifeSterilizationStérilisation

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Area of Science:

  • Healthcare
  • Medical Device Reprocessing
  • Sterilization Assurance

Background:

  • Reprocessed reusable medical devices (RMD) are typically assigned a 3-month expiration after packaging.
  • Current practices for RMD packaging, transport, and storage may impact their long-term sterility.
  • A comprehensive risk analysis is needed to validate the existing shelf life.

Purpose of the Study:

  • To reevaluate the shelf life of reprocessed reusable medical devices (RMD).
  • To identify critical control points in the RMD lifecycle that could compromise sterility.
  • To implement evidence-based recommendations for extending RMD shelf life.

Main Methods:

  • A risk-analysis study was conducted using the French National Authority for Health template.
  • Evaluation of packaging, transportation, and storage conditions for RMD across 52 wards in ten healthcare facilities.
  • Prioritization of identified risks into non-critical, track, and priority management categories.

Main Results:

  • While pouch integrity was generally maintained, 85% of RMD were stored in dedicated units, 58% were observed closed, and 81% were stacked.
  • 36% of storage units contained expired RMD, indicating potential issues with adherence to current shelf life.
  • Key risks identified included RMD damage during transport and storage conditions affecting packaging integrity.

Conclusions:

  • Current storage and transport practices present risks to RMD sterility, necessitating improved control measures.
  • The study supports extending the shelf life of reprocessed RMD to 6 months for containers and 4 months for other pouches.
  • Enhanced understanding and control of the RMD circuit can optimize reprocessing and extend device usability.