[Study of the deadlines for the use after sterilization of hot-sealable bags and sheaths]

Abstract

Introduction: The choice of packaging is crucial for the sterility of a reusable medical device. The use-by dates for sterile barrier systems (SBSs) are currently determined solely on the basis of an empirical rating scale developed in 1985. The objective of our work is to validate in a scientific way this deadline for the use of SBS for heat-sealable sleeves and bags, with protective packaging.

Materials and methods: Thirty SBSs were tested after different storage periods ; six, nine and twelve months. They contained five different types of medical devices, followed the different sterilization steps and were stored in the operating room. The SBSs have or have not been folded in order to analyze this practice in our unit as well. Various tests were carried out on the paper side of the SBS, the plastic side and the welds.

Results: After 6 months of storage, SBS are still sterile. After 9 and 12 months, the results are more moderate. Folding the SBS will affect the weld, regardless of the storage time.

Discussion: This study allowed us to extend all our expiration dates up to 6 months, to stop the habit of folding the SBS and to become aware of the importance of having a size of SBS adapted to the different devices to be packaged and lastly, to protect the ends.

Conclusion: Each sterilization unit must carry out its own study and risk analysis because the determination of shelf life periods depends on many factors.

Keywords: Emballage; Expiration; Packaging; Péremption; Sterile barrier system; Sterilization; Stérilisation; Système barrière stérile.