Dulière BenoîtAnrys PaulineBlaise DelhauteurDelfosse, SarahSarahDelfosse2025-05-142025-05-142025-05-142024https://hdl.handle.net/2078.2/41099Determining the shelf life (SL) of medical devices (MD) is a critical aspect in the management of a centralized sterilization unit. This aspect relies on various factors, including the Sterile Barrier System (SBS) and the conditions during transport and storage. The main objective is validation of SL extension of various SBS under usual transport and storage conditions post-sterilization. The financial objective is assessment of the costs associated with resterilizing expired SBS’s versus the costs associated with leading this study. The final objective evaluates current practices in Belgian hospitals: applied SL and validation method used. This study involves 147 MD’s packed in 3 different SBS, sterilized, transported, and stocked. “THE WORST CASE" approach is used at each step to allow results’ extrapolation. Analyses conducted at 0, 3, 6, and 12 months include sterility, leak, air permeability and assessments of opening resistance. The cost comparison is evaluated based on DIN dimensions in SLBO. A survey is conducted through the Forms® and is sent to the Association of French speaking Belgian Hospital Pharmacists. After 12 months, one sample was non-compliant: Bacillus cereus, was taken in SBS Ultra® stored under non-ISO conditions. The study’s financial investment amounted to €8,367while the costs of resterilizing SBS’s that have exceeded their SL was of 151 906 € in 2023. Twelve hospitals completed the survey: SL is established on an empiric rating system combined with a risk analysis (33%) or the continuation of unknown customary practices (25%). SL of sterile status is mainly 6 months. This study suggests validation of 3 SBS to 6 months, given current storage conditions not meeting CSS recommendations, in a non-ISO environment at SLBO (loss of €48,371). This challenges the company's recommendation of a 12-month SL for their Ultra®. A new sterile storage area meeting these standards would extend SL of all SBS to 12 months, resulting in significant economic benefits. Given the absence of a defined universal method for determining SL, this study proposes a standardized protocol.StérilisationDate limite d'utilisationStockageSystème de barrière stérileEmballageConditionnementtext::thesis::master thesisthesis:46322