Sterile Procedure Pack with ETO Sterilization and Microchip Traceability
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Solution Overview
Problem
Current methods for sterilizing operating room kits are incompatible, requiring separate processes for reusable technical textiles and single-use items, leading to high preparation and supply costs due to the inability to combine steam-sterilized and ethylene oxide-sterilized materials in a single pack.
Innovation Solution
A method involving the use of ethylene oxide gas for sterilizing both reusable technical textiles and single-use items within a controlled environment, ensuring traceability and compatibility, allowing for the creation of a combined sterile procedure pack that includes both types of materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate sterilization processes are used for reusable technical textiles (steam autoclave) and single-use items (ethylene oxide), then each category achieves its required sterility, but the preparation and supply costs increase due to the inability to combine materials in a single pack
Solution Approach 1:
The patent merges previously separate sterilization processes by using ethylene oxide gas sterilization for both reusable technical textiles and single-use items within a single autoclave cycle. This allows multiple product categories to be combined into one sterile pack, eliminating the need for separate preparation and supply chains while maintaining sterility guarantees through validated sterilization parameters and biological indicators.
2Reliability
If steam sterilization is used for reusable technical textiles, then traceability can be guaranteed, but the process is incompatible with ethylene oxide sterilization required for single-use items
Solution Approach 1:
The patent makes the ethylene oxide sterilization process universal by validating it for both reusable technical textiles and single-use items. The autoclave system is configured to handle mixed loads with different material compositions, and traceability is maintained through electronic identification systems that track each item through the unified sterilization process, enabling one sterilization method to serve multiple product categories.
3Reliability
If separate packs are prepared for steam-sterilized and ethylene oxide-sterilized materials, then each pack meets its sterilization requirements, but the supply chain complexity and time consumption increase
Solution Approach 1:
The patent implements preliminary action by pre-configuring the autoclave system to handle mixed sterilization loads and pre-validating the compatibility of different materials within a single ethylene oxide cycle. This allows multiple items to be loaded and sterilized together in advance, eliminating sequential processing steps and reducing overall pack preparation time while ensuring all sterilization requirements are met through pre-established process parameters.
Data Source
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AI summary
A method for the preparation and packaging of a sterile procedure pack or kit for operating room use comprises the following work steps: a) washing and folding of reconditioned reusable technical textile RTT garments and microchip reading and saving of traceability data through appropriate electronic means; and/or a' ) washing and folding of new reusable technical textile RTT garments and microchip association and saving of traceability data through appropriate electronic means; b) provision of a controlled contamination environment for the preparation of a procedure pack or kit for operating room use; c) provision, within the environment referred to in paragraph b), of said reusable technical textile RTT garments equipped with microchips, of further single-use technical textile NWF garments, as well as typical accessories for the operating room, in particular extensions, bowls, caps, scalpels, syringes, needles, tweezers, valves, cotton gauze, etc. d) preparation, packaging and closing of a procedure pack containing the materials or products referred to in paragraph c) within said controlled contamination environment; e) sterilisation of the procedure pack referred to in paragraph d) through treatment with ethylene oxide gas ETO for a predetermined time, at a predetermined temperature, predetermined pressure and predetermined humidity level; f) natural and/or forced evacuation of the ETO sterilising gas from said pack for a predetermined time and control of the potential presence of ETO inside said procedure pack; g) reading via appropriate electronic means of the data contained in the microchip of the RTT material contained inside the pack; h) storage of said pack inside a sterile storage area; i) release of the sterile procedure pack and delivery to users in the operating room; j) collection of the RTT material after use for the appropriate reconditioning process.