Biological Indicator Ports for Liquid-Chemical Sterility Testing
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Solution Overview
Problem
Existing biological indicators for vapor-based sterilization are not suitable for liquid-chemical sterilization processes, as they do not effectively assess the sterility of endoscopes with lumens, and require user intervention to handle residual liquid sterilant, posing safety risks.
Innovation Solution
A biological indicator system with integrated ports, valves, and a carrier for liquid-chemical sterilization, allowing automated fluid management and detection of sterility through fluorescence changes without user intervention, using a liquid-chemical sterilization system with integrated incubation and reading capabilities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If vapor-based sterilization indicators are used for liquid-chemical sterilization, then the indicator structure remains simple, but the reliability of sterility assessment deteriorates
Solution Approach 1:
The biological indicator is divided into separate functional components: a vial containing the biological indicator material, a cap with ports and valves, and a holder for positioning. This segmentation allows each component to be optimized for its specific function while maintaining overall reliability.
Solution Approach 2:
A carrier material is introduced as an intermediary between the liquid sterilant and the biological indicator. The carrier absorbs the liquid sterilant and delivers it to the biological indicator material, ensuring reliable contact and sterility assessment while protecting the indicator from direct exposure to harsh chemicals.
2Object-affected harmful factors
If manual handling of biological indicators is required, then the device structure remains simple, but safety risks increase due to user intervention with residual liquid sterilant
Solution Approach 1:
The biological indicator system is designed to be self-contained and self-processing. The integrated ports and valves allow automated fluid delivery and extraction without requiring user intervention. The system handles its own sterilant exposure and processing, eliminating safety risks associated with manual handling.
Solution Approach 2:
The biological indicator material is extracted from direct contact with the liquid sterilant through the use of a carrier material and controlled port/valve systems. The sterilant is delivered through the carrier rather than directly to the indicator, and the entire process is automated, removing the user from the harmful environment.
3Measurement precision
If existing biological indicators are used without modification, then manufacturing remains simple, but the ability to assess deep lumen sterility deteriorates
Solution Approach 1:
The biological indicator system is designed with multi-functionality to address various sterilization challenges. The same indicator can assess sterility in different locations including deep lumens, and the system can handle both liquid and vapor sterilization methods. This universal design improves measurement precision without requiring multiple specialized indicators.
Solution Approach 2:
The indicator system transitions from a single-point measurement to a multi-dimensional assessment capability. By incorporating ports, valves, and carrier materials, the system can deliver sterilant to multiple locations and assess sterility in deep lumens, adding spatial dimensionality to the measurement process.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Ensures reliable assessment of endoscope sterility in liquid-chemical sterilization processes, reducing safety risks and improving efficiency by automating the process and providing real-time sterility assurance.
Implementation Method 1
detection of sterility through fluorescence changes
Data Source
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AI summary
Disclosed herein are biological indicators suitable for use in a liquid-chemical sterilization process that may be conducted by an automated endoscope reprocessor. The biological indicator may include one or more ports for introducing and removing a liquid-chemical sterilant therefrom. The biological indicators may include features, such as a declivity leading to a port opening or a pipette, that may assist in transferring the liquid-chemical sterilant. The system may additionally include a holder having features that facilitate use of the system and biological indicators.