Composite Contamination Model for Surgical Instrument Cleaning Evaluation
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Solution Overview
Problem
Conventional contamination models for evaluating cleaning of medical instruments contaminated with blood and tissue components are inadequate as they either lack blood or tissue components, or are too simplistic, failing to accurately represent the difficulty of removing actual surgical contaminants.
Innovation Solution
A contamination model comprising an extracellular matrix component and hemoglobin, which mimics the adherence of blood and tissue components to medical instruments, allowing for adjustable difficulty levels in cleaning by varying the concentration of the extracellular matrix component and treating with disinfectants.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a contamination model containing only blood components is used, then the cleaning process is easy to remove, but it cannot properly evaluate the cleaning of actual contaminants which contain both blood and tissue components
Solution Approach 1:
The patent uses a composite contamination model consisting of both blood components and tissue components. This composite approach allows the model to simultaneously represent the ease of removing blood while also capturing the difficulty of removing tissue, thereby providing accurate evaluation of cleaning processes for actual surgical contaminants.
Solution Approach 2:
The patent adjusts the ratio of blood components to tissue components in the contamination model to match different levels of contamination severity. By varying these parameters, the model can evaluate cleaning processes across different difficulty levels, from easily cleanable to difficult-to-remove contaminants.
2Device complexity
If a contamination model lacking blood or tissue components is used, then the model is simple, but it fails to represent actual surgical contaminants
Solution Approach 1:
The patent applies different characteristics to different components within the contamination model. Blood components represent easily removable contaminants, while tissue components represent difficult-to-remove contaminants. This local differentiation allows the model to maintain simplicity at the component level while achieving accuracy at the overall evaluation level.
3Measurement precision
If the concentration of extracellular matrix component is increased, then the cleaning difficulty increases, but it allows better representation of actual contamination levels
Solution Approach 1:
The patent systematically varies the concentration of extracellular matrix component and the ratio of blood to tissue components to create contamination models representing different contamination levels. This parameter adjustment allows the model to accurately represent actual surgical contamination while maintaining the ability to evaluate cleaning processes across varying difficulty levels.
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
Enables accurate evaluation of the cleaning process for medical instruments contaminated with blood and tissue components, allowing for adjustment of cleaning difficulty to match real-world surgical conditions, thereby improving the quality of cleaning evaluation.
Implementation Method 1
a composition comprising an extracellular matrix component and hemoglobin behaves, in a cleaning process, closely like patient's blood and tissue components adhered to a medical instrument during, for example, surgery
Implementation Method 2
treating the composition with a disinfecting agent to denature the proteins therein
Data Source
AI summary
The present invention provides an indicator composition for evaluating cleaning of a medical instrument that includes an extracellular matrix component and hemoglobin, as a contamination model having cleaning profile resembling an actual contaminant adhered to a medical instrument such as a surgical instrument.