Surrogate Contaminant Blend for Cleaning Verification

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Solution Overview

Problem

Current wash indicators are inadequate for monitoring the effectiveness of pH neutral enzymatic cleaners and fail to detect residues of organic materials like fat and brain tissue, which are resistant to removal and can lead to surgical site infections and equipment corrosion.

Innovation Solution

A method and device using a non-infectious surrogate contaminant blend, such as calf serum, rabbit blood, and gelatin, applied to a surrogate substrate to simulate real-world contaminants, allowing for simultaneous cleaning and verification of cleaning effectiveness without risking actual substrates, using disclosing compositions to detect residual contaminants.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If visual inspection is used to determine cleaning effectiveness, then the inspection process is simple and quick, but it fails to detect invisible contaminants like fat and brain tissue residues

Engineering Contradiction:

Improveinspection processVSAvoidcontaminant detection accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent introduces a disclosing composition as an intermediary substance that reacts with residual contaminants to make them visible. The disclosing composition contains agents that bind to organic residues like fat and protein, producing color changes or fluorescent signals that enable detection of otherwise invisible contaminants while maintaining a simple inspection process

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent utilizes color change reactions between the disclosing composition and residual contaminants to indicate cleaning effectiveness. When contaminants are present, the disclosing composition undergoes visible color changes, providing a straightforward visual indicator that combines ease of inspection with improved detection accuracy

Inventive Principle:

Principle #32Color changes

2Ease of manufacture

If hemoglobin and fibrin are used as test soils to simulate organic soils, then the test materials are readily available, but they do not accurately represent resistant contaminants like fat and brain tissue

Engineering Contradiction:

Improvetest soil preparationVSAvoidcleaning effectiveness assessment

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The patent modifies the composition parameters of test soils to include fat, brain tissue, and other resistant organic materials that accurately represent real-world surgical contaminants. This changes the chemical and physical properties of the test soil to better simulate actual cleaning challenges, improving the reliability of cleaning effectiveness assessments

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent creates composite test soil formulations that combine multiple organic materials including fat, protein, and brain tissue simulants to better represent the complex composition of real surgical contaminants. These composite materials provide a more comprehensive and realistic test substrate for evaluating cleaning performance

Inventive Principle:

Principle #40Composite materials

3Object-affected harmful factors

If pH neutral enzymatic cleaners are used to clean surgical instruments, then the cleaners are less corrosive to instruments, but they are ineffective against resistant organic soils like fat and brain tissue

Engineering Contradiction:

Improveinstrument corrosionVSAvoidcontaminant removal effectiveness

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent modifies the chemical parameters of the cleaning solution by adding specific enzymes and adjunct chemicals that enhance the ability to break down resistant organic soils like fat and brain tissue. This allows the cleaner to maintain its pH neutral, low-corrosiveness properties while improving contaminant removal effectiveness through enhanced biochemical activity

Inventive Principle:

Principle #35Parameter changes

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

This approach provides a more comprehensive assessment of cleaning efficacy, ensuring surgical instruments are thoroughly cleaned and safe for use, reducing the risk of infections and equipment corrosion, while optimizing cleaning protocols and reducing costs.

Implementation Method 1

Existing wash indicators on the market were and are designed primarily to monitor protein residuals or the effectiveness of alkaline cleaners

Methodology Applied

Scientific EffectProtein detection:

Implementation Method 2

using disclosing compositions to detect residual contaminants

Methodology Applied

Scientific EffectVisual detection:

Implementation Method 3

monitor the effectiveness of pH neutral enzymatic cleaners

Methodology Applied

Scientific EffectEnzymatic cleaning: Enzyme

Data Source

PatentUS9885664B2Detection method for assessing the efficiency of a cleaning operation

Publication Date: 2018.02.06 CASE MEDICAL INC

AI summary

A method of assessing the efficiency of a cleaning operation and assessing likely residual contamination on substrates after a cleaning operation.