Process Indicator for Endoscope Disinfection Verification

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Solution Overview

Problem

Automated endoscope reprocessors lack the ability to monitor chemically-related parameters during disinfection cycles, making it difficult to confirm the efficacy of disinfection for flexible endoscopes with complex, narrow lumens, which are prone to contamination and pathogen transmission.

Innovation Solution

A method involving a disinfectant with a synthetic amine-containing compound on a substrate, which reacts to form an adduct, allowing spectral observation to determine if a predetermined disinfectant exposure criterion is met, ensuring effective disinfection of medical devices.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If visual inspection method is used to verify disinfection, then the method is simple and easy to implement, but it cannot effectively inspect complex narrow lumens in flexible endoscopes

Engineering Contradiction:

Improveease of verificationVSAvoiddisinfection verification reliability

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent introduces a process indicator as an intermediary element that reacts with the disinfectant to produce a visible signal. This indicator serves as a mediator between the disinfectant and the visual inspection method, allowing indirect verification of disinfection efficacy in areas that are otherwise invisible, thus resolving the contradiction between ease of operation and reliability

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces direct visual mechanical inspection with a chemical reaction-based indication system. Instead of relying on human visual inspection of narrow lumens, the system uses chemical reactions between the process indicator and disinfectant that produce observable changes, substituting mechanical visual inspection with a chemical-optical detection mechanism

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Device complexity

If only parametric information (time and temperature) is monitored during disinfection, then the monitoring system is simple, but it cannot establish the efficacy of the disinfection cycle

Engineering Contradiction:

Improvemonitoring system complexityVSAvoiddisinfection efficacy measurement

Core Design Contradiction:

Device complexityVSMeasurement precision

Solution Approach 1:

The patent implements a feedback mechanism where the process indicator provides real-time visual feedback about disinfection efficacy. The indicator's chemical reaction with the disinfectant creates an observable signal that confirms whether the disinfection cycle has achieved the required efficacy, closing the feedback loop between the disinfection process and verification

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The patent utilizes color changes of the process indicator as a visual signal to indicate disinfection efficacy. The chemical reaction between the indicator and disinfectant produces a detectable color change that provides precise measurement information about whether the disinfection criteria have been met, enhancing measurement precision through optical detection

Inventive Principle:

Principle #32Color 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 method provides a reliable way to confirm the achievement of disinfectant exposure criteria, ensuring thorough disinfection of medical devices like endoscopes, thereby reducing the risk of pathogen transmission.

Implementation Method 1

the synthetic amine-containing compound is reactive with the disinfectant to form at least one adduct

Methodology Applied

Scientific EffectChemical reaction forming adduct: Chemical Bonding

Implementation Method 2

spectrally observing the process indicator and obtaining at least one parameter therefrom that is predictive of the predetermined disinfectant exposure criterion

Methodology Applied

Scientific EffectSpectral observation: Absorption Spectroscopy

Data Source

PatentUS10792383B2Method of disinfecting a medical device

Publication Date: 2020.10.06 SOLVENTUM INTELLECTUAL PROPERTIES CO

AI summary

A method of disinfecting a medical device comprises three steps. First, a disinfectant is contacted with a process indicator and the medical device. The disinfectant comprises at least one aldehyde. The process indicator contains a synthetic amine-containing compound disposed on a substrate. The synthetic amine-containing compound comprises at least one of primary amino groups or secondary amino groups, and is reactive with the disinfectant to form at least one adduct. The synthetic amine-containing compound and the medical device are in fluid communication through the disinfectant. A predetermined disinfectant exposure criterion exists for contacting the disinfectant with the medical device. Second, the process indicator is spectrally observed and at least one parameter is obtained therefrom that is predictive of the predetermined disinfectant exposure criterion. The third step is determining that the predetermined disinfectant exposure criterion has been achieved.