Process Indicator for Automated Endoscope Reprocessors
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Solution Overview
Problem
Automated endoscope reprocessors lack the ability to monitor chemically-related parameters for disinfection efficacy and provide feedback on disinfectant flow, making it difficult to ensure effective disinfection of complex medical devices like flexible endoscopes.
Innovation Solution
A substrate with a process indicator that reacts with disinfectants such as glutaraldehyde, ortho-phthalaldehyde, and hydrogen peroxide, forming a flow channel to visually indicate disinfectant flow and concentration, enhancing the disinfection process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Extent of automation
If automated endoscope reprocessors are used to clean and disinfect flexible endoscopes, then the disinfection process can be automated and time-consuming manual handling is reduced, but the system lacks the ability to monitor chemically-related parameters for disinfection efficacy and provide feedback on disinfectant flow
Solution Approach 1:
The patent introduces a process indicator that provides visual feedback on disinfectant flow through complex lumens of the endoscope. The indicator changes color or provides visible signals that allow operators to verify whether disinfectant is properly flowing through all channels, addressing the lack of feedback in automated systems.
Solution Approach 2:
The process indicator acts as an intermediary between the disinfectant and the operator. It translates invisible chemical flow into visible signals, enabling monitoring of disinfection efficacy without requiring complex electronic sensors or chemical analysis equipment in the automated reprocessor.
2Ease of operation
If liquid disinfectant is recirculated through the AER for a prescribed time with only parametric information (time and temperature) available, then the disinfection process is simplified and easy to monitor, but this information is insufficient to establish the efficacy of the disinfection cycle
Solution Approach 1:
The process indicator utilizes color changes to provide visual information about disinfectant flow and concentration. Different colors indicate different states of the disinfection process, allowing operators to assess efficacy at a glance without complex instrumentation.
Solution Approach 2:
The process indicator is designed as a disposable, low-cost component that provides critical monitoring information. Rather than investing in expensive, complex monitoring equipment, the system uses inexpensive indicator strips or markers that are discarded after use, maintaining simplicity while improving measurement capability.
3Reliability
If process indicators are provided to use with an AER, then some monitoring capability is added, but the process indicator does not necessarily provide details on the flow of liquid disinfectant which can be used to diagnose issues with the AER
Solution Approach 1:
The process indicator is divided into multiple segments or zones that correspond to different sections of the endoscope lumens. Each segment provides localized information about disinfectant flow in specific channels, enabling operators to identify which particular lumen or channel has flow problems.
Solution Approach 2:
Different portions of the process indicator are designed to respond to different conditions or locations within the disinfection system. This allows localized diagnosis of flow issues in specific endoscope channels rather than providing only a general system-wide status.
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
Provides visual feedback on disinfectant flow and concentration, ensuring effective disinfection of medical devices by addressing the limitations of existing automated reprocessors.
Implementation Method 1
The process indicator reacts with at least one liquid disinfectant selected from the group consisting of glutaraldehyde, ortho-phthalaldehyde, hydrogen peroxide, and peroxyacetic acid
Data Source
AI summary
The present disclosure relates to an article for detecting a disinfectant via visual feedback. The article have a first substrate with a first major surface and opposite ends. The article also comprises a process indicator disposed on at least a portion of the first major surface. The process indicator reacts with at least one liquid disinfectant selected from the group consisting of glutaraldehyde, ortho-phthalaldehyde, hydrogen peroxide, peroxyacetic acid, and combinations thereof. The process indicator can be formed from a synthetic amine-containing polymer derived from polyethylenimine (PEI). The article can have a flow channel that is formed by a portion of the process indicator and that extends between the opposite ends. The disclosure also relates to a kit containing the article as well as a method of using the article in a disinfection process. The article is used to diagnose issues in an automated endoscope reprocessors (AERs).