Digital Autoreader for Sterilization Monitoring
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Solution Overview
Problem
Existing systems for verifying the effectiveness of sterilization processes are prone to inaccuracies and misreadings due to the manual handling and interpretation of chemical and biological indicators, which can lead to improper verification of sterilization status.
Innovation Solution
A digital autoreader system that includes a housing with sensors to read chemical and biological indicators without manual intervention, utilizing a processor with machine learning algorithms to determine sterilization efficacy and provide automatic documentation of results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If manual handling and interpretation of chemical and biological indicators is used, then the system is simple and easy to operate, but the accuracy and reliability of sterilization verification deteriorates due to human error and misreading
Solution Approach 1:
The patent replaces manual visual inspection and interpretation of chemical indicators with an electronic sensor-based reading system. The sensor detects optical property changes in the chemical indicator and converts them into digital signals for automated analysis, eliminating human error in reading and interpretation while maintaining system simplicity through electronic automation.
Solution Approach 2:
The patent introduces an electronic sensor as an intermediary between the chemical indicator and the user/verification process. The sensor acts as a mediator that objectively detects and quantifies the chemical indicator's state, providing accurate data without requiring direct human observation and interpretation, thus improving verification accuracy.
2Reliability
If chemical indicators with visual changes are used, then the indicator is easy to manufacture and read, but the reliability deteriorates because the indicator must be removed from the PCD and can be misread
Solution Approach 1:
The patent replaces the manual removal and visual reading process with an in-situ electronic sensing system. The sensor remains positioned to detect the chemical indicator within the PCD, eliminating the need to remove the indicator and preventing misreading through automated detection and digital recording of results.
Solution Approach 2:
The patent creates a digital copy or representation of the chemical indicator's state through sensor detection. Instead of relying on direct visual observation that can be misinterpreted, the sensor captures the indicator's optical properties and converts them into reliable digital data that can be accurately stored and analyzed.
3Productivity
If biological indicators requiring manual activation and incubation are used, then the indicator provides sterility assurance, but the productivity and time efficiency deteriorates due to multiple manual steps and incubation time
Solution Approach 1:
The patent replaces manual activation steps and incubation processes with automated electronic detection. The sensor system can detect sterilization efficacy directly from the biological indicator's state changes without requiring manual activation or extended incubation periods, significantly reducing verification time while maintaining sterility assurance through objective measurement.
Solution Approach 2:
The patent enables skipping of time-consuming manual steps such as activation and incubation by using an electronic sensor that can rapidly detect the biological indicator's state. This allows the verification process to rush through what would traditionally require extended time periods, improving productivity without compromising the reliability of sterility verification.
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
The digital autoreader system significantly reduces the risk of human error in interpreting sterilization indicator results, providing accurate and automated verification of sterilization processes, thus ensuring the safety of sterilized products.
Implementation Method 1
the first sensor configured to read a variable of the at least one indicator of the at least one indicator of the process challenge device and determine whether the process challenge device has been adequately sterilized
Data Source
AI summary
A digital autoreader is provided. The digital autoreader includes a housing including an interior and an exterior; a well for receiving a process challenge device, the process challenge device including at least one indicator, the well including an opening and a block for retaining the process challenge device, wherein the block is located within the interior of the housing; a first sensor located within the interior of the housing and positioned adjacent to the block of the well, the first sensor configured to read a variable of the at least one indicator of the at least one indicator of the process challenge device and determine whether the process challenge device has been adequately sterilized; and an interface to alert a user if the process challenge device has been adequately sterilized.