Integrated Process Challenge Device for Sterilization Monitoring
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing systems for verifying the effectiveness of sterilization processes are prone to inaccuracies and misreadings due to the need for manual handling and interpretation of chemical and biological indicators, which can lead to improper verification of sterilization status and potential safety risks.
Innovation Solution
An integrated process challenge device with separate compartments for chemical and biological indicators, combined with a digital autoreader that allows for automatic reading and documentation of results without opening the device, thereby reducing human error and improving accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If manual handling and interpretation of chemical and biological indicators are used, then the system is simple and easy to operate, but inaccuracies and misreadings occur leading to improper verification of sterilization status
Solution Approach 1:
The patent replaces the manual mechanical system of reading and interpreting indicators with an automated digital reading system. The digital autoreader optically scans the chemical indicator and detects biological indicator status without human intervention, eliminating reading errors and improving measurement precision while accepting increased system complexity.
Solution Approach 2:
The system enables self-service by allowing the sterilization verification process to complete itself automatically. The digital autoreader independently reads both indicator types, documents results, and determines sterilization efficacy without requiring human operators to manually interpret indicators, thereby improving accuracy while managing complexity through automation.
2Ease of operation
If chemical indicator is removed from PCD to be read, then the visual change can be observed, but the CI may be misread by the user resulting in improper verification
Solution Approach 1:
The patent replaces manual visual inspection of the chemical indicator with an automated optical reading system. The digital autoreader uses optical sensors to detect and interpret the visual change in the chemical indicator, eliminating human reading errors while maintaining the ease of observation. The system automatically captures the color change information without requiring user interpretation.
3Reliability
If SCBI is manually activated and placed in incubator, then the microorganisms can be tested for sterilization, but contamination may occur during handling resulting in improper verification
Solution Approach 1:
The system implements self-service by enabling the biological indicator to be activated and tested without manual handling. The digital autoreader activates the SCBI through controlled compression that ruptures the ampoule and mixes contents, then automatically incubates and reads the result. This eliminates contamination risks associated with manual activation while maintaining the ability to test for sterilization efficacy.
Solution Approach 2:
The patent introduces an intermediary automated system between the user and the biological indicator. The digital autoreader acts as a mediator that handles all activation, incubation, and reading processes, preventing direct human contact with the sterile components and eliminating contamination risks while preserving the reliability of verification.
4Loss of information
If separate documentation of each indicator component is required, then complete records are maintained, but the process becomes more time-consuming and prone to errors
Solution Approach 1:
The patent merges the separate documentation processes for chemical and biological indicators into a single integrated digital documentation system. The digital autoreader simultaneously reads both indicator types and consolidates the results into one comprehensive record, maintaining complete documentation of all sterilization parameters while eliminating the time and errors associated with separate manual documentation processes.
Data Source
AI summary
An integrated process challenge device is provided. The integrated process challenge device includes a shell including an interior and an exterior; a first compartment defined by the interior and exterior of the shell, the first compartment shaped to retain a first indicator; a second compartment defined by the interior and exterior of the shell, the second compartment shaped to retain a second indicator; a barrier formed by the shell, the barrier formed between the first compartment and the second compartment to prevent fluid exchange between the first compartment and the second compartment; a first opening located on the exterior of the shell adjacent to the first compartment; and a second opening located on the exterior of the shell adjacent to the second compartment, wherein the first and second openings allow a sterilant to enter and exit the first and second compartments respectively.