Medical Device Configuration File Parameter Validation
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Solution Overview
Problem
Errors in setting or modifying configuration file parameters for medical devices, such as insulin pumps, can lead to serious health consequences for users due to incorrect basal and bolus insulin delivery rates.
Innovation Solution
A method and system utilizing a computing device with a user interface, processor, and memory to read, modify, and confirm configuration file parameters, ensuring accurate entry and validation of focal parameters before writing them to the medical device, thereby reducing errors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If automatic parameter modification is implemented to improve efficiency, then productivity increases, but reliability decreases due to potential errors in setting or modifying pump configuration file parameters
Solution Approach 1:
The system prompts the user to manually re-enter focal modified parameters and automatically verifies that the re-entry matches the displayed parameter. This feedback loop allows automatic modification efficiency while ensuring accuracy through user confirmation and system validation.
Solution Approach 2:
The system identifies and flags focal parameters before final writing, prompting users to confirm and re-enter these critical parameters in advance. This preliminary action prevents errors by validating parameters before they are committed to the medical device.
2Reliability
If manual confirmation of all parameters is required to ensure accuracy, then reliability improves, but productivity decreases due to increased time for parameter setting and modification
Solution Approach 1:
The system applies different levels of verification to different parameters: focal parameters require manual re-entry and automatic verification, while non-focal parameters are modified automatically without additional user interaction. This selective approach ensures accuracy for critical parameters while maintaining efficiency for routine modifications.
Solution Approach 2:
The parameter set is segmented into focal and non-focal categories. Focal parameters undergo rigorous validation with manual re-entry requirements, while non-focal parameters are processed automatically. This segmentation allows the system to balance reliability and productivity by applying appropriate verification levels to different parameter types.
3Ease of operation
If simplified parameter entry is used to improve ease of operation, then ease of operation improves, but manufacturing precision decreases due to increased risk of entry errors
Solution Approach 1:
The computing device serves as an intermediary between the user and the medical device, providing a user-friendly interface for parameter modification while implementing automatic verification protocols. This intermediary role simplifies user interaction while maintaining precision through systematic validation of focal parameters.
Solution Approach 2:
The system replaces manual verification mechanics with automatic computer-based validation. The computing device automatically reads, validates, and verifies parameter entries, substituting human checking with automated error detection and confirmation protocols that enhance precision without complicating user interaction.
Data Source
AI summary
Disclosed is a method of configuring a medical device through utilization of a computing device that includes a user interface, a processor and memory. The method includes the steps of determining whether a configuration file contains a focal modified parameter, displaying the focal modified parameter, prompting a manual re-entry of the displayed focal modified parameter, receiving through the user interface the manual re-entry of the displayed focal modified parameter, and utilizing the processor to automatically determine whether the manual re-entry of the displayed focal modified parameter matches the displayed focal modified parameter.