Infusion Pump Disposable Validation for Safe Infusate Delivery
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Solution Overview
Problem
Medical devices lack the ability to acquire, recognize, or utilize information about disposable components, which hinders improved functionality and safety.
Innovation Solution
Infusion pumps are equipped with the capability to read identifying information from disposable components, determine their validity, and adjust operating parameters or deliver infusate accordingly, while allowing user intervention and notifying the user of invalid components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the infusion pump reads identifying information from disposable components and validates them, then the safety and functionality of the medical device is improved, but the device complexity increases due to additional validation logic and information processing requirements
Solution Approach 1:
The patent introduces an intermediary validation system that acts as a mediator between the infusion pump and disposable components. The pump reads identifying information from disposables and compares it against stored validity criteria, using this intermediary validation process to ensure safety without requiring complex integration of all disposable characteristics directly into the pump's core control logic.
Solution Approach 2:
The validation process is segmented into distinct functional modules: information reading from the disposable, validity comparison against stored criteria, and control decisions based on validation results. This segmentation allows the safety function to be implemented through separate, manageable components rather than a monolithic complex system.
2Adaptability or versatility
If the infusion pump acquires and processes information about disposable components, then the adaptability and functionality of the device is improved, but the loss of time increases due to information acquisition and processing steps
Solution Approach 1:
The patent implements preliminary action by pre-storing validity information and acceptance criteria in the infusion pump's memory before actual use. When a disposable is connected, the pump can quickly compare the disposable's identifying information against pre-loaded validity data, eliminating the need for complex real-time analysis and reducing the time penalty for information processing.
3Ease of operation
If the infusion pump allows user intervention to override validity determinations, then the ease of operation is improved, but the reliability decreases due to potential use of invalid disposables
Solution Approach 1:
The patent implements a feedback mechanism where the system provides information about the disposable's validity status to the user and seeks confirmation before allowing operation with potentially invalid disposables. This feedback loop ensures that user awareness and intentional confirmation are required, maintaining reliability while still allowing user override when clinically justified.
Data Source
AI summary
A method for managing use of a disposable with an infusion pump is provided. The method can include adding validity information about a particular set of disposables to a list of disposables. Subsequent to adding the validity information, the method can include modifying the validity information about the particular set of disposables on the list of disposables. The method can include an infusion pump reading identifying information from a disposable, and can include determining whether the disposable is valid for use, based at least in part upon comparison of the identifying information read from the disposable by the infusion pump with the validity information about the particular set of disposables on the list of disposables. The method can also include the infusion pump making a determination of whether to deliver or not deliver an infusate based at least in part upon the determining whether the disposable is valid for use.