Infusion Pump Formulary Validation for Full Scenario Coverage
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Solution Overview
Problem
Traditional infusion pump validation processes are inadequate in testing each possible combination of infusible materials, dosages, and rates, failing to ensure accurate and safe operation across diverse patient demographics.
Innovation Solution
A method and system that generate comprehensive validation infusion pump operational instruction sets by combining configuration files defining unit of measure, route of administration, dosage, subject demographics, and formulary data to simulate various scenarios, monitor pump operations, and record output signals for validation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional validation testing is performed on infusion pumps, then basic operational safety is ensured, but comprehensive validation across all possible combinations of infusible materials, dosages, and rates is inadequate
Solution Approach 1:
The system performs preliminary computational generation of validation instruction sets that encompass all possible combinations of infusible materials, dosages, and infusion rates before actual pump operation. This pre-computation approach ensures comprehensive validation coverage is achieved systematically, addressing the inadequacy of traditional testing that fails to cover all parameter combinations.
Solution Approach 2:
The system systematically varies multiple parameters simultaneously (infusible material type, dosage amounts, infusion rates, patient demographics) to generate comprehensive validation scenarios. By changing these parameters in structured combinations, the system achieves thorough validation coverage across the entire operational space of the infusion pump, resolving the limitation of traditional single-parameter or limited-combination testing.
2Reliability
If comprehensive validation instruction sets covering all combinations are generated and executed, then validation thoroughness is improved, but the complexity of the validation process increases
Solution Approach 1:
The validation process is segmented into distinct modular components: configuration file management, computational instruction generation, instruction set execution, and results analysis. Each module handles a specific aspect of validation, making the overall complex process manageable and systematic. The segmentation allows comprehensive validation to be achieved through coordinated execution of simpler, well-defined sub-tasks.
Solution Approach 2:
A computational algorithm serves as an intermediary between the validation requirements and the infusion pump execution. This intermediary automatically generates the comprehensive set of validation instructions based on configuration files, eliminating the need for manual creation of each test scenario. The intermediary manages the complexity by systematically processing combinatorial parameters and translating them into executable pump commands.
3Adaptability or versatility
If manual validation testing is performed for each scenario, then flexibility in testing is maintained, but the time and resources required increase significantly
Solution Approach 1:
The validation system performs self-service through automated computational generation and execution of validation instruction sets. The system automatically configures test parameters, generates appropriate instruction sets, executes them on the infusion pump, and analyzes results without requiring manual intervention for each validation scenario. This self-service capability maintains flexibility while dramatically improving validation efficiency and reducing resource requirements.
Solution Approach 2:
Manual mechanical validation processes are replaced with automated computational systems. Instead of manually configuring and executing each validation scenario, a computer-based algorithm automatically generates and manages the validation instruction sets. This substitution of computational automation for manual processes maintains the ability to adapt validation scenarios while significantly increasing productivity and reducing time and resource consumption.
Data Source
AI summary
Systems, executable process, and methods for validation of infusion pumps is described. A set of configuration files is loaded into a validation operational instruction generator. The configuration files may define the configuration of infusion pump operational instructions, the potential units of measure, the potential routes of administration, the potential dosages, and the formulary of potentially infusible materials. A set of operational instructions are generated for each combination of the potentially infusible materials for each potential route of administration for each potential dosage. The operational performance of an infusion pump is monitored during execution of the generated operational instructions.