Infusion Pump Documentation With Real-Time Protocol Compliance
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Solution Overview
Problem
Existing medical drug administration systems, particularly in clinical trials, lack precise documentation and compliance monitoring, leading to potential invalidation of trials due to incorrect parameter recording, necessitating repeated procedures and increased costs.
Innovation Solution
A medical system with a server, infusion pumps, and mobile devices for real-time communication and compliance checking, ensuring accurate and timely documentation of treatment parameters by comparing infusion pump status with user input, and providing notifications or warnings to maintain protocol adherence.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual documentation with pen and paper is used, then ease of operation is improved, but reliability and measurement precision deteriorate due to transcription errors and timing inaccuracies
Solution Approach 1:
The patent replaces the mechanical pen-and-paper documentation system with an automated electronic system. Mobile devices capture treatment parameters digitally, and the server automatically compares timestamps against protocol requirements, eliminating manual transcription and timing errors while maintaining operational simplicity through user-friendly mobile interfaces.
Solution Approach 2:
The system enables self-service automation where the server automatically receives status information from infusion pumps, compares documentation timing against the protocol, and generates compliance notifications without requiring manual intervention. This automates the compliance checking process while keeping the interface simple for users.
2Reliability
If automated real-time monitoring is implemented, then reliability and measurement precision are improved, but device complexity increases due to multiple interconnected components
Solution Approach 1:
The server performs multiple functions: receiving status information from infusion pumps, storing treatment protocols, comparing timestamps for compliance, and generating notifications. This multi-functionality consolidates what could be separate complex systems into a single coordinated platform, managing complexity through functional integration.
Solution Approach 2:
The mobile device acts as an intermediary between the infusion pump and the server, capturing treatment parameters locally and transmitting them to the server for compliance checking. This intermediary role simplifies the overall system architecture by providing a user-friendly interface layer that manages the complexity of real-time data collection and transmission.
3Ease of operation
If manual transcription of parameters is required, then ease of operation is improved, but loss of information increases due to transcription errors and timing inaccuracies
Solution Approach 1:
The system replaces manual transcription with automated electronic capture. The mobile device digitally records treatment parameters with precise timestamps, and the server automatically compares these timestamps against protocol requirements, eliminating transcription errors and preserving accurate timing information without requiring manual data entry.
Data Source
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AI summary
The disclosure relates to a medical system (1) for documenting and managing a drug administration procedure, comprising: a server (2), at least one infusion pump (4) configured to administer an infusion to a patient and comprising status information (14), the at least one infusion pump (4) being in data communication with the server (2) and providing the status information (14) to the server (2), and a mobile device (8) configured to receive input information (15) from a user, the mobile device (8) being in data communication with the server (2) and providing the input information (15) to the server (2). The server (2) is configured to determine whether a protocol of documentation of the administration procedure is followed and to submit a notification (16) comprising an instruction and/or a warning to the mobile device (8) based on the status information and on the input information. The disclosure further relates to a method of documenting and managing a drug administration procedure as well as a computer program.