Infusion Pump Signaling Component for Unauthorized Set Prevention
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Solution Overview
Problem
The risk of mismatch between infusion set delivery requirements and infusion pump settings in medical infusion treatments is high, potentially leading to dangerous or lethal outcomes, especially when infusion pumps are shared among patients without proper verification.
Innovation Solution
An infusion delivery system that includes a signaling component on the slide clamp with an encrypted key, which is detected by a device to validate the infusion set and configure the infusion device according to a specific administration protocol, ensuring the correct infusion set is used for a particular patient and protocol.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If infusion pumps are shared among patients without verification, then productivity and resource utilization improve, but the risk of mismatch between infusion set requirements and pump settings increases
Solution Approach 1:
The system performs verification actions before infusion administration begins. The detection device reads the signaling component on the infusion set prior to pump operation, and the controller validates compatibility before allowing infusion. This preliminary verification ensures that when pumps are shared among patients, each infusion set is confirmed to be compatible with the pump settings before use, preventing mismatches while maintaining high utilization.
Solution Approach 2:
The system implements a feedback mechanism where the detection device continuously monitors the infusion set's signaling component, and the controller provides real-time validation feedback. If a mismatch is detected between infusion set requirements and pump settings, the system alerts the operator and prevents operation. This feedback loop maintains reliability during shared pump usage by ensuring each infusion set is verified against the specific pump being used.
2Reliability
If healthcare professionals manually verify every infusion set parameter, then reliability of infusion set-pump matching improves, but loss of time and operational efficiency worsen
Solution Approach 1:
The infusion set performs self-identification through its signaling component (barcode, RFID tag, or other encoded identifier). When the detection device scans this component, the system automatically retrieves the infusion set's requirements and compares them with the pump settings. This self-service verification eliminates the need for healthcare professionals to manually check each parameter, maintaining high reliability while minimizing time loss.
Solution Approach 2:
The system replaces manual mechanical verification with automated detection and validation. Instead of healthcare professionals physically examining infusion set parameters, the detection device optically or electronically reads the signaling component, and the controller automatically validates compatibility. This substitution of manual processes with automated systems maintains accurate verification while dramatically reducing the time required.
3Reliability
If encryption algorithms and validation protocols are implemented, then prevention of unauthorized infusion set use improves, but device complexity increases
Solution Approach 1:
The controller performs multiple functions using a single integrated validation system. It detects the signaling component, decrypts the encoded information, validates infusion set compatibility, verifies authorization, and controls pump operation all through one unified system. This multi-functionality approach prevents unauthorized infusion set use while avoiding the need for separate complex systems for each function, thereby limiting the increase in overall device complexity.
Solution Approach 2:
The signaling component acts as an intermediary that carries encrypted authorization information. Rather than requiring complex direct communication between the infusion set and pump control systems, the encoded signaling component serves as a portable credential that simplifies the validation process. The detection device reads this intermediary element, and the controller validates it against stored protocols, providing secure authorization verification without excessive system complexity.
Data Source
AI summary
A system and method for automatically delivering an infusate to a patient is disclosed. The system includes an infusion set and an infusion device. A signaling component disposed on an infusion set component identifies the infusion set and is encrypted for security. The encryption may include both an encryption algorithm and a valid number algorithm. A detection device operatively connected to the infusion device decrypts and detects the signaling component and identifies the infusion set. The infusion device is then configured to operate according to an administration protocol suitable for the infusion set and an infusion device, such as an infusion pump.


