Photo-Reactive Label Authentication for Extracorporeal Photopheresis
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Solution Overview
Problem
Existing medical device systems for extracorporeal photopheresis lack effective authentication methods to prevent the use of counterfeit, already-used, or repurposed disposable components, which can compromise treatment efficacy and safety.
Innovation Solution
A medical device verification system that includes a reusable UV light source and scanner, utilizing a photo-reactive label on disposable components that changes visibility states upon UV irradiation, combined with RFID tagging for authentication, ensuring only authorized and unused components are used in the procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional authentication methods are used, then device complexity is low, but reliability of component authentication is insufficient
Solution Approach 1:
The patent employs photo-reactive labels that undergo visible color or transparency changes when exposed to UV irradiation. The label transitions from a first state (visible or transparent) to a second state (invisible or opaque), providing a clear visual indicator of irradiation status. This principle enhances authentication reliability by creating a tamper-evident mechanism that is difficult to replicate without the specific photo-reactive materials and UV exposure conditions.
Solution Approach 2:
The patent introduces a scanner as an intermediary device that detects the state of the photo-reactive label and communicates with the controller. The scanner acts as a mediator between the physical label state and the digital authentication system, enabling automated verification of component authenticity and irradiation status without requiring manual inspection, thus improving reliability while managing complexity through automation.
2Reliability
If photo-reactive labels are used for authentication, then reliability of preventing counterfeit components is improved, but ease of operation deteriorates due to additional verification steps
Solution Approach 1:
The photo-reactive label performs self-verification through its automatic response to UV irradiation. When the component is irradiated, the label autonomously changes state without requiring manual intervention or additional authentication actions from the operator. The scanner automatically detects this state change, and the controller automatically verifies authentication, reducing the operational burden on users while maintaining high security.
Solution Approach 2:
The system implements feedback through the scanner detecting the label state and communicating this information back to the controller. The controller uses this feedback to determine whether the component is authentic and whether it has been properly irradiated. This closed-loop feedback mechanism automates the verification process, improving reliability while minimizing the need for manual verification steps.
3Reliability
If dual authentication mechanisms are implemented, then treatment safety is enhanced, but device complexity increases
Solution Approach 1:
The patent combines the authentication function and irradiation verification function into a single integrated system. The photo-reactive label serves dual purposes: it authenticates the component's identity and simultaneously verifies that the component has been properly irradiated. The scanner and controller are integrated to handle both authentication and irradiation verification in one unified process, reducing overall system complexity compared to having separate systems for each function.
Solution Approach 2:
The photo-reactive label is designed as a multi-functional element that performs both authentication and irradiation verification. The same label structure and material properties are used to provide unique component identification and to indicate irradiation status. This universal approach eliminates the need for separate authentication tags and irradiation indicators, thereby enhancing treatment safety through dual verification while minimizing the increase in device complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This system effectively prevents the use of counterfeit or reused components by ensuring that only properly authenticated and unused disposable components are used, enhancing treatment integrity and safety through dual authentication mechanisms.
Implementation Method 1
a photo-reactive label comprising an identifiable code. The identifiable code is unobscured to the scanner when the label in a first state and is obscured to the scanner when the label is in a second state
Implementation Method 2
a scanner... receive a first input from the scanner prior to an irradiation step, the first input comprising identification of a state of the label
Data Source
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AI summary
A medical device verification system for an extracorporeal photopheresis procedure comprises a reusable irradiation device comprising a UV light source and a scanner. A fluid circuit comprises a disposable cell suspension container having a photo-reactive label comprising an identifiable code. The identifiable code is unobscured when the label in a first state and is obscured when the label is in a second state. The irradiation step is performed by irradiating the disposable cell suspension container for a predetermined period of time at or above the threshold UV irradiation level. A second input is received from the scanner during the irradiation step, the second input comprising identification of a state of the label. A response action is provided if the first input comprises identification of the second state of the label and/or if the second input comprises identification of the first state of the label.