Self-authenticating Intravascular Device Logic
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Solution Overview
Problem
Unauthorized intravascular devices pose significant risks to patient safety due to lack of verification of their authenticity and integrity, as third parties may sterilize and repackage used devices without adhering to manufacturer standards, leading to potential contamination and misdiagnosis.
Innovation Solution
A self-authenticating intravascular device equipped with a logic device that determines its authorization for clinical use independently, without requiring the clinical system to access its data, using a processing component to assess a parameter value and provide an authorization signal, thereby preventing unauthorized use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a computing device conducts authentication checks by accessing intravascular device data, then the authenticity verification is comprehensive, but the system complexity and implementation difficulty increase significantly
Solution Approach 1:
The intravascular device performs authentication checks independently using its own on-board processor and stored authentication data, without requiring the computing device to access or verify the device's internal data. This self-service approach maintains comprehensive verification while reducing system complexity and implementation burden on the computing device side.
Solution Approach 2:
The authentication logic and processing capabilities are extracted from the computing device and embedded directly into the intravascular device itself. This extraction transfers the computational burden to the intravascular device, simplifying the computing device's role while maintaining robust authentication verification.
2Ease of operation
If the computing device is not pre-programmed with authentication checks, then the ease of deployment improves, but the ability to verify device authenticity is lost
Solution Approach 1:
The intravascular device autonomously performs authentication verification using its embedded processor and stored authentication parameters, eliminating the need for the computing device to be pre-programmed with authentication logic. This enables immediate deployment of new computing devices without programming while maintaining robust authentication capabilities.
3Productivity
If third parties reprocess and repackaging used intravascular devices, then the availability and cost-effectiveness improve, but patient safety and device integrity are compromised
Solution Approach 1:
The intravascular device performs authentication verification before each use to confirm it has not been reprocessed or tampered with. This preliminary check prevents compromised devices from being used, maintaining patient safety while allowing legitimate device availability through proper manufacturer reprocessing channels.
Solution Approach 2:
The authentication system proactively prevents the use of unauthorized or reprocessed devices by verifying device integrity before clinical use. This preliminary anti-action counteracts the potential harm from third-party reprocessing by blocking compromised devices from entering clinical use.
Data Source
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AI summary
A method of authorizing a limited use intravascular device can include determining if the intravascular device is in communication with a clinical system; determining if the intravascular device is authorized for clinical operation without providing the clinical system access to intravascular device data stored on the intravascular device; and providing an authorization signal to the clinical system. An intravascular device can include a flexible elongate member including a sensing component at a distal portion and a connector at a proximal portion, the connector including: a memory component configured to store a parameter value; a processing component; and a charge storage component configured to power the memory component and/or the processing component; wherein the processing component is configured to determine if the flexible elongate member is authorized for clinical operation using the parameter value without providing the parameter value to a clinical system.