Cryptographic Authentication for Intravascular Device Reuse
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Solution Overview
Problem
The reuse of unauthorized and potentially tampered intravascular devices in clinical procedures poses a significant risk to patient safety and financial losses for manufacturers, as existing authentication methods can be falsified or bypassed by third parties.
Innovation Solution
Implementing a cryptographic authentication system using a memory within intravascular devices, where first and second security data are generated and written to the device's memory to ensure only authorized and properly reconditioned devices can be used, utilizing a secret key and message authentication codes to verify authenticity and expiration dates.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If cryptographic authentication is implemented using memory in intravascular devices, then device authenticity and patient safety are improved, but device complexity increases
Solution Approach 1:
The cryptographic authentication data is pre-loaded into the device memory during manufacturing before the device is deployed. The secret key and authentication algorithms are embedded in advance, allowing the device to perform self-authentication without requiring complex external verification infrastructure during clinical use.
Solution Approach 2:
A dedicated microcontroller or security module acts as an intermediary between the intravascular device components and the external authentication system. This intermediary handles the cryptographic operations and memory management, isolating the complexity from both the medical functionality and the external verification system.
2Reliability
If used intravascular devices are collected and repackaged by third parties, then financial losses for manufacturers occur, but patient safety deteriorates
Solution Approach 1:
The authentication system proactively prevents unauthorized reuse by verifying cryptographic credentials before the device can be activated. If a device lacks valid authentication or has been previously used, the system blocks its operation before contamination or misdiagnosis can occur, rather than reacting to problems after they arise.
Solution Approach 2:
The authentication system provides immediate feedback to both the device and external systems about the device's authentication status. This feedback mechanism allows the system to identify and reject unauthorized or previously used devices, preventing them from entering the clinical workflow and potentially harming patients.
3Ease of operation
If existing authentication methods are used, then device verification is simplified, but they can be falsified or bypassed by third parties
Solution Approach 1:
The patent replaces simple mechanical or software-based authentication markers (such as serial numbers or basic tags) with cryptographic authentication mechanisms. This substitution maintains ease of operation from the user perspective while providing robust security against falsification through mathematical encryption and verification protocols.
Solution Approach 2:
The authentication system changes the fundamental parameters of verification from static identifiers to dynamic cryptographic proofs. The authentication data in memory changes based on device state, usage history, and cryptographic challenges, making it computationally infeasible for third parties to forge or bypass the authentication without the secret key.
Data Source
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AI summary
Devices, systems, and methods for reconditioning an intravascular device for reuse are provided. The method includes reading first security data from a memory of the intravascular device; determining if the intravascular device is authentic; generating second security data, when the intravascular device is authentic; and writing the second security data to the memory of the intravascular device. Devices, systems, and methods for authenticating an intravascular device for use are also provided. The method includes bringing an intravascular device into communication with a computing device, the intravascular device including a memory; determining if first security data is authentic; determining, when the first security data is authentic, if the intravascular device has been reconditioned; determining, when the intravascular device has been reconditioned, if the second security data is authentic base; and permitting, when second security data is authentic, use of the intravascular device in the clinical procedure.