Disposable Medical Device Code Locking for Single-Use Compliance
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Solution Overview
Problem
Existing systems fail to effectively prevent the reuse of disposable medical devices such as sinus debriders or shavers, lacking robust mechanisms to ensure single-use compliance.
Innovation Solution
A system comprising a controller unit and a medical device unit, where the controller unit generates and verifies a coded message with a microprocessor in the device unit to ensure the device is used only once, using a hash function to generate unique codes based on device ID and operational parameters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a timer-based usage limit system is used to prevent device reuse, then the device can track usage duration, but it cannot effectively prevent reuse after disposal
Solution Approach 1:
The system performs preliminary actions by setting a usage limit counter to a predetermined value (e.g., 1) before the device is actually used. This initial configuration ensures that the device can only be activated once, as the counter decrements with each use and prevents further operation when reaching zero, thereby guaranteeing single-use compliance without requiring complex real-time monitoring mechanisms.
Solution Approach 2:
The patent replaces mechanical or electronic timer-based tracking systems with a digital counter mechanism implemented in software/firmware. Instead of relying on continuous time-based monitoring or complex mechanical switches, the system uses a simple decrementing counter variable that is easily managed through software logic, significantly reducing device complexity while maintaining reliable single-use enforcement.
2Reliability
If electronic storage componentry is used to store usage data, then the device can remember usage history, but it allows potential data manipulation and reuse
Solution Approach 1:
The system implements feedback by continuously monitoring the usage counter value and automatically adjusting device operation based on its state. When the counter reaches zero, the system provides feedback to the control circuit to disable further operation, creating a closed-loop control mechanism that prevents manual manipulation from overriding the usage limit, thereby ensuring data integrity and preventing reuse.
Solution Approach 2:
The patent applies preliminary anti-action by pre-configuring the usage counter with a fixed limit value before use and programming the control circuit to automatically enforce this limit. This preemptive measure prevents any potential data tampering or manipulation attempts, as the system is designed to reject operation when the counter reaches zero, making it impossible to reuse the device even if storage data is accessed or modified.
3Reliability
If a code verification system is implemented, then the device can be securely locked, but it increases system complexity and processing requirements
Solution Approach 1:
The system employs a disposable approach by using a single-use device with a built-in counter that is discarded after one use. This eliminates the need for complex, reusable code verification and locking mechanisms, as the entire device is designed for single use only. The simplicity of the disposable model reduces processing requirements and system complexity while maintaining high reliability in preventing reuse.
Solution Approach 2:
The patent extracts the code generation and verification functionality from the main device body and implements it as a separate, dedicated control circuit with specialized logic. This modular extraction allows the main device to remain simple while the verification function is handled by a dedicated component, reducing overall system complexity and processing requirements while maintaining secure locking capability.
Data Source
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AI summary
Provided is a medical system comprising a controller unit configured to be capable of generating a first code or coded message; and a medical device unit configured to be capable of generating a second code or coded message, the medical device unit configured to be in electronic communication with the controller unit, wherein the controller unit is configured to lock the medical device unit from being used or reused if the first code or coded message does not match or is not identical to the second code or coded message. Also provided is a method of preventing use or reuse of a medical device unit as described herein.