Medical Device Disposable Authentication via Validation Key
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current medical device instruments lack effective methods to authenticate and track the usage of disposable components, leading to potential misuse of unauthorized or counterfeit disposables, which can compromise safety and regulatory compliance.
Innovation Solution
A system and method that utilize a dual-computer authentication process, where a validation computer generates and verifies an authentication key for each disposable component, ensuring only authorized components are used by prompting users to enter a unique code, and disabling the instrument if an invalid code is entered, thereby preventing unauthorized use and tracking the number of authorized disposables.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If no authentication system is implemented, then the device is easy to operate and disposables can be used freely, but unauthorized or counterfeit disposables can be used compromising safety and compliance
Solution Approach 1:
The system performs preliminary authentication by requiring users to enter an authentication key before the disposable component can be used. The validation computer verifies the key against authorized components in memory, preventing unauthorized disposables from being used before they can cause harm.
Solution Approach 2:
A validation computer acts as an intermediary between the user and the disposable component. It receives the authentication key, verifies it against authorized components stored in memory, and only allows operation if the key is valid, thus mediating the interaction to ensure safety.
2Reliability
If an authentication key system is implemented, then unauthorized disposables are prevented from being used, but the operation process becomes more complex and time-consuming
Solution Approach 1:
Authentication is performed as a preliminary step before the disposable component can be used. The system requires the authentication key to be entered and verified before allowing operation, ensuring unauthorized components are blocked in advance.
Solution Approach 2:
The system changes the operational state parameter of the device based on authentication results. When an invalid key is detected, the system transitions to a disabled state, preventing further operation with unauthorized components.
3Loss of information
If authentication verification is performed for each disposable component, then tracking and compliance are improved, but the device complexity increases
Solution Approach 1:
The validation computer serves multiple functions: it validates authentication keys, tracks usage of disposable components, maintains records of authorized components in memory, and controls device operation state. This multi-functionality reduces the need for separate dedicated systems.
Solution Approach 2:
The system performs self-verification by comparing the entered authentication key against authorized keys stored in its own memory. The validation computer independently determines validity without requiring external verification systems for each component.
Data Source
Figure 1
Figure 2~3
Figure 4
AI summary
Systems, methods, apparatus, and computer readable media are provided for disposable component authentication with respect to a biological fluid processing device instrument. An example instrument authentication system includes a computer facilitating configuration and operation of the biological fluid processing instrument using a disposable component. A first interface is provided by the computer and is used by a service technician to configure the biological fluid processing instrument for a number of disposable components and to provide a service technician with a validation code. A key generator is to accept the validation code from the service technician and generate an authentication key in response to the entered validation code. A second interface is provided by the computer, the second interface prompting the service technician to enter an authentication key, wherein the authentication key authorizes use of a certain number of disposable components for the biological fluid processing instrument.