Syringe Plunger Unique Identifier for Device Traceability
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Solution Overview
Problem
Current medical devices, particularly syringes, face challenges in individual tracing and identification, especially when mass-produced, as they lack unique identifiers that can track a device from manufacturing to disposal, making it difficult to pinpoint defects and recall affected products.
Innovation Solution
A unique identifier, such as a 2D or 1D bar code or RFID tag, is integrated onto the plunger of medical devices like syringes, allowing for tracing from origin to use and final disposition, storing information like manufacture date, location, and materials used.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If mass production of medical devices is implemented, then productivity increases, but individual device tracing becomes difficult
Solution Approach 1:
The patent divides the identification system into hierarchical segments: lot numbers for batch tracking and unique serial numbers for individual device tracking. This segmentation allows mass production efficiency while maintaining individual device identifiability through the combination of batch and unique identifiers.
Solution Approach 2:
The patent adds a new dimension of identification by incorporating unique serial numbers alongside traditional lot numbers. This dimensional expansion transforms the identification system from two-dimensional (lot only) to three-dimensional (lot + unique serial + device specifics), enabling individual tracing without compromising mass production capabilities.
2Reliability
If lot number tracking is used for mass-produced devices, then recall efficiency improves for entire batches, but pinpointing specific defective devices becomes difficult
Solution Approach 1:
The identification system is segmented into multiple hierarchical levels: lot number for batch-level recall operations and unique serial numbers for individual device-level precision. This segmentation enables selective recall of specific defective devices within a lot rather than recalling entire batches, improving both recall efficiency and defect location precision.
Solution Approach 2:
The patent replaces traditional mechanical tracking methods with automated data capture and processing systems. Barcode scanners and RFID readers automatically capture identification information, and computer systems process and store data, enabling precise tracking and recall operations without manual intervention.
3Loss of information
If traditional labeling is attached to syringes, then device identification is provided, but the label may not remain attached throughout the device lifecycle
Solution Approach 1:
The patent merges the identification system with the syringe structure itself rather than using separate attachable labels. Unique identifiers are incorporated into the plunger assembly, which is an integral part of the syringe that remains with the device throughout its lifecycle, ensuring continuous identification capability.
Solution Approach 2:
The identification information is applied to the syringe components during the manufacturing process itself, before the product reaches the end user. This preliminary application ensures the identifiers are permanently associated with the device from its creation, eliminating concerns about label detachment during use.
4Loss of information
If unique identifiers are integrated into the device structure, then individual tracing capability improves, but device complexity increases
Solution Approach 1:
The patent designs the identification system to serve multiple functions: lot tracking, individual device identification, manufacturing date recording, and recall management. By making the system universal and multi-functional, the complexity is justified by the multiple benefits gained from a single integrated solution rather than separate systems for each function.
Solution Approach 2:
The patent replaces complex manual tracking systems with automated electronic identification and data processing. Barcode and RFID technologies provide automatic data capture, and computer systems handle data storage and retrieval, reducing the operational complexity despite the enhanced tracing capability.
Data Source
AI summary
An identifier is provided to a medical device such as a syringe to uniquely identify the medical device. For a syringe, the unique identifier may be in the form of a bar code printed onto the thumb press, stem, or both at the plunger of the syringe. The bar code may be a 2-dimensional bar code or a 1-dimensional bar code. Alternatively, an RFID tag may be attached to the plunger, for example fitted to or embedded into the thumb press. The unique identifier provides, at minimum, the manufacturing data unique to the syringe so that the history of the syringe may be readily traced and associated with the medical records of the patient the syringe is used for.