Loop Label for Medical Device Identification
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Solution Overview
Problem
There is a need for a product and method that allows for the identification and tracking of medical devices throughout their distribution and use, particularly one that complies with national and international standards and regulations, such as the FDA's unique device identification system, which requires unique device identifiers in both human- and machine-readable forms.
Innovation Solution
A supply matrix of material that can be formed into a loop to create a label or tag, made from durable materials like synthetic fibers, with features like slits and notches for easy application and removal, and equipped with human- and machine-readable information, including barcodes or RFID devices, to provide unique device identification and tracking.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a label or tag is designed to comply with FDA UDI requirements including human- and machine-readable forms, then identification and tracking capability is improved, but device complexity increases
Solution Approach 1:
The label is divided into distinct functional segments: a human-readable portion containing text information, a machine-readable portion with barcode or RFID elements, and a loop portion for attachment. This segmentation allows each segment to fulfill its specific function independently while maintaining overall compliance with UDI requirements without excessive complexity
Solution Approach 2:
The label is designed to serve multiple functions simultaneously: it provides human-readable identification, machine-readable scanning capability, secure attachment to medical devices via loop formation, and durable protection of the UDI information. This multi-functionality reduces the need for multiple separate components, thereby managing complexity while achieving comprehensive identification and tracking
2Strength
If durable materials like synthetic fibers are used for the label, then durability is improved, but ease of manufacture decreases
Solution Approach 1:
The label utilizes synthetic fiber materials with specific physical parameters including inherent elasticity and tensile strength properties. These material parameters enable the label to be formed into loops and securely attached to medical devices while maintaining durability through sterilization processes and repeated handling, balancing durability requirements with manufacturing feasibility
3Ease of operation
If features like slits and notches are added for easy application and removal, then ease of operation is improved, but manufacturing precision requirements increase
Solution Approach 1:
The label incorporates discrete structural features including slits and notches that are strategically positioned to enable easy loop formation and attachment to medical devices. These segmented features allow the label to be easily manipulated and applied by users while the manufacturing process controls their dimensions and positions within acceptable tolerances, achieving ease of operation without excessive precision requirements
Data Source
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AI summary
An apparatus and method are provided for tagging or labeling an item or equipment for identification and tracking purposes. The apparatus comprises a length of supply material having a first section with a first opening and a second section that may have additional features such as notches or second openings that are configured to engage with the first opening when the second section is pulled through the first opening in the first section. By pulling the second section through the first opening, a loop of material may be formed and applied around an item or product for identification and tracking purposes. Such a tag or label is particularly advantages for use with medical devices and equipment.