💡 Key Takeaway: UDI laser marking ensures lifelong traceability, regulatory compliance, and patient safety across the entire medical supply chain.
The medical world is continually expanding, with new technological advances and treatments being produced every day. With these new advances, however, comes an ongoing need for tools that are identifiable with universal systems. This type of traceability is necessary in order to keep track of the medical implants and other supplies being distributed to medical settings worldwide.
Why Hospitals and Clinics Need Equipment Tracking
Along with traceability needs, hospitals and clinics need to track their equipment properly for the following reasons:
- Inventory management – Hospitals and clinics need tracking systems to make sure their inventory is always full to prevent instances of running out of supplies.
- Malfunction tracing – Should a piece of tracked medical equipment malfunction and need a replacement part, doctors would know exactly where that device was manufactured and be able to place an order.
- Accountability – By making traceability mandatory for their equipment, medical device manufacturers are being held accountable in their quest to craft devices that are high-performing and high-quality.
To make this traceability process as smooth as possible, the United States Food and Drug Administration (FDA) and the European Commission have recently passed new UDI, or Unique Device Identification, requirements.
What Does UDI Mean and Why Is It Important?
UDI is a barcode identification system that contains a unique series of numbers and letters that determine a medical device’s data and product identification.
The first part of these numbers and letters that medical manufacturers are required to encode is the Device Identifier (DI), which identifies the device and labeler, rather than the product itself.
The second part of a UDI involves the identification of the product. Products can be represented by various numbers and letters that can include any of the following information:
- GS1 Global Trade Item Number® (GTIN®)
- Batch numbers
- Date codes
- Expiry dates
- Serial numbers
UDIs are important because they’re a form of identification that every single medical device is required to have. They must be represented on packages as labels that are easy to read, and one way that medical device manufacturers are complying with this necessity is via laser marking systems.
Advantages of UDI Laser Marking
Using laser marking applications to meet UDI standards offers long-term advantages:
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✅ Staying compliant with legal requirements – All medical devices sold in the U.S. or EU must include a UDI code. Promoted by the FDA, this supports a standardized system across the entire industry and impacts all medical technology. -
✅ Ensuring longevity of the UDI label – No matter the application, laser marking the UDI code will help it survive harsh environments. The mark is durable, corrosion-resistant, and built to withstand repeated cleaning cycles. A UDI label will stay readable for the life of the device. -
✅ Providing complete transparency for medical technology – Clear labeling of medical products supports overall management and supply chain responsibilities. For example, UDI labels can indicate expiration dates and dictate when it’s time to dispose of a product. -
✅ Supporting patient safety – Properly labeled and tracked medical technology promotes a safer medical system overall, ensuring patients receive the best possible treatment.
Common Questions About Laser Engraving UDI
Is laser engraving considered a safe option in the medical industry?
Yes, once a medical product undergoes laser engraving, the marks will remain intact through any type of medical process, such as surgery or sterilization.
Are all medical devices required to have UDI labels?
With current and upcoming legal regulations in the United States and the European market, UDI is the set standard requirement across the industry for any type of medical device, product, and technology.
Before laser marking medical supplies, what should I keep in mind?
There are key factors to determine before undergoing the laser engraving process to ensure the highest quality outcome. Materials, marking location, and required mark size all dictate the type of laser engraving machine you will need.
| Factor | Why It Matters |
|---|---|
| Material of the device | Dictates the type of laser engraving machine required |
| Location | Affects placement and accessibility for laser application |
| Required size of marking | Determines precision settings and machine specifications |
How Do Laser Systems Play a Role in UDI Requirements?
Laser marking systems are an important asset to medical device manufacturers because they’re able to mark UDI barcodes without affecting the piece’s functionality. Laser systems can also mark on a wide range of packages that have varying sizes and shapes. These may include flat surfaces, cylindrical parts, and more irregular 3D objects.
💡 Key Takeaway: TYKMA Electrox offers a variety of part marking services and can work with you to recommend a system and software that’s ideal for your company.
Other applications for our laser marking machines within the medical industry include, but aren’t limited to, the following:
- Syringes
- Surgical tools
- Dental implants
- Scissors
- Clamps
- Needles
- Tubes
- Implantable medical devices
Ready to Get Started with UDI Laser Marking?
Have any questions about equipment for laser marking medical devices? Simply contact our team today and we’ll be in touch shortly. We look forward to hearing from you!
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