How Medical Companies Can Navigate UDI Requirements with Laser Machines

UDI laser marking

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.

Additional reasons why hospitals and clinics would need to keep track of their equipment properly include the following:

  • 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 occur while flowing as smoothly 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.

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.

TYKMA Electrox offers a variety of part marking services from its laser marking systems 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

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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