Unique Device Identification Direct Part Marking with DataMatrix Code

More Transparency, Safety and Convenience for Hospitals and Doctors

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Why DataMatrix Code?

A device that is marked with information such as the serial number or expiration date is easily traceable, and thus its life cycle is transparent to hospitals and doctors. This so called Unique Device Identification (UDI) increases patient safety and, for example, simplifies product recalls.

To mark its devices, Olympus uses DataMatrix Code (DMC), stored directly on all Class I and II products.

Each UDI consists of a unique set of article numbers for all manufacturers, named the Global Trade Item Numbers (GTINs). As components of the GS1 standards*, GTINs identify the manufacturer and the product.

The UDI with all relevant information about the device is stored in the publicly accessible Global UDI Database (GUDID). GUDID is already supplied with relevant background information by Olympus, so hospitals and doctors can use data from this database to identify products.

*see glossary at the bottom of the page

The Benefits of Direct Part Marking (DPM) with UDI A permanently marked and thus uniquely identifiable and traceable product possesses various benefits for hospitals and doctors:

Improved safety

  • Doctors and patients are protected against counterfeit products and components.
  • Valuable data about utilization, sterilization, storage and the actual lifetime of the device are stored and can even enter the patient’s file.

Improved device management

  • The device can simply be scanned and tracked throughout the entire product life cycle and the entire supply chain.
  • Damage and failure reports are done quickly and easily.
  • Material and inventory management are easier to handle.
  • If necessary, the product-recall process becomes faster and more accurate.
  • Product-specific data can be monitored, controlled and easily handled (e.g., requested and automatically transferred).

Improved cost-effectiveness

  • The cost of care can be captured and tracked.
  • Costs for material and inventory management are potentially reduced.
  • Accurate data improves ordering and invoicing accuracy.

Example of the New Olympus Product Labels Using GTIN

Frequently Asked Questions

A scanner which can read 2D codes and the appropriate software are needed. Please contact your software supplier if DataMatrix codes can be used with your software.

Yes, on the outer product labels there are additional non-GS1 bar codes. They are easy to distinguish: Each UDI barcode starts with a (01); other bar codes are logistic barcodes.

The UDI includes the following elements:

  • GTIN – a world unique item number
  • (11) Production Date – for reusable and unsterile items only
  • (21) Serial Number (SN) – assigned by Olympus

Example: (01)12345678910111(11)170105(21)WA123456


  • GTIN – a world unique item number
  • (17) Expiration Date – for sterile products only
  • (10) Batch Number (LOT) – assigned by Olympus

Example: (01)12345678910111(17)170105(10)WA123456


For the DPM of a batch-managed product, the UDI may be supplemented with an additional non-UDI element:

  • (91) Batch Number Annex

The GS1 standards provide a common language to identify, capture and share supply chain data, ensuring important information about products, locations, assets and information about streamlining processes such as traceability.

Yes, comprehensive product information is accessible via the Global UDI Database (GUDID).

Yes!

Codes that Olympus uses consists of either the GS1 DataMatrix Code or a human readable interpretation, or it consists of both of these items.

The DataMatrix Code includes either the serial number or the batch number. In case of a batch number the products come from the same batch and thus have the same UDI.

According to regulatory criteria the following exceptions exist:

1. Single-use devices.

2. If one parent device bears UDI, the other devices including the configurable medical device system may not bear Direct Part Marking.

3. Markings that could interfere with the safety or effectiveness of the device.

4. If it's not technical feasible.

Due to error correction, DataMatrix Codes with damages such as scratches and partly missing sections, distortions, or minor defects can still be decoded accurately and do not cause total failure.

In cases of small or barely readable code, the scanning performance can be improved by making sure the surroundings do not interfere with the scan, for example:

  • Increase ambient light
  • Avoid reflections
  • Avoid shadows

Glossary

DPM = Direct Part Marking (DPM) is the process of permanently marking a device in order to reliably identify its parts and track them throughout their life cycles. Olympus uses DataMatrix Code (DMC) to mark its products. DPM contains the expiration date and batch or serial number of a device.

GTIN = Global Trade Item Numer (GTIN) the code serves as the key to a global Unique Device Identification database (UDID) that contains comprehensive digital information about the products. A worldwide unique article number, consisting of a set of article numbers valid for all manufacturers.

GS1 standards: GS1 is a global standards organization that provides the GTINs.

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