Laser Marking for UDI

UDI is an abbreviation of Unique Device Identification. 

Identifying medical devices helps improve safety in the medical field, including in the distribution stage. This operational system was designed to make providing the optimal treatment even easier. 

In December 2013, the International Medical Device Regulators Forum (IMDRF) the UDI Guidance document in order to ensure global consistency in adoption of the UDI system. 

At present, only the US is subject to the UDI rules, but other countries are also gradually adopting the UDI system.

UDI requirements in the US

Need for direct marking

Advantages

What kind of marking is necessary?

Comparison of laser marking methods

Advantages of cold marking

Ability to mark extremely small codes

UDI requirements in the US

Put into effect in the US in September 2013, the UDI system gradually became mandatory a year later in September 2014. Adoption of the UDI system began on the following dates in other countries where production of US-bound medical devices exists.

Classification Incidental conditions Label display

database registration Main unit display

Class III and 

PHA (Public Health Act)

licenced products Life-support/extension equipment 09/24/2014 09/24/2015

Equipment not for life support/extension 09/24/2016

Class II, Class I,

unclassified Embedded devices 09/24/2015 Non-operating

Life-support/extension equipment 09/24/2015

Class II Other than the above 09/24/2016 09/24/2018

Class I, unclassified 09/24/2020 09/24/2022

Refer to: GS1 Healthcare Japan conference “Operational guide to direct marking on to medical devices”

Typical products made with laser marking

[Class I]

Components related to the following equipment, small steel objects

[Class II]

Endoscopes, X-ray diagnostic equipment, ultrasonic image diagnosis equipment

Need for direct marking

Medical instruments such as steel instruments and endoscopes are generally compact and precise. Repeated use after washing and sterilising is common, so usual display labels such as paper or film are problematic due to limited space for affixing and long-term durability. 

There are also unacceptable risks in terms of medical practices, such as the label coming off during surgery and becoming residual foreign particles within a patient’s body. 

These concerns have resulted in a growing need to establish a system that incorporates a direct marking method.

Need for direct marking

Advantages

Managing medical equipment through the use of direct marking carries the following advantages.

Quality maintenance through tracking of usage frequency

Optimisation of replacement/order timing

Improved efficiency and standardisation of instrument sets

Tracking of processes for each instrument (location management)

Reduction in excess inventory

Analysis of loss/theft

Advantages

What kind of marking is necessary?

The following GS1 code is used for direct marking on medical instruments.

GS1-128

GS1 Data Matrix (if surface area for GS1-128 cannot be