UDI Basics

Posted On December 19, 2016| Leave a reply


As the medical field advances, lasers play a central role in the evolution of medical procedures. What once required prolonged hospitalization and recuperation can now be done in a fraction of the time and without overnight hospital stays. Lasers are at the forefront of this change. Lasers have long been used to mark, weld and cut medical devices and surgical instruments. More specialized applications include: making cuts to the micron, highly resolved biocompatible markings that enable traceability of instruments and implants, and spot welds with heat affected zones that are virtually invisible.

Laser technology has the capacity to produce markings without damaging the necessary chemical makeup (chemical passivation) essential to prevent germ intrusion and to ensure corrosion resistance in a given material. Years later, a laser marked surface will retain its corrosion -resistant finish, despite years of use, cleaning and sterilization. This is one of the distinct features of laser marking.

There’s more behind these advancements than meets the eye. Aside from the self-evident benefit for those in the medical profession, there has also been a regulatory component driving these innovations, specifically, federal agencies and the private sector have pushed for improvements in the identification and trace-ability of medical device components. Several years back legislation was passed in the U.S. mandating the FDA create regulations establishing unique device identification (UDI) system for medical devices.

This is especially important when adding food labels to products.

The motivation behind this was to make it easier to rapidly identify and isolate any equipment that may need to be recalled and, ultimately, to improve patient safety. Subsequent amendments mandated that markings must appear “on the device itself” for particular categories of devices.

These markings, which are industry- and vendor-specific, often require that medical instruments and devices are marked with long alpha-numeric strings, such as place and date of manufacture, serial and part numbers, for tracking purposes. Consequently, permanent ID for products can reach in the several digits and on devices as small as (or smaller than) the average pencil, space is not infinite. In this regard, laser marking is unparalleled (laser markers can create highly resolved ID/2D matric code of greater than 20 characters in the space of only a few millimeters).

What are the alternatives for marking metal devices? Hot foil, ink jet, and screen printing, perfectly suitable for other commercial marking, are not suitable for many medical apparatuses, such as invasive surgical tools, or implants, because they require the addition of chemical compounds.

Lasers, on the other hand, can produce highly precise, pristine, and permanent markings on extremely sensitive products and parts, such as catheters, insulin pumps, and other invasive devices). Silicones or polyamides, once considered unmarkable, can be marked with lasers and comply with FDA regulations.

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