UDI Labeling for Medical Devices

Unique Device Identification or UDI is an initiative that impacts the vast majority of medical equipment providers today. This mandate, signed into law on September 27th, 2007 emphasized the importance of tracking and traceability and opened many doors for the use of laser marking machines to aid operations manufacturing in the medical industry. This article will help you understand how KEYENCE laser marking systems may be able to assist your process today.

What is UDI Labeling?

UDI is an abbreviation of Unique Device Identification, a system used to identify medical devices. Read on to learn basic knowledge of UDI, adoption advantages, and the corresponding marking methods.

Identifying medical devices improves safety in the medical field, including in the distribution stage. This operational system was designed to make providing optimal treatment even easier. A unique device identifier comes in two forms: device identifiers and production identifiers. Device identifiers identify the product’s name, while production identifiers are the product code, lot number, expiration date, serial number, and manufacturing date. With all this information readily available, traceability practices and anti-counterfeiting efforts are even better than before.

In December 2013, the International Medical Device Regulators Forum (IMDRF) published guidance for the international adoption of UDI. Currently, UDI is only mandatory within the USA, but other countries are also pursuing compliance.

When labeling a unique device identifier, there are strict UDI requirements. The UDI must be clearly shown on a device and be readable by humans and machines. Information from UDI medical devices must be uploaded to the FDA Global Unique Identification Database (GUDID), which is then processed into the public GUDID, also known as AccessGUDID. Anyone from patients to healthcare providers and manufacturers can view the AccessGUDID and learn more about medical devices.

What are the Advantages of UDI Labeling?

Quality Control by Monitoring How Frequently Tools are Used

Since UDI medical devices are linked to the GUDID, healthcare professionals can track their use of tools and the tool’s life cycle. With that information, healthcare professionals can see if a tool was used beyond its life term and is no longer effective.

Optimized Part Replacement and Ordering

With the ability to quickly access information about the source of a part, part replacement is sped up. If a part breaks, a healthcare professional can quickly use the unique device identifier to find where it came from and instantly order the same part again.

Improved Efficiency and Standardization of Instrument Sets

Unique device identifiers simplify the process of assembling instrument sets by being a reference point for employees. With a clear reference point, there are fewer mistakes of instruments being confused with one another and put in the wrong instrument set.

In-Process Instrument Tracking (Location Management)

When a medical device is manufactured with a unique device identifier, the tracking data is updated at each location. Because of this, anyone in the manufacturing process has a clear view of the devices coming in and out of their location.

Excess Stock Control

Instead of manufacturers over-producing and healthcare locations over-ordering parts, both parties can easily use UDI medical devices to refer to the GUDID and view stock.

Loss and Theft Analysis

A unique device identifier tracks a device throughout its manufacturing process. From the initial production site to the final location, UDI medical devices are traced the whole way. Because of this, if a device is lost or stolen, the UDI shows the exact location where the problem occurred. With this information, a location-specific investigation is launched.

Laser Marking Solutions for UDI Compliance

One of the most common means of producing these UDI markings on a vast array of medical devices is through laser marking. Using a laser marker for UDI compliance guarantees that UDI medical devices follow requirements. Laser marking creates clean, high contrast, and permanent marks that withstand the stringent post-production verification and testing cycles that medical devices must endure. Unlike ink, marks from a laser do not smudge, erase, or distort over time.

Using a UV laser, specifically KEYENCE’s 3-Axis UV Laser Marker MD-U Series, is a sure way to meet UDI requirements. This UV laser doesn’t rely on heat stress to mark and produces permanent marks that remain permanent and visible even with consistent washing. The 3-axis control of the laser autofocuses for the laser marker to mark even the most compact and odd-shaped devices. Additionally, the MD-U’s thin laser beam makes for small but precise marks that are readable by machines and humans.