How UDI is Improving Medical Devices

The safety and reliability of medical devices is paramount. However, there are times that issues arise, causing safety and other potential concerns. To quickly and efficiently handle these situations when they arise, several practices have been implemented over the years. 

In 2007, Congress decided that medical devices should not face lengthy recall periods like this. It instructed the Federal Drug Administration (FDA) to build a governed identifier system for medical devices. The system’s goal is to decrease medical errors and quicken recalls. 

Thus, unique device identifiers (UDI) were born. After a successful starter implementation saved California over $30 million in supply, the FDA officially published 21 CFR 801 in 2013. 21 CFR 801 requires all medical devices—besides class 1 consumer devices—to have a UDI. Since then, accountability, top-tier patient care, and cost savings have blossomed in the MedTech industry.

What is a UDI?

In short, a UDI is a detailed label that signifies regulatory and product information. The label is a 2D code or a numerical barcode to be scanned by a machine for quick recall. A UDI comprises two parts: device identifier (DI) and product identifier (PI). 

The DI stores regulatory information like the model type and name of the device. Since this indicator is solely for identification, it does not change through the supply chain or post-market process.

The PI does change throughout a device’s lifecycle. This information includes serial numbers, manufacturing data, lot numbers, and shelf life. 

The UDI is stored in a national database called the Global Unique Device Identifier Database (GUDID) and AccessGUDID for the public. 

How UDIs are Made

All devices require a UDI on their packages, and some also require a UDI on the actual device. When a UDI is added to a device, it’s called direct marking. Direct marking is used for devices that have disposable packages and are used on multiple patients through many sanitation cycles. 

When marking a UDI on a package, manufacturers may use a laser, ink printer, or stamping. However, devices needing direct marking are more tricky. 

It’s more difficult to directly mark because the mark must withstand frequent sanitation and be readable even on a complex-shaped device. Not to mention that these devices come in contact with the human body, so the mark also must be biocompatible. Laser marking methods for manufacturers like etching, engraving, and annealing are the best options for direct marking medical devices. 

Laser marking tackles hard metals like steel, and specific lasers are able to tackle complex geometries as well. The codes are high contrast, permanent, and read by both machines and humans. Devices are put onto an assembly line and a laser-marked UDI-compliance code occurs in seconds.

Benefits of UDIs

UDIs standardize the MedTech industry to hold a high standard for patients, manufacturers, and providers. It ensures that all participating parties are benefiting equally.

Prevents Counterfeiting

Although there’s no way to know for sure, Forbes estimates that $1.7 trillion to $4.5 trillion is sold in counterfeit goods per year. Counterfeiters target every industry and make cheap products with cheap labor.

Adding UDIs prevents counterfeiters from being successful in the medical device industry. The addition of UDIs spotlights counterfeit devices because the identifiers are chosen by the organizations GS1, Health Industry Business Communications Council (HIBCC), and the International Council for Commonality in Blood Banking Automation (ICCBBA). Therefore, it’s almost impossible for the number to be replicated or put into the GUDID. 

Lowers Costs

Before the requirement of inputting data into the GUDID system, healthcare providers were not required to track inventory data. Even if they did, the database may have fallen onto a neglected administrative task.

UDIs make sure every provider location is consistently updating inventory. In turn, there’s a better structure for inventory and ensuring correct inventory purchasing. Also, since UDIs promote speedy recall, there’s less of a cost associated with recalling a defective product or going through the claims process. 

Increases Transparency

UDIs improve transparency end to end: from manufacturers to patients. The UDI labeling information stores data that pull back the curtain between a provider and a manufacturer. Both parties are assured that the device is following the correct supply chain, has been updated, and is used correctly. Additionally, the UDIs stored on the database reveal possible defective trends for a transparent view of device production and use.

UDIs also improve transparency for patients. The creation of UDIs is also the creation of the public UDI database, AccessGUDID. Anyone can access this database and ensure a device is compliant. 

Top Tier Patient Care

UDIs benefit manufacturers, healthcare professionals, and institutions, but above all, UDIs benefit patients. The anti-counterfeit protects patients from devices that produce inaccurate results, break easily, or threaten their lives. UDIs make it known to patients that the devices used on them have gone through a detailed device standardization process.

Further, the identification ensures that the correct device is always in the hands of the provider and used adequately. If there is a problem with a defective product or a recall, providers can quickly find the root of the problem with little patient disruption. Patients do not have to wait long periods for a reinstated device. 

The Impact of UDIs Now and in the Future

The success of U.S UDIs and other countries inspires international organizations to discuss a global UDI system. Since supply chains, inventory, and distribution flow through many countries, the International Medical Device Regulatory Forum (IMDRF) advocates for an international system. However, with differing manufacturing and medical regulations, organizations are still trying to figure out how to standardize the system and keep track of it. 

UDIs are leading the MedTech industry into a well-structured structure from end to end. Accountability is flourishing for devices, and all parties are confident in the device manufacturing system. The MedTech industry acts as one singular unit rather than separate providers that are also separate from manufacturers. With an industry made to help vulnerable populations, the UDI is the tie that promises a commitment to upholding the best care.