UDI: Enhancing Patient Safety and Traceability of Medical Devices

Unlike medications, whose primary application is the treatment of diseases, medical devices are present at every stage of medical care. A medical device is any instrument, apparatus, machine, or software that does not perform its function through pharmacological means and is crucial in care, rehabilitation, and diagnosis; for example: prostheses, orthoses, diagnostic equipment, surgical materials, and hygiene products.

In the healthcare industry, ensuring patient safety is the highest priority. Considering the existence of medical devices that outnumber pharmacological substances, how do we ensure that the medical device used is the correct one and the safest for us?

Organizations such as the US FDA and the European Community are making a great effort to make Unique Device Identification (UDI) a global reality.

In 2013, the FDA published the UDI Final Rule recognizing GS1 as a UDI-issuing agency, meaning its standards can be used to meet specific UDI regulatory requirements.

UDI is a regulatory framework in the healthcare industry that enables medical devices to be identified and tracked throughout their life cycle. 

In essence, UDI is the digital fingerprint of each medical device, from the simplest to the most sophisticated. This system assigns a unique and unrepeatable code to each product, allowing complete traceability, from the moment it leaves the factory to its final use, when it is linked to control systems.

The UDI system aims to enhance patient safety by providing accurate and accessible information about medical devices, ensuring quick identification, monitoring, and response to any issues related to their use.

This standardized identification system is globally harmonized, streamlining communication and co-ordination within the healthcare ecosystem.

Device classification is based on the risk they pose to human health, from low risk (such as gauze) to very high risk (such as pacemakers), which are essential for sustaining life.

The adoption of UDI, driven by agencies such as the FDA and the European Community, has demonstrated tangible benefits. In the UK healthcare system, its implementation has yielded the following benefits:

• Patient safety

• Efficiency

• Data interoperability

• Real-time location

• Improved inventory control

• Waste reduction

• Alerts for expiring products

In numbers

• £10 million (US$13 million) reduction in inventory

• 140,000 hours of increased patient care time

• 98% compliance with preventative maintenance for medical devices

An important part of the UDI structure is the Global Trade Item Number (GTIN), better known as the GS1 Barcode, and we must keep in mind that it sometimes needs to change, for example:

• If the quantity of products in a package changes.

• If the packaging changes to be sterile.

• If the product is recalled

• If the label languages ​​change for other countries.

• If the item obtains a new certificate.

When a company requires the use of a UDI to identify its products, they must begin by assigning a unique and unrepeatable identification. This is known as a GTIN in general merchandise (not in the healthcare sector). Depending on the criticality of the product, whether it should include the manufacturing date, expiration date, batch, or other data depends on the classification. In GS1 terms, these are included for communication purposes through application identifiers. The graphical representation of this information is GS1 DataMatrix or GS1 128.

What are the benefits of UDI?

• Increased patient safety
• Improved post-market surveillance
• Enhanced capture of correct information
• Enhanced business processes

Given this scenario, GS1 offers advisory services focused on its standards, both for the manufacturer and the importer/exporter. The latter is responsible for determining the correct path to compliance in each country.

In short, the UDI is a powerful tool that combats the illicit market with the help of enabling technologies and strengthens patient safety, creating a more trustworthy healthcare ecosystem for all.