A Simple Concept With Enormous Promise

Unique Device Identification (UDI) is a simple concept with enormous promise. It holds the key to unlocking supply chain efficiencies and the potential for improved patient safety and outcomes. The secret lies in understanding how this system works and what every stakeholder in the healthcare supply chain must do to ensure that it is implemented properly.

Origin of UDI

In 2007, Congress instructed the FDA to create a system that would identify medical devices and guarantee uniqueness. The goal was to help the FDA track devices more effectively and keep unsafe products out of the marketplace. UDI addresses this need, but also has other potential benefits, including improved post-market surveillance and ties to comparative effectiveness.

The FDA has now released its proposed regulation. Once in place, manufacturers will have up to five years to submit information to a centralized database and mark their products. Manufacturers will also be able to use existing commercial barcode standards to comply with the upcoming directive.

Uniting Both Worlds

UDI occupies a critical space in healthcare.

The barcode standards are an essential element in an efficient supply chain. These indicators also allow clinical systems to match individual medical devices to specific procedures. The framework of UDI unites both worlds through the use of a single, unique identifier.

What UDI Means For Healthcare

A number of recent studies identified billions of dollars in potential savings in the healthcare supply chain if the system could operate more efficiently. When compared with other industries, one of the key differences is the healthcare supply chain’s lack of a standard model for device identification. In fact, a single product can have multiple reference numbers: manufacturer reorder codes, hospital system codes, and possibly even distributor codes. This multiplicity of numbers can make identification difficult and standardization nearly impossible.

UDI will eventually provide a common platform.

Barcodes are commonly used in other industries. Retailers and grocers have employed this underlying technology for decades. Every checkout scanner relies on the same basic rules. Without this crucial infrastructure driving clean master data, healthcare is unable to adopt many of the best practices that power the most efficient supply chain operations. 

UDI will also help simplify recalls.

Instead of searching for all of the aliases for any specific product, we can use the UDI to help provide a common reference that can pinpoint the issue with much greater precision.

UDI may also help improve outcomes for patients.

UDI will serve as a key component in the creation of medical device registries. The FDA is now sponsoring direct research to investigate additional uses for these identifiers. Through the Medical Device Epidemiology Network, there are studies underway to examine the potential use of the UDI in longitudinal studies and comparative effectiveness.

There are other potential uses for UDI. The Centers for Medicare and Medicaid Services (CMS) are planning to add UDI requirements into their reimbursement rules. UDI may also provide a solid link to electronic health records and could offer objective data that may reduce procedural variation that increases the overall cost of care.

In order for UDI to succeed, every stakeholder must contribute to the cause. Manufacturers must provide accurate information to the FDA and mark their products according to the established guidelines. Caregivers will have to adopt the appropriate equipment and tools to help account for their inventory and tie the proper products to their patients. Our united efforts will help to transform this important idea into an essential element of modern healthcare.

Federal Drug Administration Safety and Innovation Act (FDASIA)

Since the initial announcement by the U.S. Congress in 2007 informing the U.S. Food and Drug Administration (FDA) that the agency would be required to create an industry standard system of labeling and tracking all medical devices, Covidien operations has been preparing.

On July 9, 2012, the U.S. Congress passed the Federal Drug Administration Safety and Innovation Act (FDASIA) that requires the release of the UDI rule and compliance for life supporting and life sustaining devices within two years. On July 10, the FDA released its draft regulations and Covidien is ready.

Covidien has launched a program for the implementation of UDI (Unique Device Identification) to drive compliance to global / regional regulations and conformance to customer and industry requirements, while maximizing operational efficiencies leading to enhanced patient care and safety. The UDI Program at Covidien will deliver Unique Device Identifiers using the GS1 Data Standards, product attribute data through enhanced data systems and application of Unique Device Identifiers to Covidien labeling.