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Implementing Unique Device Identifiers: Are You Ready?

11/02/16

By:

Ricki Wilson, Senior Director, Analytics Services

Unique device identifiers (UDIs) have begun their integration into hospitals and their supply chains. Supply chain leaders are preparing to take the next step in their journey to ensure patients receive high quality products that improve outcomes – and the government is helping pave the way.

The FDA’s requirement that manufacturers label their products with UDIs was a beginning but now the Centers for Medicare & Medicaid Services (CMS) has put in place regulations requiring providers to include UDI for implantable devices in the Common Clinical Data Set and the Office of the National Coordinator (ONC) requires EHR vendors to provide the technological capabilities to support this requirement. 

The CMS ruling requires that to be in compliance with Meaningful Use Stage 3, providers must capture UDI for implantable devices in the patient record in the EHR and include the implantable device list in the Common Clinical Data Set by 2018.

The ONC 2015 IT Certification contains requirements for EHR vendors to include fields that capture UDI, parse UDI into its components (Device Identifiers and Production Identifiers) and display additional attributes from the FDA’s Global UDI Database (GUDID) by 2018. 

In addition, CMS and the FDA have both stepped forward to support the inclusion of UDI in claims data. This is an important step and recognizes the importance of UDI for patient safety, medical device innovation and the development of a National Evaluation System for Health Technology (NEST).

Many hospitals are aware of the benefits and associated cost savings of incorporating UDIs into their hospital’s item master and supply chain systems: locating recalled devices before they are used, managing expired or about to expire inventory, placing orders and confirming the right product is received, just to name a few. Furthermore, integrating the UDI system into patient health records and other clinical systems can ensure more accurate patient information is available to support product recalls, improve coordination of care, support physician/patient decision-making and enhanced quality reporting.

In a recent conversation I had with Nancy LeMaster, vice president, supply chain transformation for BJC HealthCare, she said, “We are putting in place the building blocks that will ultimately allow comparative effectiveness research at the device level. This will ultimately support true evidence-based decision-making that will improve patient outcomes.”

So, what steps should your hospital take to ensure readiness?

Software: Assess current software capabilities and update accordingly to support documentation of the UDI. The software should be able to distinguish among the various bar code and device identifier standards and parse the device and production identifiers.

Scanning: Clinicians and hospital staff should use bar-code scanners and other automatic identification and data capture (AIDC) methods to prevent errors associated with manually documenting UDIs. Scanning capabilities should be able to capture UDI in various formats. This includes linear bar codes, 2-D matrix, radiofrequency identification, etc.

Interoperability: Supply chain management and clinical systems should be able to exchange UDI to support automated product reordering and transmitting UDI information between internal systems. Hospitals should also be able to transmit the UDI to entities outside the facility, such as other health care providers, registries, payers, and patients.

Process: Work through process maps for how UDI can flow throughout your organization, identify what barriers exist, what technical upgrades are needed and how staff will capture and use UDI information.

Following these recommendations will help ensure your organization is prepared to realize the full potential of the UDI system.

In support of UDI implementation, Vizient is an active participant in the Learning UDI Community (LUC), a group organized and hosted by AHRMM. LUC is a broad-based coalition comprised of health care leaders from the association whose goal is to develop a common understanding and approach to UDI adoption for supply chain and clinical care.

To learn more about LUC or to join, click here (membership in AHRMM not required).

About the author. In her role at Vizient, Wilson leads the team responsible for ensuring acquisition, adoption, and utilization of health care data standards by Vizient and its members. She is responsible for leveraging data standards in Vizient tools and databases to drive efficiencies in analytics and to connect supply and clinical data. Additionally, she supports Vizient members in the implementation of data standards within their organizations, and works with suppliers and distributors on transacting with data standards to gain efficiencies in procurement and inventory management.

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