BUILDing Blocks to a High-Value UDI System

July 22, 2022

When the U.S. FDA published the UDI rule, requiring medical devices to be labelled with a unique device identifier (UDI), the government agency fully expected the healthcare ecosystem (suppliers, providers, payors, etc.) to voluntarily adopt the UDI for multiple purposes, thereby building out a more holistic UDI system. That did not happen, with many still insisting that government mandates are the only way we will see broad adoption of UDIs across the healthcare ecosystem and realization of the benefits, from improved supply chain efficiencies to better data on how products perform in routine clinical practice. 

Others, including researchers with the FDA-funded Building UDI into Longitudinal Data for Medical Device Evaluation (BUILD) initiative, have been hard at work documenting what works (and what doesn’t) among health systems that have moved forward with UDI despite the lack of mandates. The BUILD researchers recently published two new reports, both of which provide some helpful guidance, while also highlighting what I respectfully consider to be some now out-of-date excuses. 

The first publication, Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies and Next Steps in Health System Implementation of Unique Identifiers, provides perspectives from multiple stakeholders (clinicians, supply chain and IT) at hospitals where UDIs have been implemented in the Cath lab and/or OR.  They outlined what they consider to be the barriers to adoption.  Several of which are still very real, including:

Lack of organizational support, including not recognizing the time and resources required, often leaving UDI advocates to do extra work on top of their “day jobs” 

• Provider IT Gaps, primarily around lack of interoperability, including closed loop systems that can accept but not share information

• Clinical Resistance to new workflow processes they consider difficult, e.g., knowing which barcode to scan on a product

• Limitations in manufacturer support, with providers viewing many manufacturers as just doing the bare minimum to comply, with little consideration for how providers will use the UDI data

• Gaps in the FDA Global UDI Database (GUDID), with providers noting inconsistencies and errors in product data published by manufacturers in the agency’s publicly accessible database (another UDI regulatory requirement) 

The paper speaks to the importance of continued relationship building and education with those stakeholders that can benefit from UDIs to overcome these challenges. 

The interviews also highlighted another barrier that I believe is no longer a valid excuse: IT technology vendor resistance to deploying broad scale enhancements to support the use of standards.   The interviews with hospital stakeholders were conducted in 2018, when many hospitals were not yet using the most advanced versions of on-premise ERP systems that had begun to support the use of UDIs.  Today, most still using on-premise systems have since made those upgrades, mostly because the major ERP vendors no longer support earlier versions.  At the time, most electronic health record (EHR) vendors had also met Office of the National Coordinator for Health IT (ONC) requirements to support UDIs for implantable devices, but there was still relatively little coordination between ERP and EHR vendors.  Today, that is all changing, most notably with Oracle’s acquisition of Cerner, but all of the major ERP vendors are working more closely with EHR companies.  Much of that is driven by the groundswell of hospitals and healthcare systems moving to cloud-based ERP systems that can leverage the capabilities of virtual item masters supported by technology companies that curate product data from multiple sources, including but limited to the GUDID. 

The second paper, Multi-institutional distributed data networks for real-world evidence about medical devices, explores the use of a distributed data network (DDN) across multiple health systems to generate more robust data about how specific products perform in routine clinical practice.  The three health systems that participated in the research each built their own individual research databases into which they populated data from multiple sources (EHRs, claims and a clinical registry) about the care delivered, including the devices used, for patients receiving one of two different kinds of drug-eluting stents.  The data was populated according to a common data model (CDM) that the systems collaborated to create and which includes UDIs for device identification.  That data, in turn, was made available to all three systems via the DDN for their respective analysis. 

Ultimately, the authors envision a DDN that aggregates data from a substantial number of health systems to provide even more reliable data on product performance.  Based on the results of the other paper, there is still work to be done to ensure data from the GUDID is accurate and actively maintained by manufacturers, while providers have more work to do to ensure the completeness of device data captured in EHRs.  Despite these problems, there is still room to celebrate movement forward, mostly driven by the willingness of various stakeholders to collaborate to build a more complete UDI system that can address our individual and collective objectives.

Karen Conway works to advance the role of the supply chain as a critical enabler in the pursuit of a value-based healthcare system. As Vice President, Healthcare Value for Global Healthcare Exchange (GHX), Conway explores how the supply chain and improved data quality and visibility can support understanding of what increases value for patients and to those organizations that develop and deliver healthcare products and services.