FDA's unique device identifier (UDI) system is supposed to help providers track medical devices, but few hospitals have implemented the technology necessary to leverage the information, Adam Rubenfire and Joseph Conn write for Modern Healthcare.
Challenges getting UDIs into EHRs
FDA in September 2013 issued a final rule establishing its UDI system. The final rule calls for manufacturers to assign UDIs to medical devices to make it easier to track the devices' expiration dates, lot or batch numbers, and manufacturing dates.
FDA is phasing in the UDI system over seven years, and so far, most manufacturers have been successful in phasing in UDIs for their products, Rubenfire and Conn write. But even though device data are now available, few providers have the technological capacity to leverage the data to their advantage.
One challenge is that the Office of the National Coordinator for Health IT has not mandated that EHR manufacturers include UDI data-capture abilities into their systems—a decision that stakeholders say could lead to input errors and incompatible systems. And providers are not required to incorporate UDIs into patient records.
The result? So far, no EHR developer has certified a product as capable of handling UDIs.
For its part, the American Hospital Association (AHA) has supported UDIs for their potential to help patient safety, according to Ashley Thompson, AHA's senior vice president of public policy analysis and development. But AHA also has voiced concerns about UDI adoption, saying implementation will present a major burden to providers and will require technological upgrades, particularly if UDIs are added to claims forms, as some have suggested.
Suzanne Alexander-Vaughn—a senior product manager at Omnicell, developer of the supply-chain-management system, Optiflex—described the complexity of the integration: For EHRs to receive UDI information, they need to have matching data fields. "It's not a huge leap for most of these systems to have that information," she said. "But when you start lining it up between systems ... making sure you're both talking about the same product is where you sometimes come up with that challenge in identifying the product across the systems."
EHR manufactures including Cerner, Epic, and Meditech say their systems will be ready by 2017. The challenges they currently face, however, include a lack of standardized UDI formats, the absence of a set way to record and migrate UDI codes into EHRs, and time constraints.
Geoff Smith, associate vice president for product development at Meditech, said of EHR-UDI integration, "I wouldn't say it's easy ... This one is pretty big when you add up all the things that are modified and all the technical complexities."
Other avenues toward implementation
Terrie Reed, FDA's senior adviser for UDI adoption, said agency officials aren't particularly concerned with the slow adaptation of EHRs to include UDI data. She noted providers can access and leverage UDI data if they incorporate UDIs into the inventory management process.
But incorporating that data isn't simple, Rubenfire and Conn write. Many hospitals lack the necessary inventory management software, while others don't know that it's possible or even beneficial.
Those benefits have been proven. In 2013, the hospital and its supply chain organization ROi participated in an FDA-sponsored demonstration evaluating the effects of recording UDIs from coronary stents in Mercy health system's inventory management system. The system found that UDI capture prevented procedure delays, cut costs, and boosted revenue by making inventory management more efficient. Moreover, according to Paul Helmering, ROi's VP of information and technology systems, the UDI capture let the system track specific devices' outcomes in specific patients.
Mercy is now implementing Omnicell's Optiflex data-capture system to enable providers in the system's operating rooms and catheter laboratories to scan product barcodes and log the information into both the inventory management system and its EHR. Currently, Optiflex can send device data to Epic and Meditech EHRs; Omnicell is trying to add Cerner to the list.
To spur widespread adoption, Helmering said providers must be made aware of these benefits. "Until that becomes clear and people start understanding, I think there's going to be slow adoption," he said (Rubenfire/Conn,Modern Healthcare, 9/17).
Why the EHR life cycle is just like raising a child
A successful EHR system requires budget, resources, and planning—not only before it goes live, but after as well.
In fact, the process of implementing, deploying, maintaining, and optimizing an EHR system is similar to that of raising a child—each stage of the process requiring a unique subset of people to ensure its success. Learn more about the seven stages of the EHR life cycle in this infographic.