Today, a UDI is required on labels and packaging for all FDA-rated Class III devices—the highest-risk devices on the market because their failure could be life-threatening—and all implantable and life-supporting and -sustaining devices. Manufacturers must submit data for these products to the FDA's global database. On Sept. 24, both of these requirements will be extended to Class II devices and two years later to Class I.
All life-supporting or life-sustaining devices that are intended to be used more than once and eventually reprocessed must bear a permanent UDI marking. This requirement will be phased in by device class for all multi-use devices by 2020.
FDA officials aren't especially concerned that EHRs aren't ready, said Terrie Reed, the agency's senior adviser for UDI adoption. Even if the UDI isn't included in the EHR, Reed said, the ability to specifically identify devices will still help providers, especially if they include UDIs in their inventory management processes.
That's possible, but it's not easy. Many hospitals don't have the sophisticated inventory management software that's necessary. Other just aren't aware that it's possible—and also useful and important.
Chesterfield, Mo.-based Mercy, along with its supply chain organization, ROi, participated in an FDA-sponsored demonstration project in 2013 that studied the benefits of recording UDIs from coronary stents into the hospital's inventory management system. The study found that UDI capture prevented procedure delays, lowered costs and increased revenue by more efficiently managing inventory.
Before this system was implemented at Mercy, its hospitals used a color-coded system of Post-it notes that denoted when a product would expire. Now Mercy is phasing in point-of-care systems in its operating rooms and catheter labs that allow providers to scan the barcodes of products, logging the UDI-related information into its inventory management system and its EHR from Epic Systems Corp.
Not only has UDI capture automated a rudimentary sticky note system, but it's also allowed the system to track outcomes related to specific devices in specific patients, said Paul Helmering, ROi's vice president of information and technology systems. That benefit needs to be conveyed to providers, he said.
“For providers, there's really not that burning desire to utilize the information,” Helmering said. “Until that becomes clear and people start understanding, I think there's going to be slow adoption.”
Mercy's UDI capture system was made by Omnicell, a Silicon Valley provider of supply chain software and equipment, which estimates that around half of all hospitals have some kind of supply-chain-management software. The system, called OptiFlex, can send device data to Epic and Meditech EHRs, and the company is working with Cerner Corp. on integration. But Suzanne Alexander-Vaughn, a senior product manager at Omnicell, said the EHRs will need to have matching data fields to receive this information.
“It's not a huge leap for most of these systems to have that information,” Alexander-Vaughn 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.”
The FDA's UDI regulation applies only to the companies that make and distribute the products. Other government agencies have been working on the other pieces of the puzzle.
The CMS incorporated UDIs into the Stage 3 requirements for the meaningful use of EHRs, and HHS' Office of the National Coordinator for Health Information Technology included it as essential functionality in the 2015 certification requirements for EHR products. But resistance from providers and vendors has pushed back implementation of those rules.
Acting CMS Administrator Andy Slavitt, meanwhile, joined FDA Commissioner Dr. Robert Califf in a letter calling for UDIs to be logged in universal health insurance claims, a measure pushed by policy experts as a way to ensure the identifiers are put to use before EHR technology catches up. HHS endorses including UDIs in claims, they wrote, “if sufficient funding and resources are provided to make the necessary Medicare claims processing system changes.” They also acknowledge it would require a change in workflow and systems for providers and billing companies, and it's unlikely such a change would precede UDIs in EHRs.
Though it's been an advocate for an improved device identifier system, the American Hospital Association has expressed concerns about implementation, including delays in EHR support. The AHA has previously said that implementation will be a major burden on providers and require significant technology upgrades, especially if UDIs are to be added to claims forms.
“Patient safety is of the utmost importance to hospitals, and we support a UDI, because we believe it can lead to improved patient safety, and it can also create supply chain efficiency,” said Ashley Thompson, AHA's senior vice president of public policy analysis and development. The AHA is adamant that UDIs be stored with clinical data so that hospitals are able to swiftly inform their patients if they may be in danger, she said.
No EHR developer so far has any product tested and certified as capable of handling UDIs. Meditech, Cerner and Epic, three of the biggest EHR vendors, say their systems will be upgraded to handle the identifiers by 2017, at which point providers will need to make upgrades.
The developers face technical challenges such as a lack of standardization for UDI formats, no set way to record and migrate UDI codes into EHRs, and time constraints since they must incorporate other new certification requirements into their software.
“I wouldn't say it's easy,” said Geoff Smith, associate vice president for product development at Meditech, a Westwood, Mass.-based developer of hospital and physician EHRs. “This one is pretty big when you add up all the things that are modified and all the technical complexities.”
Even the Veterans Health Administration, which is often seen as an innovator, has struggled to put together a system for tracking device information. In 2014, the Veterans Affairs Department suspended development of a system that would have allowed it to electronically store and retrieve information about surgical implants and the veterans who receive them, according to a GAO report.
Though the FDA requires a machine-readable version of the UDI on device labels, the ONC did not require EHR developers to build UDI data-capture capabilities into their systems, such as barcode scanning, so labels could be automatically captured by providers.
In the 2015 update of its EHR rule, the ONC said it expects customer demand to drive the market for UDI scanning without the ONC requiring it. Patient-safety advocates and providers have pointed out that barcode scanning will be essential to prevent data-entry errors and avoid the labor strain of manual data entry.
In its comments on those requirements, the Electronic Health Records Association criticized the lack of guidance on how to handle UDIs when exchanging information between physicians' EHRs. Ambiguity in the data exchange standard, called the Consolidated-Clinical Document Architecture, could lead to “variant, incompatible implementations,” an organization spokesman said.
Alexander-Vaughn, at Omnicell, said EHR vendors are late in developing products that make use of UDIs because, when UDIs were first being developed, vendors were busy implementing many providers' first-ever EHR systems during the wave of IT adoption under the federal EHR incentive program fueled by the 2009 stimulus law.
EHR developers “were heads-down at the time, just trying to get systems in place, trying to meet huge demand and trying to get things done around clinical documentation,” Alexander-Vaughn said. “I think they did not really have the focus on what the impact of UDI would be on their systems and how it could flow through the entire hospital and the entire healthcare supply chain.”