In 2013, the U.S. Food and Drug Administration (FDA) established a unique device identification system to adequately identify medical devices through their distribution and use. The system, when fully implemented in 2020, will require the labels of most devices to include a unique device identifier (UDI) in a form that uses automatic identification and data capture technology and is searchable in the publicly available Global Unique Device Identification Database (GUDID). Life-supporting or life-sustaining class III medical devices, such as implanted pacemakers and heart valves, were required to be appropriately labeled and added to the GUDID by September 2015. By this September, class II devices will have to be compliant, followed by class I devices in 2018.
FDA’s reason for establishing the UDI system was twofold: to reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use, and to improve the quality of information in medical device adverse event reports. From a supply chain perspective, adopting standards can also help improve and streamline inventory management.
Any way you look at it, adopting standards is a good idea—better adverse event reporting leads to increased patient safety, while supply chain efficiency results in cost reduction. But it’s also an expensive one. Standards adoption requires investments in new or upgraded systems that can read the data, as well as be interoperable with other clinical, supply chain and finance systems in the organization, according to Carrie Wilkie, vice president of standards management for GS1 US, a nonprofit charged with setting standards to improve supply chain management and one of the FDA’s three accredited issuing agencies for UDIs.
“It can be a huge undertaking because all of the systems, hardware and software have to speak the same language,” she says. “But that’s also the beauty of standards. Having one single standard means you always know your systems are talking and you can plan for what’s coming, in terms of new standards initiatives.”
The massive scope of standards adoption means hospitals, in general, have been slow to adopt them, says Greg Bylo, vice president of healthcare for GS1 US. That, and the standards just aren’t that commonplace—yet.
Currently, only about 15 to 25 percent of devices have UDIs. Later this year, when class II devices will have to be in compliance, up to three-quarters of all devices will be labeled with UDIs. When that happens, providers should be more likely to adopt these standards in their organizations, he says.
“As hospitals start to see these numbers on more devices, it will make sense to start using them,” Bylo says. “The next two years will be a major tipping point for providers.”
In line with the FDA’s work on UDI compliance, the Office of the National Coordinator for Health Information Technology (ONC) announced in October a final rule that will require the integration of UDIs in electronic health record (EHR) systems. That’s also when the Centers for Medicare & Medicaid Services (CMS) announced it would tie some of its Stage 3 meaningful use incentive payments to UDI integration. While the fate of the meaningful use initiative is to be determined, it’s likely that UDI integration will be included in a future version of the agency’s EHR incentive program.
Compliance Dates for UDI Requirements:
Sept. 24, 2014 Class III devices needed to be compliant.
Sept. 24, 2015 Implantable, life-supporting and life-sustaining devices needed to be compliant.
May 2016 Global Data Synchronization Network Major Release 3 added on environmental attributes.
Sept. 24, 2016 Class II devices will have to be compliant.
Sept. 24, 2018 Class I devices will have to be compliant.
2023 The Drug Supply Chain Security Act, which sets up an electronic, interoperable system to identify and trace certain prescription drugs, will be fully phased in.
The Drug Supply Chain Security Act of 2013, which is creating an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States, will also influence standards adoption by providers with pharmacies. The program will be fully phased in by 2023, and GS1 US is working on creating a series of standards and tools, including the Electronic Product Code, to help pharmacies capture the information that’s required of them.
These coordinated moves by various government agencies should force hospitals into adopting standards, Bylo says.
“Previously, the UDI requirements didn’t appear to pertain to providers, but these new regulations from the FDA, ONC and CMS show they are moving in that direction,” Bylo says. “The excuse that hospital providers can’t capture the information will no longer work. They’re going to have to. It can be manual, but ultimately we see it moving in the direction of automation.”
UDI: Speaking the Same Language
Healthcare organizations can leverage other GS1 US standards. With a Global Location Number (GLN), hospitals can communicate with hundreds of suppliers using a single, standards-based identifier instead of numerous proprietary account numbers, helping to reduce order discrepancies, and invoice and shipment errors. As a supporter of the GLN initiative, HealthTrust assigns GLNs to each of its members. Additionally, HealthTrust has modified its IT systems to support business transactions using GLNs.
Using Global Trade Identification Numbers in supply chain transactions helps reduce ordering errors associated with the unit of purchase and can help improve invoices and shipping notifications, while their use in identifying products in patient records supports and facilitates recalls.
Finally, the GS1 Global Registry and Global Data Synchronization Network (GDSN) is a shared data pool of product information on more than 15 million products worldwide.
Dona Kambeyanda, assistant vice president of Business Solutions at HealthTrust, says members should be aware of these standards and working toward adoption, while understanding that they’re still in development.
“It all starts upstream, and the very last step of the process is on the provider side,” she says. “We’re now at a point where we have partnered with a GDSN solution provider and working through how best to ingest and manage the data for downstream consumption.”
As a member of Practice Greenhealth’s GPO Workgroup, HealthTrust was instrumental in helping GS1 US add environmental attributes to the GDSN to help facilities better identify products in support of their sustainability initiatives. The environmental attributes had previously been available as an add-on, but will be available to all users in the roll out of GDSN Major Release 3 in May 2016, says GS1 US’s Wilkie.
Meanwhile, “Practice Greenhealth is in the process of updating its standardized questions for Environmentally Preferable Purchasing (EPP) and continues in its efforts to make the supplier community aware of the importance of providing this data at the line-item level to assist providers in their purchasing decisions,” adds Faye Porter, director of Education & Sustainability for HealthTrust.
Some third-party data sources are attempting to help standardize information around these attributes so suppliers can complete the information one time, in one format versus responding separately to multiple GPO requests for proposals, all asking the information in different ways.
Promoting Standards Adoption
Regarding today’s typical user of GS1 standards in healthcare, Bylo suggests, “Organizations with that strategic vision tend to be IDNs or larger hospitals. They see the potential impact on patient safety and realize there is a financial benefit to adopting the standards sooner rather than later. But if you’re a smaller hospital, your balance sheet is tighter, and your resources are fewer, so you can’t prioritize GS1 standards adoption because there are other, more pressing issues.”
Another problem is the lack of information about return on investment (ROI), though the FDA does say that integrating UDIs in electronic health records will save $16 billion in supply chain costs annually. To help sell standards adoption, GS1 is in the process of developing ROI estimates, which Bylo expects to be ready in the coming months. “We want to demonstrate that there are financial benefits to adopting these standards, and that it’s not just a good thing to do,” he adds.Share Email