Multiple UDI Issuers Could Slow Adoption, Experts Tell FDA

An FDA decision to allow multiple entities to issue unique device identifiers could backfire and actually impede the uptake of UDI, medical device and healthcare industry experts warn.

Speaking at a workshop hosted by the FDA, HHS’ Office of the National Coordinator for Health IT and Pew Charitable Trusts, panelists said having three different standards for UDI design is proving a significant barrier to the program’s launch.

“There’s no good case for the lack of a mandate” on a single UDI standard, said Leslie Kelly Hall, senior vice president at Healthwise and a member of the federal advisory committee on health IT. Other panelists agreed that UDI will only have value if it is widely adopted in a universal format.

Currently, devicemakers can obtain UDIs from one of three standards-issuing organizations: GS1, the Health Industry Business Communications Council or the International Council for Commonality in Blood Banking Automation. The idea, explained former FDA staffer and UDI architect Jay Crowley, was to minimize disruption of devicemaker operations. Many companies already work with GS1 and HIBCC, while ICCBA standards have wide currency in the blood and tissue markets, said Crowley, who is now a vice president at west coast consultancy USDM Life Sciences.

Russell Branzell, president and CEO of the College of Healthcare Information Management Executives, cautioned that allowing each hospital or healthcare system to implement UDI on its own could lead to “a big mess” where trading partners aren’t able to integrate their UDI systems. A clear, common UDI standard, along the lines of the drug code, is what is needed, he said.

Leigh Anderson, COO of informatics and technology services at Premier healthcare alliance in Charlotte, N.C., said integrating UDI into EHRs will require greater trust and collaboration throughout the industry. But, he added, the technology for sharing UDI data from a manufacturer’s system to a hospital’s system and then to a patient registry exists if stakeholders are willing to pool data. The problem is an abundance of proprietary technology that is blocking the way.

Some panelists suggested that the government could speed integration by insisting that EHRs accept UDI information to gain government certification. “We need to educate software vendors on UDI,” said Joseph Drozda, director of outcomes research at Sisters of Mercy Health System in St. Louis, Mo. “It doesn’t seem like it should be a big deal for any one vendor; they have to know how much customers want this.”

Another sticky wicket is that hospitals still need to find some efficient way to get UDIs into EHRs, as time is at a premium. “For patient safety, the last thing we want is manual UDI entry into the clinical record,” said Chantal Worzala, director of policy at the American Hospital Association. She pointed out that each UDI involves up to 75 characters, and many medical procedures use multiple device components.

The next time you hear about UDIs, it may be from an FDA investigator. Will you be ready with an answer? Stay up to date on all the latest UDI developments with How to Implement UDI: A Guide for Devicemakers.