Is UDI a Big Problem for Medtech?

A new poll of medical device professionals suggests it is. 

Chris Newmarker

Only 15% of medical device industry professionals helping to implement FDA's Unique Device Identification rule say their companies are ready for upcoming compliance deadlines, according to a report released this month by enterprise labeling services company Loftware (Portsmouth, NH) and professional services firm USDM Life Sciences (Santa Barbara, CA).

The two companies' poll involved 120 medtech professionals focused on regulatory, IT, and labeling. Most of them--93%--said the UDI requirements were noticeably impacting their company's labeling processes. Only half of them said the barcode labeling software used at their companies would be able to scale to meet long-term UDI requirements from FDA, as well and other requirements coming into play in markets outside the U.S. Nearly three-fourths said their companies were juggling between two and four barcode labeling software services. 

"Many device manufacturers are struggling to meet the FDA UDI compliance timelines--however, the overriding issue to UDI compliance is in developing and implementing a sustainable, extendable UDI program and understanding that UDI is and will be a constantly growing and evolving process. ... I can't stress enough the need to have your approach to UDI compliance be well thought through, well documented, and well implemented--in a way that's going to provide a path forward that can grow and evolve with your organization as new needs and new opportunities come along," said Jay Crowley, USDM Life Sciences vice president of UDI services and solutions. 

The FDA's UDI requirements continue to be phased in. Starting September 24, Class III devices requiring a UDI must have a permanent UDI marking on the device itself if the device is to be used more than once and intended to be reprocessed before each use. The system is also expanding to Class II devices starting September 24, with the UDI required on Class II device packaging and labeling and the UDIs for the Class II devices submitted to the GUDID database.

FDA is having to clarify its rules more, too. FDA released draft guidance last month meant to provide clearer rules around the form and content of the Unique Device Identifier. 

The UDIs are meant to greatly improve tracking of medical devices, helping FDA to identify problems with devices much faster than the present system that relies on self-reporting from medical device manufacturers and health providers. A U.S. Senate report early this year, which examined deadly hospital superbug outbreaks related to a particular type of endoscope, recommended legislation to require and promote unique device identifiers (UDIs) in insurance claims, electronic health records, and device registries for faster FDA identification of problems.

FDA commissioner Robert Califf and Jeffrey Shuren, director of the agency's Center for Devices and Radiological Health (CDRH), recently renewed calls for a national medtech evaluation system.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Image, slightly modified, courtesy of DIGITALART/FREEDIGITALPHOTOS.NET]