Expert panelists from across the medical device ecosystem discussed emerging issues in UDI implementation and how their organizations are working to solve them.
When asked about key issues in UDI adoption, Ms. Erin Quencer, Regulatory Health Scientist at FDA’s CDRH explained, “Fully realizing the benefits of the UDI system depends on UDI being integrated into data sources throughout our healthcare system. This, however, requires UDI data to be of high quality, such that all stakeholders in the healthcare community have sufficient confidence in the accuracy and completeness of the data.” Ms. Quencer concluded that “FDA continues to work with labelers on the implementation of UDI requirements, and we are working on both policy and technical items to help ensure the quality and utility of UDI data. We believe it’s important to continue focusing our resources on addressing implementation issues and data quality, especially for higher-risk devices.”
Mr. Rich Kucera, CEO and Co-founder of Symmetric Health Solutions, discussed the value UDI brings to the supply chain in his remarks. He noted, “Everywhere from rural community health systems to large multistate integrated delivery networks (IDNs) are really looking at UDI right now as a global source of truth as it pertains to the supplies that they procure throughout the supply chain into clinical operations.”
When asked about the role that provider organizations can play in increasing consistent adoption of UDI with suppliers, Mr. Dennis Black, Program Director at Becton, Dickinson & Company, answered, “I think that it’s important for healthcare providers to commit to using the unique device identification information that we have. Some of the participants on this call are effectively using UDI and have a vision of how they’d like to use it going forward. I think we really need to see more of that. I think it’s really going to require a committed use of UDI on the part of the healthcare providers for us to really get value from this.”
Mr. Mike Schiller, Senior Director of Supply Chain for the American Hospital Association (AHA), offered several key points from the supply chain perspective. He discussed the way the COVID-19 pandemic amplified the potential benefit of UDI implementation. “Additional emergency emerging issues have come about as a result of COVID-19,” said Schiller. ”Those would be lack of transparency, utilization, data analytics, and the ability to effectively and efficiently identify recalls, patients affected by the products, as well as the products and their locations. If you look at each one of those emerging issues, UDI is a common denominator to moving each of these forward and achieving the results that we hope to achieve in transparency, utilization data, and efficient recall processes.”
Mr. Chris Muir, Director, Standards Division at the Office of the National Coordinator for Health Information Technology (ONC), discussed the importance of UDI for clinicians to be fully informed while making decisions about their patients’ healthcare. “The bottom line is that the UDI inclusion and certification is aimed at delivering information to clinicians so that they can know what devices their patients have implanted, whether or not those devices are active, and are able to use that information to deliver safer, more effective care.”