Curtis Rooney, President of HSCA, recently moderated a panel of industry and public policy experts. Dennis Byer, Senior Director IT SCDM and Standards at Novation, LLC, Jim Scott, President and CEO of Applied Policy, and Frank Moore, Senior Director, Government Relations at HSCA presented the system as proposed by the FDA and as envisioned by HSCA.
Rooney and panelists reviewed relevant background for the rule, including the mandate from the 2012 FDA Safety and Innovation Act, and focused on proposed labeling requirements, data capture by the anticipated Global Unique Device Identification Database (GUDID), and the proposed timeline for implementation.
Explaining the strong interest of the GPO community in a Unique Device Identification system built upon the established GS1 model, Rooney explained, “In two words, it’s patient safety”. The UDI system envisioned by HSCA would have labeling requirements met three years after a final rule and create a landscape that allows hospital can plan for and adopt in an efficient and cost-effective manner.
Panelists responded to questions that asked what healthcare system benefits could be realized from a fully implemented UDI system, how a UDI system could be fashioned to work hand-in-hand with GS1 standards, and why HSCA’s proposed three-year implementation period adequately addresses labelers’ ability to meet the labeling requirements and how compelling patient safety outcomes demand this more efficient phase-in.
Summarizing the webinar, Novation’s Byer, who also chairs HSCA’s Committee for Healthcare e-Standards (CHeS), noted that HSCA is presenting a series of simple principles that should drive the debate and development of the final rule going forward.
“If it can be labeled, then label it. If it’s an implantable device and it can be direct marked, then mark it. If it’s too small for a label, and it can be direct marked, then direct mark it. If it can’t be labeled or marked, then label the device wrapper. Every device should carry a label or mark that allows it to be scanned into an Electronic Health Record in the clinical setting so that true cradle-to-grave tracking is realized with a GS1-based UDI system.”