Today’s long-awaited release of the U.S. Food and Drug Administration’s (FDA) final Unique Device Identification (UDI) rule has far-reaching implications not only for manufacturers, but also for the healthcare community as a whole. While the rule introduces additional, complex requirements for manufacturers, it likewise opens the door to great opportunities. Those manufacturers that take a holistic, strategic approach to UDI can derive operational benefits, while helping their customers capture better data about the products used in patient care.
The UDI rule requires healthcare manufacturers to label covered products with a unique device identification code and provide additional information about their products to a UDI database. While some organizations will consider UDI as yet another regulatory box to tick, that would be a mistake. UDI should be looked at by all healthcare parties – not just manufacturers – as an opportunity to get a 360-degree view of the healthcare supply chain. This includes regulators seeking a better approach to post-market surveillance, manufacturers having better control of and visibility to their regulatory master data and hospitals being able to do the kind of analytics necessary to achieve more value for the healthcare dollar.
According to Bruce Johnson, president and CEO at GHX, “Those who look at UDI holistically will play a pivotal role in improving clinical effectiveness and patient safety, while removing waste and inefficiency from the healthcare system, which, at the end of the day, is what really matters.”
GHX has many educational resources for how both healthcare manufacturers and providers can prepare for the FDA UDI rule, including:
About GHX
Global Healthcare Exchange, LLC (GHX) is driving costs out of healthcare by transforming the healthcare supply chain. Working with providers and suppliers, GHX is accelerating change by providing a faster, more efficient and collaborative supply chain that will take billions of dollars out of the cost of healthcare. For more information, visit www.ghx.com and The Healthcare Hub.