The Unique Device Identifier (UDI) has the potential for significant impact on both suppliers and providers, following the Food and Drug Administration’s (FDA) final ruling on UDI requirements. The opportunity for the healthcare community to derive value from the final ruling was the topic of the Dec. 4 Implantable Devices Supply Chain Special Interest Group (SIG) meeting. Online polling of participants during the SIG meeting revealed that suppliers are ahead of providers in developing formal programs for adoption and use of UDIs, 64 percent to 19 percent.
This fifth SIG meeting, hosted quarterly by GHX, tackled the question of where healthcare suppliers and providers could derive the most value from the UDI ruling. Also presenting was Terrie Reed, associate director, Informatics for the FDA’s Center for Devices and Radiological Health, who is currently medical device safety consultant to the chief medical officer at the Office of the National Coordinator for Health IT (ONC). She outlined a collaborative effort between the FDA and ONC as it relates to the documentation of UDIs for implantable devices in electronic medical records.
Other findings from the meeting included participant polling on where organizations see the greatest potential value from UDIs:
“It’s all about visibility,”said Karen Conway, executive director, Industry Relations for GHX. “The final UDI rule provides the healthcare industry with an important opportunity to get closer to solving the cost/quality equation for better patient outcomes. Value from the regulation will come largely from improved visibility into the products being used. Benefits to device manufacturers and healthcare providers can go beyond recall management and adverse event reporting to product authentication, traceability, inventory demand signals and comparative effectiveness research. UDI should be viewed as a strategic opportunity, not simply a compliance effort.”
According to the final UDI rule, device manufacturers will have to assign a unique UDI-compliant code to each covered device. For most products, the UDIs will also include production-specific information such as the product’s lot or batch number and expiration date. Manufacturers will also need to provide additional data about those products to a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID).
The FDA ruling coincides with increased industry attention to the management of implantable devices in the healthcare supply chain. In 2012, GHX launched an initiative to address one of the least automated areas of the supply chain, implantable devices. Two new solutions from GHX – Case XpertSM and Order IntelligenceSM – are among the first healthcare-specific solutions designed to help reduce an estimated $5 billion(1) in losses across provider and supplier organizations each year, in the $50 billion implantable device market.
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.