The first deadline for manufacturers to comply with the U.S. Food and Drug Administration’s (FDA) Unique Device Identification (UDI) rule is just over eight months away. Today, GHX announces it will offer an industry solution that enables manufacturers to publish data to the FDA’s Global UDI Database (GUDID) through a single connection that can meet a variety of needs, such as synchronizing data with business partners for e-commerce or other purposes. The GHX UDI solution will enable manufacturers to overcome the technical challenges of publishing product data to the GUDID, while at the same time, enabling them to gain incremental business value from their UDI investment.
Since 2000, healthcare manufacturers that supply the majority of medical-surgical products to U.S. hospitals have been publishing data on their products to GHX for the purposes of e-commerce. In 2014, manufacturers will be able to leverage their existing connectivity to GHX and its expertise in data accuracy to streamline their UDI publication requirements.
“While compliance with the UDI rule seems to pose some costly, labor-and technology-intensive challenges to medical device manufacturers, UDI may also present an opportunity for them to transform their product master data management strategy for greater process efficiency and business transaction accuracy,” says Karen Conway, executive director, Industry Relations, GHX. “In our experience, the manufacturers garnering the greatest benefit from their UDI investments are those implementing a product master data management strategy that enables them to comply with UDI requirements, including UDI data submission, as well as tackle the product data challenges they are currently facing with other regulations and business partners, including those they do business with globally.”
GHX has been involved with healthcare business partners and regulatory groups working on global data standards in healthcare since 2000 and specifically with the UDI database for the past five years. GHX assisted with the 2009 pilots to test the usability and feasibility of the prototype UDI database and with the 2013 GUDID user acceptance tests. To learn more about the work GHX is doing in the area of UDI, visit the Product Identification section of the Global Data Standards Resource library on the GHX website (UDI Resources).
The GHX UDI solution is designed to help manufacturers meet their FDA UDI compliance deadlines by supporting them through every step of this process, and comprising:
- GHX Business Solutions: Assisting manufacturers with developing a data governance model, establishing a process for capturing, validating and preparing product data, and identifying a staging solution
- GHX Health ConneXion(SM) Data Pool: A GS1 Global Data Synchronization Network (GDSN) compliant data pool that helps manufacturers synchronize product data with customers and business partners via a single channel
- GHX UDI Submission Service: This new GHX offering will enable manufacturers to submit Unique Device Identifiers and the associated attributes to the FDA GUDID in HL7 Structured Product Labeling (SPL) format and review FDA responses to those submissions.
During UDI readiness engagements, the GHX Business Solutions team has found it takes manufacturers an average of nine months to prepare product data for submission to the FDA. Key steps in this process include gathering the required product attributes from various sources, cleansing and normalizing the data, assimilating it into a central repository, and submitting it to the FDA GUDID in the required HL7 SPL format. Manufacturers must also consider how they will communicate to the FDA and other data consumers about product changes that impact these attributes.
A key benefit of the GHX UDI solutions and services is that they will help establish a master data management strategy whereby a manufacturer can both publish UDI data to the FDA GUDID and share product data with other regulators and business partners to address a broad range of global industry and regulatory requirements. By publishing data to the GHX Health ConneXion data pool, manufacturers can synchronize product data with multiple parties using a single data source and route changes to all data consumers in one step. This approach will enable a manufacturer to garner incremental business benefit from its UDI investment in the form of greater operational efficiency and lower costs throughout its supply chain.
“While other UDI preparedness solutions take a piecemeal approach to product data management, leveraging point-to-point systems that draw data out of a supplier’s system for a one-time submission to the FDA, the GHX UDI solution will support a more holistic, sustainable master data management strategy that will enable a manufacturer to not only meet their current needs but also address emerging regulatory and industry demands in this ever-changing healthcare business environment,” said Derek Smith, chief commercial officer, GHX.
The GHX Business Solutions UDI services and GHX Health ConneXion Data Pool are currently available to manufacturers, while the GHX UDI Submission Service is scheduled for launch in early 2014.