The deadline for medical device manufacturers to comply with the FDA’s Unique Device Identification (UDI) is looming. Global Healthcare Exchange (GHX) announced it now enables medical device manufacturers to publish data to the FDA’s Global UDI Database (GUDID) and synchronize product data across systems through a single connection.
This is critical, as healthcare’s move from a fee-for-service to a fee-for-value environment requires manufacturers to overcome the technical challenges of publishing data to the GUDID. GHX empowers manufacturers to transform their master data management strategy for greater process efficiency and lower costs throughout the supply chain, resulting in tangible UDI investment returns.GHX has already helped US supplier/provider customers save $4B+ by leveraging the supply chain to provide critical data to achieve better costs, quality and outcomesSince 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.
