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KSR Publishing, Inc.
Copyright © 2016

         Clinical intelligence for supply chain leadership



November 2014

Standard Practices


Questions can be e-mailed to: editor@hpnonline.com

Called in to Jeannie Akridge at:
(941) 927-9345 ext.202

Mailed to:
HPN Standard Practices
2477 Stickney Point Road,
Suite 315B
Sarasota, FL 34231

UDI: We’ve only just begun

by Karen Conway, Industry Relations Director, GHX

The first official deadline associated with the Food and Drug Administration’s (FDA’s) Unique Device Identification (UDI) Rule has come and gone, but for manufacturers, their work around compliance has only just begun. As of September 24, 2014, all Class III products were to be in compliance with the UDI rule. That includes making sure the products are labeled with UDI compliant codes and publishing additional data attributes on those products to the FDA’s Global UDI Database (GUDID). Another deadline looms, next September 24, for products described as implantable, life-saving and life-sustaining regardless of class. You can find a list of those products on the FDA’s UDI website at: www.fda.gov/udi. All remaining Class II devices must be in compliance by September 24, 2016, and all non-exempt Class I devices two years later. Within two years, more than 50 percent of products should be in compliance. But even then it is not the end, but rather just the beginning.

Manufacturers will need to keep the GUDID updated, as new products are added to their portfolios of devices sold in the U.S., as products are withdrawn from market, and as changes are made to those products, especially when those changes are significant enough to warrant a new UDI. The FDA plans to make the UDI the way it will identify products across the agency for a variety of regulatory purposes. This includes requirements around how "user facilities" (think hospitals and other healthcare delivery organizations) report adverse events involving death to the FDA.

Some manufactures like Covidien have decided to do more than just "check the regulatory box" to comply with the rule. Covidien used the regulation as the catalyst to invest in a master data management (MDM) strategy that will not only make it easier to comply with UDI-related regulatory requirements, but also to create a true master catalog for Covidien’s products and their attributes. David Brooks, Senior Project Manager, Corporate Project Engineering, and Covidien’s UDI lead, says, just like the FDA, Covidien wants to identify the same product with the same unique identifier for multiple purposes, e.g., for billing, rebates, e-commerce, inventory management, etc., as well as regulatory compliance.

Covidien began working on both UDI and its MDM strategy several years ago, which helped the company get a headstart on its UDI compliance efforts. In August, more than a month ahead of the deadline, Covidien, working with GHX and PTC, successfully submitted data in the required Health Level 7 Structured Product Label format to the GUDID. But Brooks says it did not come easy. "We were one of the first suppliers to begin working on UDI data submission to the FDA, but it was harder than any of us thought it would be."

Submitting data to the GUDID is a new process — for manufacturers, for third-party submitters and the FDA. A collaborative effort among all parties was necessary to understand how to format the data in a manner acceptable to the FDA and to understand when and what kinds of corrections were required to ensure a successful submission. Brooks advises other suppliers to be prepared for several attempts before getting it right. "Key to our success was the ability to submit our data first to a staging environment provided by GHX and PTC where we could pre-verify the data in what is essentially a submission simulator. We were able to catch a lot of formatting issues before actually submitting our data to the FDA," explains Brooks. As a result, Covidien achieved a high compliance rate on its first submission, as opposed to taking multiple attempts to get it right.

Covidien has also decided to take a portfolio wide approach to UDI, working on the data for all of its products at once, rather than just focusing on those covered by the most pressing deadline. "It might have been easier to begin with, but we would have faced scalability problems down the road." [Covidien has hundreds of Class III products, compared to tens of thousands of products in other classes.] "Plus," adds Brooks, "It would have taken longer for Covidien and its customers to reap the benefits of its master data management strategy."

Covidien’s strategy took into consideration not only the need for regulatory compliance, but also the benefits that can be provided to both the company and its customers. For example, Covidien is eliminating redundant work and potential version control issues that come with managing multiple databases. It also hopes its efforts around UDI and MDM will make it easier for customers to do business with the company by having accurate, up-to-date and standardized information.

"Our ultimate goal is to work with a third party data partner like GHX to meet both regulatory and market data requirements," says Brooks. As outlined in September’s Standard Practices column, the processes are not only different, but Brooks says customers are also asking for additional data attributes. "We want to provide what our customers need, but we also want to make sure we are working together to make sure we are focusing on what is most important first. Sharing and synchronizing data is great, but you want to be sure the data is both accurate and usable," says Brooks.

Karen Conway is industry relations director for GHX. She serves on the board of directors of AHRMM, on the leadership council of the Arizona State University Health Sector Supply Chain Research Consortium and as co-chair of the HIMSS Supply Chain Special Interest Group. She is also active in the Strategic Marketplace Initiative (SMI) and a member of the editorial board of Healthcare Purchasing News.