Registrar Corp was among more than 350 medical device industry professionals attending the U.S. Food and Drug Administration’s (FDA) UDI Conference in Baltimore, Maryland from October 28th-29th. The conference addressed the Unique Device Identification (UDI) system put in place by FDA. This post will focus on some of the highlights of the conference. Visit our blog to learn more information about the UDI requirement.
The conference opened with Linda Sigg, FDA’s associate director for informatics, and Anita Rayner, FDA’s associate director for policy and communications, who presented UDI statistics thus far. They reported that, to date, there have been more than 33,000 device identifier records entered into FDA’s Global Unique Device Identification Database (GUDID) via 240 Labeler GUDID accounts. The UDI Helpdesk has received more than 4,000 inquiries of which 91% have been closed.
Following Sigg and Rayner, FDA Regulatory Analyst Erin Quencer provided information about the benefits of the UDI system. The UDI system provides benefits to both FDA and device consumers. For FDA, the UDI system eliminates confusion by providing a unique identifier for different device versions and models, gives FDA the ability to link device data throughout the pre-market and post-market process, and allows FDA to make use of the data for better research, analysis, and decision making. For consumers, the UDI system contributes to patient safety by allowing for more accurate adverse event reporting, reducing medical errors, and providing better recall management. It also allows for quicker and more accurate acquisition, recording, and retrieval of device use data in health delivery systems and provides a foundation for a global, secure distribution chain to address counterfeiting, shortages, and emergencies. Quencer also announced that FDA is partnering with the National Library of Medicine to create the GUDID system, which will be publicly available online during the first quarter of 2015.
Later in the day, Covidien Director of Information Systems Corwin Hee, Covidien Senior Project Manager David Brooks, and Columbus Regional Hospital Director Lean Sigma Doug Sabotin spoke about expanding the uses of UDI. They offered their experiences with UDI from a health care provider’s point of view. According to the speakers, the UDI system gives the health care industry an opportunity to streamline the supply chain, eliminate waste, and evaluate the efficacy of specific devices more easily.
Jay Crowley, former senior advisor for patient safety at FDA’s Center for Devices and Radiological Health, began day two of the conference with an overview of what FDA has learned in the past year about how to implant UDI in the medical device industry. He focused on important questions and decisions to think about before starting the UDI process and recommended that companies talk to their business partners to set up the right UDI solution for their supply chain. Crowley also discussed UDI’s Data Universal Numbering System (DUNS) requirement.
FDA GUDID Program Manager Indira Konduri also presented during the second day of the UDI conference. She announced that labelers of products whose deadline for UDI compliance is in September 2015 should be able to submit information to GUDID in January 2015.
Registrar Corp provides low cost UDI solutions for industry. If you have questions relating to UDI, contact one of Registrar Corp’s Regulatory Specialists by phone: +1-757-224-0177 or via 24/7 Live Help: http://www.registrarcorp.com/LiveHelp