2015 UDI Conference Highlights

2015 UDI ConferenceAlthough the 2015 UDI Conference had record participation, many Medical Device Manufacturers were not able to attend, consequently this summarization of highlights from the sessions should be of value.

FDA kicked the first session off with an overview of UDI, a review of compliance dates, a listing of benefits derived from UDI and an update on GUDID status. Biggest achievements since the conference last year: Brookings Institution to create a “roadmap” for provider systems, patients, payers, supply chain personnel, and many others, to adopt and utilize UDIs. Another major achievement noted during the 2015 UDI Conference was the announcement of AccessGUDID. Challenges either addressed or being addressed: Managing input to the UDI helpdesk through implementation of tracking software, software labeling guidance, Contact Lens labeling guidance and UPC for retail guidance. A challenge that FDA is calling upon the Medical Device Manufacturing industry to address is ensuring data quality, such as product codes matching pre-market information.

FDA went on to lay out plans for the future including: working with SMI (strategic market initiative), working with standards organizations, expanding capabilities within AccessGUDID such as moving from basic search capabilities to advanced search capabilities and adding web services capabilities. Also announced were Direct Marking guidance (which incidentally was released during the conference), and the opening of the GUDID after January 1, 2016 to Class II products that are not implantable, life-supporting, and life-sustaining devices. The biggest news from FDA is that Terrie Reed is coming back.

AIM (Global trade association for the Automatic Identification and Data Capture (AIDC) industry) presented a session demonstrating the way that technologies using unique device identification (UDI) are being employed to meet recent U.S. compliance rules. The takeaways from the 2015 UDI Conference are that: various types of direct marking technologies are available and some are a better fit than others depending upon the particular medical device, vision inspection is a very useful tool to help with addressing the accuracy required for the new data elements on the labels, and software was demonstrated that can handle master data management (using information pulled from other systems in real-time), regulatory data upload, label management and printing anywhere in the world via browser using a single solution.

The key takeaway from the track concerning UDI in the supply chain is that medical device manufacturers need to be concerned with getting data all of the way through to the providers. The important thing about GMDN is that terms will change and it is up to you as labeler to make sure you keep pace and keep the GMDN information in your GUDID records up to date. The most salient point from the session on understanding efforts that are similar to UDI around the globe is that harmonization is not taking place to the extent that one might hope. Surmise that there may be some challenges and budget accordingly.


Ardi Batmanghelidj, Chairman of the AIM NA Healthcare Committee and President & CEO of Innovatum, Inc., to Speak at UDI Conference 2015

Cranberry Township, PA – May 21, 2015 – AIM North America (AIM NA), the industry association and authority on barcode, RFID, RTLS, NFC and mobile computing, has announced that representatives of the AIM NA Healthcare Committee were chosen to be featured in a general session for the upcoming 7th Annual UDI Conference in Baltimore, Maryland, June 24th – 25th.

Representatives from the AIM NA Healthcare Committee will present Auto ID Technologies & In-House Systems for UDI Compliance during the first day of the Conference, which highlights The Reach of UDI. The session has been designed to showcase the automatic identification technology options which enable compliance with the UDI Regulation issued by the Federal Drug Administration (FDA) in the U.S. It will provide not only live demonstrations of the technologies at work, but discuss how to make the best choices which will most benefit a specific business.

Speaking on behalf of fellow colleagues and presenters, Ardi Batmanghelidj, Chairman of the AIM NA Healthcare Committee and President & CEO of Innovatum, Inc., said,”The opportunity to present live technology demonstrations while also delivering valuable information on how to best use and implement these various technologies, will not only help in UDI compliance for the FDA, but offer valuable insight on how automatic identification technologies can benefit businesses beyond compliance. Our presentation team will certainly represent a unique perspective to the audience at the Conference and show how the adoption of automatic identification is evolving.

In addition to the general session at the UDI Conference, AIM NA and its Healthcare Committee will have a significant presence throughout the event. Many of the exhibitors available to attendees during the conference will be showcasing their respective services and products. AIM North America will also host the AIM Resource Station featuring industry information and demonstrations of a variety of automatic identification innovations and technologies.

For more details on AIM North America at the 7th Annual UDI Conference, or to register, visit UDI Conference 2015 today. Special early registration rates are available through May 24th.

About AIM North America

AIM North America is the industry trade association that represents the Automatic Identification and Mobility industry in the US, Canada and Mexico. AIM North America provides education, news and information, legislative affairs, and marketing resources to grow the businesses of the industry’s resellers, systems integrators, solutions providers, manufacturers, and distributors. AIM North America is a chapter of AIM, Inc., the worldwide authority on automatic identification and mobility for more than 40 years.

For more information, contact the AIM North America office.

20399 Route 19, Suite 203, Cranberry Twp., PA 16066 |+1 724 742 4473(Phone) | +1 724 742 4476(Fax)

Visit us at  AIM North America