AAMI Conference to Offer UDI Tips

An upcoming conference is designed to help manufacturers and healthcare facilities kick off implementation of the Food and Drug Administration (FDA)s proposed unique device identifier (UDI) rule.
The UDI Conference 2012, which will be held Sept. 18-19 in Orlando, Fla., will feature presentations from FDA officials and medical device experts. The conference is being sponsored by the Association for the Advancement of Medical Instrumentation (AAMI) and several other associations.

Conference organizers say it can help attendees grasp the fundamentals of a UDI system, and create an implementation plan. The information can be useful for healthcare providers and distributors in addition to manufacturers.

A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety, the agency said in a bulletin released on July 3 alongside the proposed rule.

If the proposed rule, which five years in the making,  is approved it will require manufacturers to place a numeric or alphanumeric code on their products. The code will contain information such as serial and batch numbers, the agency says.

The FDA is also creating a database that will include a standard set of basic identifying elements for each UDI, and will make most of it available to the public so that users of a medical device can easily look up information about the device, the FDA says.

Interested parties have until Nov. 7, 2012 to comment on the proposed rule, which is available HERE.

For more information on the conference, including how to register, CLICK HERE.