FDA Unveils Key UDI Regulations at Orlando Conference

On September 18 and 19, 2012 the FDA sponsored the 2012 Unique Device Identification (UDI) Conference in Orlando, FL. The conference marked the final call for comment on the UDI proposal to develop a unique item identification standard for medical devices.
Expected to take effect in May of 2013, the ruling would require all medical devices to be identified with an Automatic Identification and Data Capture (AIDC) technology such as a barcode label, RFID or other machine readable technology. Medical devices are defined broadly by the FDA to include any “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.” Essentially, this means any product used by a hospital or doctor’s office that is not a prescription drug or an over-the-counter medication.
The proposed UDI system has the potential to improve the quality of information on medical devices, including adverse events reports. This information helps the FDA identify product problems more quickly, better target recalls, and improve patient safety.
Several key points were clarified by the FDA during the conference:

• The FDA is accepting comments on the proposed ruling up on until November 7, 2012. The proposed ruling is available on the FDA’s website.
• One of the major sticking points in the proposed ruling is specification of AIDC technology – both the barcode symbols accepted and the data format. The FDA plans to appoint at least two registering agencies (HIBCC and GS1) that have different data structures and a variety of barcode symbologies from linear to data matrix and more.
• Camcode is proposing an addendum to the ruling that requires that the UDI mark be “as permanent as the normal life expectancy of the device and be capable of withstanding the usage and cleaning procedures specified for the item to which it is affixed.”
• All UDIs will be uploaded to a publically available Global Unique Deice Identification Database (GUDID) where the devices unique number will be stored along with several other data points including a description of the device and whether or not it includes latex.
• Although the FDA hopes the rule to take effect in May 2013, the scheduled implementation will come to bare over seven years with critical care Class III devices being regulated first, followed by Class II and Class I devices, respectively.

In between sessions, several AIDC experts, including Camcode, staffed booths to help device manufacturers plan to comply with the pending regulation and showcase UDI Labels. Camcode will continue to research, review, and understand the information provided on the UDI initiative, and offer our thoughts and comments as new developments occur.
For more information on the FDA’s proposed rule on Unique Device Identification for medical devices, visit:
FDA.gov
OpenCongress.org
Regulations.gov 
Pharmaceutical and Medical Packaging News
Camcode’s UDI Labels page: https://www.camcode.com/facility-management/healthcare.