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:
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:
Pharmaceutical and Medical Packaging News
Camcode’s UDI Labels page: https://www.camcode.com/facility-management/healthcare.