Discussion of UDI Particulars Underway

The Global Harmonization Task Force (GHTF) is a group of representatives from medical device regulatory agencies and the medical industry. GHTF has released a discussion paper on UDI for medical devices and hopes to prepare a draft of guidelines for Unique Device Identification soon.

Currently there is no definition of a worldwide UDI tracking mechanism, and there needs to be. The goal of a Unique Device Identifier is to enable tracking of a medical device. Should a device fail, the UDI would enable faster recalls and give medical providers detailed information about the device. The UDI would also provide protection against counterfeiting. A common global tracking mechanism would benefit not only patients, but the device manufacturer and regulatory authorities as well.

GHTF aims to draft guidelines to define a common UDI code using a globally accepted standard format, and establish a UDI database with a defined list of attributes. GHTF does not specify a particular format of AIDC technology; linear or two-dimensional bar code of RFID based on ISO standards is acceptable. Placement of the UDI code on the device is also an important consideration under discussion.

GHTF has invited public comments on UDI and hopes to solidify some definitions and practices for UDI, particularly how the UDI database should be designed and implemented worldwide and how it will interact with other standardization organizations.

The deadline for submitting comments on the discussion paper is March 31, 2010. Your comments can be submitted via email to entr-cosm-med-dev@ec.europa.eu.