A proposed FDA rule requiring a unique identification system for medical devices is scheduled for release this September, according to a Semiannual Regulatory Agenda of the Department of Health and Human Services (HHS).

The FDA Amendments Act of 2007 added language to the Food, Drug and Cosmetic Act, which requires the FDA to promulgate regulations establishing a unique identification system for medical devices. The proposed rule would require the labeling of a medical device to bear a unique identifier, unless specifically noted otherwise by the administration. The unique identifier would adequately identify the device through distribution and use, and may include lot and serial numbers as well.

According to Jay Crowley, senior advisor for patient safety, HHS, the FDA, the Center for Radiologic Health, unique identifiers can improve the visibility of device movement, recalls, post-market surveillance, adverse-event reporting and anti-counterfeiting, as well as facilitate data transfer across IT systems.

The establishment of a unique identifier system may take place in four steps, Crowley noted in a 2010/2011 GS1 Healthcare Reference:

• Create a standardized unique identifier, using globally accepted standards for device identification.
• Require the unique identifier to be placed in human readable and/or AutoID format directly on the device, its label, or both. It is important to remain technology neutral in this area and not establish a rule defining which carrier (i.e. linear bar code, 2d data matrix bar code) to use.
• Create and maintain a unique identifier database that facilitates the storage, exchange and integration of data and systems.
• Drive adoption and implementation. The entire industry must work together to make unique identifiers work.

The Agenda is available online.