In 2004, the U.S. Food and Drug Administration (FDA) published a final rule that will require bar codes on human drugs and biologics by 2006; however, this rule did not extend to medical devices. Numerous comments submitted to FDA regarding the bar coding rule for human drugs and biologics raised a number of questions or concerns related to requiring bar codes on medical devices, such as the diversity of medical devices available on the market as well as the lack of a standard, numerical identification system for medical devices. While numerous opportunities using automatic identification technologies to prevent adverse events associated with pharmaceuticals have been demonstrated; a similar case for medical devices has not yet been made. At the time it issued the rule, FDA stated that medical devices presented different issues compared to human drug and biological products and while it would not include medical devices in the rule, it would continue to study whether to develop a proposed rule to require bar codes on medical devices and/or issue another type of guidance.

Bar codes are a type of automatic identification technology -- automatic (or ``auto``) identification is the broad term given to a host of technologies that are used to help machines identify objects or persons. Automatic identification is often coupled with automated data capture. There are a host of technologies that fall under the automatic identification umbrella. These include bar codes, smart cards, voice recognition, some biometric technologies (retinal scans, for instance), optical character recognition, radio frequency identification (RFID) and others.

The goal of this white paper is to provide a general overview of some of the most prevalent technologies available to support automatic identification of medical devices, to briefly review the current published positions and standards of various stakeholders in the medical device industry and user community, and to highlight some of the general applications reported in the literature to date involving automatic identification systems for medical devices. The white paper also examines some key issues related to unique identification of medical devices, including standard device nomenclatures.

Reprinted with Permission from www.fda.gov