FDA Seeks Comments on Identifier System for Medical Devices

The Food and Drug Administration (FDA) is seeking information on how the use of a unique identifier system for medical devices may reduce medical errors, facilitate device recalls and improve medical device adverse event reporting. A notice will appear in the August 11 Federal Register (www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm).

The agency is seeking public comment for the next 90 days. A public meeting is planned in the fall; FDA will provide details when they become available. The comments will be used to help the agency determine what next steps the agency should take related to a unique device identifier (UDI) system for medical devices.

"Much like the bar code rule for drugs and biological products, unique identifiers for medical devices could have many potential benefits for improving the quality of care for patients," said Daniel Schultz, MD, Director, Center for Devices and Radiological Health, FDA. "A unique device identifier system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting and encouraging cost effectiveness by improving delivery and supply chain efficiency."

An FDA news release stated that the number and complexity of medical devices is growing and that it is important for FDA to quickly identify new risks and work with industry and device users to manage these risks appropriately. A UDI system may be used to identify a device and the information associated with that device throughout its lifetime. For example, a UDI could identify which devices are compatible, such as implanted devices being used safely with magnetic resonance imaging (MRI) systems.

"It is essential that we monitor the performance of medical products after they are approved and make sure that we quickly discover any potential problems that might arise," said Andrew C. von Eschenbach, MD, Acting Commissioner, FDA. "To improve our postmarket data collection at FDA, we are using a total product lifecycle approach to how we look at medical devices and focusing more attention on the kinds of systems and processes we need to have in place to monitor products after they are approved."

During the comment period, FDA wants to learn about the feasibility, utility, benefits and costs associated with developing and implementing a UDI system for medical devices. In addition, the agency wants to hear about various automatic identification technologies, such as bar code and radiofrequency, which could be used with a UDI system. A list of questions as well as what a UDI could look like, are included in the Federal Register notice.

To submit electronic comments, visit www.fda.gov/dockets/ecomments. Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must be received by Nov. 9 and include the docket number 2006N-0292. For more information, visit www.fda.gov/cdrh/ocd/udi/index.html.