U.S. FDA Seeks Research for Medical Device Tracking System

By Claire Swedberg

April 23, 2008—The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) says it hopes to issue draft specifications by the end of 2008 for a nationwide system that could be employed to identify individual medical devices and supplies, and to make it easier to locate and recall such items.

As it prepares its recommendations, the FDA is now seeking input from the RFID industry, and from end users that have piloted RFID systems in the health-care market, as to the effects the technology has on other transmissions in a hospital setting, and on the devices themselves. That's what Ann Ferriter, issue manager for the CDRH, told attendees last week's RFID Journal LIVE! 2008 conference in Las Vegas.

Ann Ferriter

Almost two years ago, the FDA began investigating how a unique device identification (UDI) system might help automate the collection of information, including the manufacturer, make and model, unique attributes, serial numbers, identifying lot and manufacturing numbers, and expiration dates (see FDA Seeks ID System for Medical Devices and Supplies). In August 2006, it issued a notice seeking comments from the device industry, health-care facilities and device users regarding the current use of UDI systems, the need for a comprehensive, standardized UDI system, what FDA's role should be in the development of such a system and the potential costs and benefits.

At the conclusion of the three-month comment period, the FDA had hoped to draft specifications in early 2007 and put them out for public review and comment, but the agency ultimately failed to meet that goal. The U.S. Congress put additional pressure on the FDA seven months ago by ordering it to establish such a system, but did not specify a deadline (see FDA Works on Draft ID System for Medical Devices, Supplies).

Last week, Ferriter told RFID Journal LIVE! attendees that the CDRH is now seeking research indicating whether there is any RF interference or health risk that could occur from the use of RFID technology in hospitals or other health-care settings. The CDHR, she said, hopes to further examine the potential risks related to RFID use around medical equipment.

The agency is presently studying whether RFID equipment operating at 134.2 KHz, 13.56 MHz, 433.5-434.5 MHz, 902-918 MHz or 2.4 GHz could pose a risk to other electronics in a health-care environment. Ferriter cited pacemakers, which cannot necessarily differentiate between the pulse of an RFID reader and a heartbeat. "We haven't seen any cases of RFID interfering," she said. Other RF-sensitive devices might include infusion pumps, hearing aids, defibrillators and programmable heart valves.

The FDA recognizes the benefits RFID provides the health-care industry in the areas of tracking and visibility, Ferriter said. However, she added, her organization would like to see more studies, particularly those focusing on the use of 13.56 MHz wristbands in hospitals. Addressing the RFID industry, she stated, "I think you do a tremendous amount of research," and appealed to attendees to share their findings with the FDA.