Aug 18, 2006The U.S Food and Drug Administration (FDA) is already investigating the use of RFID to protect the U.S. pharmaceutical supply chain against counterfeit drugs (see FDA Will Issue Drug-Pedigree Guidelines). Now the government agency wants to look at RFID and other technologies to track and trace medical devices.
The FDA published a notice in the Federal Register last week, asking for information to help it understand how the use of a unique device identification (UDI) system might improve patient safety. The main purpose of a UDI system would be to reduce medical errors by providing more automated collection of information about various devices, such as the manufacturer, make and model, unique attributes, serial numbers, identifying lot and manufacturing numbers and expiration dates. In addition, a UDI system could be used to facilitate device recalls, improve medical device reporting and identify device incompatibilities or potential allergic reactions.
"This is really about medical-device safety," says Larry Kessler, director of the FDA's Office of Science and Engineering Laboratories, Center for Devices and Radiological Health. He explains that it can be very difficult for hospitals to locate recalled devices and move them out of inventory because there are so many makes and models of each type of device, even from the same manufacturer.
The FDA receives about 180,000 "adverse-event" device reports each year, and "the information in the reports can be sketchy," Kessler explains. "The report might be about a malfunctioning insulin pump from company X, but company X might make 10 different types and even more models of insulin pumps."
A UDI system would provide a standard method of collecting identification information on each device being recalled or reported on.
The FDA's interest in a UDI system has been spurred by various groups, including congressional members and various hospital groups asking the FDA to consider the inclusion of medical devices to the so-called bar-code rule pertaining to certain human drug and biological products. The rule requires manufacturers to encode a unique National Drug Code (NDC) number in a linear bar code on the product's label.
"The first question we are asking is whether or not the FDA should require some sort of identification," says Kessler. "The next question we're asking is how should we do that—should we require one technology, or should we allow [the requirement] to be more flexible?"
The FDA will also consider what information should be included on any identifier. Should it be only a number, which could then be correlated with more information obtained from the device manufacturer? Or should it be a number and additional information, such as the model number, expiration date and whether the medical device includes tissue from live organisms?
Although the bar-code rule calls for items to be identified by means of bar codes, the FDA is interested in the use of RFID. Kessler says the technology decision is complex, however, because there is such a wide variety of medical devices on the market, including bandages, MRI machines, implantable devices such as hip implants and disposable devices such as catheters.
"When you start to think through the incredible diversity of devices, you start to realize one system may not fit all, and that is the real challenge for us," Kessler says. "A bar code on a hip implant doesn't do much good because you won't be able to scan the implant because it will be in a body. But RFID may not suit every medical device."
Interested parties have until Nov. 9 to submit comments, Kessler states, including those presented by means of an electronic form. After that, the FDA will review all comments received. Kessler says he expects the FDA to write a regulation in the winter and put it out for public review and comment in 2007. If a regulation is adopted, he adds, there will likely be a phased-in compliance period lasting one to five years.
