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

The organization's Center for Devices and Radiological Health is requesting input from RFID vendors and end users regarding the effects RFID has on other transmissions in a hospital setting, and on the devices themselves.
By Claire Swedberg
Currently, there is no specific tracking system or serialized identification of medical devices in the United States, says Jay Crowley, senior advisor for patient safety at the CDRH. While prescription drugs are labeled with identification numbers indicating product type, medical devices are not. What's more, the FDA is investigating a pedigree system for pharmaceuticals that would require the drugs' history to include every point along the supply chain (see All Eyes on FDA for Drug E-Pedigree).

Counterfeiting is a critical concern for prescription drugs, Crowley says. There have also been cases of counterfeiting high-value medical devices, he notes, but such cases are much less common. The greater concern, according to Crowley, is having the ability to quickly identify the location of specific devices in the case of recall. With pharmaceuticals, because the medications carry serial numbers, the FDA can trace the location of a medication that needs to be recalled. "With medical devices, that clarity just doesn't exist," he says.

The FDA may eventually consider the implementation of a similar pedigree system for medical devices, but not in the current plan being drafted. Instead, the agency wants the ability to locate specific items in the event of a recall, and to ascertain an item's manufacturing and expiration dates. "At this point," Crowley says, "we are trying to put the foundation into place. So when it comes time to put a pedigree in place, we'd have a foundation to build on."

To date, Crowley states, no country has a nationwide system for tracking medical devices, though many are looking into such a system in conjunction with the FDA. The agency is currently working with Japan, China, the European Union and several countries in South America to develop a harmonized system with serial numbers that could be recognized internationally.

At present, Crowley says, the FDA is still studying the medical device market itself. "We are trying to address issues such as what an identifying system would look like, how it would work, getting an understanding of supply chain issues." The identification system, he notes, could cover everything from a box of rubber gloves to $30,000 stents, while the tracking requirements and the technology used to conduct that tracking could vary depending on the item.

"There are a lot of device types that could or should have RFID [technology for tracking]," Crowley explains. However, bar coding is also being considered. "We would like to remain as technology-neutral as we can," he says, though he expects the FDA to recommend a human-readable label with the ID number encoded electronically as well.

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