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FDA Seeking Comments on Unique Identifier System for Medical Devices

The Food and Drug Administration (FDA) is seeking public comments on the possible benefits of a uniform system for the unique identification of medical devices.

The system, if implemented, might cover devices such as implants, ventilators and automated external defibrillators (AEDs), Jay Crowley, FDA's senior advisor for patient safety, told

FDA, in a notice in the Aug. 11 Federal Register, announced it wants to learn about the feasibility, utility, benefits and costs associated with developing and implementing a unique identification system (UDI) for medical devices. In addition, the agency said it 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.

The agency explained that federal law now requires bar codes on certain human drug and biological products "to enable health care professional to use bar code scanning equipment in conjunction with computerized medication administration systems to verify that the right drug, in the right dose, is being given to the right patient at the right time."

The bar code rule, however, does not apply to medical devices, according to FDA.

With the number and complexity of medical devices growing, a UDI system may be used to identify a device and the information associated with that device throughout its lifetime, according to the agency.

For example, a UDI could identify which devices are compatible, such as implanted devices being used safely with magnetic resonance imaging (MRI) systems.

"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, M.D., director of FDA's Center for Devices and Radiological Health.

Study Found One in Five AEDs Affected by Advisories

The agency's request for comments comes on the heels of a study published in the Aug. 9 issue of the Journal of the American Medical Association that concluded roughly one in five AEDs was affected by a recall or safety alert between 1996 and 2005. (For more, read "Study: Despite Malfunctions, AEDs Save Thousands of Lives.")

While FDA already had been looking at the potential benefits of a UDI system, Crowley noted the article "further supports our desire to do this."

"This gives us the idea that something like this might be warranted," Crowley said. "It's a good example of why we would need such a system."

Over the past year, FDA met with various stakeholders and found most supported the development of a UDI system as a way to improve patient safety, according to the agency. FDA said it learned from the meetings that stakeholders recognize such a system could provide supportive benefits, such as better management of the purchase, distribution and use of medical devices.

FDA also commissioned two reports from outside experts on automatic and unique identification of medical devices. The reports identified several potential benefits of a UDI system, including identifying incompatibility with devices or potential allergic reactions.

In addition, FDA has been working with the Agency for Healthcare Research and Quality in the Department of Health and Human Services and with other federal partners to better understand the issues with the development, implementation and use of a UDI system.

"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 von Eschenbach, M.D., acting commissioner of FDA. "To improve our post-market 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."

To view FDA's notice in the Aug. 11 Federal Register, click here.

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