FDA proposes unique ID system for medical devices
WASHINGTON - The Food and Drug Administration (FDA) released a proposed rule on July 3 that most medical devices distributed in the United States carry a unique device identifier (UDI).
A UDI is a unique numeric or alphanumeric code that identifies the model, lot or batch number, serial number and expiration date of medical devices and pharmaceuticals.
Congress passed legislation in 2007 directing the FDA to develop regulations establishing a UDI system for medical devices.
The system has the potential to help the FDA identify product problems more quickly, better target recalls and improve patient safety, according to the proposed rule.
"The safety of medical devices is a top priority for the FDA, Congress, industry and patients," said FDA Commissioner Margaret A. Hamburg, MD, in a statement. "The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety."
The FDA is also creating a database that will include a standard set of basic identifying elements for each UDI and will make most of it available to the public so that users of a medical device can easily look up information about the device.
Industry reaction to the proposed rule has generally been positive.
Joe Pleasant, CIO of Charlotte, N.C.-based Premier healthcare alliance says that while he believes the process has taken too long and Premier members are disappointed with the seven-year timeframe for implementation, he is mostly happy with the rule.
"We've been talking about this for five years," he said. "I would say while I've been very disappointed in FDA taking as long as they have to make the ruling available, they have done a lot in the last 3 to 5 years to talk to manufacturers, distributers and hospitals about what is needed... They should be applauded for the fact that they have done enough pilots and testing."
Pleasant expects the introduction of the UDI system to improve patient safety, noting it will make it easier to recall high risk products, identify patients who are using recalled products and compile electronic medical records for clinicians to know what devices patients have used or are currently using.
Additionally, the UDI system will create supply chain efficiencies, he said, noting, "if (providers) can depend upon the coding on the package, they can begin to eliminate internal barcoding and labeling and the costs associated with them."
According to Dan Sweeney, senior vice president of information and data services at Irving, Texas-based supply contracting firm Novation, the enhanced ability to recall devices will improve safety.
"It's extraordinarily difficult today to communicate to a patient that they may have been exposed to a recalled product," said Sweeney, who added that the new level of information management would positively impact patient safety after a procedure has been done.
Although Sweeney says he is still concerned about the long timeframe for implementation, the lack of a single standard and the lack of clarity around exemptions contained within the proposed rule, he is mainly optimistic.
"The good news is this is progress," he said. "We could probably find flaws all day long in the proposed rule, but we're happy progress is being made. We will just keep pushing forward on the areas that need more clarity."
The FDA is currently accepting comments and is expected to issue a final rule in November.
