The Food and Drug Administration (FDA) released Tuesday a
proposed rule 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 includes
a device identifier, which is specific to a device model, and a production
identifier, which includes the current production information for that specific
device, such as the lot or batch number, the serial number and/or expiration
date.
Congress passed legislation in 2007 directing the FDA to
develop regulations establishing a UDI system for medical devices.
The system has the potential to improve the quality of
information in medical device adverse event reports, which will help the FDA
identify product problems more quickly, better target recalls and improve
patient safety, according to the proposed rule.
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. The UDI does not indicate, and FDA’s database
will not contain, any information about who uses a device, including personal
privacy information.
When fully implemented, the UDI system may:
- Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
- Reduce medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
- Enhance analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust postmarket surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
- Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
- Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and preparation for medical emergencies.
- Lead to the development of a medical device identification system that is recognized around the world.
Industry reaction to the proposed rule has generarly been
positive.
“A robust UDI system will significantly enhance product
identification, improve the device recall process and ensure the integrity of
the product throughout the transportation process, and most importantly,
advance and improve patient safety,” said Dan Sweeney, senior vice president of
information and data services at Irving, Texas-based supply contracting firm
Novation, in a written statement. “A UDI system also has the potential to
generate significant savings for the healthcare industry through improved
efficiencies and automated processes.”
Joe Pleasant, CIO of Charlotte, N.C.-based Premier
healthcare alliance, told Healthcare Finance News that their members are
excited that the proposed rule has been issued but most are disappointed by the
seven-year timeframe for implementation.
“I think it’s too long,” said Pleasant. “We’ve been talking
about this for five years.”
“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 last
3-5 years to talk to manufacturers, distributors and hospitals about what is
needed… They should be applauded for the fact that they have done enough pilots
and testing,” he said.
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.
“It will also help reduce errors,” said Pleasant.
Additionally, the UDI system will create supply chain
efficiencies, he said, adding, “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.”
Source: healthcarefinancenews
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