13TH ECR ASIA PACIFIC CONFERENCE ... - GS1 Singapore

FDA proposes Unique Device
Identification (UDI) System for
Medical Devices
On 3 rd July 2012, in response to requirements in legislation
that passed Congress with broad bipartisan support, the U.S.
Food and Drug Administration proposed that most medical
devices distributed in the United States carry a unique device
identifier, or UDI.
A UDI system has the potential to improve the quality of
information in medical device adverse events reports, which
will help the FDA identify product problems more quickly,
better target recalls, and improve patient safety. The FDA
has worked closely with industry, the clinical community and
patient and consumer groups and conducted four pilot
studies in the development of this proposed rule. The FDA is
seeking comment on the proposal for 120 days.
"The safety of medical devices is a top priority for the FDA,
Congress, industry, and patients," said FDA Commissioner
Margaret A. Hamburg, M.D. "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."
With certain exceptions, under the proposed rule, a UDI
would include:
a device identifier, which is a unique numeric or
alphanumeric code specific to a device model; and
a production identifier, which includes the current
production information for a device.
The FDA is proposing a risk-based, phased-in approach to
implementation, focusing on the highest-risk medical devices
first and exempting low-risk devices from some or all of the
requirements. The FDA is proposing to exempt over-thecounter
devices sold at retail; these devices generally have
UPC codes in place.
A UDI is a unique numeric or alphanumeric code that acts as
a key to certain basic identifying information about a device,
such as the name of the manufacturer and the type of device,
and may represent certain other information about the
device, such as its expiration date and batch or lot number.
This information will be contained in a publicly available UDI
database, and no identifying patient information will be stored
in this device information center.
The proposed rule reflects the considerable input the FDA
received from the medical device industry, the clinical
community, patients and consumers, and industry experts.
To minimize industry costs and expedite implementation, the
proposed rule builds upon current standards and systems
already in use by some companies.
Example of what a universal device identifier (UDI) would look
like on a medical device label. The label contains information
about the product name, its expiration date, reference and lot
numbers, manufacturer information, bar code, details about the
item, and an illustration of the item.
A UDI system can provide multiple benefits, including:
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.
Provide a consistent way to enter information about
devices in electronic health records and clinical
information systems.
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 prepare for medical emergencies.
__________________________________________________
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs,
vaccines and other biological products for human use, and
medical devices. The agency also is responsible for the safety
and security of our nation’s food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for
regulating tobacco products.
GS1 Singapore News - July 2012 GS1 Singapore Limited, 2985 Jalan Bukit Merah Singapore 159457 page 9/10