http://bit.ly/R4LAZS
FDA PROPOSES Unique Device Identification
Regulations for Medical Device
Unique Device Identification System Will
Provide FDA
With a Critical Tool For
Protecting Patients
07/03/12 at 12:13 pm
Consumers Union Safe Patient Project
WASHINGTON, D.C. – The Food and Drug Administration (FDA) issued a proposed regulation today to establish
a unique device identification (UDI) system for medical devices marketed in the
U.S. A UDI system was mandated by
Congress in 2007 but still is not in place. Legislation passed by
Congress in June requires the FDA to implement the UDI system for high risk, life sustaining and
implantable medical devices within two years of finalizing the regulations.
Consumers Union, the policy and advocacy division of Consumer Reports,
applauded the FDA for issuing the proposed regulations, while noting that it
was still reviewing the specifics of the draft rule. Consumers Union will
file formal comments to the proposed regulations later this year.
“These regulations are
long overdue and are critical for protecting patients from faulty and dangerous
medical devices,” said Lisa Swirsky, senior policy analyst for Consumers Union, the
policy and advocacy division of Consumer Reports. “Effective post-market surveillance of medical devices depends on
having UDI in place. Once it is fully implemented, this system will
enhance the FDA’s ability to identify problem medical devices more quickly and
inform patients when their safety is at risk.”
For most medical devices, the UDI will include a
device identifier, which is a unique code tied to a specific device model, and
a production identifier, which includes production information for the
device. The FDA has proposed phasing in the implementation of the UDI
system beginning with the highest risk medical devices first. Low risk
devices will be exempt from some or all of the regulations. The FDA is seeking public comment on the
proposed regulations for 120 days.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310505.htm
FDA NEWS RELEASE
For Immediate Release: July 3, 2012
Media Inquiries: Karen Riley,
301-796-4674, karen.riley@fda.hhs.gov
Consumer
Inquiries: 888-INFO-FDA
FDA proposes unique device identification system
for medical devices
Today,
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-the-counter 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.
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.
For
more information:
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.
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