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.”
FDA NEWS RELEASE
For Immediate Release: July 3, 2012 Media Inquiries: Karen Riley, 301-796-4674, firstname.lastname@example.org 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.