On July 3 the U.S. Food and Drug Administration proposed that most medical devices distributed in the U.S. must carry a unique device identifier (UDI). The hope is that this system will improve speed of response to adverse events reports, identify and issue target recalls more efficiently, and improve patient safety.
For the vast majority of medical devices the UDI would consist of:
- A device identifier (unique numeric or alphanumeric code) specific to each device model
- A production identifier that lists the current production information for the device
This information (including manufacturer, expiration date, and batch or lot number) will be contained in a new Global Unique Device Identification Database that is available to the public and stores information related to patient safety.
Benefits of a UDI System
- Allows more accurate reporting, reviewing, and analyzing of adverse event reports so that problem medical devices can be identified and corrected more quickly
- Reduces medical errors by enabling health-care professionals and others to more rapidly and precisely identify a medical device and obtain important information concerning the characteristics of the device
- Provides a consistent way to enter information about medical devices in electronic health records and clinical information systems
- Provides a standardized unique device identifier that will allow manufacturers, distributors, and health-care facilities to more effectively manage medical device recalls
- Provides a foundation for a global, secure distribution chain, thereby helping address counterfeiting and diversion and prepare for medical emergencies
The FDA is proposing a risk-based, phased-in approach to unique device identification implementation, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements.
For example, high-risk medical devices will require UDI labeling within one year from the date the final version of the law is passed (at the earliest 2014); Class-II devices would be allowed three years and Class-III devices five years after the law is passed.
Exempt from the UDI system will be medical devices that are not required to meet GMP (good manufacturing practice) standards, such as bedpans. Over-the-counter devices will likely be excluded because they already are identified with UPC codes.
Medical devices with a National Drug Code (NDC) number will have to be re-identified with a UDI number. Any device that is not compliant with the UDI system by the date required will have its NDC number rescinded.
The majority of the costs of the proposed FDA unique identification system rule will be incurred by labelers of medical devices including manufacturers, reprocessors, specification developers, repackagers, and relabelers.
According to the FDA, “the estimated present value of the costs for domestic labelers over 10 years would be $499.4 million at a 7 percent discount rate, and $571.5 million at 3 percent. Over 10 years, the annualized costs for domestic labelers would be $66.5 million at a 7 percent discount rate, and $65.0 million at 3 percent. The largest components of one-time costs would include the costs to integrate the UDI into existing
information systems, to install, test, and validate barcode printing software, train employees, and purchase and install equipment needed to print and verify the UDI on labels.”
In addition, other significant components of one-time costs include costs to redesign labels of devices to incorporate the date format within one year and to allow space for the UDI barcode, and the direct marking of certain devices.
Medical device associations are showing support for the proposal.
For example, AdvaMed “supports a system of unique device identifiers that, if appropriately implemented, holds the promise of more accurate and consistent post-market surveillance, and more rapid medical technology improvements,” said spokesperson Wanda Moebius. “We are reviewing the details of the proposed UDI rule and, after consultation with our members, will be submitting detailed comments.”
The FDA is seeking comment on the proposal for 120 days.
Pilgrim Software representatives will be at the 2012 RAPS Regulatory Conference October 26-30 in Seattle. Please stop by and visit us at Booth #216 to discuss your specific company challenges in a global regulatory environment.