The 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 in the development of this rule. Medical device manufacturers call implementation of a UDI system a “costly and challenging endeavor,” and say that it is “imperative that it is implemented correctly the first time.”
Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, says, “UDI represents a landmark step in improving patient safety, modernizing our post-market surveillance system for medical devices, and facilitating medical device innovation.”
The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date and manufacturing date when that information appears on the label.
The second component is a publicly searchable database administered by the FDA called the Global Unique Device Identification Database (GUDID), which will serve as a reference catalog for every device with an identifier. No identifying patient information will be stored in this device information center.
The FDA plans to phase in the UDI system, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule. Once fully implemented, the UDI system rule is expected to have many benefits for patients, the healthcare system, and the device industry. It will enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports, and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion. It will also offer a clear way of documenting device use in electronic health records and clinical information systems.
The UDI system builds on current device industry standards and processes, and reflects substantial input from the clinical community and the device industry during all phases of its development. In addition, the FDA worked to reduce the burden on industry by building upon systems already in place.
Janet Trunzo, senior executive vice president of technology and regulatory affairs for the Advanced Medical Technology Association (AdvaMed), issued the following statement in response to the FDA’s release of a final rule for the UDI system:
“While we are still reviewing all the details of the final rule, AdvaMed commends FDA for addressing many of the concerns industry raised in the proposed rule. We have long supported a UDI system for medical devices that, if appropriately implemented, holds the promise of more accurate and useful post-market surveillance and more rapid medical technology improvements. And this rule is a good step toward achieving that goal.
“We are pleased that FDA recognizes the difficulty and limited benefit of direct marking of implants and has eliminated this requirement. Similarly, we commend FDA for concluding that multiple single-use devices within multi-packs only need the UDI on the multi-pack and not the individual device.
“We are encouraged that FDA understands that many manufacturers will still have extensive inventories of product when the UDI rule goes into effect and will allow an additional three years for inventories to be depleted. Also, in line with industry recommendations, FDA acknowledges that one year may not be enough time to implement a UDI system for all Class III devices and will allow firms to petition to extend the implementation period based on public health and supply disruption issues.
“Finally, while FDA recognizes the ISO date format is more appropriate than their proposed American format, we are puzzled that the final rule includes the day of the month for expiration dates when expiration date testing generally does not include the day of the month.”
Key part of post-market plan
The UDI system is a key component of the National Medical Device PostMarket Surveillance System proposed in September 2012.
In general, high-risk medical devices (Class III) will be required to carry unique device identifiers on their label and packaging within one year and this number and corresponding device information must be submitted to the new database. Manufacturers will have three years to act for most Class II (moderate risk) devices. Manufacturers of Class I devices not exempt from UDI requirements will have five years to act.
Included in the most recent announcement is the publication of a draft guidance for manufacturers outlining how to submit information to the database.
For more information, search the FDA website for the Unique Device Identification (UDI) and Regulatory Impact Analysis of UDI System Final Rule sections
