UDI rule finally passed, but takes hits
The Food and Drug Administration on Sept. 20 announced a long-awaited final rule for the unique device identification system intended to provide a consistent way to identify medical devices.
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, FDA officials said in announcing the final rule.
But, at least one healthcare organization says the government could have done better. While applauding the move, the Premier healthcare alliance, made up of 2,900 U.S. community hospitals and thousands of other healthcare sites, criticizes the implementation timeline.
"Since we have already been waiting six years for UDI, it’s unfortunate that patients will have to wait until 2020 to have a fully functional device tracking system, particularly since such systems are so pervasive in the retail setting," said Premier's Blair Childs, senior vice president, public affairs, in a news release.
"It is our goal to work with our member hospitals to implement the provisions of this rule as quickly as possible to ensure that patients will have confidence that the devices implanted in their bodies are safe and effective," Childs added.
FDA officials, though cast the move as a milestone. a landmark step in improving patient safety, modernizing our post-market surveillance system for medical devices and facilitating medical device innovation," said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in press statement.
Premier's Childs agrees: "With this rule, we are one step closer to a UDI system that will enhance adverse event reporting, a safety gap that the Institute of Medicine said made it impossible to draw conclusions about the safety of medical devices," he said in a statement. "Moreover, UDI will dramatically improve the recall process. Research also shows that UDI can save as much as $16 billion annually by automating manual processes and improving efficiencies."
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 FDA, called the Global Unique Device Identification Database, which will serve as a reference catalogue 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, officials say. It will also offer a clear way of documenting device use in electronic health records and clinical information systems.
"A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative and less costly device development," said Shuren.
FDA issued the proposed rule requesting input from industry, the clinical community and patient and consumer groups on July 10, 2012.
The UDI system builds on existing device industry standards and processes, Shuren said. 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 a 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 today’s announcement is the publication of a draft guidance for manufacturers outlining how to submit information to the database.