UDI rule is here, but is it enough?
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.
[See also: Group aims to speed UDI uptake.]
FDA officials, though cast the move as a milestone.
"UDI represents 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.