The U.S. Food and Drug Administration announced proposed rules for most medical devices to bear a unique device identifier on Tuesday, underscoring the agency’s efforts to improve adverse event reporting, recall efforts and patient safety.
After a 120-day comment period, FDA will issue a final ruling that will require many devices in the U.S. to bear two codes. One is an alphanumeric code called the device identifier specific to a device model. They will also bear a production identifier containing production information regarding the lot or batch number, serial number and an expiration date among other data, said Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health, in a phone briefing with reporters. The system is being called the Unique Device Identifier system or UDI.
Most medical devices will bear the codes, although over-the-counter devices sold at retail are exempt. All low-risk, Class I devices are exempt from having a production identifier, but not the device identifier.
“Today’s proposal outlines the cornerstone of a modern post-market surveillance system for medical devices,” Shuren added. “It describes a standardized way to identify devices across all information sources systems including electronic health records and device registries. Once fully implemented, it will improve the quality of information in medical device adverse event reports, which will help us identify product problems more quickly and efficiently.”
Currently, some of the information about adverse event reporting contained in the MAUDE (Manufacturer and User Facility Device Experience) does not properly identify, Shuren said.
“It will allow more accurate reporting for viewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly,” Shuren said.
The medical device industry signaled that it is behind the effort.
“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 Wanda Moebius, a spokeswoman with AdvaMed, the Washington, D.C.-based trade and lobbying group. “We are reviewing the details of the proposed UDI rule and, after consultation with our members, will be submitting detailed comments.”
If such a system works as intended, it will likely help repair an image problem that the FDA has in that many believe it moves too slowly on product recalls. Others have criticized the agency’s oversight of recalls. The FDA estimates that over 10 years the measure will cost the industry$499.4 million at a 7 percent discount rate and $571.5 million at 3 percent discount rate.
Shuren said the agency spent time and money soliciting the input of various stakeholders including the device industry, clinicians and foreign government regulators involved in harmonization or creating a standard for how medical devices were reviewed. The agency also invested $250,000 in four pilot studies to gauge the logistics of having such an identifier system.
Implementation of the UDI system will occur in various stages. For instance, high-risk devices such as implantables need to have the UDI labeling on its packaging ready one year after final rules are proposed. If there are no delays, that would make it early 2014. Class II devices would get three years time and Class III devices five.
But implantable and life-sustaining devices would need to bear the UDI on the product itself and Congress is requiring that to happen in two years after the final rules are issued, Shuren noted.
Shuren also added that ultimately the MAUDE database system will be phased out as part of a broader IT initiative, but that there is no time frame on when that will occur.