FDA has opened the Global Unique Device Identification Database (GUDID) to the public. The database will serve as a reference catalog for every medical device with a unique device identifier, or UDI.
The public can download the entire database or certain parts through AccessGUDID, a portal created by FDA and the National Library of Medicine. They will not need a GUDID account. In this beta release of AccessGUDID, basic search and download functions are available, but there’s not much to search on yet. This first phase of a five-year rollout applies only to Class III devices.
Under the UDI final rule, the labeler of each medical device (in most instances, the device manufacturer) must submit information about that device to the GUDID, unless subject to an exception or alternative, the agency said. Single-use device reprocessors, convenience kit assemblers, repackagers, and relabelers are also considered labelers.
Labelers need a GUDID account to submit UDIs through the GUDID Web Interface or the HL7 SPL submission. Most devices will be required to have a UDI on their label and packaging, and for certain devices, on the product itself.
A UDI has two components:
A Device Identifier (DI) - A unique numeric or alphanumeric code specific to a device version or model.
Production Identifier(s) (PI) - Numeric or alphanumeric codes that identify production information. That can include the lot or batch number, serial number, expiration date, and manufacture date. For cell or tissue-based products regulated as devices, the distinct identification code also allows the manufacturer to associate the HCT/P to the donor. The public will only have access to the DI, the agency said.
Labelers had until Sept. 24, 2014 to submit UDIs for Class III devices. The labels of implantable, life-supporting and life-sustaining devices must bear a UDI by the same date of this year.
Making UDIs available on a database is one thing. Having them on payments from hospitals to Medicare and Medicaid is apparently another. Officials at the U.S. Centers for Medicare & Medicaid Services (CMS) apparently complained earlier this year that including such information would present too many technical hurdles and costs, according to The Wall Street Journal.
A study published in Heart Rhythm in 2011 supports the notion that the system would be costly for Medicare. Organized by University of Chicago and Northwestern University, the study scrutinized how a faulty Sprint Fidelis defibrillator lead from Medtronic was implanted in 268,000 patients before FDA pushed to remove it from the market. While UDIs would have helped manage the recall, the costs to Medtronic could fall between $287 million and $1.19 billion over five years, WSJ reported.
Officials at FDA and elsewhere have been touting a UDI system as a way to pinpoint problems with medical devices more quickly, and save lives. Advocacy groups in recent years claimed that recalled cars carry more identifying information than recalled pacemakers do.
Posted in Regulatory and Compliance by Nancy Crotti on May 5, 2015