FDA Provides Public Access To Global UDI Database (GUDID)

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA), in collaboration with the National Institutes of Health (NIH) National Library of Medicine (NLM), recently announced the public access of the FDA's Global Unique Device Identification Database (GUDID). The database contains information on specific devices submitted by manufacturers for tracking and safety purposes.

“Through AccessGUDID, anyone can search or download information that labelers have submitted about their medical devices to the GUDID. Device identification and key safety information, such as whether the device is safe for use while undergoing MRI, will be available for health care providers to search at any time,” the FDA said in a statement.

The FDA encourages healthcare systems, clinicians, patients, researchers and industry stakeholders to assess the contents and functionality of GUDID and submit feedback for future enhancements.

Opening up the GUDID database to public access is the next step of the FDA's unique device identification (UDI) program, which it began to implement in 2013.

"The unique device identification system will help reduce medical errors, and will allow FDA, the healthcare community, and industry to more rapidly review and assess adverse event reports, identify problems relating to a particular device, and thereby allow for more rapid and effective corrective actions that focus sharply on the specific devices that are of concern," FDA described the program's aim in 2012, according to an article from the Regulatory Affairs Professional Society (RAPS).

As explained in the Med Device Online article Populating The UDI Database – A Look At GUDID, a device manufacturer must affix a device identifier (DI) on the device label that corresponds to a DI record containing about 60 data elements and characteristics loaded by the manufacturer into the GUDID database. Anyone with the DI can enter it into GUDID and retrieve the public information from the DI record that identifies the device. The information is updated by the manufacturer periodically.

Some manufacturers are concerned about the use of lot numbers and serial numbers as part of the UDI. However, GUDID does not include lot numbers and serial numbers but only checkboxes (yes/no) on labels.  The public cannot go to GUDID and retrieve the number of lots or serial numbers a manufacturer has produced.

The FDA says that the UDI program provides timely and accurate information to protect public health. It wants to extend its usefulness by including UDIs in insurance claims. However, the Centers for Medicare & Medicaid Services (CMS) has opposed the agency, citing technological challenges, risks, and costs.