News Feature | May 29, 2015

UDI Database Now Public

Katie Wike

By Katie Wike, contributing writer

Healthcare Business-Intelligence Solution

The FDA has just launched its Global Unique Device Identification Database (GUDID), which provides a resource to report adverse effects of devices and hasten reactions to recalls.

The FDA has announced the launch of its new database - GUDID, or the Global Unique Device Identification Database. “Medical devices cover a wide range of products - implants, CT scanners, surgical instruments, contact lenses, wheelchairs, and blood glucose tests, to name a few,” explains the FDA. “Unlike drugs, many medical devices currently do not have a unique identifier that clearly distinguishes one product from another. But this is changing. The UDI system will provide a consistent and standard way to identify medical devices throughout their distribution and use by healthcare providers and patients.”

Modern Healthcare reports the website was established under a provision of the 2012 Food and Drug Administration Safety and Innovation Act. In 2013, the FDA’s final rule required manufacturers of Class 3 devices such as implanted pacemakers and heart valves to include a UDI on their products. This practice will be mandatory for all medical devices to have a UDI.

“The National Library of Medicine (NLM), in collaboration with the FDA, has created the AccessGUDID portal to make device identification information in the GUDID available for everyone, including patients, caregivers, healthcare providers, hospitals, and industry,” says the FDA.

iHealth Beat writes the aim of such a database is to:

  • Enable quick and efficient recall of medical devices;
  • Improve the accuracy and specificity of adverse event reports;
  • Offer a clear path for documenting device use in electronic health record systems and clinical information systems; and
  • Provide a secure, global distribution chain to address counterfeiting and diversion.

According to a report from Health IT Outcomes, just months ago experts like the Brookings Institute suggested providers incorporate UDIs into their EHR systems, and may consider adopting automatic identification and data capture (AIDC) technology to make the process more efficient. Patient safety reporting should be automated.