What is GUDID (Global UDI Database)

Purpose of this Quick Start Guide

• This Quick Start Guide discusses:
  1. The FDA’s Global UDI Database (GUDID) and the specific data elements that labelers (a regulatory term that typically refers to medical device manufacturers) are required to and/or encouraged to populate in the database.
  2. The FDA’s role in enforcing compliance with the GUDID requirements.
  3. How authorized UDI issuing agencies, healthcare providers and all users of GUDID information can help ensure the information is complete and accurate.
  4. Why data quality in the GUDID is important, including examples of the value of the data and best practices to maximize its usefulness.

Terminology

See the Glossary Quick Start Guide for the definitions to any unfamiliar terms or acronyms.

What is UDI?

The UDI is an FDA mandated code intended to improve patient safety by unambiguously identifying medical devices (from low to high-risk products) sold in the U.S. through distribution and use. Beyond patient safety, the UDI delivers a myriad of benefits across clinical, financial and supply chain functions. Manufacturers must obtain UDIs from one of three authorized issuing agencies for all of their products (unless specifically exempt) and label those products with the UDI in both human and machine-readable formats. The UDI consists of two parts: a device identifier (DI), which designates the specific make or model and packaging quantity (unit of measure) of a device, and a production identifier (PI) that includes the information used by manufacturers to control production of the product, such as lot, batch or serial number, expiry date and date of manufacture. For medical devices including human cell, tissue, cellular or tissue-based products, the UDI-PI also includes a code that can associate the device with the donor. Manufacturers must also publish additional data about their products in the Global UDI Database (GUDID), most of which is publicly accessible through AccessGUDID.

Under separate regulation from CMS and the ONC, health care providers are also required to use the UDI when documenting the use of implantable devices in electronic health records and in adverse event reports involving serious injury or death.

For more information on the UDI, see the “What is UDI” Quick Start Guide.

What is the Global UDI Database (GUDID)

The database is designed to serve as the reference catalog for every device with a Unique Device Identifier (UDI) and contains both required and optional data elements. The GUDID contains the Device Identifier (UDI-DI) component of the UDI, along with flags that indicate which Production Identifier (UDI-PI) attributes (e.g., lot or batch number, serial number, expiration date, manufacturing date, donation identification number) are included in the full UDI on the device label. Data elements are populated by and updated by the device labeler in the GUDID. The FDA has enforcement and data monitoring authority and can remove fraudulent data. The accredited UDI issuing agencies are required to: routinely audit the GUDID for DI inconsistencies, work with labelers to correct any inconsistencies, and annually report unresolved inconsistencies to the FDA.

GUDID data is available for access via two public portals:

• AccessGUDID (https://accessgudid.nlm.nih.gov/) provides a user-friendly web interface to search for and retrieve GUDID data for specific medical devices. The AccessGUDID portal also includes helpful Application Programming Interfaces (APIs) that support the ability to download GUDID data into the information systems used by health care providers and other end users.
• OpenFDA (https://open.fda.gov/) also provides APIs and data downloads from the GUDID but is geared more for programmers and data aggregators.

Importance of GUDID Data Quality

The UDI-DI serves as the link to the meta data contained in the GUIDID. The GUDID provides open source, structured data that is periodically audited and refreshed. This information is utilized in numerous ways that directly impact patient care, patient billing, analytics and decision-making. The following are examples of how GUDID data can be used.

• Data elements, such as description, GMDN code, company name, brand name, model, MRI safety, and if a product contains latex, are populated into the patient’s electronic health record (EHR).
• The GMDN (Global Medical Device Nomenclature) code assists in accurately identifying implantable devices and assigning the correct billing code.
• MRI safety information helps determine the product’s impact on a patient safely undergoing an MRI.
• Information such as single use, sterile package, contains latex and clinically relevant size is helpful in selecting the proper device.
• Medical device history, which is maintained by the FDA, and other data elements can be downloaded into master data management systems for advanced analytics.

Device Labeler (typically the manufacturer) Responsibilities

• Review the UDI to confirm that the data elements in AccessGUDID (specifically, within the Device Identifier (DI) Information, Device Characteristics, Alternative and Additional Identifiers, and Customer Contact sections) match the labeling and UDI information on the device. Ensure that the data submitted to the GUDID match the attributes on the device label (or the device itself).
• Populate the GUDID with all required data elements and consider including the best practice data elements listed below.
• Update the GUDID immediately when any of those data elements change.
• If a device has been discontinued from distribution, ensure that the DI Information in AccessGUDID for both the “Commercial Distribution Status” and “Commercial Distribution End Date” fields is updated.
• If a specific packaging level for a device is no longer being sold (e.g.: BX/25 is no longer available, but EA/1 and PK/5 are still sold), ensure that the “Package Discontinue Date” and “Package Status” fields are updated.
• If a manufacturer is claiming applicability of an exception or alternative to UDI requirements, confirm that the associated Product Codes are listed on the UDI website.
• Follow the requirements of the chosen Accredited UDI Issuing Agency regarding DI assignment and how it manages labeler/manufacturer information.

FDA Responsibilities

• The FDAs Center for Devices and Radiologic Health (CDRH) has responsiblity for enforcing compliance with the UDI regulatory requirements.
• CDRH considers an action when UDI violation(s) are disclosed during inspections. These can include (but are not limited to) the following:
  1. Manufacturer fails to ensure that the label of every covered medical device bears a UDI.
  2. Manufacturer fails to provide required information to the GUDID.
  3. If a firm has already received a Warning Letter for UDI violations and still fails to comply with the regulation, the Center considers recommending an administrative or judicial action.
• FDA maintains a help desk where issues related to the GUDID (i.e., inaccurate or missing data) can be reported. A ticket can be submitted to the UDI help desk at https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/fda-udi-help-desk.
  

  Healthcare Providers and other users of GUDID Responsibilities

  • Report missing or inaccurate data to the manufacturer first. If the manufacturer does not respond, or has not included contact information in the GUDID, report the issue to the FDA UDI Help Desk.
  • Review the GUDID Data Elements Reference Table (DERT) at www.fda.gov.udi to better understand the required and optional elements contained in the GUDID and their applicability in clinical and business operations.
  • Understand who is responsible for creating and maintaining specific data elements within the GUDID. The labeler is responsible for creating most of the data elements and ensuring ALL the data elements in the GUDID are updated and accurate. Some data elements such as the FDA Product Code and the DUNS number originate elsewhere. All data requirements and who is responsible can be found on the GUDID Data Elements Reference Table (DERT)

  Best Practices -Device labelers (Typically Manufacturers)

  • Recognize that some “optional” data fields are critically important to healthcare providers and other users of GUDID data. Include these fields to optimize the use of the UDI and improve patient safety.
    1. Catalog Number – serves as a link between the manufacturer submitted UDI-DI and the provider’s internal item master number
    2. Device Description – critical for identifying medical devices and distinguishing between similar devices. It also must be documented in the EHR for implanted devices. The FDA’s Data Elements Reference Table indicates the description field should include additional information about the device that is not already captured as a distinct GUDID data element. Make the device description concise and reflect the same plain-language identifying terminology used on the package label.
    3. Customer Contact Information – Facilitates the ability of both the FDA and users of GUDID information to contact the manufacturer with questions and concerns about submitted data. A dedicated e-mail address that is monitored by knowledgeable parties is considered best practice.
  • Prevent assignment of multiple Primary Device Identifiers to the same packaging level of a specific medical device by following best practices outlined in the AHRMM LUC multiple device identifier report and utilizing Production Information attributes for Lot/Batch or Serial Number to manage production control.
  • Develop and implement a communication feedback loop to communicate when corrections and updates have been made to the GUDID.
  • Develop and implement a process to communicate with distributors and health care providers when and why a UDI-DI change has been made.

  Best Practices – Healthcare Providers

  • When missing or incorrect data is identified in the GUDID, contact the manufacturer.
  • If the manufacturer is unresponsive or did not include contact information in the GUDID, open a ticket with the FDA UDI Help Desk.
  • During the contracting process, request contact information for the party with the labeler/manufacturer responsible for managing GUDID submissions.
  • Track labeler/manufacturer data quality and inclusion of best practice data elements in the GUDID.
  • Report responsiveness to data issues on supplier scorecards and discuss during business reviews.
  • Consider data quality metrics when choosing manufacturers.
  • Consider the types of analytics and business decisions that need to be made to support your organization. Review the data elements available within the GUDID to support these activities.
    1. While the labeler is responsible for the accuracy of the data, understanding why and how the data may change helps providers catch data anomalies or erroneous information and version changes that otherwise go unnoticed.

  Resources

  Global Unique Device Identification Database (GUDID) | FDA

  UDI Rule, Guidance’s, Training, and Resources

  GUDID Data Elements Reference Table (DERT)

  GS1 US Best Practice Guide for Sharing Vital Attributes in Healthcare

  AHRMM LUC GUDID Best Practices Guide

  Resources for AccessGUDID