FDA Launches Searchable Database of Tracked Medical Devices

May 9, 2015 in News

On Monday, FDA launched a new database with information on tracked medical devices, Modern Healthcare reports (Ross Johnson, Modern Healthcare, 5/4).

Background

In April 2013, FDA published an updated strategy, detailing the steps it would take to create a National Medical Device Postmarket Surveillance System.

In its modernization plan, FDA called for the creation of an automated surveillance system that would leverage electronic health data.

In September 2013, FDA issued a final rule establishing a unique device identification system for tracking medical devices, with the aim 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 (iHealthBeat, 2/23).

Database Details

Using FDA’s new Global Unique Device Identification Database, or AccessGUDID, the public can access device information that has been submitted by companies (Modern Healthcare, 5/4).

The information in the database is administered under FDA’s unique device identifier system and is updated each business day.

According to the database, the beta version has basic search and download capabilities, but FDA plans to add advanced functions in the future.

AccessGUDID does not:

  • Collect any information on patients or those who use the devices; or
  • Store product identifiers.

The database was created in collaboration with the National Library of Medicine (AccessGUDID, 5/4).

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