This database contains information on more than 120,000 Recalls, Safety Alerts and Field Safety Notices about medical devices distributed worldwide. The information connects with medical device companies and their subsidiaries.
Compiled by the International Consortium of Investigative Journalists (ICIJ) and 58 media partners in 36 countries during our year-long Implants File investigation, the database fills a critical information void.
The data is drawn from both public sources and responses to Freedom of Information requests.
ICIJ is publishing it in the public interest to provide vital safety alerts and potential recourse to patients who, in most parts of the world, have been shut out from such information until now.
The Implant Files investigation discovered that fewer than 20 percent of the countries in the world had public data online permitting citizens to find medical device safety alerts and recalls.
The initial November 25, 2018 data release included data from 11 countries. On December 19, 2018 more than 5,900 records from two more countries were added to the database.
On February 27, 2019 more than 16,000 records from five more countries were incorporated, and on May 15, 2019 more than 16,600 records from eight more countries were also included.
For the anniversary of the Implant Files Investigation, on November 25, 2019 more than 15,000 records from 20 more countries were added. This is the final batch incorporated to the database.
The database allows users to explore events associated with the same product in different parts of the world. It covers not only implants, but a wide range of devices that have been recalled by manufacturers and reported to local authorities — everything from condoms and gloves to complex high-risk devices like pacemakers and defibrillators.
Because there is no universal numbering system for devices, ICIJadded a parent company category to facilitate visualize connections between manufacturers. ICIJ used U.S. Securities and Exchange Commission filings and Dow Jones Factiva reports as primary sources to identify parent companies of manufacturers.
The team also used FDA Device Classification Panels to identify broad categories of medical specialties, such as cardiology and orthopedics, that would use specific devices. Products that were part of class 1 recalls in the U.S. and their respective categories were used to match them with the same medical device in other countries and include their classification. The matches were not done against class 2 and class 3 recalls, which means not all devices outside the U.S. have a Device Classification linked to them.
Recalls are classified as class 1 in situations in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Read the FAQ for more information on recall classifications.
Devices may have different names in different countries. To aid identification, the database includes the device number when it is available.
Recalls usually aren’t done at the same time in all jurisdictions where they occur. Sometimes months, or even years, elapse between the first and last countries where they occur. ICIJ found that too often vital warnings don’t reach patients and doctors at all. Some devices are officially recalled, withdrawn or even banned in some nations but not others, raising questions of unequal treatment of patients across the globe.
The International Medical Devices Database includes links to primary sources for reference purposes and an interactive map that allows exploration by country.
Read more about why ICIJ is making this information publichere.