Safety data from 20 countries added to Implant Files database
The International Medical Device Database now has more than 120,000 records about faulty or even dangerous medical devices from 46 countries.
Today the International Consortium of Investigative Journalists is releasing the last batch of medical devices data to its International Medical Devices Database (IMDD), giving patients access to more than 120,000 records about faulty or even dangerous medical devices from around the world.
An additional 15,000 safety reports from 20 new countries have been incorporated in this latest release, making the database the world’s largest resource on medical device recalls, safety alerts and field safety notices. The IMDD, which now has data from 46 countries, has been visited more than 1.1 million times in the past 12 months.
ICIJ is publishing this data in the public interest, to bring more transparency to the medical device industry and provide a resource to patients who, in many parts of the world, don’t otherwise have access to these types of reports.
ICIJ and its media partners collected the new data by scraping documents published in online databases or made accessible through Freedom of Information requests. For example, in Slovenia ICIJ member Anuška Delić obtained more than 800 records – data that had never before been disclosed to the public – following an FOI request.
Each record – after being translated into English, where applicable – was checked for accuracy, classified, and the device manufacturer’s parent company was added. Whenever available, the original documents are accessible directly through the database.
Tracking medical safety data across borders
Typically, when a manufacturer withdraws a device from the market or detects a problem with a device, the company would be required to issue an alert and inform authorities. However, sometimes a device can be recalled in one country but remain on the market in another. While not meant to replace healthcare providers’ expertise, the IMDD aims to plug some of these holes between jurisdictions by providing unprecedented insight into a broken system.
Adding to the existing difficulties patients face, technical updates such as website redesigns can make it even harder to access information on medical devices.
For example, in the case of Colombia, the local authority, the National Food and Drug Surveillance Institute (INVIMA), decided as part of a website migration to no longer publish safety alerts dated in 2012 and before. INVIMA told ICIJ that “the epidemiological information after five years is not considered representative.”
In the case of Turkey, ICIJ was able to replace broken or deactivated database links with historic links stored on archive.org, thereby ensuring patients can still see the original records.
The problems ICIJ and its media partners exposed as part of the Implant Files investigation are still visible in the newly released data: there is no universal numbering system for devices in the available data, some devices have different names across multiple countries, and there are substantial variations across jurisdictions in the quality of information available. This makes it harder for patients to be informed on the risks presented by medical devices.
The records published in the IMDD span decades, from the early 1990s in some cases, to 2018. Not all countries cover the same time range. With this release, ICIJ is publishing 2019 data from Philippines, Russia, Saudi Arabia, Slovenia and the United Kingdom.
Power of collaboration
The latest IMDD release also adds data from Serbia that would not have been included without the support of the Balkan Investigative Reporting Network (BIRN).
Following a presentation of the database at the European Investigative Journalism Conference last May, Ana Ćurić from BIRN offered to find data in Serbia and interpret the documents that used both the Cyrillic and Latin alphabets. Thanks to her help, the IMDD now includes 137 records from Serbia.
ICIJ welcomes tips from anyone with further relevant information on medical devices, medical implant safety data or the healthcare industry in general. Please contact us via any of the methods on this page.
The full IMDD dataset is available for download pursuant to specific terms.
The IMDD team:
- Developers: Pierre Romera, Hilary Fung
- Database developer: Miguel Fiandor
- Data Researchers: Pauliina Siniauer, Margot Williams, Karrie Kehoe, Delphine Reuter, Cécile S. Gallego
- Research Editor: Emilia Díaz-Struck
- Chief Technology Officer: Pierre Romera
- Editors: Martha M. Hamilton, Fergus Shiel
- Fact-checker: Richard H.P. Sia
- Contributors: Barnaby Skinner, Antonio Hernández Rodríguez, Fabiola Torres, Andrew Lehren, Emily Siegel, Valerie Ouellet, Ville Juutilainen, Minna Knus-Galan, Marco Visser, Daniele Grasso, Helena Bengtsson, Caelainn Barr, Boyoung Lim, Ricardo Brom, Yasuomi Sawa, Amy Wilson-Chapman, Hamish Boland-Rudder, Spencer Woodman, Haïfa Mzalouat, Anuška Delić, Ana Ćurić, Razzan Nakhlawi, Scilla Alecci, Mexicanos contra la Corrupción, Quinto Elemento Lab and Proceso.
- System administrator: Jorge González, Jmp