IMPLANT FILES

New countries, new languages added to the International Medical Devices Database

Medical device recall and safety data from five new countries have been added to database, boosting the total number of records to more than 90,000.

International Medical Devices Database

Medical device recall and safety data from five new countries have been added to the International Medical Devices Database (IMDD) which is now introduced in several languages other than English.

Germany, Japan, South Korea, Sweden, and Tunisia are the fresh additions, boosting the recall events in the database by 16,400 to more than 90,000.

With this release, the International Consortium of Investigative Journalists has made searchable nearly 11,000 events from Germany alone. ICIJ is now providing the interface of the website in French, Spanish and Korean, as well as English, and we plan to add more languages.

The database was first published in November 2018 with the Implant Files investigation, which revealed how health authorities across the world had failed to protect millions of patients from poorly tested devices.

Reporter Boyoung Lim, from the Korea Centre for Investigative Journalism – Newstapa welcomed the release, saying: “The South Korean data provides detailed information on recalls and adverse events that were not available to the public up to this point.

“This is the first time the Korean public will have access to such important information. The South Korean government makes the recall data public for only three months from the last day of the public recall of a certain device. The general public has no access to recall data older than three months through the government portal website.”

In Tunisia, medical device recall information is scattered among official authorities. Journalists from the local online media Inkyfada who worked on the Implant Files investigation told ICIJ that although they sent several requests for access to information, the documents they received were incomplete, with serial numbers, names or models missing. “If a patient needs information about a medicine or a medical device, it is not easy to find it from state agencies,” said one of them, Haïfa Mzalouat.

Some 635,000 people – from patients and medics to researchers – have so far connected to the Implant Files’ medical devices database.

Among those was Austrian researcher Dr. Claudia Wild.

Dr. Wild, the director of the Ludwig Boltzmann Institute for Health Technology Assessment, told ICIJ that the database helped her team to cross-check safety warnings published online against their own research. She felt it was politically timely, too. “On the political level, it’s landed during the transformation period of the new European medical devices regulation”.

Mary Baude, a U.S. patient who had an elbow joint prosthesis implanted in 2015 that was recalled a year later, found the database more user-friendly than the U.S. Food and Drug Administration’s website.

“The FDA website doesn’t have a tab for searching for recalls and you have to find three different links to be able to enter information for a search. Clicking on the International Medical Devices Database link takes you directly to the page to enter your information,” she said.

Since the Implant Files investigation was published, regulators around the world have vowed to fix gaps in medical device oversight.

ICIJ plans to add more countries to the IMDD in 2019. Want to be alerted when we next update it? Subscribe to our newsletter to know about our next release.

Contributors: Pauliina Siniauer, Margot Williams, Karrie Kehoe, Boyoung Lim, Haïfa Mzalouat, Miguel Fiandor Guttiérez, Pierre Romera, Razzan Nakhlawi, Scilla Alecci, Emilia Díaz-Struck