The International Consortium of Investigative Journalists has compiled a global database of medical devices that are either faulty or dangerous. It allows users to explore more than 70,000 recalls, safety alerts and field safety notices of medical devices in 11 countries – Australia, Canada, Finland, India, Lebanon, Mexico, Netherlands, Peru, Spain, Switzerland and the United States – in its first release.
The International Medical Devices Database has been compiled and released after an investigation by the consortium showed that less than 20% countries in the world have public data online on the safety alerts and recall information on medical devices. The year-long investigation by the consortium and its media partners, including The Indian Express, in 36 countries has scrutinised all devices used in medical procedures. The result is a series of reports called the Implant Files, which the consortium and its partners began publishing on Sunday evening.
The reports show how devices like coronary stents, pacemakers, breast and knee implants, pelvic meshes and intrauterine devices are advertised, sold, and surgically implanted in lax regulatory systems putting patients at risk of injury or death. In India, the Supreme Court is currently hearing a case against Johnson & Johnson for allegedly using faulty hip implants.
The new database has an interactive application that connects more than 1,100 device companies and their subsidiaries around the world, according to the consortium. Users can use the “search” feature of the database to enter the name of the device and check recalls, safety alerts and field safety notices initiated across countries. The database also allows a patient with a device who lives in a country where no data is available to see whether the device is listed as high risk elsewhere.
The database has been compiled by collating publicly available data on medical devices and data acquired through right to information requests. But information from some countries without public data may be missing.
The consortium said that the data was drawn from several sources from the early 1990s to 2018 but varies in structure and quality. The investigation shows that this is largely because the same product can have different names across countries and model numbers can present variations, making recalled devices hard to track across borders. Moreover, there is no international consensus on what constitutes a device “safe enough” to remain on the market, or a warning system to communicate health alerts and recalls to patients and health care providers across national borders.
The reports warn that while the database allows patients access to facts about faulty and dangerous medical devices, it is not a substitute for medical advice by the doctor.
