A project by The International Consortium of Investigative Journalists (ICIJ), including journalists from the BBC, ABC, and the Guardian, has discovered that the deaths of more than 80,000 people globally in the past decade, could be linked to dangerous medical devices.
The project – titled ‘The Implant Files’ – also discovered the medical devices may have caused injury to 1.7 million people. The year-long investigation involved over 250 journalists from 36 countries.
Writing about the investigation, the ABC said: “It has revealed for the first time how lax regulations and vested interests have allowed dangerous and malfunctioning devices onto the market, putting patients’ lives at risk.” The ABC also stated that: “The investigation has revealed how the regulator’s dependence on jurisdictions like Europe can mean problematic devices there, are exported here.”
The data gathered included over 8 million device-related health records.
In Australia, the Therapeutic Goods Administration (TGA) is in charge of regulating the safety of medical devices. A Spokesperson for the TGA has made comment on The Implant Files, stating the investigation “presents a number of inaccuracies and points where context is absent – giving an incorrect view of how medical devices are regulated in Australia.”
“The TGA is not reliant on the European regulations,” it said. “The TGA along with other major regulators, who are members of the International Medical Device Regulatory Forum, identify areas where alignment and/or where there could be benefits in sharing regulatory decisions/assessments to reduce duplication of effort.”
However, the ICIJ said that while the medical device industry is experiencing a boom, the industry lacks transparency. It also claims that since 1996, the average time for new devices in the US to be approved has dropped by more than 200 days.
“Faster approvals may yield devices more prone to faults,” the ICIJ report claims. “Manufacturers are drawn by Europe’s light-touch regulations, widely seen as allowing new devices to be quickly approved with minimal testing. A 2016 study from ICIJ partners at The BMJ, one of the world’s oldest medical journals, found that devices approved first in the EU were associated with a higher rate of safety alerts and recalls than those approved in the US.”
Database of faulty medical devices now available
The Implant Files investigation discovered that fewer than 20 percent of the countries in the world had public data online permitting citizens to find safety alerts and recall information on medical devices.
As a result, the ICIJ has now also given patients across the world access to a new database of dangerous medical devices — including life-threatening ones.
The International Medical Devices Database (IMDD) offers unprecedented insight to be able to check prior to use if a medical device has been found to cause problems in other patients. It permits users to explore more than 70,000 recalls, safety alerts and field safety notices executed in 11 countries in its first release. Users can search by device name, by manufacturer, or by country.
ICIJ is broadcasting the data 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. ICIJ will add data from more countries as it becomes available.
Netflix has also recently released a documentary on the topic of faulty medical devices called The Bleeding Edge. You can watch the preview below.