020 7650 1200

Data Protection Hospital

Patient power and the new international medical devices database

The International Consortium of Investigative Journalists (ICIJ) has published a series of reports following an investigation into the defective regulation of medical devices across 36 different countries and the shocking human cost of that lack of regulation

Posted on 26 November 2018

The investigation, titled the Implant Files, focusses on implantable medical devices – from pacemakers to contraceptive devices, and is the work of more than 250 reporters and data specialists from 58 news organizations in 36 different countries.

The ICIJ report that the Implant Files are the ‘first-ever global examination of the medical device industry and its overseers’, based on material gathered through extensive interviews with patients, epidemiologists and regulatory insiders, the report exposes the speed with which novel products are brought to market and the fact that even the most high risk implantable devices, pacemakers, can be brought to market with very limited in-patient testing.

The ICIJ report states that ‘manufacturers, doctors, and others potentially linked more than 1.7 million injuries and nearly 83,000 deaths to medical devices in reports to U.S. regulators over the last decade’.

The Implant Files also provide a new resource to patients internationally in the form of an ‘International Medical Devices Database’(IMDD)

The ICIJ explain that this new, free to download and internationally available resource ensures that ‘Patients across the world now have access to facts about faulty or dangerous medical devices — including life-threatening ones — thanks to the publication of a database that for the first time brings together information from different countries’.

Zahra Nanji, a solicitor in the Leigh Day product liability team, commented: "The International Medical Devices Database (IMDD) empowers patients internationally to do their own due-diligence in relation to any implantable medical device which they have been offered, or with which they are already implanted.

"The database includes data on more than 70,000 recalls, safety alerts and field safety notices across 11 different countries. In the UK, doctors and patients may look at the UK regulatory database – published through the Medicines Healthcare and Regulatory Authority (MHRA) to check the track-record of a device, and possibly the US equivalent (through the FDA), but are unlikely to look further afield.

"The IMDD collates data from 11 countries in its first release. Users can search by device name, by manufacturer, or by country. Lack of transparency regarding problems with medical devices is a consistent and life-threatening problem right across the medical devices industry – this new database has the potential to shed much needed light in this area."

The IMDD publishes critical, previously unseen data including more than 6,700 from Spain, Finland and Mexico that have never before been disclosed to the public. The ICIJ explain that this information was obtained through freedom of information requests from ICIJ partners in those countries.