The International Medical Devices Database Now Covers 26 Countries

The ICIJ's team comprised 252 reporters and data specialists from 36 countries and 50 media partners, including The Australian Financial Review.

While the industry has unquestionably revitalised or saved the lives of millions, it is fiercely competitive and repeatedly runs foul of global law enforcement, financial and health authorities.

It also uses formidable lobbying clout to pressure regulators to speed approvals and lower safety standards.

Casualty of growth

The files show governments in dozens of countries in Africa, Asia and South America don't regulate medical devices at all. They depend on the European authorities or the US Food and Drug Administration.

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For the investigation more than 1500 public records were requested and more than 8 million device-related health records were collected including recall notices, safety warnings, legal documents and corporate financial filings.

As no global resource for recalls and safety notices exists, ICIJ built one. Its International Medical Devices Database (IMDD) now gathers recalls, safety alerts and field safety notices to create a searchable portal for anyone to access.

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The devices industry is growing fast with annual sales rising from about $118 billion in 2000 to about $400 billion in 2018. In Australia, the industry is estimated to be $12 billion.

It is suggested safety is a casualty of growth. In 2017, the FDA approved three times more devices than it did in 2010. In the same period, its warnings to manufacturers about product safety fell by almost 80 per cent.

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