Summary of Medical Devices Harm Patients Worldwide as Governments Fail on Safety

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While medical devices such as pacemakers or artificial joints help improve the quality of life of millions, they also come with a slew of health risks. An extensive, global investigation by the International Consortium of Investigative Journalists reveals that poor regulation, lax safety rules and the failure to systematically monitor medical devices once on the market is harming patients around the world.   

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The International Consortium of Investigative Journalists is a US-based nonprofit organization. 



Demand for medical devices, such as pacemakers and orthopedic implants, is growing. Yet an international investigation of the booming industry is raising concerns about the devices’ safety and regulatory oversight. The causal relationship between faulty implants and injuries or fatalities is not always straightforward. However, between 2008 and 2018, manufacturers have reported 5.4 million “adverse events” – associated with about 1.7 million injuries and almost 83,000 deaths.

New medical devices are not subject to the same stringent approval standards. In the US, medical devices manufacturers don’t need to conduct randomized controlled...

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