After the ‘Implant Files’

Strengthening oversight:U.S. health officials have said that they plan to overhaul the decades-old system for approving most medical devices, which has long been criticised by experts for failing to catch problems with risky implants and medical instruments. The Food and Drug Administration has announced plans aimed at making sure new medical devices reflect up-to-date safety and effectiveness features. The system targeted by the actions generally allows manufacturers to launch new products based on similarities to decades-old products, not new clinical testing in patients. The FDA’s move comes after the publication of a global investigation into medical device safety by more than 50 media organisations, including The Associated Press. Led by the International Consortium of Investigative Journalists, the group found that more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices had been reported to the U.S. Food and Drug Administration over a 10-year period. Picture shows a combination of demonstration models of implantable neurostimulators. (Top row from left) the Medtronic Intellis and the Boston Scientific Spectra WaveWriter SCS. (Bottom row from left) the Abbott/St. Jude’s Proclaim 7 Implantable Pulse Generator and Proclaim DRG Implantable Pulse Generator. — Matthew Perrone/APAP/Mary Altaffer, FileMary Altaffer

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