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- November 26, 2018
- Maglio Christopher & Toale, P.A.
On Monday, the Food and Drug Administration (FDA) announced that it will overhaul the way medical devices are tested and approved. The changes will force device makers to design their newest devices on more updated and recent technology. The FDA’s sudden announcement came just one day after a worldwide investigative report into medical device safety, led by the International Consortium of Investigative Journalists (ICIJ). The news report is called the “Implant Files” and holds the US government and device makers accountable for “1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices (that) had been reported to the U.S. Food and Drug Administration over a 10-year period.” Those staggering numbers are the result of the FDA’s 510(k) process of getting medical devices approved by basing their design on outdated and decades-old testing and research. Orthopedic companies like Zimmer Biomet and Johnson & Johnson used designs from the 1970s to get their new metal on metal hip replacements approved, even though the older hip designs were scrapped because of severe patient reactions to metal wear. Those same problems with heavy metal poisoning from hip implants like the Biomet Magnum and Pinnacle are now haunting millions of patients facing serious health risks. The change in the 510(k) system is welcome, but the reforms won’t happen soon or fast enough. The Associated Press reports that it “could take years to implement, in some cases requiring new guidelines and regulations for manufacturers. And the most substantive changes could require action by Congress.”