The Food and Drug Administration (FDA) has announced recommendations to improve oversight concerning medical devices such as pain pumps. The recommendations would allow the government to revoke already approved devices.
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Tighter Oversight for Pain Pumps and Other Medical Devices


Posted on Aug 06, 2010

The U.S. Food and Drug Administration (FDA) has announced recommendations to improve the oversight of pain pumps and other medical devices, such pacemakers and X-ray machines. The changes target the U.S. device industry and increase the government’s ability to revoke approval for any products they consider unsafe or ineffective.

The recommendations stem from a flood of public criticism from health advocates and lawmakers over complications from medical devices, such as pain pumps. Physicians had reportedly been using pain pumps incorrectly causing permanent damage in patients and leading to multi-million dollar lawsuits.

The overhaul also addresses the nearly 35-year-old system, the 510(k) system that granted speedy approval to certain medical devices. The quick approvals were generally granted to devices that were considered similar to other products currently on the market.

Though, critics of the FDA consider the recommendations a positive step, they were hoping for more aggressive action to be taken by regulators. The FDA has also indicated that they intend to pursue additional options that would make it even easier to revoke already approved devices.

If you or someone you know has been injured by the use of a shoulder pain pump, you should contact one of our experienced Northern Kentucky injury attorneys at the law office of Schachter, Hendy & Johnson at (859) 578-4444 or (888) 606-5297.

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