One such device is the LIFEPAK CR Plus automated external defibrillator. It was recalled on July 31, 2009 because, the FDA said, "An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy."
Other 510(k)-approved but now recalled devices included another 20 "general hospital" products, including an infant warmer used in hospitals, insulin pumps, intravenous infusion devices and patient lifts. Also approved by the 510(k) process, or slipped through with no review at all, were 10 now-recalled anesthesiology devices, such as mechanical ventilators.
Nissen says that during the 2005-2009 period of their review, 112 million medical devices were recalled, but not before 2,000 people a year died because of their failures.
This gives me cause to ask, Where are the doctors who are seeing this on the front lines, and why aren't they speaking out?
These are their patients that in many cases must undergo repeat procedures to remove and replace devices, re-enduring the risk of infection and other complications. Moreover, as an aside, it's unclear who pays for the added care required in a patient unfortunate enough to be a guinea pig.
Over time, the researchers wrote, the FDA's categorization of such devices has been modified to become even more lenient; now devices approved under the 510(k) process are increasingly less "substantially equivalent" than the ones that paved their way.
These standards have eroded so that devices approved under 510(k) criteria included those made from different materials, with different mechanisms of action than the parent product they were supposed to be substantially equivalent to.