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Doctors, Hospitals Should Share Blame For Recalled Medical Devices

Cheryl Clark, for HealthLeaders Media, February 17, 2011

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.

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2 comments on "Doctors, Hospitals Should Share Blame For Recalled Medical Devices"


Mary Potter (2/18/2011 at 1:40 PM)
How presumptuous to suggest that hospitals and most physicians fail to report device failures. My experience is that physicians and clinicians consistently report device failures and offer recommendations for improved functionality. The majority of manufacturers thank us for our interest and advise that no one else has reported the issue and no one else has requested functional change. Instead of attemping to assign blame, maybe we should devote our energies to improving the reporting structure and making it transparent.

Linda Ollis FACHE (2/17/2011 at 3:12 PM)
Hospital leaders are generally very cautious of clinical trials and should have a solid, tested IRB Committee and process in place for research protocols. Once a device has been approved for use, hospitals still have the responsibility of reporting incidents and/or poor outcomes that include the use of a medical device, allowing trends to be tracked. We also rely on outside experts from such organizations as Sg2 and ECRI to warn of issues. We cannot make independent medical judgements as to the causes of any problems. There are a number of patient safety organizations in existence now who should be reviewing the system and issues and making recommendations for improvement that hospitals can support.