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Doctors, Hospitals Should Share Blame For Recalled Medical Devices

Cheryl Clark, for HealthLeaders Media, February 17, 2011

Lifesaving devices need to work, and they need to undergo clinical trial scrutiny. And doctors and hospitals need to pay attention, and get upset and even angry when their patients get harmed by them. Yes, doctors want to provide their patients with the next best thing. And no one wants to tamp innovation; but safety should be a greater concern.

In a phone interview this week, I asked Nissen if it's all the FDA's fault, or whether physicians and hospitals should bear some responsibility for letting these products slip through the cracks.

"There's lots of blame to go around," he says. He and his co-authors put some of the blame on AdvaMed, the manufacturers' advocacy group, for successfully blocking recent efforts to strengthen FDA's purview over these devices. FDA wanted to require clinical trials in more 510(k) reviews, have more premarket inspections and postmarket studies. But "AdvaMed, the largest association representing medical device manufacturers, opposes these changes," Nissen and his co-authors wrote.

Nissen also blames physicians who design and test these devices, and then own a share of the stock, as well as the doctors who flock to use the latest new thing, knowing it didn't have to go through a clinical trial and may not yet be totally safe.

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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.