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Doctors, Hospitals Should Share Blame For Recalled Medical Devices

Cheryl Clark, for HealthLeaders Media, February 17, 2011

This week's report that 80% of medical devices so dangerous that they had to be recalled had been cleared for use under a flawed, federal process (and others were barely reviewed at all) points a damning finger at the U.S. Food and Drug Administration.

Nevertheless, doctors and hospitals should absorb some of the responsibility,  too.

These were Class I recalls, the most serious kind, necessary because "there is a reasonable probability that the use of or exposure to a violative (harmful) product will cause serious adverse health consequences or death," according to the FDA definition.

The largest category of these recalls involved 35 devices for cardiac patients, two-thirds of which were approved under the FDA's 510(k) process. That The 510(k) speeds approval for devices considered "substantially equivalent" to other devices approved under the more rigorous, premarket approval process (PMA) and requires little safety documentation and no clinical trials, according to a research paper published this week in the Archives of Internal Medicine.

These are devices classified by the FDA as the most dangerous kind, the type that "pose the greatest potential risk and include such items as implantable pacemakers, stents, heart valves, and human immunodeficiency virus diagnostic tests," wrote the researchers, Diana Zuckerman and Paul Brown of the National Research Center for Women & Families and Steven Nissen, MD, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic.

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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.