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Doctors, Hospitals Should Share Blame For Recalled Medical Devices



This week's report that a whopping 80% of medical devices so dangerous that they had to be recalled had been cleared for use under a flawed, federal processleaves no room for doubt: there's plenty of blame to go around.



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.