Program Report On FDA Medical Device Oversight
The CBS News Sunday Morning program yesterday, (April 1, 2012) ran a critical report on medical device regulation at the FDA. The primary focus was on implantable devices, especially implantable defibrillators and a 21 year old man who died when the defibrillator didn’t fire as it should have from a known reported flaw that that did not cause a timely FDA recall. The recall was only issued after the patient’s concerned doctor went to the New York Times with the story.
Again the media went to ADVAMED for comment. They took the position of defending the FDA and its current device regulations. They did not have comment from AAMI or ECRI. Have they lost relevancy to the news media?
It was revealed that some regulations on specific medical devices were due to be issued in 1976 have yet to be issued.
CLICK HERE to view this 13.5 minute video.
Contributed By:
William D. Knight, CBET-R, KJ6TBE
Posted by Ohio Clinical Engineering Association 
