Diagnostic Workstations and the FDA 510(k) Clearance
I'm looking for advice and opinions from this group. A situation has
arisen for me in a point of discovery that a vendor who has been
selected (not my choice) and is currently being deployed claims to be
510(k) exempt. I have searched the entire FDA database and can only
find their exemption. Nothing pending and no clearance.
From a medical legal standpoint should one be performing final
diagnostic reads on a workstation that has not been FDA 510(k)
cleared? Can a PACS system and its related workstations for such reads
ever be given an exemption and be considered truly a diagnostic
medical device? For the sake of augment lets assume they are
completely DICOM complaint including workstation calibrations. In a
lawsuit would this fact be enough as a point of contention to put the
radiologist at risk for losing the lawsuit or the factoid of being
100% DICOM compliant (smile) be enough to protect?
Have I just stepped into one of those grey zones trying to achieve
clarity? Am I making a mountain out of a molehill? Or should I oppose
the deployment to protect the legal creditability of the hospital,
radiology department and the radiologists?
I invite all to reply in this newsgroup as I am trying to maintain a
certain amount of anonymity at this time. Thanks in advance for your
time, thoughts and feedback.