We will never know how the courts will rule until some real test cases come
before the court and this point of FDA approved versus not FDA approved is
argued.
----- Original Message -----
From: "Tyrus Maynard" <[EMAIL PROTECTED]>
To: <hardhats-members@lists.sourceforge.net>
Sent: Friday, August 12, 2005 3:06 AM
Subject: Re: [Hardhats-members] Re: VistA Imaging FDA and NonCommercial Use
Re: [Hardhats-members] Re: TIU Interface for Document Scanning
This thread has covered various theories about the scope of FDA regulation
for viewing images. I have previously posted a *question* asking where
Title 21 describes regulation of Electronic Medical Records .... except
within the scope of Part 11 describing their receipt of documents
supporting various stages of device approvals with data.
I must respond to this post by Steven which invokes the scenario of
lawyers.
So let's take a scenario of an interested general practitioner simply
wanting to have TIFF 2d still radiographs for immediate review, beyond
the reach or any ominous meaning of DICOM. Yes let's add the layer of
culpability for converting the format and having contrast controls in
some viewer.
Scenario 1
MD receives text interpretation of radiologist for a scheduled chestXray
and is liable to treat according to that interpretation whether or not
that image is even viewed personally. In many ways efficient viewing
accrues to the ongoing education and motivation of a practitioner, while
treatment must acknowledge the definitive interpretation of one (or more)
radiologist...always. Clinical signs and symptoms are another storyline
(that every motivated radiologist also seeks before rendering an
interpretation) (and will note it in the record if MD doesn't provide
that ). MD hasnt even looked at the TIFF image yet and is of course
liable for addressing clinical picture and the consultants
interpretation.
Scenario 2
MD in acute care does first reading of silver radiograph and is entirely
liable to treat or amend treatment according to the second reading which
will come from a radiologist. MD also hopes that film quality will be
found "adequate" by the radiologist ( otherwise really out on a limb).
If lucky the site of care has a digital version for immediate review by
remote radiologist . Over time same MD may followup at another site
outside of the DICOM infrastructure, attending to things like patient
education and self education which can never circumvent the written
interpretation of a radiologist . In later chart review,are these other
endeavors of education impeded by shunning the generic tools of image
processing ?
MD's in court will be burned by their omissions and commissions, but
evidence of interest in following images (in a parallel archive) does not
displace definitive interpretation which is also archived in the same
record system. If your defense lawyer cannot show that viewing multiple
times and in parallel is commendable asset in practice, then don't
bother to ask whether obaining continuing education is admissable
evidence.
Scenario 3
While reviewing a time series of 3 TIFF images of plain Chest Xrays on an
average monitor with various contrast enhancements, MD notices a shadow
on film 2&3 which wasnt cited in text report and strikes up a dialog with
the radiologist requesting an additional review. Whether confirmed or
rejected using the definitive archive with the radiologist's software,
the existence of the radiologists opinion is the surest evidence that
viewing an image in a redundant archive of images is not, by itself, a
definitive diagnostic event.
Does scrutiny in a parallel archive remove the mandate for
corroboration/consultation? Not for a minute.
The lack of tools that put practitioners into efficient dialog with
consultants is one cause of undermotivated primary medical care
...if not wholesale attrition of providers in some settings. I don't
see any escape from liability in any of the 3 scenarios ...all of
which presume that an interpreted result from an approved medical
device (xray) is in the medical record.
If you draw the line in the sand which separates digitized radiographs
from other "scanned documents" or photographic images just because they
were born in a approved medical device in DICOM format, then inflated
fear of litigation will trump modern technology that is generically
available for all other imagery. Let's leave aside 3D,4D,5D images for
a few more years, but in some settings even these tools may have
educational value that will accrue to diagnostic collaboration.
The cost of efficient access to these images and the fears of owning
image information are part of the equation for transition. If other
issues of bloat and distraction can be overcome by good software and data
management, do not dismiss the enjoyment factor that image access can add
to practice and accrue to patients....which can displace the FUD of the
lawyer scenario.
I am still awaiting other interpretations of Title 21, and if lawyers
read medical records, I hope folks on this list will offer opinions of
Title 21 Part 11... ...is this the fire givng smoke?
...where are the regs which describe FDA as seeking to regulate the
viewing of images in medical records when device based procedures have
been definitively interpreted and recorded into those same medical records
according to respective skilled consultants?
RustyMaynard
(previous post McPhalen)
"Sure viewing a scanned paper document should not be under the FDA regs.
But
if the device is used for clinical interpretation, wouldn't a practicing
clinician want to use a FDA approved device? Camera taking pictures of
things probably doesn't need FDA approval for example in anatomic pathology
or dermatology. But what about devices that provide enhancements or require
a Dicom viewer? If I was a practicing clinician I would want some assurance
that my use of a medical device would not be questioned if I was involved in
litigation. Obviously my interpretations are subject to scrutiny. But I
can see it now. A lawyer finds out you made a medical decision using a
non-FDA approved device and spins it all negatively from that point on. As
Greg has stated several times, a Dicom viewer is way overkill for viewing
photographs and scanned documents."
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