Re: GE touting non-medical use of 4D US for fetal baby pictures

From: Terry J DuBose (tjdubose@juno.com)
Sun Jun 30 20:49:41 2002


Folks outside the USA may not understand the ramifications for medical sonography, but it is important here. These non-medical "baby picture" businesses are proliferating. There is no legal oversight at this time, and one can not be sure if the individual(s) using these services understand that the person operating the equipment may or may not have a clue as to what they are viewing.

Much of the situation can be blamed upon the diagnostic medical community. We spent the first 25 years convincing people it was safe, and made the obstetrical examination a fun, family affair. There will soon be an article published in the JDMS by a social anthropologist pointing this fact out.

I recently spoke to an individual who is involved with an "alternative medicine" clinic where one can go to yoga classes for back pain to chiropractors, and acupuncturist, to name a few. (I realize that in many places these are not considered "alternative medicine" as they are in the USA). He was asking about the "entertainment" uses of sonography, but he was looking at it from the point of view that if a person knew what they were doing, the patient wanted the service, payment was in cash; then neither the patient nor the person using the equipment had to deal with the bureaucracy of insurance companies, Medicare/Medicaid, etc, then what difference would it make? It moves the procedure out of the medical office "mill", and allows the procedure to be in a much more relaxed atmosphere.

I tried to argue that the cash basis would mean those with the most money would have best access making it a purely capitalistic, elitist endeavor. Of course, he argued that is how it is anyway, with most who get minimum wages not having insurance and health care anyway. The other argument was that you have more exposure to lawsuits, which he said that is no different than what we all face now. The only other argument was the problem of "non-medical", and the reply was if the person knows what they are doing, and pathology is found, then they will tell the patient that they need to go see their obstetrician for a consult.

My fear is that we are going to see sonography fall into the hands of those who do not care about quality, and are only doing it for the money. Sonography as a profession will suffer from this anarchistic approach, IMHO. And GE isn't helping.

Peace, Terry J DuBose

On Sun, 30 Jun 2002 20:21:06 -0500 ridem@msn.com (Rich Dempsey RDMS/RVT ) writes: > Dear Dr Lyons:
>
> Sorry. The GE website lists various facilities in various US
> locations.The GE California "locator page" is:
>

http://www.gemedicalsystems.com/rad/us/4d/4d_sitequest.html?address=&city =&stateÊ&zip> > There the "First Look" company is listed. It is at the "FirstLook"
> site
> that the non-medical use of US is advertised.
>
> GE reps are claiming that GE has no control over the end-use of its
> product. Still in their California "locator page" they chose to
> include
> an "entertainment ultrasound business", alongside the many
> reputable
> research facilities and "great names" in Ultrasound diagnosis in CA
> using their product.
>
> Oversight? or a "wink and a nod?"
>
> At Sat, 29 Jun 2002, Edward Lyons wrote:
> >
> >How is the GE Website "touting entertainment 4D fetal ultrasound"?
> I can see GE mentioned on the "Firstlooksonogram website but I see
> NO mention f firstlooksonogram on the GE website. Did I miss it?
> >ps has anyone seen the ever increasing number of drug company ads
> for a hole host of new drugs that patients are asked to try or ask
> their docto about? What is the difference with an imaging company
> advertising their latest CT or ultrasound imaging tool?
> >Ted
> >

>> >>----- Original Message -----
> >From: evsono@pipeline.com
> >Sent: Thursday, June 27, 2002 11:59 AM
> >To: Multiple recipients of list ULTRASOUND
> >Subject: Re: GE touting non-medical use of 4D US for fetal baby
> pictures
> >
> >Done! additionally, another tactic would be to give the phone
> number of
> >the GE salesman to any patient inquiring about getting a 4d scan.
> (
> >preferably, his home number)
> >
> >i would urge the aium, acr and sdms to issue policy positions on
> this
> >contentious issue.
> >
> >art
> >
> >At Wed, 26 Jun 2002, Rich Dempsey RDMS/RVT wrote:
> >>
> >>Cross-posted form SDMS Discussion Forum:
> >>
> >>The official GE web site is touting entertainment 4D fetal
> ultrasounds
> >>on their site:(http://www.firstlooksonogram.com/index.asp ) It is
> stated
> >>there that a company known as "First Look Sonograms" is using
> their 4D
> >>technology to produce "baby pictures". The physician in charge of
> this
> >>racket is a perinatoligist!!!!!
> >>
> >>QOUTE:
> >>
> >>"First Look Sonogram specializes in 4D prenatal ultrasounds. You
> can
> >>now share the exciting first look of your unborn child with those
> >>closest to you. This experience will impress all in attendance
> and make
> >>the forthcoming birth that much more exciting. Our services are
> >>non-medical and for your enjoyment and commemorative purposes."
> >>As to pricing: The products that are included with each paid visit
> are:
> >>
> >>• 2-5 pictures of the baby from your sonogram
> >>
> >>• Video cassette of your complete ultrasound session recorded w
> th the
> >>music of your choice.
> >>• Color images of the baby saved to CD-ROM
> >>
> >>• Website hosting for images & baby gift registry
> >>• Home theater viewing environment for all your guests
> >>
> >>Pricing
> >>
> >>First Look Sonogram will accept cash, check or credit cards only
> >>
> >>One time sonogram session
> >>Includes all the above mentioned products $275
> >>Package of two visits $475
> >>Package of three visits $650
> >>
> >>The statement that these services are "non-medical" are a
> violation of
> >>FDA policy on the use of US.
> >>
> >>I have reported it to the FDA, and ask you to do so as well.
> >>
> >>Contact:Diagnostic Devices Branch Office of Compliance Center for
> >>Devices and Radiological Health HFZ-322 2098 Gaither Road
> Rockville,
> >>Maryland 20850
> >>
> >>or
> >>
> >>notify FDA by phoning 301-594-4591 or FAXing 301-594-4636
> >>
> >>or
> >>
> >>email complaint to
> >>Howard A. Press [HAP@CDRH.FDA.GOV]
> >>
> >>The FDA's statement on the practice is at :
> >>
> >>http://www.fda.gov/cdrh/consumer/fetalvideos.html
> >
> >--
> >art fougner, md
> >
>




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