Re: Keepsake 3D
From: Dave Berck (djberck@yahoo.com)
Mon May 24 10:04:33 2004
As an aside, I happen to know the sonographer who
works at Peek in the Pod. She happens to be RDMS
certified, and a lovely, conscientious person.
PS: does anyone ever take ANY extra time at an exam to
get a nice picture for the parents? If so, welcome to
fetal foto because you are doing the same thing.
--
Dave Berck, MD, MPH, RDMS
Mt. Kisco, NY.
--- "art fougner, md" <evsono@pipeline.com> wrote:
> As a follow-up, Robert Modugno,MD posted this on
> OB-Gyn-L
>
> May 17, 2004 By MARC SANTORA
>
> "I'm going to cry."
>
> Limor Fronimos, 25 weeks pregnant, was taking part
> in one of the
> stranger and more controversial outgrowths of the
> ultrasound industry -
> the high-resolution, artistic photography of fetuses
> - and was
> overwhelmed by what she was seeing on the video
> monitor.
>
> For a few hundred dollars, expectant mothers can get
> sepia-toned prints
> to give to their families and friends, a CD-ROM with
> the pictures so
> they can be e-mailed around the world and a DVD with
> a 20-minute video
> of the fetus squirming in the amniotic sac.
>
> In an age of medical marvels, nothing would seem out
> of the ordinary
> about this experience, except that these ultrasounds
> are not being
> performed in doctors' offices or medical clinics,
> but at fetal photo
> studios that have been opening across the country in
> recent years and
> arrived in Manhattan in March.
>
> Mrs. Fronimos, 29, was a client at A Peek in the
> Pod, just off Madison
> Avenue on the Upper East Side, in a neighborhood of
> trendy maternity and
> children's stores. The top-of-the-line ultrasound
> package at the
> studio, including prints, CD-ROM and DVD, costs
> $295.
>
> But along with keepsake pictures, the new studios
> have generated a good
> deal of concern. They are not subject to
> regulation, and anyone with an
> ultrasound machine - the best cost upwards of
> $150,000 - can open up
> shop.
>
> The Food and Drug Administration in Washington has
> issued a blanket
> warning against what it calls "entertainment"
> ultrasound photos, and
> there is a move in Albany, led by the deputy
> majority leader of the
> State Senate, Dean G. Skelos, a Republican from
> Long Island, to try to
> ban the practice.
>
> "This is high-powered equipment, and every step must
> be taken to ensure
> that mothers and their unborn children are protected
> from unforeseen
> harm," Mr. Skelos said about his legislation to ban
> stores like A Peek
> in the Pod. "This legislation will guarantee that
> ultrasounds are
> limited to medically necessary treatments."
>
> Prenatal ultrasound works by sending energy into the
> mother's womb in
> the form of sound waves, which bounce off the fetus
> and are converted
> into images. When the practice first began more
> than two decades ago,
> the images were so cloudy and blurred that to all
> but the most expert
> eye they seemed more like Rorschach blots than
> portraits.
>
> However, in the past few years, there have been
> tremendous strides in
> the technology, which has moved from two-dimensional
> black-and-white
> images to three-dimensional color stills to videos.
> About a year ago,
> General Electric ran a series of national
> advertisements about the
> technology and its results. Industry officials said
> the response from
> mothers was overwhelming. They wanted to see the
> kinds of pictures
> featured in the ads.
>
> "The advances in technology that we have seen have
> created pictures that
> are much more lifelike," said Dr. Daniel Schultz,
> the acting director
> for the Food and Drug Administration's Center for
> Devices and
> Radiological Health.
>
> Dr. Schultz said that over the years ultrasound
> technology has proved
> safe, but that when the agency first learned of the
> artistic ultrasound
> photos in 1994 in Texas, it recommended against the
> technology's use for
> any purpose other than medical. The fear was that
> an irresponsible
> practitioner could subject a woman to a dangerously
> long exposure to
> ultrasound. As more shops have opened in the past
> year, Dr. Schultz
> said, the food and drug agency thought it should
> issue the warning
> again. "From the sense we are getting, we are
> dealing with a growing
> issue," he said.
>
> The F.D.A. governs only the advertising and selling
> of the equipment
> and does not police how it is used. Still, Dr.
> Schultz said: "It makes
> us nervous. The message that we would like to get
> out is that women
> should not engage in this activity or any other
> activity that could
> possibly have a harmful effect on their child."
>
> Rocky McClintock, the owner of A Peek in the Pod,
> agrees that it would
> be wise to establish a set of guidelines. In the
> absence of a standard,
> she has set her own rules.
>
> She has hired a sonographer, Narda L. Johnson, to
> perform the
> ultrasounds. She also requires that clients have
> prenatal care and
> consult with their doctors before coming in for
> sessions. The studio
> recommends that women who have the keepsake
> sonograms be from 22 to 32
> weeks pregnant, that the length of one ultrasound
> session be no more
> than 20 minutes, and that no client undergo more
> than three sessions,
> each on different days. Ms. McClintock said that
> of about 60 clients
> who have come to her seeking ultrasounds since the
> store opened in
> March, only 2 had doctors who opposed the idea, and
> those women did not
> proceed with the sessions.
>
> The room where the ultrasound is performed looks
> more like a New Age spa
> than a sterile hospital room. The bed is soft, the
> lights are chilled,
> and in the corner, for children, there is a
> PlayStation.
>
> The music playing gently in the background also
> serves as the soundtrack
> for the DVD the clients receive. It was composed by
> a client's husband,
> Marc Bazermat, who was so taken by the experience he
> had with his wife
> that he created what they call in the office "The
> Ultrasound Song."
>
> "Clients can also bring in their own music," Ms.
> McClintock said. So
> an unborn baby can groove to the Beatles or Busta
> Rhymes, depending on
> what the parents think their offspring's tastes may
> be.
>
> Mrs. Fronimos's tiny daughter seemed to favor
> chocolate.
>
> When the baby would not cooperate, choosing instead
> to shield herself
> with tiny hands from the prenatal equivalent of
> paparazzi, Ms. Johnson
> turned to a trick she picked up during the 20 years
> she has performed
> ultrasounds in doctors' offices.
>
> She gave the mother chocolate.
>
> "It goes straight to the baby," Ms. Johnson said.
> "It's a sugar rush."
>
> Sure enough, the image on the screen soon became
> clearer, and a big
> smile could be discerned.
>
http://www.nytimes.com/2004/05/17/nyregion/17fetus.html?ex=1085802642&ei=1&en=bdc3f0f54184cbb6
>
> ---------------------------------
>
> ---------------------------------
> art
> ---------------------------------
>
> At Sun, 16 May 2004, art fougner, md wrote:
> >
> >SKELOS INTRODUCES LEGISLATION BANNING "KEEPSAKE"
> ULTRASOUNDS
> >
> >Bill Follows Opening of First Prenatal Photography
> Studio in New York
> >
> >Thursday, May 6, 2004
> >
> >New York State Senate Deputy Majority Leader Dean
> G. Skelos (R-C,
> >Rockville Centre) today announced the introduction
> of legislation
> >prohibiting non-medical ultrasounds used solely for
> entertainment
> >purposes. Although private prenatal "photography"
> shops have appeared
> >in shopping malls around the country, New York’s
> first private
> >ultrasound studio recently appeared in Manhattan.
> >
> >"The FDA has concluded that these unregulated
> ultrasounds ‘put a mother
> >and her unborn baby at risk,’" said Senator Skelos.
> "This is
> >high-powered, equipment and every step must be
> taken to ensure that
> >mothers and their unborn children are protected
> from unforeseen harm.
> >This legislation will guarantee that ultrasounds
> are limited to
> >medically-necessary treatments and administered by
> trained
> >professionals."
> >
> >Generally, ultrasound equipment produces a
> high-frequency sound wave to
> >generate diagnostic images of developing babies.
> Since the 1960s,
> >ultrasounds have offered an invaluable tool for
> diagnosing pregnancy and
> >any potential abnormalities and determining the
> proper course of medical
> >care. When correctly administered by trained
> professionals, such as
> >sonographers, radiologists and obstetricians,
> low-power ultrasounds are
> >generally considered a safe means of gaining
> information about a
> >pregnancy.
> >
> >Utilizing state-of-the-art 4D technology, the most
> advanced ultrasound
> >machines can provide much clearer pictures than
> older
> >equipment—including facial contours, muscle
> definition and hair—and
> >combine these images into short videos. However,
> this modern ultrasound
> >equipment is capable of producing intensities eight
> times higher than
> >the machines commonly used by medical
> professionals.
> >
> >As introduced by Senator Skelos, S.6776-A would
> restrict the
> >administration of any ultrasound on a pregnant
> woman to those performed
> >pursuant to an order or referral by a licensed
> physician, nurse
> >practitioner or licensed midwife. In addition, the
> legislation
> >prohibits the dispensation of ultrasounds for
> entertainment purposes or
> >those not warranted by the condition of the
> patient. If enacted, a
> >violation of this new law would be a Class A
> misdemeanor, with a maximum
> >prison sentence of one year.
> >
> >"Ultrasounds on pregnant women are used for medical
> purposes, to obtain
> >information about the pregnancy," said William B.
> Rosenblatt, M.D.,
> >President Medical Society of the State of New York.
> "The practice of
> >performing ultrasounds on pregnant women without a
> medical reason and an
> >order from a physician, nurse practitioner or nurse
> midwife should not
> >be done. The Medical Society of the State of New
> York supports this
> >bill as an effort to end this unnecessary and
> extremely costly
> >practice."
> >
> >A U.S. Food and Drug Administration (FDA)
> investigation concluded that
> >non-medical, entertainment ultrasounds are often
> performed without a
> >doctor’s supervision. Moreover, the FDA warned
> that "[u]ltrasound is a
> >form of energy, and even at low levels, laboratory
> studies have shown it
> >can produce physical effects in tissue, such as
> jarring vibrations and a
> >rise in temperature." As such, the FDA concluded
> that "prenatal
> >ultrasounds can’t be considered completely
> innocuous." Further, the FDA
> >noted that many of these companies use the
> ultrasound machines at higher
> >energy levels and for as long as one hour to secure
> clear pictures
> >and/or videos for their customers.
> >
> >The FDA first became aware of the "keepsake"
> ultrasound industry in 1994
> >(Texas) and informed these providers that anyone
> promoting, selling or
> >leasing ultrasound equipment for the making of
> "keepsake" fetal videos
> >could be breaking the law. Although the ultrasound
> devices are
> >regulated by the FDA and, as such, the FDA can take
> action against the
> >"keepsake" video industry for using a prescription
> device without a
> >prescription from a medical professional, the
> qualifications and
> >behavior of technicians and physicians is regulated
> by the states.
> >
> >"In the new Manhattan studio’s first month, more
> than 40 mothers-to-be
> >have paid $300 each for a procedure that could have
> dire consequences,"
> >said Senator Skelos. "Even General Electric, the
> leading seller of 4D
> >ultrasound machines, has joined the Medical
> Society, the American
> >Institute of Ultrasound in Medicine, American
> College of Obstetricians
> >and Gynecologists and the New York State
> Radiological Society to express
> >its opposition to the use this equipment for
> nonmedical purposes. Until
> >all the risks associated with this new technology
> are completely known,
> >we must make every effort to err on the side of
> public safety."
> >
>
>http://www.senatordeanskelos.org/press_archive_story.asp?id=8664
> >
> >art
> >
> >At Fri, 14 May 2004, art fougner, md wrote:
> >>
> >>Terry
> >>
> >>In the US as you well know, every afternoon you
> can channel surf and
> >>find a court show. Americans are afflicted with
> lawsuit mania. If
> >>something bad happens, even if they don't feel
> that way, someone in the
> >>family or a neighbor encourages them to sue. And
> that is how those
> >>cases will go to litigation. Not necessarily
> because we agree with the
> >>principle but because that's the American way.
> Just as a woman can
> >>place a cup of hot coffee between her thighs and
> get burned and then sue
> >>McDonald's, just as folks who could read a pack of
> cigarettes but smoke
> >>anyway could sue, just as folks who get fat and
> bloated by subjecting
> >>themselves to supersized whoopers could sue, that
> is how folks will sue
> >>the Fetal Fotomats. And the disclaimer about we
> don't do medical will
> >>hold up about as well as the "Not Responsible"
> disclaimer in the parking
> >>lot will hold up. It will sooner or later be up
> to a jury to decide.
> >>And once that happens, the game is afoot.
> >>
> >>Terry, I agree with you in principle but there is
> a dearth of FDA
> >>inspectors for Ultrasound labs so the Fotomats
> can, as Monty Python
> >>exclaimed, "Fart in their general direction."
> Caveat emptor will prevail
> >>here - for better or for worse. Therefore, it is
> up to us to provide
> >>for our patients our best efforts and let the
> chips fall where they may.
> >>We can only hope that Karma prevails. And it
> usually does. Again, the
> >>pity is that the same folks who unhesitatingly
> fork over a wad of cash
> >>money for their Foto-op are the same folks who
> fight tooth and nail to
> >>forgo the meager copay at your lab when you
> participate with their
> >>insurance plan. To quote Yacov Smirnoff - "
> America - What a Country!"
> >>
> >>At Fri, 14 May 2004, DuBose, Terry wrote:
> >>>
> >>>Art, will an uneducated, unskilled, & unwashed
> person who doesn't have a
> >>>clue as to the difference between a uterine
> synechia vs. an amniotic
> >>>band, and won't care because it isn't a "medical"
> exam, be held to the
> >>>same standard as a registered sonographer or MD?
> This, I fear is the
> >>>fallacy in the legal solution to this problem.
> >>>
> >>>Given enough time the "unwashed" will develop the
> psychomotor skills to
> >>>acquire pretty pictures of faces, but won't have
> a clue about VSDs, etc.
> >>>and won't care. In time the public will come to
> view these folks as
> >>>the real face of sonography because that is the
> "fun" part; and the real
> >>>sonographers will become the gnomes in the bowels
> of the hospital,
> >>>giving out the bad news. We will be held to a
> higher standard because
> >>>of our experience, while the uneducated will be
> able to throw up their
> >>>hands and exclaim "gastroschisis, what is that?
> Who knew?"
> >>>
> >>>Unless the FDA actually enforces their own
> regulations on non-medical
> >>>uses, then the legal system will not treat all by
> the same standards.
> >>>The FDA needs to either enforce their own regs or
> release us all to
> >>>compete in the "free market", and then we can
> beat the unwashed at their
> >>>own game. I include registered sonographers in
> this issue of the "free
> >>>market".
> >>>
> >>>"Just my opinion, I could be wrong."
> >>>
> >>>Terry J. DuBose, M.S., RDMS, FSDMS, FAIUM
> >>>
> >>>Assistant Professor & Director
> >>>Diagnostic Medical Sonography Program
> >>>University of Arkansas for Medical Sciences, CHRP
> >>>4301 West Markham St. Mail Slot #563
> >>>Little Rock, Arkansas, 72205 USA
> >>>501-686-6510
> >>>DuBoseTerryJ@UAMS.edu
> >>>http://www.io.com/~dubose/
> >>>http://www.uams.edu/chrp/dms/default.asp
> >>>http://www.obgyn.net/us/panel/panel.htm
>
>>>---------------------------------------------------------------
> >>>
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>
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>
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>
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>
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>
>>>---------------------------------------------------------------
>
>>>---------------------------------------------------------------
>>>---------------------------------------------------------------
>>>---------------------------------------------------------------
> >>>-----Original Message-----
>
>>>---------------------------------------------------------------
> >>>From: ultrasound@obgyn.net
>>>---------------------------------------------------------------
> [mailto:ultrasound@obgyn.net] On Behalf Of
>>>---------------------------------------------------------------
>
>>>---------------------------------------------------------------
>
>>>---------------------------------------------------------------
>>>---------------------------------------------------------------
>>>---------------------------------------------------------------
> >>>art fougner, md
>
>>>---------------------------------------------------------------
> >>>Sent: Friday, May 14, 2004 11:04 AM
>>>---------------------------------------------------------------
>
>>>---------------------------------------------------------------
>>>---------------------------------------------------------------
> >>>To: Multiple recipients of list ULTRASOUND
>>>---------------------------------------------------------------
>
>>>---------------------------------------------------------------
> >>>Subject: Re: Keepsake 3D
>>>---------------------------------------------------------------
> >>>
> >>>i'm equally sure that there are anomalies missed
> at non-3D sites as
> >>>well. the glass house has many rooms. yogi had
> it right - "it ain't
> >>>over til it's over."
> >>>
> >>>however, the missed anomalies will come back to
> haunt the Keepsake
> >>>Centers as it already has haunted us all - if you
> perform an ultrasound
> >>>for whatever reason, my feeling is that you
> should and will be held to
> >>>the published standards.
> >>>
> >>>art
> >>>
> >>>At Thu, 13 May 2004, David Nyberg wrote:
> >>>>
> >>>>Larry
> >>>>
> >>>>I know of a case here in Phoenix where a
> reputable group missed a cleft
> >>>lip/palate that was then picked up by a
> commericial 3D site 2 weeks
> >>>later. I know that's not what you're looking
> for, but it could work
> >>>both ways. Of course a 3D site may be more
> likely to pick up facial
> >>>abnormalities since that's where their focus is.
> I'm sure there are
> >>>plenty of nonfacial abnormalities missed by 3D
> sites.
> >>>>
> >>>>Dave
> >>>>
> >>>>On Thu, 13 May 2004 LDPLATT@aol.com wrote:
> >>>>
> >>>>> Does anyone have or kno a patientw of had a
> keepsake video done in
> >>>one of the
> >>>>> "commercial"centers who subsequently had a
> major fetal abnormality
> >>>??? If
> >>>>> so would they be willing to talk about the
> experience? Thanks
> >>>>>
> >>>>> Larry Platt
> ldplatt@aol.com
> >>>>>
> >>>>--
> >>>>David Nyberg, MD
> >>>>10401 E McDowell Mtn Ranch Rd
> >>>>#2-372
> >>>>Scottsdale, AZ 85255
> >>>>ph cell 480-797-0993
> >>>>fax 480-512-8737
> >>>>work 480-512-3850
> >>>>
> >>>--
> >>>art fougner, md
> >>>ich bin ein New Yorker
> >>>
> >>--
> >>art fougner, md
> >>ich bin ein New Yorker
> >>
> >--
> >art fougner, md
> >ich bin ein New Yorker
> >
>
> --
> art fougner, md
> ich bin ein New Yorker
=====
David J. Berck, MD, MPH
