Re: Keepsake 3D
From: Allen Worrall (jworrall@alaska.net)
Mon May 24 12:34:45 2004
Yes, it is like Prohibition in the 1920s. If we try to legislate it away, it will not work, because it is something the public wants.
Allen
> ----- Original Message -----
From: David Nyberg
To: Multiple recipients of list ULTRASOUND
Sent: Monday, May 24, 2004 7:50 AM
Subject: Re: Keepsake 3D
I think these are excellent guidelines Allen.
What is clear is that keepsake imaging has hit a chord with a segment of our patient population and these commerical sites have filled a void. It is unlikely they are going away and we should help them fit into established practices and procedures.
I also completely agree that we all do some form of patient-directed imaging. The only difference is that the primary intent of our exams is for diagnostic purposes. Keepsake imaging could also provide some diagnostic information.
David
On Mon, 24 May 2004, Allen Worrall wrote:
> Yes, we all do that I am sure. Maybe the answer to this problem is something
> like the following:
>
> 1- All Keepsake fetal imaging centers must be licensed by the appropriate
> State agency. The State agency might require that the keepsake imaging
> center have a medical director, a radiologist or ob/gyn physician
> 2- The imaging must be done by sonographers registered in ob/gyn by ARDMS or
> the appropriate Radiological organization , or by Board Certified ob/gyn
> physicians or radiologists.
> 3- The ultrasound examination must meet the requirements of the AIUM or
> radiological organization for obstetrical exams.
> 4- The patient must be given a written formal report of the examination.
> This report must be of the same quality as would be expected from an
> ultrasound lab at a medical facility, although it may be written by the
> sonographer.
>
> Thus the main issue becomes that the patient referred herself, she was not
> referred by an obstetrical provider. Since she is paying for the exam
> herself, that should not be a big hurdle. The imaging center would be
> assuming more responsibility for what they are doing. Indeed, they probably
> would find it prudent to obtain medical liability insurance. The main thrust
> would be to provide the patient with the CD, DVD, music, photos, etc, but
> there would be more emphasis on examining the fetus. The cost of operating
> such a center probably would go up, and thus the fee would go up.
>
> Allen
>
> Joseph A Worrall MD RDMS
> OB/GYN Ultrasound at the Fairbanks Clinic
> Fairbanks, AK 99701
> http://www.obgynsono.com
> > ----- Original Message -----
> From: "Dave Berck" <djberck@yahoo.com>
> To: "Multiple recipients of list ULTRASOUND" <ultrasound@dns.obgyn.net>
> Sent: Monday, May 24, 2004 7:06 AM
> Subject: Re: Keepsake 3D
>
> > 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&en½c3f0f54184cbb6
> > >
> > > ---------------------------------
> > >
> > > ---------------------------------
> > > 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
> > >
> > >>>---------------------------------------------------------------
> > > >>>
> > >>>---------------------------------------------------------------
> > >
> > >>>---------------------------------------------------------------
> > >>>---------------------------------------------------------------
> > >
> > >>>---------------------------------------------------------------
> > >>>---------------------------------------------------------------
> > >
> > >>>---------------------------------------------------------------
> > >
> > >>>---------------------------------------------------------------
> > >>>---------------------------------------------------------------
> > >>>---------------------------------------------------------------
> > >
> > >>>---------------------------------------------------------------
> > >
> > >>>---------------------------------------------------------------
> > >>>---------------------------------------------------------------
> > >>>---------------------------------------------------------------
> > > >>>-----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
>
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
