Re: FIRMS TO STOP OFFERING KEEPSAKE SONOGRAMS
From: art fougner, md (evsono@pipeline.com)
Mon Apr 11 20:05:11 2005
would be interesting to find out ... after all, the potential to
actually get paid for services rendered is a powerful inducement to join
the dark side.
art
At Mon, 11 Apr 2005, Jeanette Burlbaw wrote:
>
>Terry, These fools don't have supervising physicians. That's why they have been closed. What about who is holding the transducer... betcha they weren't sonographers.
>
>Jeanette
>
>"DuBose, Terry" <DuboseTerryJ@uams.edu> wrote:
>Cheryl, thanks for this. Many will be interested in these events.
>Thanks Terry
>
>Terry J. DuBose, M.S., RDMS, FSDMS, FAIUM
>
>Associate 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: Vance, Cheryl (GE Healthcare) [mailto:Cheryl.Vance@ge.com]
>---------------------------------------------------------------
>Sent: Saturday, April 09, 2005 2:18 PM
>---------------------------------------------------------------
>To: terry.dubose@obgyn.net
>Subject: FIRMS TO STOP OFFERING KEEPSAKE SONOGRAMS
>
>Terry:
>
>Check this out!
>
>Cheryl Vance
>MA, RT, RDMS, RVT
>
>> FIRMS TO STOP OFFERING KEEPSAKE SONOGRAMS
>>
>> By Jan Jarvis, Fort Worth Star-Telegram (Texas), 04/08/2005
>>
>> Four keepsake ultrasound imaging companies -- three in Dallas-Fort
>Worth -- have agreed to stop offering souvenir videos of fetuses without
>physician supervision and approval.
>>
>> Saying that ultrasound machines are not toys, Attorney General Greg
>Abbott announced Thursday that the companies had agreed to comply with
>Texas law, which requires physician oversight. The companies also cannot
>advertise their services as having entertainment value without the need
>for physician involvement.
>>
>> "They can't just leave a physician out of the loop and make money
>doing it," said Tom Kelley, a spokesman for the attorney general's
>office. "The ultrasound must be done as a medical necessity and not just
>for the mother to have a souvenir or keepsake."
>>
>> The four companies are Womb With a View of Arlington, Fetal Fotos of
>Frisco, First Look Sonogram of Plano and Clearview Ultrasound Center of
>Austin. Womb With a View agreed to pay to the Texas Department of State
>Health Services to cover investigative costs and for attorney fees and
>investigative costs; the others will pay costs of each.
>>
>> There was no admission of wrongdoing as part of the agreement, said
>Bill Aleshire, the Austin attorney for Womb With a View.
>>
>> "It would be completely false to suggest there was no medical
>supervision, completely false to say there were no prescriptions and
>completely false that the only advertising for this was for
>entertainment purpose," he said.
>>
>> Aleshire said Womb With a View was shut down by the investigation.
>>
>> "Their equipment was confiscated for so long that it ran them out of
>business," he said.
>>
>> None of the other businesses returned phone calls.
>>
>> Since 2002, the U.S. Food and Drug Administration has warned against
>using ultrasound equipment for nonmedical reasons.
>>
>> Texas requires a doctor's prescription before ultrasound equipment can
>be used. But enforcement has been difficult because the businesses are
>not licensed nor routinely inspected.
>>
>> Storefront sonogram businesses have been popping up nationwide.
>>
>> The four businesses involved in the agreement were referred to the
>attorney general's office after a Texas Department of State Health
>Services investigation.
>>
>> The Health Services Department usually investigates only after a
>complaint is made, said Tom Brink, an investigator with the department's
>Medical Device Division. In these cases, the businesses did not tell
>consumers that the devices were not approved for entertainment purposes
>or that prescriptions are required.
>>
>> One or two cases involving keepsake studios are still outstanding, but
>most are closed, he said.
>>
>> Brink said keepsake video businesses sometimes don't follow medical
>guidelines for using ultrasound. Often they use multiple scans for
>longer periods than sonograms done for medical reasons, he said.
>>
>> "They're trying to get quality pictures of the fetus in various
>positions, and they're not really thinking about medical necessity," he
>said. "They are just trying to get a good picture."
>>
>> Over the past year, a handful of complaints have been made against the
>ultrasound imaging businesses, Brink said.
>>
>> The Department of Health Services investigated Womb With a View on
>April 13, 2004, and found it was conducting fetal ultrasound procedures
>without the supervision of a licensed practitioner and without a
>prescription, according to the agreement. The business was also
>promoting ultrasound imaging procedures for "keepsake purposes or
>emotional and maternal well-being which are uses not approved by the
>Federal Food and Drug Administration."
>>
>> The investigations have led state inspectors to examine how the
>businesses got access to the devices without a medical director
>involved, Brink said. >
>>
>> The bottom line is that the sonogram must be done for a medical reason
>because the health and safety of the mother must be considered, Kelley
>said.
>>
>> "These business can't operate in the way they were operating," he
>said. "They have to comply with the law."
>>
--
art fougner, md
"If you don't know where you are going, you will wind up somewhere else."
Lawrence Peter Berra