Re: FIRMS TO STOP OFFERING KEEPSAKE SONOGRAMS
From: DuBose, Terry (DuboseTerryJ@uams.edu)
Mon Apr 11 09:15:51 2005
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
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-----Original Message-----
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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."
>
