Re: FW: "keepsake" fetal sonograms

From: Philippe Jeanty (Jeanty@TheFetus.net)
Mon Jun 10 13:21:12 2002


Jim, I am not sure I understand exactly... do you mean to say that non-medically supervised and possibly partially or not trained users should be able to performed ultrasound examination for the benefit of the parents... without medical indications ? or am I confused in your message ? We are not talking about giving away pictures obtained during a legitimate scans, we are talking about purely entertainment scans

-----Original Message----- From: ultrasound@obgyn.net [mailto:ultrasound@obgyn.net]On Behalf Of James S Smeltzer MD Sent: Monday, June 10, 2002 12:40 AM To: Multiple recipients of list ULTRASOUND Subject: Re: FW: "keepsake" fetal sonograms

To All,

A copy of the medical record is the patient's right. The sonogram is part of the patient's record. One of the PROVEN benefits of sonography is the earlier and more definite bonding with the infant. This has, from the baby's point of view, a lifetime of benefit.

On this premise I have trained pro-life sonographers to use sonography for this purpose in conjunction with the diagnosis of pregnancy. This is never without the full consent of the patient. Is this wrong? Is there a higher standard in medicine than the life of the subject you are examining? If so, what is it? In my personal opinion a woman over 10 - weeks pregnant should have ability to see a sonogram to show her what she is doing before abortion.

We are all held to the same standard in what we deliver in a sonogram. Why is this an issue? My job is producing the best scans I can and interpreting them. I would not like my grandchild scanned by someone who thought their best job was doing something other than looking at them - such as telling others who and how they cannot scan. This is a job for bureaucrats, not sonographers.

Anyone afraid of keepsake videos is IMHO afraid of a hypothetical attorney the patient will hire because the person erred. This is the wrong emphasis, IMHO. If it is any consolation for those too proud to consider sonography as entertainment with a worthwhile medical purpose, neonatal intensive care started as a side show on Coney Island. This does not diminish, in the least, the accomplishments of our neonatal colleagues.

The general principle is that freedom is in the interest of the people unless there is AN OVERRIDING, CLEAR AND COGENT harm to the community in a particular freedom. Store=front scanning lies in the realm - usually - of not optimal but certainly permissable.

Jim Smeltzer

At 10:11 AM 6/7/2002 -0500, you wrote: > -----Original Message-----
>From: Sent: Friday, June 07, 2002 9:39 AM
>
>Subject: "keepsake" fetal sonograms
>
>This topic has come up again with everyone seeming to wonder...WHATS WITH
>THE FDA?
>
>Here is a quote (the concept of which most are familiar) from the FDA
>document found here: http://www.fda.gov/cdrh/consumer/fetalvideos.html
>
>"Persons who promote, sell or lease ultrasound equipment for making
>"keepsake" fetal videos should know that FDA views this as an unapproved
>use of a medical device, and that we are prepared to take regulatory
>action against those who engage in such misuse of medical equipment"
>
>Shouldn't US taxpayers be able to hold the FDA accountable for enforcing
>their own regulations?
>
>Maybe its time for a mass letter-writing campaign from the memberships
>(AIUM, SDMS, etc etc).
>
> regarding the name and address of the entrepreneur. Maybe
>
>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
>
>just one sonographer's thoughts.....
>
>TGIF!
>
>"In the 1940s and 1950s, medicine was too much an art and not enough of a
>science. Now we have more science than we know what to do with." Louis J.
>Kettel (Assoc. of American Medical Colleges, in US News and World Report,
>April, 1991)
>




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