From: Sheehan, Joseph M.
Sent: Wednesday, November 17, 2004 10:53 AM
To: Jaffe, Lyle D
Subject: FW: Acknowledgement of, or definative answer to, my 20Oct04 email discussing "The statistical support for the FDA approval of OTC Doppler fetoscopes for private, home use."



Would you please place this e-mail in Docket No. 2004P-0329?






Joseph M. Sheehan

Chief, Regulations Staff

Office of Communication, Education, and Radiation Programs (OCER)

FDA, CDRH, (HFZ-215)

1350 Piccard Drive

Rockville, MD 20850


(fax) 301-594-4795



-----Original Message-----
Russel Thomsen, M.D. []
Tuesday, October 26, 2004 2:10 AM
Kahan, Linda S
Sheehan, Joseph M.; Phillips, Philip J.; Daniel.Schultz@FDA.HHS.GOV
Subject: Acknowledgement of, or definative answer to, my 20Oct04 email discussing "The statistical support for the FDA approval of OTC Doppler fetoscopes for private, home use."


Addressing Mr. Joseph Sheehan:



      Joe, you will recall that you and I have had discussions touching on the implications for perinatal care and survival if OTC Doppler fetoscopes were randomly used by women who have, of course, nurturing instincts to which OTC Doppler fetoscope seem ideally suited.

    Perinatal deaths, a partially preventable occurrence is often manifest by abnormal heart rate patterns entered into by the as of yet unborn baby.  These changes can coincide with a scheduled obstetrical exam in the last 8 weeks of pregnancy.  But it is most likely that they occur without being heard during the very short listening done at the scheduled professional visit.  Much more logical is that these abnormal heartbeats go unheard -- unless the frequency of prenatal Doppler fetoscope is greatly increased in what I will call the predictably unpredictable use of the OTC Doppler fetoscope, originally obtained for intangible reasons such as "bonding" or more logical reasons such as letting the future grandparents hear what their as of yet unborn grandchild sounds like.


It is of great concern by professional and public health scientific charities to decrease the number of perinatal deaths which occur in the United States each year -- somewhat over 25,000.


My email of 20 October 04 summarized the work of a professional statistician who works in calculating the outcome of events which are noted for their occurrence in a predictably unpredictable way.  Therefore, really only the number of the total events as compared to a subset number sequestered for observation -- through the marvels of rarified mathematical thought -- are needed to produce probabilities of the rate of occurrence of the event under observation.


The professional statistician to whom I consorted concluded that for each 100,000 random home Doppler exams in the last 8 weeks of typical pregnancies would lead some 327 women to seek medical intervention, and might prevent the unnecessary death of up to 150 babies.  Note, this is theoretical for use of home Dopplers randomly in less than 1 in 40 pregnancies American women go on to deliver each year.


Could it be that the use of Doppler fetoscopes in the privacy of the American home is the Holy, Golden Grail for which professors, charitable organizations, governmental scientists and funded study protocols have sought to bring down the sad number of perinatal deaths in the America?


You to whom this email is addressed have before you now, not just a retired Army Obstetrician with hands on experience in some 50 countries and in the care and delivery of over 4,000 babies!  You have for your consideration the possibility that in your fixation on the possibility that after nearly 40 years of Doppler use in obstretrics and millions of patient encounters there might be some as of yet undetected danger to the use of this low output device, especially if used by women in the privacy of their own homes, that the FDA is responsible for the perinatal deaths of hundreds of American babies each year!


I stated in my email of 20 October 04 on this subject that I was specifically requesting a thoughtful analysis of, and then an equally thoughtful answer concerning the issues I have raised in these two emails.  I should have requested answers to the issue of numbers of babies who have died because of FDA temerity on allowing the OTC availability of Doppler fetoscopes for use in the privacy of the American home.  I should have asked this during my motivated discussions of the subject with Dr. Lillian Yin.  I should not have let this question be unanswered mainly because Doppler manufacturers were charging up to $1000.00 for a device costing around $50.00 to manufacture and using the FDA and its incorrect application of The Ammendments of 1976, to classify hand held Doppler fetoscopes as having about the potential for injury or patient death as a Cobalt radiation treatment facility.


It is time -- no it is past time -- for my Petitions on this subject to be answered based on common sense, scientific findings, and the recognition of possible babies' lives saved.


I request a rather immediate discussion and answer to these two emails, and a clearly stated plan of action to deal with this subject. 


To this date my Petitions on this subject have been used by both "flat earth" believers who think that CDRH has given them further proof of the evils associated with devices which use some waves of sound they cannot hear to diagnose and treat problems they do not understand.  And CDRH has, with its years of dwadling over this subject, played into the hands of the medical device industry in helping maintain astronomical pricing on these simple devicesl


I expect to talk to Mr. Sheehan in the next several days to find out if CDRH has an idea of a plan for cleaning the plate on this issue as it aims to give women medical rights inherent to them, and in the meantime effect the saving of the lives of hundreds of American babies (citizens) each year.


If I get the feeling that my reasoned Petitions are yet to be trivialized while the Doppler fetoscope industry rapidly is selling into this market at inflated prices and by totally ignoring FDA requirements, then the material I have from my years of work in this one issue  will be used for a major article in a leading womens' magazine. 


I hope that the ending of that article shows the FDA seeing the light and doing right by American women and their families.  But only time -- and not much of it -- will tell.




Russel J. Thomsen, MD




PO Box 3789

Silverdale, WA 98383


Office Phone  360-698-7666




Note:  Typo errors and other minor errors are to be disregarded or read as to be corrected by obvious context.