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    Find out what other moms-to-be are asking. Join in the discussion with Henci Goer, whose expertise is determining what the research tells us best promotes safe, healthy birth. If you would like to contact Henci outside of the Ask Henci forum, send an email to Goersitemail@aol.com.

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    Mar 12
    2007

    Computerized Labor Monitor (CLM) FDA APPROVAL

    Archived User

    Hello Henci,

          A recent question in a local forum about what may be Fetal EEG monitoring happening at a local hospital during labor, got my curiosity peeked aand I have spent the day trying to gather information that ran me into, quite by accident the CLM FDA approval announcement.

     

     The long and the short of it is I am trying to find the studies they claim to have conducted.  Any suggestions?   I'm sure we all are reminded of Monty Pythons Machines That Go Ping....

    Barnev announced FDA approval of their Computerized Labor Monitor (CLM) and premiered it at the Society of Maternal Fetal Medicine meeting in Feb. http://www.obgyn.net/fetal-monitoring/?page=/news/computerized_labor_monitoring

    I think many of us had heard of it but may be unaware of the approval and to what extent the approval is for!  Research?  Testing?  Implementation?  Wal-Mart sales??

    I am no FDA expert, but 3 hours of searching I can find nothing about this device.   Perhaps it was approved by the Federation of Dumb A, well you insert your favor A word.

    This particular article made me sick to my stomach

    http://www.stepstrategy.net/artman/publish/article_2687.shtml

    Just ONE of the statments that caused my gastric distress

    The device provides early warning of problems in delivery, which enables doctors to respond rapidly, reducing the need for later medical intervention. For the birthing mother, access to information throughout labor helps reduce stress.

    "We've seen in our clinical trials that the labor room is much more tranquil because women see exactly what is happening," Machtey told ISRAEL21c."

     

    The only "study" I could find is located here  

    http://www.barnev.co.il/clm.pdf

    The other information I have been able to find is mass amounts of it's press release and the letter calling for support and ideas in addressing this device from  Debby Gedal-Beer, CNM, MSc.  Coordinator of Women's Health and Midwifery Education
    Sheba Academic School of Nursing Midwifery Today, May 24, 2006 Volume 8, Issue 11

    I did stumble across another device just as frightning, The LaborPro by TrigMeg http://www.trigmed.com

    So, Henci any direction in my quest?    I'm feeling a little public and birth community outcry is in the making.

    Thank you for your time,

    Debbie RedWine, LCCE, CD, LTS, CCCE,

     

     

     

    Henci Goer

    I first heard of this dreadful development last year from a horrified midwife acquaintance in Israel who keeps me abreast of things in Israel. I thought she was kidding, or I must be misunderstanding her, but, indeed, as the sites you provide links for, and as my friend made clear, it is for real. I don't know what to tell you other than it seems likely that U.S OBs will probably jump on this like a robin on a junebug, and I don't see what we can do about it. It fits the obstetric belief system and the economic model. It is, as you say, a variation on the "machine that goes PING!" It also seems all of a piece with a story a hospital-based midwife friend of mine here recently told me of feeling the baby's position on a laboring woman's belly when a puzzled obstetric resident observing asked her what she was doing. He really didn't know.

    -- Henci

    Archived User

    Thanks for the reply Henci, it's sad, so very very sad.

    For those who want to keep an eye on this, I did find a limited on the FDA site.

    This is a Class II device, which means that it has moderate risk and has received FDA marketing clearance.  It's got a way to to go, but as you said, I'm sure they will be lining up to get their hands off it.   The case video on their site for a machine which is suppose to limit or wipe out vaginal exams, showed SIX manual exams in a 3 hour labor.  *sigh*

     Here is the link http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=3264

    I emailed the FDA about why it's regulatory status was Opthalmic, they said they were going to correct it.

    I also noted that while it has special conditions as a Class II device, those conditions are missing, the FDA said they would be correcting that as well.

    The approval for marketing letter is here: http://www.fda.gov/cdrh/pdf6/K060028.pdf

    Here's to hoping that it fails miserably in future studies and that women refuse to participate!

    Thanks again for the input!

    Henci Goer

    "Here's to hoping that it fails miserably in future studies and that women refuse to participate!"

    From your mouth to God's ears, but pessimist that I am, I doubt it.

    -- Henci


    All Times America/New_York

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