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
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
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
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,