ACOG: Fetal Pulse Oximetry Is Not Ready for Practice: Experts concerned that it would increase costs without improving outcomes. (Committee Opinion).

Little more than a year after federal approval of fetal pulse oximetry, experts caution that it's not ready for use in everyday clinical practice.

The device, OxiFirst, developed by Nellcor in Pleasanton, Calif., was approved by the Food and Drug Administration as an adjunct to electronic fetal heart rate monitoring. OxiFirst helps obstetricians determine whether a fetus with nonreassuring heart rate tracings is receiving enough oxygen so that a C-section can be avoided.

In a recent committee opinion, the American College of Obstetricians and Gynecologists said that it could not endorse fetal pulse oximetry at this time because of concerns that it would increase obstetrical care costs without necessarily improving outcomes.

Indeed, the only published study of the device so far--and the data on which the FDA approval was based--showed that while OxiFirst lowered C-section rates by 50% for nonreassuring fetal status, it didn't reduce the overall C-section rate. The overall rate was not reduced because more women in the oximetry group ended up receiving C-sections for dystocia, compared with those who received usual monitoring (19% vs. 9%).

And without clear evidence that it lowers the C-section rate, investing in the $10,000 device and spending $150 on probes for each patient is "the last thing we need when hospitals are already just breaking even on obstetrical care," said Dr. Charles J. Lockwood, chair of the Committee on Obstetrical Practice that wrote the ACOG document.

Maryanne Kane, a spokesperson for Nellcor, said that the "position taken by the committee not to endorse fetal pulse oximetry is actually not surprising since the committee rarely endorses the adoption of any device in clinical practice." Nor does the committee opinion detract from the fact that the device has been extensively tested in a 3-year study involving nine centers and 1,011 patients and its clinical utility passed muster with the FDA, she said.

Several obstetricians interviewed for this story echoed that confidence in the device and have said it has helped them avoid some C-sections.