Fetal Monitors Produce Inaccurate Results – FDA warning

Well, this is disconcerting.  I wonder how many unneccessary cesareans these machines caused.  How many more will they cause if hospitals don’t get these models replaced or fixed?

September 7, 2009 — Fetal monitors made by Philips Healthcare, Avalon Models FM20, FM30, FM40, and FM50 and ultrasound transducer, may produce inaccurate readings, the US Food and Drug Administration (FDA) warned on Friday.

The manufacturer states that the inaccuracies most often occur during the second stage of labor and include the following:

• Halving or doubling of the fetal heart rate (FHR)
• Switching between the fetal and maternal heart rates
• Differing audible FHR output compared with the printed trace
• Delaying of FHR display upon repositioning of transducers

“Inaccurate output readings, if not properly addressed, may lead to unnecessary interventions, failure to identify the need for interventions, and failure to identify fetal distress,” according to an alert from MedWatch, the FDA’s safety information and adverse event reporting program.

The device manufacturer recommends that users can reduce risks by confirming fetal life before using the monitor and also by using an obstetric stethoscope, Doppler, and ultrasound imaging, as per the instructions for use that accompany the device.

Clinicians should also “continue to confirm that the fetus is the signal source for the fetal heart rate particularly if abrupt changes in fetal heart rate are noted.” In addition, users should consult the instructions for use and consider monitoring the maternal heart rate using a fetal scalp electrode if a discrepancy is suspected, according to the manufacturer.

The Philips Customer Care Center can be contacted at 800-722-9377.

More information about the warning is available on the FDA’s MedWatch site.

Adverse events related to the use of Philips Avalon Fetal Monitors should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

I am pretty sure that this wouldn’t be happening on a regular basis.

The device manufacturer recommends that users can reduce risks by confirming fetal life before using the monitor and also by using an obstetric stethoscope, Doppler, and ultrasound imaging, as per the instructions for use that accompany the device.

Or more likely they would put in an internal monitor and then mom would have that unneccessary intervention because the machine malfunctioned.

I am going to print this out and put in my doula bag so I can check at the births I attend to be sure these models aren’t being used, or if they are to warn the parents, nurses and OBs about the defect.

This is one of the risks when we let machines be our decision makers.