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.

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4 thoughts on “Fetal Monitors Produce Inaccurate Results – FDA warning”

  1. Its interesting that the FDA put this warning out. Like all machines used in health care, the montior, machine, or equipment is only as good as the person interpreting it. All of the risks listed in the FDA warning are well known by RNs/OBs/MWs working with these monitors. Unusual readings are ALWAYS confirmed either by taking mom’s pulse or doing a u/s. An internal monitor is not a good way of confirming the readings since even an internal monitor can pick-up mom’s pulse in unusual situations. I think its more important to focus on good and competent care givers during your birth. Is your care giver someone you trust to make good and competent decisions? Frankly, no care giver should be practicing that blindly follows what a machine tells them.

  2. Thanks for your comment!

    I actually know a mom who was forced into an induction because during a NST the baby’s heart rate dropped to 80 for a short time. The rest of the time baby’s heart rate was fine (reactive, etc) Throughout the whole induction baby’s heartrate was fine.

    I am 99% sure that the machine was picking up mom’s heart rate as hers was consistently around 80 during the birth.

    So this mom was forced into an unnecesary induction because of a machine issue and no one double checked or said to mom, maybe it was picking up your pulse.

    So while you are right care providers shouldn’t blindly follow machines, it seems like in this case they did.

  3. I wonder if these malfunctions are specific to this brand of EFM, or can occur with ANY brand of EFM? I had one client who was consistently getting maternal heartrate on the EFM, and ended up being scared into a cesarean because of it. I don’t know what brand it was. But I’d heard of the phenomenon when I was pregnant with my first child, which would be 11 years ago.

  4. I think it happens more than we imagine. Taking moms pulse and checking it with the FHM can help. But I think sometimes they freak out wiht the low heart rate and don’t take the time, I have seen instead the OB reaching their hand out for the internal monitor, nurses handing it over and starting to do place it without even talking with parents about what is going on.

    At that point as the doula I just explain what is going on. “The OB looks like she is about to put on an internal monitor because they are worried about the baby’s heart rate, do you have any questions?”

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