Improving Electronic Fetal Monitoring: Rearranging Deckchairs on the Titanic
When the FDA isn’t busy rebutting the health claims of Cheerios, it sounds like these days they have their hands full with medical device approvals for modern enhancements to continuous electronic fetal monitoring (EFM). One supposedly “noninvasive” device in the approval pipeline features 32 electrodes attached to the mother’s abdomen that measure beat-to-beat fetal heart rate variability in pregnancies as early as 20 weeks. Another that has already received the green light from the FDA allows obstetricians to view real-time EFM data on their iPhones. And let’s not forget the comical-if-it-weren’t-so-barbaric ”BirthTrack,” an FDA-approved technology that continuously monitors cervical dilation and fetal descent in combination with fetal heart rate.
These are just a few of the latest examples of attempts to improve upon EFM, a technology that is used in 94% of labors despite evidence that it increases the chance of a cesarean or instrumental vaginal birth but does not prevent serious or long-term problems in babies. In 2006, researchers declared that measuring fetal oxygen saturation along with continuous fetal monitoring was a worthless enhancement. Confirming EFM findings by testing the acidity of a sample of the baby’s blood is another once-promising approach that is unreliable and has fallen out of favor.
OK, so tweaking the technology doesn’t solve the problem. Maybe the problem is that the professionals charged with interpreting EFM data need better training or can’t communicate effectively? This is the theory behind the latest NICHD Guidelines for interpreting EFM, and countless hospital-based patient safety programs. But even after NICHD’s last attempt at standardizing EFM interpretation, experienced maternal-fetal medicine specialists could not agree about the significance of worrisome EFM patterns, or which tracings warranted immediate cesarean surgery to prevent poor outcomes.
So why have we not seen any meaningful improvements in maternal and newborn outcomes even with electronic fetal monitoring done earlier in pregnancy, with more bells and whistles, and with countless federal and hospital dollars spent training health care workers in its use?
Perhaps it is the underlying premise itself that we must reassess. Maybe fetal heart rate isn’t such a great predictor of fetal wellbeing after all. Sure, at the extremes it can tell us which babies are in serious trouble and which are sailing through labor with no trouble at all. But anywhere between these extremes is much murkier territory. Many babies will be born pink and screaming despite worrisome heart rate patterns, but a few will be compromised and need resuscitation, ongoing observation, or other measures. And even when fetal heart rate does predict the babies who will be compromised at birth, most of these babies will not suffer any serious or long-term consequences. So fetal heart rate doesn’t predict outcome at birth very well, and poor outcome at birth doesn’t predict long-term morbidity very well. How can we then expect the fetal heart rate to possibly predict or affect long-term outcome well?
Instead of the futile and costly effort to improve upon EFM, we should spend those resources providing, evaluating, and improving intermittent auscultation, the low-tech, low-risk alternative that has proven safe and effective in healthy women. Not only is intermittent auscultation safe for the vast majority of babies, it facilitates the other practices we know contribute to safe and healthy birth – continuous labor support, freedom of movement, and upright pushing positions, to name just a few.
I agree with you. The difficulty is that doctors and nurses view the fetal monitor strip as their legal back up.
People expect great outcomes and think that technology delivers it. We know that more and more interventions impact outcomes. This opens the door to lawsuits. Everyone is afraid of lawsuits.
The system has to change in the legal/lawsuit area.
If we can move women and their partners to greater involvement (responsibility) for their own care and outcome, less dependency on technology to provide their desired outcomes, it may help.
From the iPhone application article you linked:
“The data is sent directly from hospitals’ labor and delivery units and can be accessed on the iPhone anytime and anywhere the doctor gets a cell-phone connection.”
So what happens when the doctor is driving around in an area with poor reception and misses an alert of a non-reassuring heart tone? If it’s really a big concern, maybe she or he should be with the patient in the first place? There are those deckchairs you mentioned.
If a doctor is at home with their Airstrip iPhone app, they can get the information during dinner, finish dinner, hop in the shower, tuck kids into bed, drive back to hospital, park, prep and have that EMERGENCY cesarean started within an hour or two.
It’s so clear that this has nothing to do with patient health or even with convenience for the doctor (it’s really no different than a nurse paging her or him). It’s yet another litigation buffer, isn’t it?
The makers of Airsrip agree:
“Noting that labor and delivery is one of the riskiest and most litigious environments in healthcare, and that communication errors lead to a measurable majority of actionable bad outcomes, Powell added that AirStrip OB aims to mitigate that risk by closing the communication gap among caregivers.”
Risk mitigation versus maternal-fetal wellbeing. With the current c-section rate, it’s clear what’s winning.
Carol, I wholeheartedly agree that patients assuming greater responsibility for their care would improve things. Developing a healthier attitude toward birth would help also. Bad outcomes happen sometimes. Unless they are iatrogenic in nature, no physician following emergency protocol (in the event of an ACTUAL emergency) should be held financially responsible for something that could have happen in any birth setting.
The problem is that hospitals are not allowing women to take more responsibilty even if they indicate that they want to. A great example is VBAC bans, whether official or de facto. Even if a woman says she’ll sign anything and assume any liability personally in the extremely rare chance of a uterine rupture, doctors can simply say that they will not attend.
I’ve recently learned of a new technology that measures ST segment changes in the fetus; the person presenting this technology made a good case for and against its use without trying to do either. I see disaster written all over it as it requires continuous monitoring- that in itself is an issue for me- but despite the company’s strict guidelines in which women it should be used I see L&D units all over the country not following them and sticking it on everyone “just in case”.
Yes, this is the new enhancement that seems to be all the rage now that the others haven’t lived up to hopes/expectations. Just today the BJOG published an article that found that interobserver agreement (that is, the ability of different clinicians looking at the same data to come up with the the same decision about its clinical significance) was still low, even with ST segment analysis. It performed a wee bit better than EFM alone, but the overall consistency across providers was still poor. Here’s the abstract: http://www3.interscience.wiley.com/journal/122454389/abstract. Of course, this study doesn’t tell us if any of the babies or mothers were better or worse off for having the ST segment analysis, only that doctors didn’t agree on the significance of the findings, with strongly suggests that the clinical outcomes would be unchanged.
I think continuous EFM rather than intermittent auscultation is another example of “it’s the economy, stupid.” It just takes more nurses at the sides of laboring women. In some hospitals, EFM can be monitored centrally from the nurses’ station for multiple women at a time without even having to enter the rooms. I gave birth at a freestanding birth center, but I was told that if I chose to use the hospital instead I would not have had the option of intermittent auscultation because the hospital did not have the resources (staffing) to make that available. Fortunately, I never had to test that.
Oh, a question about EFM – where is the evidence in support of the “20-minute strip” taken when a woman in labor is first admitted to the hospital? What is that all about?
Nurses treat the fetal monitor strip, not the patient. They sit staring at the centralized monitoring system like they are air traffic controllers. What ever happened to treating the patient? Being at the bedside? Seeing how mom is doing? Using the excuse of liability is getting old. Even when you have a low risk patient that wants intermittent auscultation, it is like pulling teeth to get it. I try to educate and give my patients the power of participating in their healthcare, give them options, know their bodies. It can be an uphill battle.
I am totally on board with women taking more control of their medical and obstetrical care. MDs are trying to make it even more difficult by trying to obtain a CPT code for “non-compliant” patients. So the woman who asks for intermittent auscultation (shown to be totally appropriate for the low-risk patient) is told by her physician that he “requires” continuous EFM and if she doesn’t agree, she will be labelled non-compliant and with the proposed CPT code, she is labelled a trouble-maker for the rest of her life.
Why the FDA looks at whether the device is dangerous or not, and ignores the question of whether it provides better outcomes is a totatl mystery to me. EFM was never truly researched to determine whether it improved outcomes and now we are saddled with it. FDA wants to add more gizmos to our collection of useless/unneeded products.