WORSHIPPING AT THE FALSE SHRINE OF WESTERN MEDICINE
The data has been there for some time. Electronic fetal monitoring (EFM) does not save infant lives. The only thing EFM has been proven to do is to raise the number of cesarean operations that are done. This month, one manufacturer in particular has been named by the FDA as producing a piece of junk that should be recycled for parts ASAP. See: FDA Warns of Potential Inaccurate Readings by Philips Avalon Fetal Monitor Instead of insisting that these malfunctioning devices be trashed immediately to save women and babies from inaccurate readings, Philips Electronics (and the FDA) merely suggests double-checking strange readings against another machine or (if one can be found in the hospital) simply listening with a fetoscope. Now, my rhetorical questions are: If the machine is giving false readings of distress in babies who are well, isn’t it conceivable that the machine is giving reassuring readings on babies who are in trouble? And, what is the point of having faulty equipment around a hospital?
I can recall a birth I attended in a hospital where the decision was made that the mother needed an augmentation of the birth process about midnight. She was hooked up to a pitocin intravenous drip but not much happened through the night and, when the day shift came on, one of the nurses said “Oh, that infusion pump doesn’t work, it should have been sent down to maintenance.” This is how you lose all faith in institutions. Having equipment that you can’t count on has to be draining for the staff as well as having the potential to completely destroy the birth experience for the family.
Another birth that I attended more than 20 years ago is a classic example of the false worship of obstetrical electronics. My client entered hospital nearly fully dilated. Just as we got into her hospital room, the membranes released and the fluid was meconium stained. The nurse requested a 10 minute monitoring strip to check on the well-being of the baby. This seemed reasonable and the parents okayed the belts being put around the mother’s abdomen. The belts were very uncomfortable for the mother and so her husband and I anxiously watched the clock to see
when the 10 minutes would be up and we could remove them.At the 10 minute mark, I went to get the nurse. She was talking on the phone and motioned to me that she’d be right there. Another 10 minutes passed and the father took the belts off his wife. Just then, the nurse walked in and she was furious that he had done that. She said that she needed to do more monitoring because the baby did not look good at the beginning of the strip. The father said “The reason the tracing was poor then is that you were moving the electrode around looking for the baby’s heart, but once you found it, the heart rate has been in the normal range.” The nurse’s response was “Sir, I think I know a little bit more about these machines than you do and I think this baby is showing signs of distress.” The father said “No, I happen to design and build this type of equipment and I wouldn’t use this piece of junk to even test another piece of equipment.” It turned out that he was some kind of engineering genius at our local university. I’ve never forgotten that interaction. Of course, when the doctor arrived, she got into a big huff about how uncooperative the family was being, too, but the mother birthed her baby fairly quickly so all ended well despite technology.
I’d like to see some press coverage of this revelation from the FDA. The public doesn’t get to see most things that are published in the medical journals or online at PubMed. These machines are dangerous toys that can harm children. We have the right to demand a recall and to demand that the company fully disclose on its website. Right now, the Philips corporate website says: Quote
|Reliable monitoring throughout the obstetrical care continuum
Philips Healthcare has a long and proud history in obstetrical care technologies — offering fetal and maternal monitors, obstetrical information systems, and monitors and measurements used during routine and high-risk deliveries.
If that isn’t blatant false advertising, I don’t know what is.
For further dismaying reading on the hoax of electronic fetal monitoring, here is a published legal paper by Margaret Lent from ten years ago which concludes with this line, “In short, there are no excuses left to defend the continued use of EFM. “
The Medical and Legal Risks of the Electronic Fetal Monitor
Journal article by Margaret Lent; Stanford Law Review, Vol. 51, 1999
The medical and legal risks of the electronic fetal monitor.
by Margaret Lent
Electronic fetal heart monitoring (EFM) is the most widely used method of monitoring the fetal heartbeat for possible signs of distress during delivery. Soon after its development in the 1960s, EFM replaced intermittent auscultation as the standard of care in the obstetrical community. However, Margaret Lent argues that the widespread use of EFM is both medically and legally unsound Lent points to a series of clinical trials that demonstrate that EFM does not reduce fetal mortality, morbidity, or cerebral palsy rates. These studies suggest that EFM has a very high false positive rate, and that EFM usage correlates strongly with a rise in cesarean section rates. Similarly, EFM provides no protection in the courtroom. Though obstetricians believe that they should use EFM because its status as the standard of care will protect them from liability, Lent argues that it may in fact expose them to liability given its failings. Instead, she argues that
auscultation is equally, if not more, safe and effective, and is more likely to protect physicians from liability. Lent concludes that obstetricians have an obligation to their patients and to themselves to adopt auscultation as the new standard of care.
The medical profession depends on the latest medical technologies to provide top quality care and to extend that care to a greater pool of patients. This dependence is all well and good where the method, drag, or device is tested in clinical trials that establish its efficacy and safety. But what happens when new technology diffuses rapidly into mainstream medicine well before it has been adequately tested?
The story of electronic fetal heart monitoring (EFM) reveals the problems posed to physicians and patients by the hasty acceptance of relatively unproven devices and techniques. When EFM was introduced in the 1960s, enthusiastic advocates promised that by enabling the continuous, electronic monitoring of the fetal heart rate during labor and delivery, EFM would enable physicians to detect dangerous heart rate patterns and to intervene more promptly than with intermittent auscultation, the long-employed technique of periodically monitoring fetal heart rate with an obstetrical stethoscope. Thus, announced EFM proponents, the device would reduce rates of neonatal illness and death. Based on these promises, EFM became the predominant form of fetal heart monitoring by the mid- to late 1970s.(1) However, experts now conclude that these promises remain unfulfilled and that EFM is, at best, a “disappointing story.”(2) In the twenty-five years of its almost
ubiquitous use, no randomized controlled trial has demonstrated that electronic monitoring does a better job of saving babies or improving infant health than intermittent auscultation.(3)
Moreover, studies indicate that the inaccuracy of the technique prompts unnecessary interventions and contributes to the nation’s excessively high rate of cesarean delivery, a major surgical procedure which places mother and infant at greater risk of injury and death than noncesarean delivery.(4) Despite the increased risks, the device remains employed in nearly all American delivery rooms. Continued high use of EFM is often attributed to physician concerns about medical malpractice liability and professional inertia. As one EFM critic has observed: “[Doctors] talk about [abandoning EFM] at conferences and at [medical] rounds and listen intently and all of that, but it’s not measurable in terms of changes in behavior. Everybody’s waiting for the next person to get brave.”(5)
A quarter century of failure in clinical trials and striking new evidence documenting EFM’s imprecision indicate that now is the ideal time for the obstetrical profession to “get brave.” To ensure the safety of their patients and to preserve national confidence in the profession, obstetricians must abandon EFM and adopt safer, more effective monitoring methods such as intermittent auscultation. Close analysis of the legal and medical consequences of the use of EFM reveals that obstetricians have little to fear in discontinuing use of the technique. Not only is EFM an inferior diagnostic tool in the delivery room, but it fails to offer the courtroom protection obstetricians suppose. Moreover, a physician’s decision to return to safer, effective methods such as auscultation should not expose her to liability. In short, there are no excuses left to defend the continued use of EFM.
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Added September 2015
Study showing no value proven for doing so called “non stress tests” before baby is born.
A U T H O R S ’ C O N C L U S I O N S
Implications for practice
We found no good evidence to support the use of traditional cardiotocography
(CTG), or computerised CTG, in pregnancy for
improving fetal outcomes. The data are not of high quality and
lacked power to detect possible important differences in either
benefit or harm. We recognise that many aspects of maternity care
may have changed since the trials reviewed here were carried out,
so new studies are needed to assess the effects of traditional and
computerised antenatal CTG before they are used in clinical practice.