Medical Professional Liability and the Delivery of Obstetrical Care Volume II, An Interdisciplinary Review (1989) / Chapter Skim
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The Impact of Technology Assessment and Medical Malpractice on the Diffusion of Medical Technologies: The Case of Electronic Fetal Monitoring
The Impact of Technology Assessment and Medical Malpractice on the Diffusion of Medical Technologies: The Case of Electronic Fetal Monitoring
Pages 9-26
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From page 9... ...
and meconium staining of amniotic fluid were recognized as indicators of fetal distress in the late nineteenth century. Attempts to record the fetal heart rate (FHR)
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From page 11... ...
Moreover, labors monitored with EFM had superior outcomes compared with other, less complicated labors without EFM in the same institution. Nonetheless, widespread introduction of this technology prompted national controversy in the 1970s, controversy that was heightened after four randomized clinical trials indicated little or no benefit with EFM.~5 Reports of five additional clinical trials have been published- all but one with negative results— yet established policies for intrapartum surveillance with EFM have not been altered as a result.
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From page 12... ...
None of the nine RCTs noted in the last section demonstrated a statistically significant decrease with the use of EFM in the rates of perinatal death, intrapartum stillbirth, neonatal death, 1-minute Apgar score of < 7, 1-minute Apgar score of < 4, or neonatal intensive care admissions (Table 1~. The first Melbourne trial and the second Denver trial showed a decrease in neonatal seizures associated with EFM and the use of fetal scalp-blood sampling.~9 20 Whereas the decrease was not statistically significant, this observation confirmed the finding in the Dublin study.2i The first Melbourne study suggested a significant decrease associated with EFM in the rate of admission to neonatal intensive care units, associated with EFM, a finding not confirmed elsewhere.
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From page 13... ...
It also had statistically significant increases in the rate of both abdominal and total operative deliveries. A review of only those RCTs that involved high-risk pregnancies shows nonsignificant increases in the EFM group in the rates of perinatal death and of infants with Apgar scores of < 7 and nonsignificant decreases in the rates of neonatal seizures and admission to neonatal intensive care units.
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From page 16... ...
CBecause of a statistically significant increase in heterogeneity, results of the Dublin trial could not be pooled with cesarean deliveries and operative vaginal deliveries, but they are included in total operative deliveries. SOURCE: Thacker, S
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From page 17... ...
supports research, including some clinical trials; the Food and Drug Administration (FDA) requires companies to demonstrate efficacy and safety of medical devices before marketing; health planning agencies have some limited control over the diffusion of certain technologies; Medicare and Medicaid reimburse for the use of technologies that are determined to be medically necessary; and the Peer Review Organizations (PROs)
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From page 18... ...
Policies Toward Development of Electronic Fetal Monitoring The National Institutes of Health awarded to investigators at the University of Southern California (a major developer of EFM) almost $1 million in contracts for specific developmental research on EFM between 1971 and 1975.
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From page 19... ...
For drugs, this policy has meant that anticoagulants, for example, are evaluated for their ability to prevent coagulation and not for their ability to intervene in disease processes such as recurrent myocardial infarction. The use of the Food and Drug Act as a model for the Medical Devices Amen~nents implies that EFM devices will be evaluated on their ability, for example, to reliably record the fetal heart rate but may not be evaluated on whether accurate recording of the fetal heart rate makes any difference to the outcome of the infant.
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From page 20... ...
Policies Toward Use of Electronic Fetal Monitoring The only federal program that deals directly with technology use is that involving the Peer Review Organizations.4~ Most PROs are transformed Professional Standards Review Organizations, and although reviews are restricted to Medicare patients, PROs have been encouraged to enter into similar contracts with Medicaid and other third-party payers. The PRO program is a cost-control and quaTity-assurance program that reviews primarily hospital services.
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From page 21... ...
More important, this fear of liability may not be well grounded. Careful reading of the relevant legal literature indicates that failure to use EFM should not result in liability, whereas using EFM in a routine labor and delivery may result in malpractice allegations.43 44 The critical legal assumptions regarding liability for not using a procedure are that (a)
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From page 22... ...
Hence, the use of EFM in a particular case may not be justified. The law recognizes a wide scope of discretion in the medical profession, and in a situation in which a "reputable minority" favors a particular practice, such as intermittent auscultation, no liability may be found when a physician fails to use a procedure favored by the majority (that is, customary practice)
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From page 23... ...
A 1975 study of obstetrical and gynecological malpractice verdicts found that the "medical consumer frequently looks back upon this Ethe informed consent process] as 'selling the procedure' rather than giving information and getting consent."5i It is incumbent on the physician, therefore, to conscientiously provide a thorough, clear presentation of a procedure, including both the benefits and the risks.
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From page 24... ...
1959. The fetal heart rate patterns preceding death in uterus.
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From page 25... ...
1987. Evaluating a new technology: The effectiveness of electronic fetal heart rate monitoring.
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From page 26... ...
1984. Electronic fetal monitoring: Physician liability and informed consent.
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