title: Beware: the misuse of technology and the law of unintended consequences.
abstract: Electronic monitoring of the fetal heart rate during labor (EFM), originally designed to assess fetal stress and allow the early detection of the compromised fetus, has instead led to increasing maternal morbidity without decreasing fetal morbidity. The unintended consequences of this technologic advance have led to the creation of a pseudodisease and unwarranted intervention in response to its detection. Is it ethical to introduce a new technology without adequate assessment of its possible consequences? Are we about to repeat this (error resulting from the introduction of EFM?) There is increasing interest in monitoring the function of the newborn brain, to enable the early detection of subclinical seizures. The monitor may also be used for assessing brain function in older children and adults who are comatose or paralyzed and cannot appropriately respond to stimuli. Use of this amplitude-integrated electroencephalography (aEEG) in the newborn for detection of seizures and other brain abnormalities is not dissimilar to the use of electronic fetal heart rate monitoring. Whether seizures or subclinical seizures themselves cause harm to the developing nervous system is unclear. The effectiveness of medications for treatment of seizures in the newborn has not been established. Therefore, the consequences of introducing automated EEG for the detection of subclinical neonatal seizures are likely to be similar to the results of the introduction of EFM: creation of another pseudodisease, followed by unwarranted intervention, and increased legal liability. What are the ethics of continued approval and introduction of unevaluated technology? What is the wisdom of its use? Beware of the unintended consequences.
authors.affiliation: Department of Neurology and the Berman Institute of Bioethics, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA. jfreeman@jhmi.edu
authors.forename: John M
authors.initials: JM
authors.lastname: Freeman
mesh_terms: D001927:Brain Diseases / Q000175:diagnosis*; D002986:Clinical Trials as Topic; D004569:Electroencephalography / Q000009:adverse effects*; D005260:Female; D005323:Fetal Monitoring / Q000009:adverse effects*; D006801:Humans; D007231:Infant, Newborn; D011247:Pregnancy; D013673:Technology Assessment, Biomedical