Doppler echocardiography in the human fetus.

Fetal echocardiography has allowed prenatal diagnosis of heart disease to become a reality over the last decade. Recently, pulsed Doppler flow studies have been applied to the examination of the fetal cardiovascular system. In fetuses with dysrhythmias, complex structural heart malformations, nonimmune hydrops fetalis, or mothers receiving nonsteroidal prostaglandin synthetase inhibitors, pulsed Doppler echocardiographic studies are clinically indicated. These studies involve noninvestigational tests that provide information of critical clinical import. These studies may occasionally, require energy intensities that exceed the 510(k) limits. The physician should be held responsible for educating patients to the potential risks versus benefits of any imaging study they undergo, but appending potentially alarming labels to transducers, machines, or cathode-ray tube displays can only serve to undermine the fabric of the physician-patient relationship without achieving the desired goal of protection of the patient.