Prescription Use Only
Call it a victim of its own success: Vast improvements in the quality of images obtained with three- and four-dimensional ultrasound technology have contributed to the modality's wide-spread use for non-medical reasons or "entertainment OB scans."
According to a Food and Drug Administration's Consumer Health Information report entitled Taking a Closer Look at Ultrasound, "Ultrasound equipment is regulated by the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). Ultrasound imaging devices are approved for use only with a prescription. Information accompanying the devices explains the risks and benefits of the approved uses. However, FDA does not regulate how health professionals actually use the equipment."
Another FDA document warns the public to Avoid Fetal "Keepsake" Images, Heartbeat Monitors: "The use of ultrasound imaging devices for producing fetal keepsake videos is viewed as an unapproved use by the FDA. Doppler ultrasound heartbeat monitors are not intended for over-the-counter use. Both products are approved for use only with a prescription."
But the FDA's warnings and regulations have done little to stop the proliferation of entertainment OB services (an unfortunate example of supply meeting demand), and while the legitimate health care industry is suffering from the impact of state and federal funding cut-backs and the overall economic down-turn, the demand for non-medical obstetrical sonograms continues to grow.
But recently, the use of sonography for entertainment purposes has gained the attention of lawmakers in Connecticut. A new bill, HB-5635 titled "AN ACT CONCERNING ULTRASOUND PROCEDURES FOR MEDICAL AND DIAGNOSTIC PURPOSES," threatens to ban all non-medical sonograms.
It will be interesting to see how this precedence-setting measure impacts the OB entertainment industry in this country as well as around the world.
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