By Susan Dammann RN
The FDA has issued a warning. While the FDA's main focus in the warning is to advise pregnant women to avoid commercial sonogram services for nonmedical purposes that could pose a danger to the developing fetus, emphasizing that these are prescription medical devices, are to be used only by trained health care professional and only with a prescription, included within the warning are guidelines/recommendations which we in the pregnancy help medical clinics should be aware of.
Below are three excerpts from the 12/16/14 FDA Consumer Update which may pertain to the use of ultrasound imaging in the PMC, and a question for you to consider.
"Fetal ultrasound imaging provides real-time images of the fetus. Doppler fetal ultrasound heartbeat monitors are hand-held ultrasound devices that let you listen to the heartbeat of the fetus. Both are prescription devices designed to be used by trained health care professionals. They are not intended for over-the-counter (OTC) sale or use, and the FDA strongly discourages their use for creating fetal keepsake images and videos."
Question: Are the sonograms in your center being performed by trained health care professionals?
"The long-term effects of tissue heating and cavitation are not known. Therefore, ultrasound scans should be done only when there is a medical need, based on a prescription, and performed by appropriately-trained operators."
Question: Are the sonograms performed in your center based on a prescription for a medical need?
"Similar concerns surround the OTC sale and use of Doppler ultrasound heartbeat monitors. These devices, which are used for listening to the heartbeat of a fetus, are legally marketed as "prescription devices," and should only be used by, or under the supervision of, a health care professional."
Question: If your center uses Doppler, is it being used under the supervision of a health care professional?
As you consider the above FDA recommendations in relation to the ultrasound services performed in your PMC keep in mind also that one of the points in the Commitment of Care and Competence to which all Heartbeat Affiliates sign in agreement is:
Medical services are provided in accordance with all applicable laws, and in accordance with pertinent medical standards, under the supervision and direction of a licensed physician.
To read the full FDA Consumer Update click here.