FDA Alert: Avoid Fetal “Keepsake” Images, Heartbeat Monitors

CHARLESTON, SC, January 13, 2015 – The FDA recommends that health care providers consider ways to minimize exposure while maintaining diagnostic quality when using ultrasound. As with all other imaging modalities, the principles of As Low As Reasonably Achievable (ALARA) should be practiced by health care providers.[1]

Because the long-term effect of tissues heating and cavitation are not known, both the FDA and ACOG recommend that ultrasound scans should only be done when there is a medical indication, based on a prescription, and performed by appropriately-trained operators. “Keepsake videos,” which have become popular with expectant parents and have surfaced in many retail venues, are considered controversial because there is no medical benefit gained from exposing the fetus to ultrasound, often for as long as an hour. Ultrasound energy has the potential to produce biological effects on the body. Ultrasound waves can heat the tissues slightly, and in some instances can also produce small pockets of gas in body fluids or tissues (cavitation). The long-term consequences of these effects are still unknown.

In 2004, ACOG endorsed the following statement from the American Institute of Ultrasound in Medicine (AIUM):

The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM strongly discourages the non-medical use of ultrasound for psychosocial or entertainment purposes… although there are no confirmed biological effects on patients caused by exposures from present diagnostic ultrasound instruments, the possibility exists that such biological effects may be identified in the future.[2]

Health care providers are encouraged to share the FDA’s Office of Women’s Health consumer update with expectant parents. SE Healthcare Quality Consulting can assist facilities and practitioners in on-site quality and safety assessments and confidential reports and action plans for superior risk reduction and management solutions to organizations.

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[1]http://www.fda.gov/radiation-emittingproducts/radiationemittingproductsandprocedures/medicalimaging/ucm115357.htm

[2] http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Ethics/Nonmedical-use-of-Obstetric-Ultrasonography

 

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