ACR criticizes Tom Cruise's reported unsupervised use of fetal keepsake ultrasound
Actors Tom Cruise and Katie Holmes may be placing their unborn child at risk if they are performing fetal ultrasound on Holmes, who is about 6 months pregnant, with no medical supervision and, if so, should not, in any way, view their fetal keepsake ultrasound images as a substitute for appropriate medical attention, the American College of Radiology says. Use of such medical equipment by unlicensed individuals may also be a violation of federal law. Tom Cruise said last night in a televised interview with ABC's Barbara Walters that he has purchased an ultrasound system and plans to do fiancé Holmes' ultrasound exams himself.
The ACR says it fully supports the views of the FDA that fetal ultrasound be performed only for medical purposes, by certified technologists, with a prescription from an appropriately licensed provider.
"This is a patient safety issue. Untrained people, even if they have the financial means, should not buy, or be allowed to buy and operate, ultrasound machines which are, in fact, medical devices and should not be used without a medical indication," said Carol M. Rumack, MD, FACR, chair of the ACR Ultrasound Commission. "Images of the fetus are an opportunity to diagnose problems before birth that may require treatment. These images should be obtained by certified technologists under the supervision of physicians properly trained in ultrasound. The images should then be interpreted by properly trained physicians and discussed with the parents and treating physicians in order to plan for the best care of the baby and mother," Rumack said.
"The ACR is concerned that Tom Cruise has been badly advised regarding the use and potential abuse of ultrasound. There are many abnormalities that may be missed by the untrained eye. Also, if it is not medically necessary, the use of ultrasound raises unnecessary physical risk to the fetus, said Dr. Rumack.
The FDA has also stated, "Persons who promote, sell or lease ultrasound equipment for making "keepsake" fetal videos should know that FDA views this as an unapproved use of a medical device. In addition, those who subject individuals to ultrasound exposure using a diagnostic ultrasound device (a prescription device) without a physician's order may be in violation of state or local laws or regulations regarding use of a prescription medical device."
The ACR says it fully supports the views of the FDA that fetal ultrasound be performed only for medical purposes, by certified technologists, with a prescription from an appropriately licensed provider.
"This is a patient safety issue. Untrained people, even if they have the financial means, should not buy, or be allowed to buy and operate, ultrasound machines which are, in fact, medical devices and should not be used without a medical indication," said Carol M. Rumack, MD, FACR, chair of the ACR Ultrasound Commission. "Images of the fetus are an opportunity to diagnose problems before birth that may require treatment. These images should be obtained by certified technologists under the supervision of physicians properly trained in ultrasound. The images should then be interpreted by properly trained physicians and discussed with the parents and treating physicians in order to plan for the best care of the baby and mother," Rumack said.
"The ACR is concerned that Tom Cruise has been badly advised regarding the use and potential abuse of ultrasound. There are many abnormalities that may be missed by the untrained eye. Also, if it is not medically necessary, the use of ultrasound raises unnecessary physical risk to the fetus, said Dr. Rumack.
The FDA has also stated, "Persons who promote, sell or lease ultrasound equipment for making "keepsake" fetal videos should know that FDA views this as an unapproved use of a medical device. In addition, those who subject individuals to ultrasound exposure using a diagnostic ultrasound device (a prescription device) without a physician's order may be in violation of state or local laws or regulations regarding use of a prescription medical device."