Ultrasound Machine

Risks and Safety

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Part of the ultrasound machine safety guide....

Whilst the FDA remains passive, the ultrasound industry is openly contravening regulations. In spite of the official ban on non-diagnostic use of ultrasound equipment, the majority of keepsake fetal portrait studios are still regularly advertising non-diagnostic examinations.

Evidently, there is a profit to be made at all levels of the 4d ultrasound food chain: according to one trade association, worldwide sales of ultrasound equipment reached $3.2 billion in 2004. And that figure doesn’t include the incomes of franchisers such as Geddes Keepsake, or mom-and-pop keepsake portrait studies. The sales of equipment alone are forecast to increase threefold by 2009.

ultrasound machining

Market researcher Harvey Klein recently commented that 4D technology has been a surprising area of incredible growth for General Electric. He noted that is has helped them to achieve an 18 percent increase in ultrasound equipment sales in 2003, triple the 6 percent average growth for other manufacturers.

Ultrasound Machine Safety Complicated by Social Agendas

Anti-abortion movements have thoroughly embraced 3D ultrasound technology, calling the images a “miracle”. Activist newsletters and magazines are full of reports about pregnant women who changed their mind about having an abortion after viewing 3D videos of their unborn baby.

Congress man Cliford Stearn (Republican from FL) created the “Informed Consent Act” during 2003. The meant that ultrasound equipment would be subsidized for anti-abortion “crisis pregnancy counseling” centers. The law, if passed, would allow such centers to receive up to fifty percent off the cost of prenatal sonograms equipment. It would also require that all pregnant women would see images of their unborn baby.

So have abortion politics had an impact on the FDA’s move toward passive enforcement? Neither FDA officials nor business leaders are prepared to provide an official answer. One expert commented, “Off the record, I don’t doubt it for a minute.”

A number of observers have compared the fetal portrait craze to earlier trends involving “perfectly safe” imaging technologies and the natural curiosity to take a look inside the human body. This began in the 1920s, when a device known as the “shoe-fitting fluoroscope” was commonly featured in shoe stores, showing x-ray images of customers’ feet.

Regardless of decades of warnings by medical professionals and rising attempts by regulatory agencies to halt the practice, shoe-fitting fluoroscopes continued to prove popular until the early 1960s.

A Gap in the Ultrasound Machine Safety Net

At the heart of the trend for fetal portraits, are the natural desires of expectant parents to be reassured that their unborn child is healthy. Unfortunately this makes parents very vulnerable to the clever sales techniques used to promote technologies whose safety is still uncertain.

It is true, of course, that an ultrasound machine plays a vital role when used for legitimate medical reasons. However caution is still advised, as with any powerful technology. Dr. Abramowicz states that “I recommend against keepsake ultrasounds. The principle is simple. You should not use a medical device for a non-medical purpose.”

In the meantime, the issue of prenatal ultrasound has drawn attention to a major flaw in the regulatory system. Medical devices are not subjected to the same animal and human testing as new drugs before they are released.

Whilst it is reassuring that researchers are finally beginning to comprehend how ultrasound may affect brain development, it would have been preferable for such research to have been undertaken before the FDA loosened the limits on ultrasound exposure. Since the rules were altered in 1993, around 28 million pregnant women have been exposed to ultrasound machine waves.

Concerned members of the public should push for the FDA to fully enforce the existing rules on ultrasound, so that prenatal ultrasound is limited to appropriate medical uses. However this alone is not enough and action needs to go further than that.

The approval process needs altering so that medical devices, including the new higher intensity ultrasound machines, are tested comprehensively, before – not after – being put into widespread use by ultrasound technologists.

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