When most people think of the Food and Drug Administration (FDA), they think food, drugs, and possibly medical devices, but FDAs Center for Devices and Radiological Health (CDRH) is also responsible for consumer, industrial, and medical products that emit electromagnetic radiation, from radio waves to microwaves to light and sound, as well as X-rays. In the early years, the FDA relied solely on mandatory standards to address manufacturing and equipment problems. There are now effective national and international consensus standards in addition to the mandatory standards. In part, due to these standards, the design and manufacturing of electronic products is less of a problem. Over time, excessive radiation from items such as televisions and microwave ovens has become a thing of the past. At the same time, medical X-ray equipment can emit more intense radiation for longer periods of time, and is being used by more practitioners on more patients for more types of procedures than ever before. Meanwhile, the FDA has faced declining financial and staff resources. The once 400-strong staff of the radiological health group dropped to about 90, with about 40 of those individuals dedicated to implementing the Mammography Quality Standards Act.
As both the world at large and the financial landscape changed, CDRH needed to focus its efforts and resources in an area where the risk was greatest and where the greatest gains in public health and safety could be achieved. One of the areas that fits this paradigm is medical X-ray, especially for dose-intensive procedures such as CT and fluoroscopy, where preventable cancer deaths from population radiation burden and injuries such as bums result when exposures are unnecessary or unnecessarily high. For example, in 2001, Brenner et al. [1] estimated that the number of CT examinations done in this country in one year could result in 2,500 deaths from cancer in the future.
In an effort to reduce dose, CDRH partners with the international CT community by actively participating in the International Electro-technical Commission (D3C) standards development committees to ensure that equipment is designed and built to maximize the diagnostic information while allowing the control and reduction of unnecessary radiation dose. While equipment improvements and features such as more sensitive image intensifiers, last image hold, and digital systems in general can result in reduced patient dose, care in delivering dose must be taken, as some of the old "safeguards" to alert radiologists to high doses, such as film overexposure, are absent.