Medical Device Regulation And CT Scans

The US Food and Drug Administration has announced that it will step-up its medical device regulation concerning healthcare machines which emit radiation. Concern has grown over recent years that some procedures which expose patients to high levels of radiation are being overused and not monitored closely enough. There have also been episodes in the news when patients have been given extremely high doses of radiation by mistake and have only realised when their hair fell out. The worries are concerned with radiation-emitting devices that are used as part of diagnosis and also therapy.

The FDA is hoping that the increase in medical device regulation over these devices will reduce the amount of unnecessary exposure to radiation that patients experience. The FDA will be concentrating on three devices in particularly. The CT scan, where the scanner produces a 3D image of the body. Nuclear medicine studies when a doctor watches as a radioactive fluid is injected and moved around the body. And last but not least, the fluoroscopy which transfers images of the body onto a monitor whilst emitting radiation. The link between these machines is that they all produce ionizing radiation which can increase the risk of developing cancer over a patient’s lifetime. Women and children are most at risk of developing cancer as a result of radiation exposure and an overdose can lead to health problems including hair loss, cataracts and skin burns.

In recent years there has been much discussion over the regulation of radiation-emitting devices. There have been reports of machines being incorrectly programmed so that they produce too much radiation, or the safety precautions have not been followed properly. The health problems mentioned above can be a result of this. The laws and regulations governing the radiation device industry are weak and they are not evenly applied across the USA. And, although the FDA has jurisdiction over radiation-emitting medical devices, they have allowed manufacturers to release a number of them onto the health market without testing their safety and efficiency.

The aim of introducing more medical device regulation for radiation-emitting machines is to limit the exposure of patients to radiation during diagnosis and therapy, thus reducing the risk of developing cancer or the other health risks mentioned.