The American Food and Drug Administration is set to increase its medical device regulation over radiation-emitting machines used in healthcare. Over recent years there has been growing concern that there is not enough monitoring of the radiation equipment used on patients. News stories when patients have been given dangerously high levels of radiation by mistake and subsequently lost their hair have helped to spark these concerns. The worries are concerned with radiation-emitting devices that are used as part of diagnosis and also therapy.

The FDA hopes that by implementing more stringent medical device regulation, the amount of radiation that patients are exposed to throughout their life will be reduced. There will be three devices and procedures looked at more closely. 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. These three devices all emit ionizing radiation which can increase a patient’s risk of getting cancer during their 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. In the past there have been reports of machines being programmed incorrectly so that safety rules were ignored or too much radiation was used. The health problems mentioned above can be a result of this. There are only a small number of laws and regulations governing the radiation device and consumer groups and industry watchdogs have found that these are only sporadically applied. 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 increased medical device regulation will help to reduce the number of patients being exposed to radiation during diagnosis and therapy or at least reduce the amount of radiation which is emitted during the tests.

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