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. 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 wants to cut the amount of radiation that patients are exposed to during their life through the medical device regulation. Three devices will be focused on intensely. 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. The laws and regulations governing the radiation device industry are weak and they are not evenly applied across the USA. And it has even been found that despite the FDA having jurisdiction over these devices, some have been allowed to enter the market without going through safety checks and tests.

It is hoped that by increasing the number of medical device regulationover radiation-emitting devices that the risk posed to patients will be reduced and the procedures will no longer be overused.