Health & Fitness Tools

Medical Device Regulation And CT Scans

6th December, 2010 - Posted by health news - No Comments

The US Food and Drug Administration has announced that it will step-up its medical device regulation concerning healthcare machines which emit radiation. There have been concerns that patients are being put at risk y these radiation machines because of a lack of mentoring and safe-guarding by the FDA. 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 concerns surround the use of radiation-emitting devices which are used during diagnosis as opposed to treatment, although therapeutic devices will also be looked at.

The FDA wants to cut the amount of radiation that patients are exposed to during their life through the medical device regulation. There will be three devices and procedures looked at more closely. CT scans, where a 3D image is created. Nuclear medicine studies where a radioactive substance is injected into the body and doctors can follow it around the body. And lastly, the fluoroscopy where a radiation emitting device projects an image of the body onto a monitor. 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 and there are other health issues which arise when an accidental overdose of radiation is given including skin burns, hair loss at cataracts.

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. These events can leave patients at risk from the health risks mentioned above. 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.