Medical Device Regulation And Radiation Machines In Health Care
The US Food and drug Administration has recently announced that it will increase its medical device regulation over radiation-emitting machines. 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 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. Ct scans where a 3D image of the body is produced. Nuclear medicine studies where a radioactive product is injected into the body and studied by a doctor. And finally, fluoroscopies, where a radiation-emitting device carries an internal image to a monitor. These three machines all emit ionizing radiation which can increase your lifetime risk of cancer. Women and children are at the highest risk of this and there can be health problems including skin burns, hair loss and cataracts if a high dose of radiation is given by mistake.
The regulation of these radiation-emitting devices has been well documented in the past. In the past there have been reports of machines being programmed incorrectly so that safety rules were ignored or too much radiation was used. 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 it has also been found that some devices have been released onto the market without going through testing and verification, even though the FDA has jurisdiction over the devices.
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.
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