Because imaging practice and the patient population can vary amongst and within countries, each country or region should establish its own DRLs. While the focus of the list of resources below is on U. Note that while the use of DRLs is voluntary in the U. In addition to the references specific to diagnostic reference levels above, the following resources provide facility quality assurance and personnel training information important to radiation protection:.
Other FDA publications relevant to promoting safety and quality in X-ray imaging among health care providers:. For more specific FDA resources, see also the webpages for the individual X-ray imaging modalities.
Under the Mammography Quality Standards Act MQSA , the FDA regulates personnel qualifications, quality control and quality assurance programs, and accreditation and certification of mammography facilities. The FDA also has regulations covering the safety and effectiveness and radiation control of all X-ray imaging devices see the section "Information for Industry".
Individual states and other federal agencies regulate the use of the X-ray imaging devices through recommendations and requirements for personnel qualifications, quality assurance and quality control programs, and facility accreditation. This requirement does not apply to hospitals, which are subject to separate Medicare Conditions of Participation at 42 CFR Individual states have regulations and guidelines that apply to imaging facilities and personnel.
A number of states are updating their regulations and guidelines to improve radiation safety. In addition, professional organizations have published guidelines to ensure that facilities and state inspectors have the information they need to follow these regulations. While this comprehensive set of voluntary guidelines for pediatric and adult imaging was written for federal facilities, most of the recommendations are applicable to all X-ray imaging facilities and professionals.
Manufacturers and assemblers of electronic radiation-emitting products sold in the United States are responsible for compliance with the radiological health regulations found in Title 21 of the Code of Federal Regulations Subchapter J, Radiological Health. Manufacturers of X-ray imaging systems are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations Subchapter J, Radiological Health Parts through - General - Records and Reports - Notification of defects or failure to comply - Repurchase, repairs, or replacement of electronic products - Importation of electronic products.
The following resources provide further information on radiation-emitting products, the EPRC provisions, and corresponding reporting requirements:. The following are guidance to FDA staff, but may also be valuable to industry subject to X-ray equipment inspections:. For more information about medical device requirements, see:.
When manufacturers submit pre-market notifications to the FDA for device clearance or approval, declarations of conformity to FDA-recognized standards may obviate the need for manufacturers to provide data supporting the safety and effectiveness covered by the particular recognized standards to which the devices conform.
For more information see:. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with the product. We encourage health care providers and patients who suspect a problem with a medical imaging device to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Medical device manufacturers, distributors, importers, and device user facilities which include many health care facilities must comply with the Medical Device Reporting MDR Regulations of 21 CFR Part These exams differ in their purpose: Radiography - a single image is recorded for later evaluation. Mammography is a special type of radiography to image the internal structures of breasts. Fluoroscopy can result in relatively high radiation doses, especially for complex interventional procedures such as placing stents or other devices inside the body which require fluoroscopy be administered for a long period of time.
CT - many X-ray images are recorded as the detector moves around the patient's body. A CT exam involves a higher radiation dose than conventional radiography because the CT image is reconstructed from many individual X-ray projections. They are used to: noninvasively and painlessly help to diagnose disease and monitor therapy; support medical and surgical treatment planning; and guide medical personnel as they insert catheters, stents, or other devices inside the body, treat tumors, or remove blood clots or other blockages.
Risks As in many aspects of medicine, there are risks associated with the use of X-ray imaging, which uses ionizing radiation to generate images of the body. Risks from exposure to ionizing radiation include: a small increase in the possibility that a person exposed to X-rays will develop cancer later in life.
General information for patients and health care providers on cancer detection and treatment is available from the National Cancer Institute. For example, the typical use of a CT scanner or conventional radiography equipment should not result in tissue effects, but the dose to the skin from some long, complex interventional fluoroscopy procedures might, in some circumstances, be high enough to result in such effects.
The risk of developing cancer from medical imaging radiation exposure is generally very small, and it depends on: radiation dose - The lifetime risk of cancer increases the larger the dose and the more X-ray exams a patient undergoes. For a comparison of radiation doses associated with different imaging procedures see: Effective Doses in Radiology and Diagnostic Nuclear Medicine: A Catalog The medical community has emphasized radiation dose reduction in CT because of the relatively high radiation dose for CT exams as compared to radiography and their increased use, as reported in the National Council on Radiation Protection and Measurements NCRP Report No.
Balancing benefits and risks While the benefit of a clinically appropriate X-ray imaging exam generally far outweighs the risk, efforts should be made to minimize this risk by reducing unnecessary exposure to ionizing radiation.
Patient factors are important to consider in this balance of benefits and risks. For example: Because younger patients are more sensitive to radiation, special care should be taken in reducing radiation exposure to pediatric patients for all types of X-ray imaging exams see the Pediatric X-ray Imaging webpage.
Special care should also be taken in imaging pregnant patients due to possible effects of radiation exposure to the developing fetus. The benefit of possible disease detection should be carefully balanced against the risks of an imaging screening study on healthy, asymptomatic patients more information on CT screening is available on the CT webpage.
Information for Patients X-ray imaging CT, fluoroscopy, and radiography exams should be performed only after careful consideration of the patient's health needs. Informing their physician if they are pregnant or think they might be pregnant. Asking the referring physician about the benefits and risks of imaging procedures, such as: How will the results of the exam be used to evaluate my condition or guide my treatment or that of my child?
Are there alternative exams that do not use ionizing radiation that are equally useful? Asking the imaging facility: If it uses techniques to reduce radiation dose, especially to sensitive populations such as children. About any additional steps that may be necessary to perform the imaging study e. While this small amount of exposure is safe once in a while, prolonged subjection to ionizing radiation can cause health problems.
For many, this raises questions about the dangers of having multiple X-ray procedures. Below, we will discuss how many X-rays are safe to have in one year. An X-ray is a form of radiant energy that produces ionization radiation.
The images can be printed on special film or viewed via a computer. X-rays are useful when doctors need to make a diagnosis and can also serve as a guide in certain procedures such as insertion of tubes or devices inside the body. Most people are aware that X-rays do subject patients to a small amount of ionizing radiation. However, what you may not know is that most of us are exposed to small amounts of radiation on a daily basis as a result of anything from airports to even food.
Here's what to expect. While bloodletting may sound like an ancient clinical treatment, it is still used in some — albeit rare and more medically sound — circumstances today.
During iontophoresis, a medical device delivers mild electrical currents while your affected body part is submerged in water. Iontophoresis is most…. Healthline touched base with leading experts about some of the most impactful medical advances of the year and how they hint at a more hopeful….
Infusion therapy is the administration of medication or fluids intravenously. It's a way of delivering medications that need to be dispensed at a…. Health Conditions Discover Plan Connect. Medically reviewed by Deborah Weatherspoon, Ph. Why is an X-ray performed? How should you prepare for an X-ray? How is the procedure performed? What are the potential side effects of an X-Ray? What happens after an X-ray? Read this next.
MRI vs. Medically reviewed by Angelica Balingit, MD. Paracentesis Abdominal Tap. Medically reviewed by Alana Biggers, M. Abdominal Film X-Ray. Medically reviewed by Stacy Sampson, D. Medically reviewed by Debra Sullivan, Ph. What Was Bloodletting All About?
0コメント