For a particular medical-imaging task and patient size group, a DRL is typically set at the 75th percentile third quartile of the distribution of dose-index values associated with clinical practice. DRLs are neither dose limits nor thresholds. Rather, they serve as a guide to good practice without guaranteeing optimum performance.
Higher than expected radiation doses are not the only concern; radiation doses that are substantially lower than expected may be associated with poor image quality or inadequate diagnostic information. Local reference levels should be compared to regional or national diagnostic reference levels, where available, as part of a comprehensive quality assurance program.
Such comparisons are essential to quality improvement activities. However, even when regional or national DRLs are not available for comparison, tracking dose indices within a facility can be of value in helping to identify exams with doses that fall far outside their usual ranges. 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. This type of image can show tumors and lesions in the abdomen. A CT scan may also be used to look at the following:. This technique is used to examine arteries, veins, and organs in order to diagnose and treat blockages or other problems within the blood vessels. A thin tube known as a catheter is inserted into an artery or vein from the groin or arm.
A contrast agent is injected into the bloodstream to make the artery or vein visible. The goal of this test is to find blockages or narrowing of blood vessels near the heart, brain, abdomen, or legs.
Most women are familiar with this special X-ray known as a mammogram. It creates detailed images of the breast to be used both as a screening tool to detect cancer at an early stage, or diagnose breast disease from symptoms like pain, a lump, or discharge from the nipple. Call Us Today Call Us Today. Ultrasound Ultrasound Thyroid Biopsy. Mammography 3D Mammography Tomosynthesis. Interventional Radiology The following procedures are performed by our Interventional Radiology team at designated hospitals.
Biopsy General Biopsy. Tuesday, 15 March RAI Marketing. About the author. Metal can cause unclear images. You may need to wear a hospital gown.
X-rays are painless. Some body positions needed during an x-ray may be uncomfortable for a short time. X-rays are monitored and regulated so you get the minimum amount of radiation exposure needed to produce the image.
For most x-rays, your risk for cancer, or if you are pregnant, the risk for birth defects in your unborn baby is very low.
Most experts feel that the benefits of appropriate x-ray imaging greatly outweigh any risks. Young children and babies in the womb are more sensitive to the risks of x-rays. Tell your provider if you think you might be pregnant. Mettler FA Jr.
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