Radiation-Emitting Products
Medical X-Rays
- Description
- Procedures
- Risks/Benefits
- Information for Patients
- Information for Professionals
- Laws, Regulations & Standards
- Industry Guidance
- Other Resources
Description
X-rays refer to radiation, waves or particles that travel through the air like light or radio signals. X-ray energy is high enough that some radiation passes through objects (such as internal organs, body tissues, and clothing) and onto x-ray detectors (such as film or a detector linked to a computer monitor). In general, objects that are more dense (such as bones and calcium deposits) absorb more of the radiation from the x-rays and don’t allow as much to pass through them. These objects leave a different image on the detector than less dense objects. Specially trained or experienced physicians can read these images to diagnose medical conditions or injuries.
Procedures
Medical x-rays are used in many types of examinations and procedures. Some examples include
- x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects, etc);
- mammography (to image the internal structures of breasts)
- CT (computed tomography) (to produce cross-sectional images of the body)
- fluoroscopy (to dynamically visualize the body for example to see where to remove plaque from coronary arteries or where to place stents to keep those arteries open)
- radiation therapy in cancer treatment
Risks/Benefits
Medical x-rays have increased the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. When applied and performed appropriately, these procedures can improve health and may even save a person’s life.
X-ray energy also has a small potential to harm living tissue. The most significant risks are:
- a small increase in the possibility that a person exposed to x-rays will develop cancer later in life; and
- cataracts and skin burns only at very high levels of radiation exposure and in only very few procedures.
The risk of developing cancer from radiation exposure is generally small, and it depends on at least three factors—the amount of radiation dose, the age at exposure, and the sex of the person exposed:
- The lifetime risk of cancer increases the larger the dose and the more x-ray exams a patient undergoes.
- The lifetime risk of cancer is larger for a patient who received x-rays at a younger age than for one who receives them at an older age.
- Women are at a somewhat higher lifetime risk than men for developing radiation-associated cancer after receiving the same exposures at the same ages.
Information for Patients
You can reduce your radiation risks and contribute to your successful examination or procedure by:
- Keeping a “medical x-ray history” with the names of your radiological exams or procedures, the dates and places where you had them, and the physicians who referred you for those exams;
- Making your current healthcare providers aware of your medical x-ray history;
- Asking your healthcare provider about whether or not alternatives to x-ray exams would allow the provider to make a good assessment or provide appropriate treatment for your medical situation;
- Providing interpreting physicians and referring physicians with recent x-ray images and radiology reports; and
- Informing radiologists or x-ray technologists in advance if you are pregnant or think you may be pregnant.
See also:
Information for Professionals
- Alliance for Radiation Safety in Pediatric Imaging image gently Campaign
- American College of Radiology Appropriateness Criteria
- Radiation Injuries with Fluoroscopy
- Questions and Answers for Physicians about Medical X-Rays
- Questions and Answers about the Radiation Safety Performance Standard for Diagnostic X-Ray Systems (June 10, 2005)
Laws, Regulations & Standards
Manufacturers of electronic radiation-emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control.
Manufacturers of medical x-ray products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005:
1003 - Notification of defects or failure to comply
1004 - Repurchase, repairs, or replacement of electronic products
1005 - Importation of electronic products
In addition, medical x-ray products must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1020.
1010 - Performance standards for electronic products: general
1020.30 - Diagnostic x-ray systems and their major components
1020.31 - Radiographic equipment
1020.32 - Fluoroscopic equipment
1020.33 - Computed tomography (CT) equipment
Because they are medical devices, medical x-ray equipment must also comply with the medical device regulations. For more information, see Getting to Market with a Medical Device.
Industry Guidance
- Electronic Submission of Diagnostic X-ray Reports of Assembly (January 6, 2009)
- Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment (May 15, 2008)
- Guidance for Industry, FDA Staff and Third Parties - Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography (October 20, 2006)
- FDA Issues Amendments to the Federal Radiation Safety Performance Standard for Diagnostic X-Ray Systems (June 2005)
- Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Final Guidance for Industry & FDA (September 5, 2003)
- Routine Compliance Testing Procedures for Diagnostic X-Ray Systems (February 1, 2001)
- Resource Manual for Compliance Test Parameters of Diagnostic X-Ray Systems (November 21, 2000)
- A Guide for the Submission of an Abbreviated Radiation Safety Report on Cephalometric Devices Intended for Diagnostic Use (March 1996)
- Guide for Filing Annual Reports for X-ray Components and Systems [PDF Only] (July 1980)
Other Resources
- Device Advice: Does the Product Emit Radiation? (July 28, 2006)
- Frequently Asked Questions for Manufacturers of Electronic Products that Emit Radiation (April 25, 2006)
- Regulated Industry: Reports and Recordkeeping
- FDA eSubmitter
- Regulated Industry: Imports & Exports
- Guidance for FDA Staff - Compliance Program Guidance Manual: Field Compliance Testing of Diagnostic (Medical) X-ray Equipment
- CDRH Organ Dose handbooks containing reference values of radiation doses absorbed in tissues of patients undergoing representative procedures
- ADA / FDA Guide to Patient Selection for Dental Radiographs