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Risk Assessment and Federal Guidance Programs:  

Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures: Federal Guidance Report No. 14

The proposed Federal Guidance Report No. 14 provides federal facilities that use diagnostic and interventional x-ray equipment with recommendations for keeping patient doses as low as reasonably achievable without compromising the quality of patient care.

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What is the proposed Federal Guidance Report No. 14?

The proposed Federal Guidance Report No. 14 provides federal facilities that use diagnostic and interventional x-ray equipment with recommendations for keeping patient doses as low as reasonably achievable without compromising the quality of patient care. It is an update of Federal Guidance Report No. 9, which was issued in 1976.

The Interagency Working Group on Medical Radiation prepared this proposed update to address the significant increase in the use of digital imaging technology and high dose procedures such as computed tomography (CT scans).

What is the status of Federal Guidance Report No. 14?

EPA sought comments from members of the public on the proposed Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures (Federal Guidance Report No. 14) during a 60-day public comment period. The public comment period ended on June 3, 2013.

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How can I obtain a copy of the proposed Federal Guidance Report No. 14?

Click on the following link to view or download the proposed Federal Guidance Report No. 14: Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures (PDF) (111 pp, 644 KB) About PDF

You can access all materials related to the proposed Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures (Federal Guidance Report No. 14) through www.regulations.gov at Docket ID No. EPA-HQ-OAR-2010-1064.

How do I submit comments?

The 60-day public comment period closed on June 3, 2013. For more information, please see the Federal Register Notice announcing the public comment period.

What is the next step in the process after the comment period?

The Interagency Working Group on Medical Radiation is working to assist EPA in reviewing the comments and updating the document as appropriate. EPA will publish a notice in the Federal Register when the final guidance is available.

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Frequently Asked Questions

Federal Guidance Report No. 14 Questions

Why is Federal Guidance Report No. 14 targeted at federal facilities and not at other facilities that use x-ray in their medical, dental, or veterinary practice?

The U.S. Environmental Protection Agency's Federal Guidance authority allows EPA to provide advice to federal agencies with respect to radiation matters that directly or indirectly affect public health. While most of the recommendations can be applied to any type of medical facility using radiological diagnostic and interventional imaging equipment, there are some considerations unique to federal facilities, such as using portable x-ray units in battlefield conditions.

Private health care facilities may already be familiar with and using many of the proposed recommendations in this document. Many of the recommendations have been identified as best practices by international and U.S. radiation protection organizations and U.S. professional medical organizations. This guidance should serve as a reminder to all medical professionals who use radiological diagnostic and interventional imaging equipment to keep patient doses as low as reasonably achievable without compromising patient care.

Will this guidance reduce the dose to the public from medical x-rays?

If followed, this guidance will remind doctors to keep radiation doses to patients as low as reasonably achievable without compromising quality of care. The document helps medical practitioners decide on the correct procedure at the correct dose for each individual patient, thereby reducing unnecessary radiation exposure.

Why is the guidance being updated now?

Federal Guidance Report No. 14 is an update to the 1976 x-ray guidance in Federal Guidance Report No. 9. Since 1976, we have seen two related trends in x-ray technology:

  • Digital technology has largely replaced x-ray film. With digital technology, overexposure does not degrade the image. This is different from film where an overexposure blackens the film, making the image useless for diagnosis.
  • With the increased use of computed tomography (CT) scanning, there have been several reports of unnecessarily high radiation doses given to children because equipment exposure settings were not properly "dialed down" from adult settings.

In response to these trends and reports from the National Council on Radiation Protection and Measurements (NCRP) about the sharp increase in CT scanning among all age groups, the federal Interagency Steering Committee on Radiation Standards (ISCORS) asked EPA to consider revising Federal Guidance Report No. 9. As a result, the Interagency Working Group on Medical Radiation was formed to develop Federal Guidance Report No. 14: Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures.

Why doesn’t this guidance include recommendations for nuclear medicine or radiation therapy?

Nuclear medicine and radiological pharmaceuticals are regulated by the Nuclear Regulatory Commission (NRC) and NRC agreement states. NRC agreement states are states that have signed formal agreements with the NRC authorizing them to regulate certain uses of radioactive materials within their states.

Radiation therapy requires precise dose management in order to appropriately treat patients. Although high, the radiation doses used in radiation therapy are deemed necessary for treatment.

The Interagency Working Group focused on diagnostic and interventional x-ray technologies, where there is the greatest potential to reduce unnecessary exposure.

When can we expect to the final guidance to be published?

The completion date will depend on the number and type of comments received and the ability of EPA and the Interagency Working Group on Medical Radiation to come to consensus on addressing comments. This process could take several months following the close of the comment period. EPA will publish a notice in the Federal Register when the final guidance is available.


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Medical Imaging Exposure Questions

Like any medical test, the beneficial information gained from diagnostic and interventional x-ray imaging procedures should outweigh the risk of having the test performed. Medical imaging is a very powerful and valuable technique that can provide important and lifesaving information.

What are x-rays and how are they used in medicine?

X-rays refer to radiation that travels 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, more dense objects (such as bones and calcium deposits) absorb more radiation, reducing the amount of radiation that passes through to the detector. Therefore, more dense objects leave an image on the detector (that is, they appear lighter) than less dense objects (which appear darker). This is why bones appear white on x-ray images. Specially trained or experienced physicians (including radiologists) can read these images to diagnose medical conditions or injuries.

A typical medical x-ray, or x-ray radiograph, produces a two-dimensional picture and can help find fractures (broken bones), tumors and foreign objects. Medical x-rays are also used in other types of examinations and procedures, including CT scans, mammography, and interventional fluoroscopy.

What is a CT scan and how is it used?

CT scans (also known as CAT scans or computed axial tomography scans) are advanced x-ray procedures. When a person has a CT scan, they are having many x-rays taken of their body (or part of their body) at nearly the same time. The computer in the CT scanner then combines all of these x-rays to create cross-sectional views and three dimensional images of a patient's internal organs. When a person has a CT scan, they are being exposed to more radiation than when they have a "regular" or conventional x-ray.

CT scans are useful because they help doctors diagnose problems by creating very clear images of internal organs. The detailed images help identify problems inside the body, like tumors or damage to organs. CT scans can also help doctors prepare for surgery by providing a map of the disease or injury that surgeons can follow when operating.

What is interventional fluoroscopy and how it is used?

Fluoroscopy is like a real-time x-ray movie. It can show the movement of a body part (like the heart) or the course that a medical instrument or dye (contrast agent) takes as it travels through the body.

Unlike a regular x-ray, during fluoroscopy an x-ray beam is passed continuously through the body. The image is transmitted to a monitor so that doctors can see the body part and its motion in detail. The total exposure to x-rays depends on the time of the fluoroscopy procedure and the dose of the materials used.

Fluoroscopy is used in many types of examinations and procedures. Some examples include:

  • Barium x-rays and enemas (to view movement through the GI tract)
  • Catheter insertion (to direct the placement of a catheter during angioplasty or angiography)
  • Blood flow studies (to visualize blood flow to organs)
  • Orthopedic surgery (to help doctors see broken bones and to set the fractures in good alignment)
How much radiation am I exposed to when I get a medical x-ray procedure?

Different imaging procedures expose patients to different amounts of radiation. Projection radiography procedures, such as a chest x-ray or mammography, use relatively low amounts of radiation.

CT scans and fluoroscopic procedures involve multiple or extended exposures to radiation. For this reason, these types of exams are associated with a higher radiation dose than projection radiography.

Radiation Doses from Various Types of Medical Imaging Procedures
(1 Chest X-ray = 0.02 mSv)

Type of Procedure Comparable Number of Chest X-rays
Dental X-Ray 0.25-0.5
Chest X-Ray 1
Mammography 20
CT 100-800
Interventional Fluoroscopy 250-3500
Who sets and enforces medical radiation dose standards?

Individual states regulate the practice of medicine by licensing doctors, including radiologists. A licensed doctor is then permitted to use his or her experience and discretion when deciding how much radiation should be used to diagnose or treat a patient. For that reason, the use of radiation in medical imaging is exempt from federal dose limits.

What are the risks from radiation exposure from medical imaging?

There is no conclusive evidence that radiation from diagnostic or interventional x-rays causes cancer. However, some studies of large populations exposed to radiation have demonstrated slight increases in cancer risk even at low levels of radiation exposure, particularly in children. To be safe, doctors should presume that even low doses of radiation may cause harm.

A person's cancer risk from having a medical procedure should be evaluated against the statistical risk of developing cancer in the entire population. The overall risk of a person dying from cancer is estimated to be 20-25 percent. This means that out of every 1,000 people, between 200-250 will eventually die of cancer even if they never had a single x-ray, CT scan, etc., in their entire life. Doctors and scientists are not entirely sure how much a medical radiation procedure will increase a person's risk of dying from cancer (above the 20-25 percent). Doctors estimate that the increased risk of cancer over a person's lifetime from a single CT scan is very small, only 0.03 to 0.05 percent.

These cancer risk estimates are averages for the U.S. population. Any individual's cancer risk might be higher or lower depending on a number of factors, including age, lifestyle and heredity.

Like any medical test, the beneficial information gained from diagnostic imaging procedures should outweigh the risk of having the test performed. Medical imaging is a very powerful and valuable technique that can provide important and even life-saving information.

Is it safe for children to have x-ray procedures?

Radiation exposure is a concern in both adults and children. However, these concerns are greater for children because they are more sensitive to radiation and have more years to live than adults. As a result, accumulated exposures over a child's lifetime may be more likely to result in an adverse health effect.

A child's smaller size must also be considered whenever they have an x-ray procedure. For example, if an x-ray procedure or CT scan is performed on a child using the same settings as those used on an adult, an unnecessarily large dose will be delivered to the child. Equipment settings can (and should) be set to deliver a lower dose while, at the same time, maintaining diagnostic image quality.

Like any medical test, the beneficial information gained from the test should outweigh the risk of having the test performed. Medical imaging is a very powerful and valuable technique that can provide important and even life-saving information. You can reduce radiation risks and contribute to a successful examination by addressing these issues with your doctor:

  • Imaging tests like ultrasound and magnetic resonance imaging (MRI) may be adequate substitutes for radiological techniques, like a CT scan, but without exposure to radiation. You should ask your doctor and imaging provider whether these alternatives are appropriate.
  • You should keep a "medical x-ray history" with the names of your radiological exams or procedures, the dates and places where you had them and the referring doctor. Make your current doctors aware of your medical x-ray history.
  • If radiological imaging is best for the situation, make sure that your health care provider uses the lowest appropriate dose and best shielding techniques to minimize unnecessary radiation exposure during the test.
What should I do if I am pregnant and need to get an x-ray?

The first thing you should do is tell your doctor if you are, or might be, pregnant. Discuss together if the need for the procedure outweighs the potential risk to the fetus. If the procedure is necessary, ask about the use of shielding (like a lead apron) and ways to modify the procedure to limit the radiation exposure to the fetus.

The following are questions you can ask your health care provider:

  • Is this test necessary?
  • Is there a test that would give the same information (benefit) without the use of radiation or with a lower dose of radiation?
  • Can shielding be used to minimize exposure to the fetus?
How can I minimize unnecessary medical x-ray radiation exposure?

Consumers have an important role in reducing radiation risks from medical x-rays. The U.S. Food and Drug Administration (FDA) recommends these steps:

  • Ask your health care provider how an x-ray will help. How will an x-ray, CT scan, or fluoroscopy procedure help find out what is wrong or determine treatment? Ask if there are other procedures that might be lower risk but still allow for good assessment or treatment.
  • Don't refuse an x-ray. If your health care provider explains why an x-ray is medically needed, then do not refuse the test. The risk of not having a needed x-ray is greater than the risk from radiation.
  • Don't insist on an x-ray. If your health care provider explains there is no need for an x-ray, then do not demand one.
  • Tell the x-ray technologist in advance if you are, or might be, pregnant.
  • Ask if a protective shield can be used. If you or your children are getting an x-ray, ask whether a lead apron or other shield should be used.
  • Ask your dentist if he/she uses the faster (E or F) speed film for X-rays. It costs about the same as the conventional D speed film and offers similar benefits with a lower radiation dose. Using digital imaging detectors instead of film further reduces radiation dose.
  • Know your X-ray history. Keep a list of your imaging records, including dental x-rays. When an x-ray is taken, fill out the card with the date and type of exam, referring physician, and facility and address where the images are kept. Show the card to your health care professionals to avoid unnecessary duplication of X-rays of the same body part. Keep a record card for everyone in your family.

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