Medical Devices - FAQs:

Consumers have an important role in reducing radiation risks from medical X-rays. FDA recommends these steps:

Ask your health care professional how an X-ray will help. How will it help find out what's wrong or determine your treatment? Ask if there are other procedures that might be lower risk but still allow a good assessment or treatment for your medical situation.

• Don't refuse an X-ray. If your health care professional explains why it is medically needed, then don't refuse an X-ray. The risk of not having a needed X-ray is greater than the small risk from radiation.
• Don't insist on an X-ray. If your health care professional explains there is no need for an X-ray, then don't 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. "Just as you may keep a list of your medications with you when visiting the doctor, keep a list of your imaging records, including dental X-rays," says Ohlhaber. 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.

If you have no symptoms of illness but are considering getting a whole-body CT screening exam, you may be thinking either or both of the following:.

1. "For my peace of mind, I just want to know that I don't have any diseases now."
2. "If I have a disease, I want to know about it now so that I can do something about it."

What you may not realize is that getting a whole-body CT screening exam may not accomplish either of these goals. In particular, an abnormal finding may not be a serious finding at all. And a normal finding may be inaccurate. We will consider these one at a time below, but before we do, the good news is that, if you have no symptoms of illness, the probability is high that there is nothing seriously wrong with you--and this is true without your ever getting a whole-body CT screening exam.

Should you be screened? Like any other medical procedure, there are risks involved. Before undergoing this exam, be sure to research all the issues.

Consider further that the FDA has never approved CT for screening any part of the body for any specific disease, let alone for screening the whole body when there are no specific symptoms of disease at all. No manufacturer has submitted data to FDA to support the safety and efficacy of screening claims for whole-body CT screening.

Today there are many sources of information about medical devices and procedures including information on the Internet from health care organizations, medical centers, and consumer organizations. One accurate source of information about the risks and benefits of the product is patient labeling prepared by the manufacturer and reviewed by the HHS Food and Drug Administration (FDA).

Patient labeling is available for many of the devices listed on the "Recently Approved Devices" page http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/MDA/mda-list.cfm?list=1.