FDA Addresses CT Radiation Overdose Concerns

The Food and Drug Administration (FDA) recently investigated the possibility of CT Radiation overdose and discovered that radiation overdose is more common than it expected to find. As a result of these findings, the FDA has released a press release with instructions on how to prevent CT radiation overdose.

The press release  by the FDA reveals that there have been 206 patients that have had radiation overdose in Cedars-Sinai Medical Center in Los Angeles over an 18-month period. The FDA has found an additional 50 patients who have been exposed to excess radiation. The press release by the FDA also chronicled how the radiation overdose sometimes exceeded eight times more than the expected level and involved more than one manufacturer of equipment for CT radiation.

As a result of these instances of radiation overdose, patients can suffer from increased risks of cancer and cataracts. Officials recommend that precautions be taken. NPR quotes Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health as saying, "While we do not know yet the full scope of the concern, facilities should take reasonable steps to double-check their approach."

Some of the steps outlined in the FDA press release in order to ensure that facilities prevent CT radiation overdose are:

1. Facilities assess whether patients who underwent CT perfusion scans received excess radiation.
2. Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study.
3. Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered.
4. Radiologic technologists check the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient.
5. If more than one study is performed on a patient during one imaging session, practitioners should adjust the dose of radiation so it is appropriate for each study.

These guidelines by the FDA are just interim recommendations. It is currently working with manufacturers, professional organizations, and state and local public health authorities in order to put permanent guidelines into place as well as figure out the scope and depth of CT radiation overdose to date.

If you or a loved one has undergone CT radiation, and have had a death or serious injury occur, report it directly to the device manufacturer or MedWatch (FDA's voluntary reporting program). This can be done on-line by filing a voluntary report, by phone at 1-800-FDA-1088, or by obtaining the fillable form online, print it and fax to 1-800-FDA-0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.

For more information, please visit our Related Resources links.

Related Resources:

• Sub-Standard Care, Treatment, or Surgery (Findlaw)
• Computed Tomography: CT (FDA)
• Computed Tomography -- An Increasing Source of Radiation Exposure (New Englad Journal of Medicine)
• Brain Injury Overview (provided by Ashton & Price, L.L.P.)
• Defective Products (provided by Monsees, Miller, Mayer, Presley & Amick)