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FDA urges CT Scan makers to make safety changes

Monday, November 15, 2010By Richard Alexander

The FDA has issued a letter to manufactures of CT Scan devices after is was discovered that hundreds of patients received excess radiation after undergoing a CT brain perfusion scans to test for strokes.

As of October 26, 2010, the FDA is aware of approximately 385 patients from six hospitals who were exposed to excess radiation during CT brain perfusion scans.

Some patients reported obvious signs of excessive radiation exposure following their scans, such as hair loss or skin redness, which called attention to the problem. It is important to note that if patient doses are higher than the expected level, but not high enough to produce obvious signs of radiation injury, the problem may go undetected and unreported. Over time, excessive radiation exposure can place patients at increased risk for long-term radiation effects, such as cancer.

The reported cases of radiation overdose involved scanners manufactured by GE Healthcare and Toshiba America Medical Systems. FDA inspections of these companies found there were no violations of FDA laws and regulations. The FDA evaluated the manufacturers’ specifications for multi-slice CT scanners and found that when these scanners were used according to the manufacturers’ specifications, they did not result in overexposure. The FDA also reviewed literature that supports that the manufacturer-defined protocols do provide reasonable and appropriate image quality and dose. Further, the FDA found no evidence that the manufacturers were involved in modifying any of the hospitals’ scanning protocols so as to cause the overexposures.

However, FDA’s investigation did reveal improvements that industry could make to its equipment, user information and training in order to improve the safety of their equipment and reduce the likelihood of overexposures. The FDA is working with manufacturers of CT scanners to improve their instructions and training programs for this complex equipment, and to provide software safety checks that would prevent unreasonably high radiation doses from being delivered unintentionally. In a letter dated Nov. 8, 2010, FDA communicated to industry a need for better instructions for use and more information to users about manufacturers' default protocols.

The FDA encouraged CT facilities to review their protocols and make sure that the values displayed on the control panel corresponded to the doses normally associated with the protocol. We continue to urge this practice for all protocols.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with a CT device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

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