FDA advises CT manufacturers to add safety, training features

Safety recommendations follow patient lawsuits against CT manufacturers and hospitals.

The Food and Drug Administration is recommending that computed tomography (CT) manufacturers provide more training to end users and add radiation gauges and alarms to reduce the risk of overexposure.

After a year-long investigation into hundreds of cases of radiation overexposure reported in two states between 2008 and October 2010, the FDA reported Nov. 9 that the excess exposure was due not to CT equipment failure but to improper use of the scanners.

The FDA investigated procedures in place at hospitals in California and Alabama where nearly 400 people received higher than recommended doses of radiation from CT brain perfusion scans.

The FDA is advising CT manufacturers to make the following changes:

• Add a notification to the CT console that alerts the operator of a high radiation dose

• Provide specific information and training on brain perfusion protocols to all facilities that receive CT equipment, whether or not the facilities purchase the related software enabling quantitative analysis 

• Clarify the dose parameters and provide clear instructions on how to appropriately set the parameters

• Improve user manuals, paying particular information to dose-related information.

It’s unclear whether the FDA findings will have an impact on any of the remaining lawsuits patients have filed against GE Healthcare, a CT manufacturer, or the hospitals where they received the scans.

At least one family has settled out of court. Carrie and Padre Roth had sued Mad River Community Hospital after their 2-year-old son received an extreme overdose from a CT scan in 2008. The overdose was due to a poorly trained technician. The family settled with the hospital in May 2008.

In a letter to the Medical Imaging Technology Alliance, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, invited industry response to the FDA’s recommendations. The Medical Imaging Technology Alliance is a division of the National Electrical Manufacturers Association.

CT brain perfusion scans are used to determine the presence of a stroke and diagnose brain injuries. According to an Oct. 6 2010 report in the Journal of the American Medical Association (JAMA), CT and magnetic resonance imaging (MRI) scan use in emergency rooms nearly tripled between 1998 and 2007 without an equal increase in the prevalence of life-threatening conditions.

Related Reading:

• When done properly, CT scans involve very little risk, say medical physicists

• Mayo Clinic: Perfusion CT radiation dose may be halved without loss of image quality

• Calif. hospital fined for X-ray overdose of a child