FDA advises manufacturers to enhance CT scanner safety

by Olga Deshchenko, DOTmed News Reporter | November 09, 2010
The U.S. Food and Drug Administration urged manufacturers to provide additional training and information and incorporate safety features into CT scanners to forewarn operators of potential overdose accidents.

In a letter sent to the Medical Imaging Technology Alliance Monday, the agency offered a list of enhancements to CT scanners aimed at improving patient safety, including an on-screen notification on the device to alert the user of a potentially dangerous radiation dose and additional clarity on the parameters that affect dose, according to the FDA's release.

The recommendations are a result of the agency's yearlong investigation into radiation overdose accidents in CT brain perfusion scans. The FDA looked into information from states and facilities where radiation overdoses took place from 2008 to Oct. 26, 2010.
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Since the start of the investigation, the FDA looked into at least 385 cases of radiation overdoses. Many of the patients were undergoing the scan to confirm the presence of a stroke.

"Improving patient safety is part of our public health mission," said Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, in prepared remarks. "Patients should not have to worry that a device designed to diagnose an illness exposes them to unnecessary risks."

The FDA found CT scanners to be safe when properly used. The agency noted that it "uncovered potential enhancements to CT equipment that could reduce the likelihood of radiation overexposure if improper use occurs."

In its letter to MITA, the agency urged manufacturers to organize "all dose-related information into one section of each user manual, in a dedicated dose manual, or indexed comprehensively in a concordance covering all manuals."

In a statement e-mailed to DOTmed News, Dave Fisher, MITA's executive director, wrote the organization is aware of the issues and is collaborating with the agency on enhancing the safety of CT equipment.

"The recommendations in the FDA's letter are issues we have been working on with the agency over the last year and include an important component of MITA's CT Dose Check Initiative," said Fisher. "While reported incidents have not been attributed to CT scanner malfunction, as part of our longstanding commitment to educating users and to developing technologies that reduce radiation levels, MITA looks forward to continuing our work with the FDA. In the end, the optimal solution will require action by all stakeholders including, manufacturers, users and regulators."