The U.S. Food and Drug Administration (FDA) has proposed specific changes for computed tomography (CT) brain perfusion scan equipment to help lower the chances of radiation overexposure if the devices are improperly used. According to an FDA news release, the agency has been inspecting CT scanner equipment manufacturers and investigating reports of radiation overdose from CT scans from 2008 to October 26, 2010. Since the FDA began their probe in 2009, the agency has been informed of at least 385 patients who have experienced excessive radiation from CT brain perfusion scans that were conducted at five hospitals in California and one in Alabama.
The FDA’s investigation determined that improper use of CT scanners most likely led to the radiation overdoses. The FDA found that when used properly, the CT scanners did not malfunction and did not cause radiation overdoses in patients. Nevertheless, the FDA has developed a series of steps to make this procedure safer and reduce the possibility of a radiation overdose even if a CT scanner is improperly used.
The FDA has sent a letter to the Medical Imagining and Technology Alliance and will continue discussion of the changes listed below with manufacturers of CT scanners and other radiological imaging devices:
- Addition of a fixed display notification to alert operator of a high radiation dose
- Supply of specific information and training on brain-perfusion protocols to all facilities that receive CT equipment
- Clarification of factors affecting radiation dose in addition to precise instructions as to how to accurately establish those parameters
- Compilation of all dose-related data organized into one section of each user manual, in a specific dose manual or noted clearly in an index covering all manuals
While the proposed improvements to CT scan operation are important and should assist in reducing incidents of radiation overexposure, they come too late for individuals who have already suffered the serious side effects of radiation overdose. At Panish Shea & Boyle LLP, our Los Angeles CT scan radiation exposure lawyers have the legal resources and knowledge to help patients hold negligent parties responsible. To find out more about how we can help, call our firm today for a free consultation at 1-877-800-1700.
