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.
A recent article from scientificamerican.com reported on a serious hospital error that has left residents of Los Angeles and citizens throughout the United States shocked and questioning the standard of care provided by hospitals and medical professionals, as well as the quality of medical devices. According to the report, health care workers at the Los Angeles Cedars-Sinai Medical Center are responsible for an error that was made when resetting a computed tomography (CT) scanner. As a result, 206 patients who underwent an x-ray CT scan received eight times the normal dose of radiation during brain scans over an eighteen month timeframe. Shockingly, this mistake remained unnoticed from February 2008 until this August after a stroke patient notified the hospital that he had experienced significant hair loss after having a scan.
Apparently, the CT scan had to be re-set to override the preprogrammed instructions and accommodate new protocol for CT brain perfusion scans so that doctors could properly examine any disruptions in the flow of blood to brain tissue and diagnose strokes. As it turned out, the use of this protocol caused the amount of radiation to be eight times higher than the expected dose.
There is no doubt that radiation exposure is a serious issue, and there is no excuse for hospital professionals to make a mistake that puts trusting and innocent patients at risk of radiation overdose, nor is it acceptable for a defective medical device to go unnoticed by its manufacturers or be used on patients by doctors.
As the skilled CT scan radiation exposure attorneys at Panish, Shea & Boyle, LLP continue to monitor the inaccurately calibrated and potentially defective GE CT scan machines, we advise anyone who has experienced radiation overdose from such machines to contact our firm. Our lawyers are well-versed in product liability, medical malpractice, personal injury, and pharmaceutical litigation, lending us the wide range of legal experience and knowledge that you need to successfully obtain compensation that you deserve from negligent parties. For more information about defective CAT scanners , or if you or a loved one has experienced any ill-effects from such scans, please call Panish, Shea & Boyle, LLP at 1-800-591-8116.
Source:http://www.scientificamerican.com/blog/post.cfm?id=hospital-error-leads-to-ct-scan-rad-2009-10-13
