Late last year, the U.S. Food & Drug Administration (FDA) issued an alert after hospitals in several states reported that patients who had undergone CT perfusion brain scans had experienced radiation overdoses. Machines involved in the botched CT scans, made by General Electric and Toshiba, had been wrongly calibrated and subjected patients to 8 times the appropriate dose of radiation. It is not yet know if the botched <"http://www.yourlawyer.com/practice_areas/medical_malpractice">CT scans were the result of a machine malfunction or human error.
The FDA issued alerts in October and December 2009. At least 260 patients were injured in this way at Cedars-Sinai Medical Center in Los Angeles, California. CT scan machines there had been set at the higher level since February 2008, but went undetected for 18 months. It wasn’t until patients began complaining of hair loss and skin reddening that the error was found.
According to various media reports, the FDA was also investigating 10 incidents at Glendale Adventist Medical Center and an unknown number of cases at Providence St. Joseph Medical Center in Burbank, California. An unnamed Huntsville, Alabama hospital was also the site of reports, the agency said.
Patients who received these radiation overdoses now face an increased susceptibility to a variety of health problems that are caused by radiation poisoning. These include organ damage and cancer.
Based on its investigation, the FDA issued interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure. These recommendations apply to all CT perfusion images, including brain and heart, because they use similar procedures and protocols.
These recommendations include:
1. Facilities assess whether patients who underwent CT perfusion scans received excess radiation.
2. Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study.
3. Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered.
4. Radiologic technologists check the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient.
5. If more than one study is performed on a patient during one imaging session, practitioners should adjust the dose of radiation so it is appropriate for each study.
Since the FDA issued its alerts, a number of lawsuits have been filed against GE Healthcare, Cedars-Sinai and other facilities where these radiation overdoses occurred. Among other things, the lawsuits seek funds to monitor individuals over the long-term for health problems associated with radiation poisoning.