FDA Urges Facility Review CT Scanners
A third Los Angeles area hospital has been notified by federal health regulators that its CT scans may have exposed patients to unnecessary radiation.
34 stroke patients have been added to the list of radiation overexposed patients at Providence St. Joseph Medical Center in Burbank. The facility recently reviewed its protocols for CT perfusion studies and found it may have a problem.
The 34 patients received the excessive radiation over a 20-month period ending in October, reports the Burbank Leader.
A spokeswoman says “We are working with the manufacturer to ensure that proper dosages were administered. As I said, there have been no adverse reactions reported to date.”
The FDA issued interim guidelines Monday regarding radiation exposure during the CT imaging of the brain and heart. It urges facilities to review their radiation dosing protocols for all CT perfusion studies.
THE FDA also announced it had identified at least 50 additional patients who were exposed to excess radiation during CT perfusion scans dose at Cedars-Sinai Medical Center, adding to the more than 200 patients who were exposed to excess radiation over an 18-month period.
That discovery triggered the FDA CT Scan Safety Investigation in October.
Glendale Adventist Medical Center was also found to have administered three to four times the radiation dose to 10 stroke patients using a triple-imaging General Electric CT scan. The California Department of Public Health discovered the error last month during an audit of CT scan protocols.
At both Glendale and Cedars-Sinai the hospitals reprogrammed the scanners.
After Cedars-Sinai in Los Angeles reset a CT scan machine in February of last year, the patients received brain scans received more than eight times the normal dose of radiation, the Los Angeles Times reports.
Patients were put in “immediate jeopardy” say investigators with the California Department of Health. The revelation of the error came to light when a patient reported that he began losing his hair after the scan.
After contacting 206 people who had had the same procedure, the hospital learned that about 40 percent had also suffered hair loss. Some also had a skin rash.
The hospital has initiated a plan of correction to prevent any future overexposure and stopped short of blaming General Electric. That company says its scanners are free of defects. Whether the errors are human errors or complications with CT equipment is unclear at this time.
The Glendale facility says a General Electric technician supervised the changes. The FDA has also found problems with the Toshiba scanner which is used at Providence St. Joseph.
CT Scans are popular as a more affordable way to attain 3-D pictures of a body in trauma, suffering seizures, and chronic headache. A CT scan radiation risk is about 50 to 100 times greater than a traditional X-ray. #