In October, the FDA released an initial safety notification after learning of 206 patients who had been exposed to excess radiation at Cedars-Sinai Medical Center in Los Angeles over an 18-month period. The agency has since been working with state and local health authorities and has identified at least 50 additional patients who were exposed to excess radiation of up to eight times the expected level during their CT perfusion scans.
The FDA has received reports of possible excess radiation from states other than California, and the cases so far involve more than one manufacturer of CT scanners, according to the release. Some of the patients outside of California have reported hair loss or skin redness following their scans. High doses of radiation can cause cataracts and increase the risk of some forms of cancer.
Based on the investigation, the FDA has 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.
They include:
- Facilities assess whether patients who underwent CT perfusion scans received excess radiation.
- Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study.
- Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered.
- 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.
- 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.
The FDA is continuing to work with manufacturers, professional organizations and state and local public health authorities to investigate the scope and causes of these excess exposures. The agency is also advising manufacturers to review their training for users, reassess information provided to healthcare facilities and put into place new surveillance systems to identify problems quickly, according to the release.
The FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If an adverse event is identified, healthcare professionals should follow the reporting procedures at their facility. Report these directly to the device manufacturer or to MedWatch, the FDA’s voluntary reporting program. This can be done on-line by filing a voluntary report, by phone at 1-800-FDA-1088, or by obtaining the fillable form online, print it and fax to 1-800-FDA-0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
Read the FDA’s release about excess radiation exposure from CT scans.
